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National Institute of Biologicals

ANNUAL REPORT2013-14

NATiONAL iNsTiTUTE Of BiOLOgicALsMinistry of Health & Family Welfare

Govt. of IndiaNOIDA

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Annual Report 2013-2014

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Contents

s.No. Title Page No.

1. Report from the Desk of Director i

2. introduction ii

3. scientific Progress

I. Blood Reagent Laboratory 1

II. Blood Products Laboratory 13

III. Enzymes & Hormones Laboratory 29

IV. Immunodiagnostic Kit Laboratory 40

V. Recombinant Product Laboratory 64

VI. Animal Facility 78

VII. Sterility Laboratory, Bio-Assay Division 86

VIII. Allergen Testing Laboratory 90

IX. Biochemical Kit Laboratory 96

X. Viral Vaccine Laboratory 102

XI. Bacterial Vaccine Laboratory (BCG) 111

XII. Bacterial Vaccine Laboratory (Polysaccharide) 115

XIII. Therapeutic Monoclonal Antibody Laboratory 118

XIV. Nucleic Acid Testing Laboratory 123

XV. Support Services:

• Quality Management Unit 125• Sample Receipt & Report Dispatch Unit 134

4. Report of the Administrative work 136

5 composition

5.1 Composition of the General Body 138

5.2 Composition of the Governing Body 140

5.3 Composition of the Standing Finance Committee 141

6. Personnel 142

7. Empowering consumers: Right to information Act, 2005 145

8. Auditors Report 146

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i


It is a pleasure for me to present the Annual Report and Audited Statement of Accounts of National Institute of Biologicals (NIB) for the year 2013-14. The achievements of NIB are due to shared dedication of scientists to core values of quality of biological and bio-therapeutic products used in diagnosis and treatment of various diseases.

NIB has been performing Quality Evaluation of biological and bio-therapeutic products including Albumin, Normal and Specific Immunoglobulin, Coagulation Factor VIII & IX, Insulin and its analogues, Erythropoietin, Filgrastim, Interferon, Streptokinase, Follicle Stimulating Hormone, Glucose Test Strip, Immunodiagnostic Kits (HIV-Ab, HCV-Ab, HBsAg, and Syphilis) and Blood Grouping Reagents etc. in its various State-of-the-art Laboratories and Animal House by following various Pharmacopoeial conformance and requirements of manufacturers’ specifications. In addition, standardisation and validation studies of many viral and bacterial vaccines, Allergen, NAT as well as Rituximab are going on.

The Institute has a proper Quality Management System as per ISO 17025 which is evident from the achievements of accreditations from the NABL, Department of Science & Technology, Govt. of India on 36 chemical and 34 biological tests conducted by the different laboratories. Steps have also been initiated to declare the Institute as Central Drugs Laboratory (CDL) for 12 additional biologicals and bio-therapeutic products tested by three laboratories. Draft notification in this regard has been issued by the Ministry.

NIB during this period has performed Quality Evaluation of 1812 batches of 120 different types of various biologicals and bio-therapeutic products which is much more than tested so far. With regard to renewal of contract of additional manpower, the Institute after the approval of the ministry has renewed the contract of 129 staff on contract basis. Recruitment Rules (RR) of the Scientist have been revised and submitted to the Ministry for approval. A separate proposal has also been submitted to the Ministry for creation of 43 regular posts.

The ties between NIB, CDSCO and IPC have been strengthened by having close interaction and meetings regarding Quality Evaluation of Biological and newer Bio-therapeutic drugs, preparation of Sera Panel,

reviewing and up-gradation of existing Monographs and development newer Monographs for inclusion in newer edition of Indian Pharmacopoeia (IP). 27 Monographs in this regard have been published in IP 2014.

Successful participation of Scientists in different scientific meetings, External Quality Assessment Scheme (EQAS), NRL, Australia; European Directorate of Quality Medicines (EDQM) France, CMC, Vellore and regular supply of National Reference Standard of Insulin as well as Sera Panel of HIV-Ab, HCV-Ab, HBsAg to the indigenous manufacturers are some of the important achievements. Scientists have also successfully participated with NIBSC, UK in collaborative studies conducted on 1st IS for biosynthetic human insulin and 1st IS for human pegylated G-CSF.

A Centralised Haemovigilance Programme was launched across the country during December, 2012 with an objective to track Adverse Reactions / Events and Incidence associated with Blood Transfusion and Blood product Administration (Haemovigilance) and to help identify trends, recommend best practices and interventions required to improve patient care and safety. In order to collect and collate the data pertaining to Haemovigilance coming from medical institutions all over the country, a software “Haemo-Vigil” has been developed by IT Division of the Institute. The NIB has organised 15 CMEs across the country besides publishing three Haemovigilance News Letters. It also aims at becoming a member of International Haemovigilance network.

NIB is making sincere efforts to live up to its mandate. It strives to assist the Government in its endeavour to provide quality biological and biotherapeutic products to all patients. I hope that with its committed scientific and technical manpower and collaborative work, NIB will continue to provide safe, potent and efficacious biologicals and biotherapeutic drugs for promoting and protecting public health.

RepoRt fRom the Desk of DiReCtoR

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The National Institute of Biologicals (NIB) is an autonomous Institute under the administrative control of Ministry of Health & Family Welfare, Government of India. The Institute is located at A-32, Sector-62, NOIDA, Uttar Pradesh in an area of 74,000 Sq. M. The mandate of the Institute is to ensure safety, potency and standard supply of Biological and Biotherapeutic products, both imported and manufactured indigenously, as per Pharmacopoeial specifications, collaborate with Indian and other Pharmacopoeia in finalizing the specifications, train personnel in the public and private sectors, prepare National Reference Standards, collaborate with other Scientific Institutions in upgrading technologies and keeping abreast of scientific advances made in the field of quality assessment of Biological and Biotherapeutic products. The Institute also provides technical expertise to the Central Drugs Standards and Control Organization (CDSCO) and participates in joint inspections carried out of manufacturing premises by a team of officers constituted by the CDSCO. The

main Laboratory and Animal House facility of the Institute, constructed in February, 2006 has 42 BSL-2 and 2 BSL-3 laboratories equipped with modern scientific equipment for testing of Biological and Biotherapeutic products. There are 20 walk-in-cold rooms and 03 walk-in-deep freezers (-20OC), and 64 bio-safety cabinets. All equipment are calibrated annually or biannually by a NABL accredited laboratory and are under AMC or CMC. An Administrative Building with Conference Rooms, and Laboratory facilities for Hands-on-training, Hostel, Guest House, Cafeteria, External Services (Civil & Electrical) provide the infrastructure required by the Institute to meet its mandate as per the Bye-laws. The Institute also has Essential Staff Quarters, Maintenance Engineering Building, and a Library.

The expenditure on salaries, maintenance, procurement of reagents, chemical, scientific equipment etc., is met from the grants given by the Ministry of Health & Family Welfare, Govt. of India.

iNtRoDUCtioN

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1. Name of the Head :

Dr. J. P. Prasad - Scientist Grade II, (Till July 8, 2013)

Dr. Reba Chhabra - Scientist Grade II, (From July, 2013)

2. Manpower in the Laboratory:

i. Name of scientific staff

Mrs. Kanchan Ahuja, Laboratory In-charge (Scientist Grade III)

Ms. Priya Bhatt, Laboratory Assistant

ii. contractual manpower: Four

3. Aim and scope:

The Blood Reagent Laboratory is a notified laboratory by Government of India vide Gazette No. 158, dated 4th April, 2002 for quality control evaluation of Blood Grouping Reagents. The laboratory has the infrastructure and expertise for testing different types of Blood Grouping Reagents and Gel cards. The scope defined for the year April, 2013 to March, 2014 has been:

To carry out Quality Control Evaluation of 33 different types Blood Grouping reagents i.e, Anti-A, Anti-B, Anti-AB, Anti-D (IgM), Anti-D (IgG+IgM), Anti-D (IgG), Anti-A1 (Lectin), Anti Human Globulin (AHG), Bovine Serum Albumin (BSA), Anti-K, Anti-k, Anti-M, Anti-N, Anti-Jka, Anti-Jkb, Anti- Fya, Anti- Fyb, Anti-Lea, Anti-Leb, Anti- Kpa, Anti-S, Anti-s, Anti-P1, Anti-Cw, Gel cards for Forward /Reverse grouping for new born and blood grouping cards for safe blood transfusion. For batch release, tests are carried out as per the Indian Pharmacopoeia 2010, Indian Pharmacopoeia Addendum 2012, Transfusion Technical Manual Second

Edition 2003, International Blood Grouping Reagents Standards and Requirements, UK (IBGRL), Center for Biologics Evaluation and Research (CBER) and as per manufacturer’s specifications.

For preparation of In-house reference standards carried out calibration of Anti-A, Anti-B, Anti-D (Blend), Anti Human Globulin (AHG) reagents and preparation using International reference standards obtained from National Institute of Biological Standards and Control (NIBSC).

To strengthen the repository of routine and rare cryopreserved red blood cells for Rh phenotyping and rare red blood cells by collecting whole blood from donation camps organized by the Indian Red Cross Society for evaluation of newer products.

To participate in an external Proficiency Testing program with Indian Red Cross Society.

To participate for an Annual Review of Accreditation Assessment by NABL as per requirements of ISO 17025.

To prepare monographs for Anti-A and Anti-B for Indian Pharmacopoeia 2014.

To impart training to scientific and technical staff from other Institutes.

To carry out the disposal of date expired reagents as per the Laboratory SOP.

4. scientific activities undertaken:

4.1 Preparation of in-house standards

i) Calibration of Anti-A, Anti-B , Anti-AB, Anti-D (Blend) and Anti Human Globulin reagents and preparation of working standards using Secondary

sCieNtifiC pRoGRessi. BLooD ReAGeNt LABoRAtoRY

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Standards (in house controls) which were calibrated against National Institute of Biological Standards and Control (NIBSC, UK). Details of reference standards are given in Table 1:

S.No Name of Reagent Reference Standard Source1 Anti-A 03/188, version 2; 11/11/05 NIBSC, UK2 Anti-B 03/164, version 2; 11/11/05 NIBSC, UK3 Anti-D(IgM) 99/836, version 2; 20/5/05 NIBSC, UK4 Anti-D(IgM+IgG) 99/836, version 2; 20/5/05 NIBSC, UK5 Anti Human Globulin 96/666, version 2; 19/04/04 NIBSC, UK

4.2 collection of samples:

The laboratory collected a total number of four hundred eleven (411) red blood samples from camps organized by Indian Red Cross Society, New Delhi. These samples were grouped, subgrouped and Rh phenotyped to be used for Quality Control evaluation of Blood Grouping Reagents and for cryopreservation of red cells. The details of the samples collected are given in (Fig. 1, 2).

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Fig.2 RH PHENOTYPING OF BLOOD SAMPLES (2013-2014)

4.3 List of Qc test parameters for Blood grouping Reagents, gel cards and Blood grouping cards

The products were tested as per Indian Pharmacopoeia 2010, Indian Pharmacopoeia Addendum 2012, Transfusion Medicine Technical Manual (2003) and as per manufacturer’s specification are given in the following Table-2:

Table 2

Name of the Blood grouping Reagent/ gel cards

Test(s) conducted

Anti-A

Anti-B

Anti-AB

Anti-D (Blend)

Anti-D (IgM)

TitreAvidity (Sec) /IntensitySpecificityRouleauxHaemolysisProzonePhysical Appearance and Colour

Anti-D (IgG),

Anti H (Lectin)*#,

Anti A1 (Lectin)*#

TitreSpecificityRouleauxIntensity *HaemolysisPhysical Appearance*Clarity#

Anti Human Globulin (AHG)

Titre Hetero Specific Antibodies Reaction with enzyme treated cellsRouleauxIntensityHaemolysisPhysical Appearance and Colour

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Bovine Serum Albumin (BSA)

Potentiating abilityIgG ContaminationSpecificityRouleauxHaemolysisProzonePhysical Appearance

Anti-KAnti-kAnti-Fya

Anti-Fyb

Anti-Lea Anti-Leb

Anti-Kpa

Anti-MAnti-NAnti-P1Anti-SAnti-sAnti-Jka

Anti-Jkb

Anti-Cw

RouleauxHaemolysisSpecificityTitre ProzonePhysical Appearance

Gel Cards for forward, grouping and Anti-K

Physical Appearance Specificity

Blood grouping cards Physical Appearance Specificity

*Parameter not applicable for Anti-A1 (Lectin) and Anti-H (Lectin) #Clarity parameter only for Anti-A1 (Lectin) and Anti-H (Lectin)

4.4 Newer products undertaken:

a) The laboratory carried the Quality Control testing of a total number of sixteen (16) newer products, details are given in the following Table-3.

Table 3

s.No. Name of the Product Number of batches tested1 Anti- K 022 Anti -k 043 Anti- Fya 044 Anti- Fyb 025 Anti- Lea 036 Anti- Leb 037 Anti- Kpa 018 Anti-M 03

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9 Anti-N 0410 Anti-P1 0311 Anti-S 0312 Anti-s 0113 Anti- Jka 0414 Anti- Jkb 0215 Anti-Cw 0116 Gel Cards for forward grouping and Anti-K 01

TOTAL 41

b) The laboratory prepared repository for newer rare red cells. A total number of 18 new rare panel members were cryopreserved. The numbers of aliquots for the new panel members were 649.

4.5 inter laboratory testing of Blood Products

The laboratory extended support of test facility for Quality evaluation of Blood Products for Anti-A and Anti-B heamagglutination test parameter as per NIB/BP/SOP/28/R1. A total number of 143 batches of Blood Products were tested and all were found to be negative for Anti-A and Anti-B heamagglutination test parameter.

5. Testing of Biologicals : A total of 135 batches of Blood grouping reagents and Gel cards were re-ceived for Quality Control evaluation. Out which 131 batches were of Blood Grouping reagents, 01 was Gel cards and 03 were Blood Grouping Cards. Details are given below in Table-4:

Table 4

Name of the Manufacturer

Name of the product No. of batches received and evaluated

No. of batches found to be of standard Quality

No. batchesfound not to be of standard Quality

Remarks

M/s Diagast, France

Anti-A 02 22 NIL NILAnti-D(RH1) (Totem) 05Anti-B (ABO1) 01Anti-D (IgM) 01Anti A (Bulk) 03Anti B (Bulk) 03Anti A (Concentrate Bulk) 01

Anti D (IgM) (Bulk) 03Anti B (Concentrate Bulk) 01Anti D (Totem) (Bulk) 02

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M/s Dominion Biologicals Limited

Anti-A (Monoclonal) 02 10 NIL NILAnti-B (Monoclonal) 02Anti-AB (Monoclonal) 02Anti-D (Blend) 03Anti Human Globulin 01

M/s Span Diagnostics

Anti-A (Monoclonal) 01 06 NIL NILAnti-B (Monoclonal) 01Anti-AB (Monoclonal) 01ABO Rh typing cards 03

M/s Tulip Diagnostics, Goa

Anti-A1 (Lectin) 01 08 NIL NIL

M/s Aggape Diagnostics

Anti-A (Monoclonal) 02 06 NIL NILAnti-B (Monoclonal) 02Anti-D (Blend) 01Anti-D (IgM) 01

M/s Ortho Clinical Diagnostics

Anti-A(Monoclonal) 0236 NIL 01 batch

each of Anti-S and Anti-K not tested due to short expiry

Anti-B(Monoclonal) 02Anti-AB(Monoclonal) 03Anti-D (IgM) 03Anti- D(Blend) 02Gel Cards 01Anti-Fya 02Anti-Fyb 02Anti-Lea 02Anti-Leb 02Anti-Jka 02Anti-Jkb 02Anti-Cw 01Anti-S 02Anti-s 01Anti-M 02Anti-N 02Anti-K 02Anti-k 01Anti-P1 02

M/s Immucor

Anti-A 07 40 NIL NILAnti-B 06Anti-AB 04Anti-D (Blend) 04

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Anti-H (Lectin) 02Anti-P1 01Anti-Fya 02Anti-Kpa 01Anti-Lea 01Anti-Leb 01Anti-Jka 02Anti-M 01Anti-S 02Anti-N 02Anti-K 02Anti-k 02

M/s Meril Diagnostics

Anti-A(Monoclonal) 03 12 NIL NIL

Anti-B(Monoclonal) 03Anti-AB(Monoclonal) 03Anti-D (IgM) 03

TOTAL 135 batches received and 133 batches evaluated

133 NIL 2 batches

Out of 135 batches received for evaluation, 25 batches were from indigenous manufacturer and 110 batches were imported from different countries. Details are given in Figure-3:

135

25

110

0

20

40

60

80

100

120

140

160

Total Indigenous Manufacturer Imported Manufacturer

Fig. 3 Batches received from Indigenous & Imported Manfacturerers(2013 -2014)

Num

ber

of M

anuf

actu

rers

6. Trend in volume of work as compared to the previous year:

6.1 cryopreservation of red blood cells: The laboratory strengthened the repository for cryopre-served panel members for routine and rare red blood cells from 39 to 55 and the total number aliquots increased from 3975 to 6397. Details are given in Figure-4:

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2392

3084 3298

3975

6397

0

1000

2000

3000

4000

5000

6000

7000

2009-2010 2010-2011 2011-2012 2012-2013 2013-2014

Num

ber

of re

d bl

ood

sam

ples

cry

opre

serv

ed

Year

Fig. 4 Trend for cryopreservation of red blood cells

Fig-4: Trend for cryopreservation of red blood cells

6.2 Quality control testing for Batch release: The laboratory evaluated a total number of 133 batches of Blood Grouping Reagents, Gel cards and Blood Grouping Cards as compared to 112 batches evaluated in 2013-2014 and details are given in following Figure-5:

Fig-5: Trend in No. of Batches Received for QC testing

6.3 inter laboratory testing of Blood Products:

The laboratory tested 143 samples of Blood Products for Anti-A and Anti-B heamagglutination test parameter as compared to 58 batches tested in the year 2012-2013 and details of same are given in the following Figure-6.

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7. infrastructure facilities existing and newly developed:

The Blood Reagent laboratory is well equipped and all the temperature controlled equipment, Electronic Balance pH meter and centrifuges were calibrated by the National Accreditation Board for Testing and Calibration Laboratories (NABL) certified agency at periodic intervals. Intermittent checks for pH meter and Electronic balance were also performed by the laboratory.

The walk- in cold room of the laboratory has been labeled shelf wise to keep the following:

a) Tested and Recommended reagents, Gel cards and Blood Grouping Cards

b) Tested and not recommended reagents, Gel cards and Blood Grouping Cards

c) Legal samples

d) Procured reagents

e) Dated expired reagents

8. Proposed target for testing of new Biologicals likely to be undertaken are as following Table-5:

Table- 5:

s.No. Proposed New Biologicals

1. Anti- Lua

2. Anti- Lub

3. Anti-Kpb

9. NABL accreditations: The laboratory got NABL accreditation for 7 Biological tests (Certificate No. T-2010) and 2 Chemical tests (Certificate No.T-2011) as per ISO 17025:2005 for eight (08) Blood Grouping Reagents are given in the following Table-6:

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Table 6:

Name of the Blood grouping Reagent

Biological Test(s) chemical Test(s)

Anti-A

Anti-B

Anti-AB#

Anti-D (Blend)

Anti-D (IgM)

Physical Appearance @ Colour @

Clarity^TitreAvidity (Sec) /IntensitySpecificityRouleaux#Haemolysis#Prozone#

Anti-D (IgG),#Anti H (Lectin)*Anti A1 (Lectin)*

TitreRouleaux#Intensity*Haemolysis#SpecificityProzone

@ Physical Appearance and Colour parameter for Anti-A1 (Lectin) and Anti-H (Lectin) not included for the Chemical test.

^ Parameter applicable for only Anti-A1 (Lectin) and Anti-H (Lectin)

# Test are not NABL accredited

10. Participation in Proficiency testing:

The staff participated in an external proficiency program for Anti-A, Anti-B, Anti-D (IgM) and Anti-D (Blend) blood grouping reagents conducted by Indian Red

Cross Society, Delhi on 23rd January, 2014. The performance of the staff was found to be 100% satisfactory.

11. Preparation of Red cell Panel:

The laboratory cryopreserved a total number of 55 panel members and the number of aliquots of these panel members were 2422, which are stored at -70oC. The details of the routine panel members and rare panel members are given in Figure-7 & Figure-8 respectively.

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2012

3 6 6 6 9 6 10 9 6 18 18 9 12

2130

0

500

1000

1500

2000

2500

A2 + B Neg A1B Neg A2B + R0r R1R2 O Neg R1R1 R2R2 R1r R2r R2RZ R1RZ rr Total

Num

ber o

f Blo

od Sa

mpl

es

Different Group/Sub group/Phenotype of Blood Samples

Fig. 7 Status of rou�ne Cryopreserved (RBC) Cells (Store at -700C)2013-2014

12

70

27

45

6

3527

15

3

106

135

6

21

7

23

6358

30

0

20

40

60

80

100

120

140

160

Mne

gN+v

e

MN

+ve

M+v

eNne

g

Jk(a

+b)

Jka

pos

Jkb

neg

Fy(a

negb

+ve)

Cw

+ve

S +

ve

P1

+ve

A1

imm

unoc

ompr

omi…

Lua

+ve

Lub

+ve

Kpa

+ve k

Lea

+ve

Leb

+ve

K +

ve

Num

ber

of v

ials

Cryopreserved rare red blood cells

Fig. 8 Status of rare cryopreserved red blood cells (2013-2014)

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12. Participation in Training/ Workshop/conference:

Name of the scientist

Name of the Programme Duration and date

Place

Mrs. Kanchan Ahuja

“Adopting Practices to Revolutionize Immunohematology in India”

10th April, 2013 Indraprastha Apollo Hospital, New Delhi

Mrs. Kanchan Ahuja

“IPC-USP 12th Science & Standards Symposium” organized by Indian Pharmacopoeia Commission and United States Pharmacopeia

16th to 17th April, 2013

ITC Maurya, New Delhi, India

Mrs. Kanchan Ahuja

“Awareness on Health Safety and Environment” on organised by FICCI

21st May, 2013 National Institute of Biologicals, Noida

Mrs. Kanchan Ahuja & Ms. Priya Bhatt

“Assuring Quality of Results in Test & Calibration” organised by FICCI at.

9th to 10th July, 2013

National Institute of Biologicals, Noida

Mrs. Kanchan Ahuja

2nd International conference on Pharmacoeconomics and Outcomes Research”

9th to 10th October, 2013

India Habitat Centre, New Delhi.

Ms. Priya Bhatt Training on “ABO grouping, phenotyping and antibody screening”

16th to 20th December 2013

Indian Red Cross Society, New Delhi

13. Publication:

Publication of Monographs for Anti-A (Monoclonal) and Anti-B (Monoclonal) in the Indian Pharmacopoeia 2014.

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1. Name of Head :

Dr. J. P. Prasad, Scientist Grade-II

2. Man Power in the Laboratory

i. Name of the scientific staff:

1. Mrs. Sudha V. Gopinath, Scientist-III (On study leave from January 2014)

ii. Name of the Technical / supportive staff

1. Md. Daud Ali, Lab Technician

2. Ms. Girija L.V, Lab Technician (On maternity leave from February 2014)

3. Mr. Pradeep Kumar, Lab Assistant

ii. contractual Manpower: Nine

3. Aim and scope:

Human plasma is a source of important medicinal products which are obtained by a combination of large-scale processing steps known as “fractionation”. It is important that these products have an appropriate quality and safety profile. Plasma contains several therapeutically important proteins, currently more than 25 of them are commercially available to treat life-threatening diseases.

Plasma has limited utility in its raw form for various coagulopathies, plasma exchange, etc., but is one such important blood component which can be further processed to make many more lifesaving proteins of immense clinical significance. Such proteins are known as Plasma Derived Proteins (PDP). Example of PDP include Albumin, coagulant proteins such as Coagulation Factor VIII & Factor IX, immunoglobulins such as Normal Immunoglobulin for Intravenous use (IVIg), Hyperimmune sera e.g. Hepatitis B Immunoglobulin (HBIg), Tetanus Ig etc. Plasma forms the

raw material for the manufacture of Plasma Derived Proteins (PDP). Currently plasma derived proteins are manufactured within the country in limited quantity by existing Plasma Fractionation Centers. These centers fractionate the unused plasma recovered from whole blood at various licensed blood component separation units of the country. Significant quantity is obtained through import from other countries.

Plasma-derived medicines produced today are safe, efficacious and available in large quantities. The cost of therapy remains the main barrier for access to these drugs in the emerging countries. The use of recovered plasma which is currently destroyed by many blood centers could alleviate some of these barriers in some countries.

The market for blood plasma has shown continuous growth in the past years growing at a compound annual growth rate (CAGR) of approximately 10% over the past decade, and is projected to expand steadily in the years to come.

Key factors contributing to growth within the market include the increase in bleeding disorders and related diseases which require an increased usage of blood plasma products. Ageing population is on the constant rise worldwide and the aged people are prone to develop diseases requiring more demand of blood derivatives like Immunoglobulin.

Furthermore, economic growth is also responsible for higher utilization of blood plasma derivatives. New proteins are being discovered in blood plasma, which are being put to use for treatment of various diseases.

New improved treatments are being developed to address the unmet needs related to blood disorders, autoimmune

ii. BLooD pRoDUCts LABoRAtoRY

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diseases and liver function impairment such as IVIG, albumin, clotting factors amongst others. These treatments are all derived from human blood plasma.

Despite, several factors suggesting future growth of the market, the high prices of blood plasma products continues to be a significant challenge. Furthermore, even in the wake of improving economies and rising GDP’s, income disparities keep the use of plasma derived products beyond the reach of numerous patients.

The leading players of the blood plasma market include: Baxter, Grifols, CSL, and Octapharma, among others, competing mainly on the basis of product pricing and performance, supply of the products, and continuous offering of new and innovative plasma derivatives.

India is a major importer of plasma derived medicines such as Human albumin, immunoglobulins, coagulation factors etc. A few Indian companies are importing bulk products and processing them indigenously and some are manufacturing such products using plasma available in the country. Since these are products derived from human plasma, consideration should be given to the following factors:

Microbial contamination may occur and

may lead to the accumulation of Pyrogens;

Viruses and other adventitious agents may be introduced by reagents during manufacture (e.g., enzymes from tissue extracts or monoclonal antibodies used for affinity chromatography);

The methods of manufacture may introduce process related impurities such as proteins, solvents, detergents, and antibodies or other ligands from chromatography;

Methods of manufacture may modify the product resulting in adverse consequences for recipients, for example by the formation of product related impurities, such as neo-antigens, or by compromising the biological activity of the active component, e.g. by activation of coagulation factors leading to enhanced thrombogenicity. This is particularly of concern for steps introduced to inactivate or remove viral contamination which may affect the quality or yield of products.

4. scientific services undertaken during 2013 –2014

a. Quality control testing of blood products:

The laboratory has tested and reported a total of 534 batches of various plasma derived products. The products tested are listed in the Table-1:

Table 1: Various Plasma Derived Products Received for Testing

S. No. Name of the product1 Human Albumin 4.5%, 5%, 20%, 25%2 Human Normal Immunoglobulin (Intravenous)3 Human Normal Immunoglobulin (Intramuscular)4 Tetanus Immunoglobulin5 Anti-D Immunoglobulin6 Coagulation Factor VIII (Plasma derived)7 Coagulation Factor VIII (Recombinant)8 Coagulation Factor IX9 Fibrin Sealant kit10 Plasma Protein Fraction11 Pro-thrombin Coagulation complex

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The tests on intravenous immunoglobulin performed by the Blood Products Laboratory includes pH, osmolality, molecular size distribution by HPLC, Identity by Double Immuno-diffusion method, potency estimation by Kjeldahl method / Biuret method, test for purity by protein composition and Prekallikrein.

The tests on human albumin solution includes pH, Haem content, Identity by Double Immunodiffusion method, test for purity by Protein composition, protein estimation by Kjeldahl method / Biuret method, other tests like Molecular size determination, Sodium, Potassium & Prekallikrein are also performed. During this year two more tests namely potency assay of Coagulation Factor-VIII and Factor-IX by clotting method were standardized using Coagulometer for quality control evaluation of these products including Anti-Inhibitor Coagulation Complex (FEIBA). The quality control testing of plasma derived and recombinant coagulation Factor VIII includes various QC tests as given in Indian Pharmacopoeia, British pharmacopoeia. The tests include Physical characteristics, solubility, identification, osmolality, pH and Potency by chromogenic / clotting assay. Testing of anti-thrombin III concentrates, anti-inhibitor coagulant complex are limited to physico-chemical tests and the general safety tests.

The general safety tests like Sterility, Pyrogen testing, Abnormal Toxicity and Bacterial Endotoxin testing for all these products mentioned in Table No. 1 are done by the support laboratories namely Sterility Testing Lab, Enzyme & Hormones Lab and Animal Facility. The Viral marker

testing of these products are conducted in the immunodiagnostic kits laboratory and the haemagglutinins test for Anti-A and Anti-B had been standardized by the blood products laboratory and test procedure transferred to the Blood Reagent laboratory for routine testing of the referred products. All the tests are being done as per laboratory’s approved SOP and in accordance with the specifications as mentioned in Indian Pharmacopoeia 2014.

Apart from the quality control testing, the summary production protocol of each product submitted to the laboratory are also scrutinized to assure the adherence to GMP regulations of the manufacturers and also to keep the track of viral safety of plasma products currently being imported to India.

b. Method development and validation

Validation for Potency assay of Coagulation Factor-VIII by Clotting method using Coagulometer has been completed and reported in the certificate of analysis (CoA) of the particular product.

c. Development of guidance Manual

Guidance Manual on Quality Control testing of Immunoglobulins is prepared and under finalization.

5. Testing of biologicals during the year 2013- 2014:

Details of various Blood Products received for Quality Control testing during the reporting year is summarized in the table 2 and Fig.1, 2 & 3 given below. The number of batches found satisfactory after conducting the testing for each product is also given in detail.

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Table 2: Details of various Blood Products received for Quality control (Q.c.) testing during the reporting year

sl No. Name of the product No. of batches received and evaluated

No. of batches found to be of standard Quality

No. of batches found not to be of standard Quality

1 Human albumin 267 257 10

2 Human Normal Immunoglobulin IV

116 115 01

3.a Human Normal Immunoglobulin IM

06 06 0

3.b Specific Human Immunoglobulin (Intramuscular)

33 33 0

3.c Human immunoglobulin (Intravenous)

01 01 0

4.a Coagulation Factor VIII 47 47 0

4.b Recombinant Coagulation Factor VIII

16 16 0

5 Coagulation Factor IX 17 14 03

6 Fibrin sealant kit 20 20 00

7 Plasma Protein Fraction 03 03 00

8 Anti- inhibitor coagulant complex (FEIBA)

05 05 00

9 Pro-thrombin –III 03 03 00

Total 534 520 14

fig. 1: Number of samples Recommended for Marketing

17


fig.2: Number of Various Plasma Derived Products Received for Quality control Evaluation and Recommended for Release in the Market

fig.3: Total Number of Batches of Various Plasma Derived Products Received and Tested

6. Trend in volume of work as compared to previous years, including examination of technical dossiers:

The trend of work load for the last four years is encouragingly increasing and the same is sum-marized in the table 3 and Fig.4 below. The total number of batches received this year for testing is more than double when compared to the previous year.

18


Table 3: The Trend of Work Load for the Last four Years

sl No. Name Product 2010-11 2011-12 2012-13 2013-141. Human Albumin 100 100 80 267

2. Plasma Protein Fraction 01 02 00 03

3. Normal Immunoglobulin (IV) & IM 05 25 36 122

4. Sp. Immunoglobulin (IM) & ( IV) 10 10 29 34

5. Coagulation factor-VIII & r-Factor-VIII 21 41 42 63

6. Coagulation factor-IX 09 12 11 17

7. Fieba (AICC) 01 05 04 05

8. Fibrin Sealant 17 13 15 20

9. Anti-Thrombin 00 00 01 00

10. Plasma Pool 15 00 00 00

11. Human fibrinogen nil nil 01 00

12. Pro-thrombin Complex nil nil 00 03

Total 179 208 219 534

fig. 4: Number of Batches Received for Testing from 2010 to 2014.

75.3% of batches were reported within 40 days. The samples reported beyond 45 days were due to pending documents that are to be submitted by the manufacturer/ importer or due to further investiga-tional procedures conducted on the samples for assuring compliance to pharmacopoeial specifications (Details depicted in fig.5 below).

19


Fig. 5: Number of Batches Reported within 40 Days

sample Testing of Other Products as common Testing facility:

Total Protein estimation, Osmolality and Molecular size distribution (HPLC) tests are also per-formed for other products forwarded by Recombinant Product Laboratory (RPL) and Viral Vac-cine Laboratory (VVL) as a common testing facility (details given in the table 4 below).

Table 4: Details of other than Blood Products received for testing

s.No. Name of the Product Tests Performed No. of Batches tested

1. Human Hepatitis B Immunoglobulin (IM) (P Behring) HPLC, Total Protein 12. Human Hepatitis B Immunoglobulin (Hepabig) I/M HPLC, Total Protein 33. Human Hepatitis B Immunoglobulin I/M HPLC, Total Protein 14. Human Hepatitis B Immunoglobulin (ProHBIG) I/M HPLC, Total Protein 15. Human Hepatitis B Immunoglobulin (Hepatect CP) I/V HPLC, Total Protein,

Osmolality2

6. Human Hepatitis B Immunoglobulin (Hepatect CP) I/V Osmolality 17. Filgen (GCSF) 300µg/0.9ml, Human GCSF,0.9 ml X 1 PFS Osmolality 18. Human Rabies Immunoglobulin HPLC, Total Protein 29. Rabies Immune Globulin (Human) HPLC, Total Protein 210. Granocyte 34 (rh-GCSF) Osmolality 111. NFIL, rh-GCSF Osmolality 112. rh-GCSF Osmolality 113. Tropin, rh-Erythropoieitin Osmolality 314. rh-Erythropoieitin Osmolality 615. Reliferon (Interferon α2β) Osmolality 116. Avonex, Interferon β 1α Osmolality 1

20


Distribution of imported and indigenous sam-ples Received for Testing:

The statistics of indigenous and imported batch-es of various Blood Products received for testing

during the year under reporting is given in the ta-ble 5 & 6 and Fig.6 & 7 below. Out of 534 batches received 248 are from indigenous manufacturers and 287 are imported in nature.

Table 5: Details of indigenous and imported batches of various Blood Products received for testing

Number of batches received Number of imported batches received

Number of indigenous batches received

Total R NR Total R NR Total R NR

534 520 14 287 287 0 248 234 14

R – Recommended NR – Not Recommended

fig.6 : Details of indigenous and imported batches of various Blood Products received for testing

fig.7: Quality control Testing Results of indigenous and imported batches of various Blood Products received for testing

21


Table 6: The details of indigenous and imported manufacturers submitted samples for Q.c. Testing at NiB:

S.No. Name of Manufacturer Name of Importer

1 M/s. Baxter Healthcare Corp., USA M/s Baxter (I) Pvt., Ltd., Gurgaon2 M/s Baxter S.A. Belgium3 M/s. Baxter, AG, Austria

4 M/s Bharat serums & Vaccines Ltd., Ambernath

5 M/s. Bio Products Laboratory, UK. M/s Alpha Drugs, New Delhi6 M/s. PlasmaGen Biosciences, Pvt., Ltd.,

Bangalore7 M/s Fresennius Biotech, GmbH, Germany M/s Manipal Acunova Ltd., Bangalore8 M/s Ortho Clinical Diagnostics USA M/s Wizman Impex Pvt., Ltd., Gurgaon9 M/s Ortho Clinical diagnostics, USA M/s Johnson & Johnson, Mumbai10 M/s Omrix Biopharmaceuticals, Ltd., Israel11 M/s. Talecris Biotherapeutics M/s Bharat serums & Vaccines Ltd., Ambernath

12 M/s CSL Behring, GmbH, Germany M/s Chiron Behring Vaccines (P) Ltd., Gujrat13 M/s Biotest Pharma GmbH, Germany. M/s.Paviour Pharmaceutical Pvt., Ltd., N.D14 M/s. Green Cross Corp. Korea M/s Biocon Ltd., Bangalore15 M/s. VHB Life Sciences, Mumbai16 M/s Bharat serums & Vaccines Ltd., Ambernath17 M/s Reliance Life Sciences Pvt., Ltd., Navi

Mumbai18 M/s Bharat serums & Vaccines Ltd., Bhiwandi19 M/s. Rushi Corporation Mumbai20 M/s. S.K. Chemical Co. Ltd., Korea M/s. Celestial Biologicals ltd.,21 M/s. PlasmaGen Biosciences, Pvt., Ltd.,

Bangalore22 M/s. Intas Pharmaceuticals Ltd., Ahmedabad23 M/s Reliance Life Sciences Pvt., Ltd., Navi

Mumbai24 M/s El-Shaddai Biological Ltd., Chennai25 M/s. CSL Behring AG, Switzerland M/s. Synergy Diagnostics, Pvt., Ltd., Mumbai

26 M/s Kamada Ltd., Beit Kama, Israel.

27 M/s. Wuhan Institute of Biological Products, China

M/s. Sinopharma India Pvt. Ltd., New Delhi

22


28 M/s Reliance Life Sciences Pvt., Ltd., Navi Mumbai

----

29 M/s Bharat Serums & Vaccines Ltd., Ambernath

----

30 M/s Bharat serums & Vaccines Ltd., Bhiwandi-Thane

----

31 M/s. Hemarus Therapeutic Ltd., AP. ----32 M/s. Virchow Biotech Pvt. Ltd., Gagillapur

vill., Quthbullapur, Mandal, R.R. Dist., A.P.----

7. infrastructural facilities-existing and newly developed:

Existing: The laboratory is equipped with instruments like, HPLC system, UV-Vis spectrophotometer, Coagulometer, Atomic Absorption Spectrophotometer, Osmometer, Horizontal electrophoresis, Vertical electrophoresis system, pH meter, electronic weighing balance, centrifuges, Gel Documentation System, Kjeldahl apparatus, and other basic and fixed equipment facilities like Bio-safety cabinets, Cooling Chamber, Under Counter Freezer etc. All the equipment are under AMC and are periodically calibrated by the authorized agencies.

New Development: The fully automated coagulation analyzer has been installed and clotting assays are being standardized using this equipment for Factor VIII, Factor IX and Thrombin.

8. Proposed target for testing of new biologicals and biotherapeutics being undertaken or likely to be undertaken:

During the forthcoming year the laboratory aims to standardize the Anti-complimentary activity in Immunoglobulin, Antibody to Hepatitis B surface antigen in intravenous and intramuscular Immunoglobulin, To-tal protein in Coagulation Factor-VIII, and Bacterial Endotoxin test in Human albumin, Immunoglobulin and Factor-VIII in place of Pyrogen testing.

9. NABL accreditations of biologicals and chemical tests:

Blood Products Laboratory is accredited by NABL for ISO 17025:2005; for testing of 13 plasma derived and recombinant products. The details of products and their tests are given below in tables 8: Human albumin, Immunoglobulin (IV), Immunoglobulin (IM), Coagulation Factor-VIII, Factor-IX, and Fibrin Sealant Kits.

23


Table 7: Details of NABL scope for chemical and Biological Tests

s. No. Name of products Tests1. Human Albumin chemical Tests

1. Molecular size distribution2. Total protein by Kjeldahl method3. Total protein by Biuret method4. Identification by Double Immunodifussion5. Haem Content by UV-Visible Spectrophotometer6. Assay for Sodium by Atomic Absorption Spectropho-

tometer.7. Assay for Potassium by Atomic Absorption Spectropho-

tometer.8. Protein composition by Zone Electrophoresis9. Test for purity by SDS-PAGE10. pH11. StabilityBiological Tests:1. Sterility.2. Pyrogens Test3. Abnormal Toxicity test

2. Plasma Protein Fraction chemical Tests1. Molecular size distribution2. Total protein by Kjeldahl method3. Total protein by Biuret method4. Identification by Double Immunodifussion5. Assay for Sodium by Atomic Absorption Spectropho-

tometer.6. Assay for Potassium by Atomic Absorption Spectropho-

tometer.7. Protein composition by Zone Electrophoresis8. Test for purity by SDS-PAGE9. pHBiological Tests:1. Sterility.2. Pyrogens Test3. Abnormal Toxicity test

24


3. Human Normal Immunoglo-bulin (IV)

chemical Tests1. Molecular size distribution2. Total protein by Kjeldahl method3. Total protein by Biuret method4. Identification by Double Immunodifussion5. Protein composition by Zone Electrophoresis6. Test for purity by SDS-PAGE7. pH.8. OsmolalityBiological Tests:1. Sterility.2. Pyrogens Test3. Anti-A, anti-B haemagglutinin

4. Human Normal Immunoglobulin (IM)

chemical Tests1. Molecular size distribution2. Total protein by Kjeldahl method3. Total protein by Biuret method4. Identification by Double Immunodifussion5. Protein composition by Zone Electrophoresis6. Test for purity by SDS-PAGE7. pH.Biological Tests:1. Sterility.2. Pyrogens Test3. Anti-A, anti-B haemagglutinin

5. Anti-D Immunoglobulin (IV / IM)

chemical Tests1. Molecular size distribution (IV/IM)2. Total protein by Kjeldahl method (IV/IM)3. Total protein by Biuret method (IV/IM)4. Identification by Double Immunodifussion (IV/IM)5. Protein composition by Zone Electrophoresis (IV/IM)6. Test for purity by SDS-PAGE (IV/IM)7. pH. (IV/IM)8. Osmolality (IV)Biological Tests:1. Sterility (IV/IM)2. Pyrogens Test (IV/IM)3. Abnormal Toxicity (IM)4. Anti-A, Anti-B haemagglutinin (IV/IM)

25


6. Tetanus Immunoglobulin chemical Tests1. Molecular size distribution 2. Total protein by Kjeldahl method 3. Total protein by Biuret method 4. Identification by Double Immunodifussion Protein 5. composition by Zone Electrophoresis 6. Test for purity by SDS-PAGE 7. pH.Biological Tests:1. Sterility 2. Pyrogens Test 3. Abnormal Toxicity

7. Human Coagulation Factor-VIII plasma derived

chemical Tests1. Physical Characteristic and solubility 2. pH.3. OsmoailityBiological Tests:1. Sterility 2. Pyrogens Test 3. Abnormal Toxicity4. Anti-A, Anti-B haemagglutinin

8. Human Coagulation Factor-VIII Recombinant

chemical Tests1. Physical Characteristic and solubility 2. pH.3. OsmoailityBiological Tests:1. Sterility 2. Anti-A, Anti-B haemagglutinin

9. Human Coagulation Factor-IX

chemical Tests1. Physical Characteristic and solubility 2. pH.3. OsmoailityBiological Tests:1. Sterility 2. Anti-A, Anti-B haemagglutinin

26


10. Anti- Thrombin III concentrate

chemical Tests1. Physical Characteristic and solubility 2. pH.3. OsmoailityBiological Tests:1. Sterility 2. Pyrogens Test

11. Anti-Inhibitor Coagulation Complex

chemical Tests1. Physical Characteristic and solubility 2. pH.3. OsmoailityBiological Tests:1. Sterility 2. Pyrogens Test

12. Fibrin Sealant kits chemical Tests1. Assay for Clottable protein2. pH.3. Physical Characteristic and solubility 4. StabilityBiological Tests:1. Sterility

13. Human fibrinogen chemical Tests1. Assay for Clottable protein2. pH.3. Physical Characteristic and solubility 4. StabilityBiological Tests:1. Sterility

10. Participation in proficiency testing/ EQAs / collaborative studies:

i) The laboratory has participated in the Collaborative study for estimating the total nitrogen content in candidate international reference standard of Human Insulin bulk conducted by NIBSC, UK.

ii) Registered for participated in Proficiency testing scheme by EDQM PTS 146 for Potency as-

27


say of Coagulation factor-VIII in year 2013, however date was deferred due to non-availability of PT material and post-poned for the year 2014.

11. Preparation of National/ international Reference standards:

National Institute of Biologicals is involved in the pre-release certification of blood products and has evaluated and reported more than batches 63 of Factor VIII concentrates in the current year out which 17 batches belong to recombinant Factor VIII.The blood product lab has standardized Clotting assay for potency determination of Factor VIII and Factor IX for batch release certification. The laboratory currently using the 13th British working standard for blood coagulation factor VIII concentrate, for the potency assay. As an initiative for development of a national standard for Factor VIII concentrates, the laboratory intends to develop an in-house working standard at the outset. The preliminary requirement for development of this standard is to assure that the development process is valid and consistent.

The laboratory has initiated process validation studies on development of in-house working standard for potency assay of Factor VIII. The three major steps undergoing are i) Validation of the kit and the reagents to ensure accuracy and repeatability of the result as well as to select the candidates batches for development of in-house working standard ii) To assess the procedure for reconstitution, dilution and distribution of the candidate batch to produce assigned value and iii) To assess and validate the procedure for freeze drying. Further, pilot study could not be continued due to non-availability of Freeze dryer.

12. Details of participation in cgMP inspections:

Dr. J. P. Prasad, Head Blood Products Lab has been involved in the Joint Inspection of M/s. Unimed Technologies, Ltd., Survey No. 22 & 24, Village Ujeti, Post Baska, Tal-halol-389350, dist. Panchmahal, Gujrat to obtained license in Form No. 29 for the manufacturing of Test batches of Follitropin beta (FSH) injection, 26th April, 2013

13. Training / workshop/ conference organized:

DR. J. P. Prasad, scientist grade-ii & Head and Mrs. sudha V gopinath, scien-tist grade-iii: participated as an experts in Continuous Medical Education (CME) on Haemovigilance Programme of India held at various places throughout India are follows:

1. CME on Haemovigilance Programme of India held at Christian Medical College, Vellore, 20th April 2013.

2. CME on Haemovigilance Programme of India held at AIIMS, New Delhi, 7th

May 2013

3. CME on Haemovigilance Programme of India held at Government Medical College, Jammu, 18th May, 2013.

4. CME on Haemovigilance Programme of India held at Government Medical College, Goa. 28th & 29th June, 2013.

5. CME on Haemovigilance Programme of India held at PGIMER, Chandigarh, 19th & 20th July, 2013.

6. CME on Haemovigilance Programme of India held at NIMHANS, Bangaluru, 28th September, 2013.

7. CME on Haemovigilance Programme of India held at Srinagar, Jammu & Kashmir, 5th October, 2013.

8. CME on Haemovigilance Programme of India held at Amrita Institute of Medical Sciences Kochi, 9th November, 2013.

28


9. CME on Haemovigilance Programme of India held at PGIMER, Chandigarh,13th & 14th December, 2013.

10. CME on Haemovigilance Programme of India held at CDSCO, South Zone, Hyderabad on 23rd to 24th January, 2014.

14. Participations in Training/ workshop/ conference:

DR. J. P. Prasad, scientist grade-ii & Head

• Participated & delivered a lectureon “Quality Control Evaluation of Plasma Derived Products with Special Reference to Immunoglobulin” in Primary Immunodeficiency Disease Conference, 8th & 9th March, 2014 at Institute of Med-ical Sciences, BHU, Varanasi.

• Attended the Annual Convention ofLaboratory Animal Science Associa-tion of India &National Symposium on Animals & Alternatives in Life Sciences Research (NSAALR), February 16th -18th, 2014 at Faculty of Sciences, BHU, Varanasi.

• AttendedandPresentedPosteron“Col-laborative Study for preparation of Inter-national Reference Standard for Insulin” the Conference on Bioprocessing India 2013 at IIT, Delhi, December 05th-07th, 2013.

• Attended “Meeting of Expert GroupCommittee to examine mandating the PCR (Polymerase Chain Reaction ) test in blood banks” held on 23rd May, 2013 at NACO, New Delhi.

15. Miscellaneous scientific activities, including interactions with manufacturers or importer of biologicals if any:

Plasma derived product monographs of Indian Pharmacopoeia 2010 were also reviewed and after necessary updating,

these monographs were sent to Indian Pharmacopeia Commission for further review by their experts and subsequent incorporation in the forthcoming edition of Indian Pharmacopoeia.The entire seven reviewed monographs i.e. Human albumin, Plasma Protein Fraction, Human Normal Immunoglobulin for intravenous use, Human Normal Immunoglobulin, Dry Anti-Hemophilic Factor-VIII, Coagulation Factor-IX and Fibrin Sealant kit were published in Indian Pharmacopoeia 2014.

16. Any other relevant information to be published in the annual report, such as training imparted to post graduate and other students:

Dr. J. P.Prasad,scientist grade-ii & Head: Act as an examiner to evaluate Ph.D.thesis on followings topics:

• Appointed as an examiner by the De-partment of Biochemistry, Faculty of Science, Banaras Hindu University Var-anasi to evaluate Ph. D. thesis entitled “Studies on the Role of Natural Resist-ance Associated Macrophage Protein 1 (NRAMP1) in Visceral Leishmaniasis” February 2014.

• Appointed as an examiner by the De-partment of Biochemistry, Faculty of Science, Banaras Hindu University Vara-nasi to evaluate Ph. D. thesis entitled“ A Biochemical Study of Cytokines in Dia-betes Mellitus with Cardiovascular Dis-ease” March 2014.

29


iii. eNZYmes AND hoRmoNes LABoRAtoRY

1. Name of the Head:

Dr. G.R. Soni; Scientist Grade-I



Dr. Shikha Yadav; Scientist Grade-II (Laboratory In-Charge)

Dr. Richa Baranwal; Scientist Grade-III

Sh. N.Nanda Gopal; Junior Scientist

ii. Name of the Technical / supporting staff:

Sh. Subhash Kumar; Lab Technician

Sh. Rajeev Shrivastava; Lab Assistant

iii. contractual Manpower: Three

3. Aim and scope:

Enzymes and Hormones Laboratory is pri-marily involved in Quality control testing of various therapeutic Enzymes and Hormones. Additionally, laboratory functions include Monograph preparation for incorporation in Indian Pharmacopoeia, Monograph Test method verification, test method standardi-zation of new Biologicals and Biotherapeu-tics, participation in proficiency testing and ILC and preparation of working reference standards. During year 2013-2014, the labo-ratory was involved in Quality control test-ing of Enzymes and Hormones mentioned in Figure 1.

enzymes

Streptokinase

Urokinase

hormones

Human Chorionic Gonadotropin

Menotropin (Human Menopausal Gonadotropin)

Follicle Stimulating Hormone i. Urofollitropin

ii. Recombinant Follicle Stimulating Hormone

Urofollitropin Recombinant Human Somatropin

fig. 1: Enzymes and Hormones received for Quality control testing

Clot Buster enzymes, Streptokinase and Urokinase are thrombolytic drugs. These are Plasminogen activators used extensively in the treatment of myocardial infractions (heart attacks), severe or massive deep venous thrombosis and pulmonary embolism. In the category of hormones, Laboratory is involved in QC testing of fertility hormones like Human Chorionic Gonadotrophin (HCG), Menotropin (Human Menopausal Gonadotrophin, HMG) and Follicle Stimulating

30


hormone (FSH). HCG is used as ovulation inducer during infertility treatments like Assisted Reproductive Therapies. Menotropin (HMG) contains Follicle stimulating hormone (FSH) and Luteinising hormone (LH) activities in 1:1 ratio that stimulates growth as well as maturation of follicles FSH or Urofollitropin, is the purified form of FSH that is used for stimulation of growth of immature ovarian follicles in ovary. These hormones are used in Assisted Reproductive Treatment like In-Vitro Fertilisation (IVF), Embryo transfer (ET), Intrauterine fertilisation (IUF) etc. IVF in India is growing at the rate of 10-15% every year 1. Global IVF Market is expected to reach $21.6 Billion by 20202 and expected to grow at a CAGR of 11.6% between 2013 and 2020 2. The Laboratory is also doing QC testing of recombinant Human Somatropin ( human Growth hormone) used to treat growth related disorders and turner syndrome. The batches received in the laboratory for QC

evaluation are tested as per the respective monographs in Pharmacopoeias.

Reference: 1: Empowering Excellence in Embryology workshop India – 2013 & 2: Allied Market Research

4. scientific services undertaken during 2013-2014:

4. A. Quality control tests performed for Enzymes and Hormones:

Enzymes and Hormones batches received in lab are evaluated as per their respective monographs in latest editions of Pharmacopoeias like Indian Pharmacopoeia 2010, United States Pharmacopoeia 2012, European Pharmacopoeia 2012, British pharmacopoeia 2012 etc. Besides Clarity, particulate matter, BET and pH that are common tests for all the products, other specific tests for each product that are performed for QC evaluation of samples are shown in Table 1A.

Table 1.A: Product specific tests performed by the laboratory

1. sTREPTOKiNAsEs.No Quality parameter/

MethodTest specification Reference

Pharmacopoeia1 Identification (A)

Clot lysisClot forms and lyses with in 30 mins with citrated human plasma and lysis does not occur with in 1 hour with citrated bovine plasma.

IP 2010

2 Streptodornase activity

A1-A2< 0.5 (A3+A4) - A2 at 260 nm IP 2010

3 Streptolysin activity Not more than 1.5 times absorbance obtained by the Reference standard at 550 nm.

IP 2010

4 Potency Chromogenic method

The estimated potency is not less than 90%& not more than 111% of the stated potency.

IP 2010

2. UROKiNAsE1 Identification

Clot lysis Clot forms and lyses within 30 minutes with Human plasma and Bovine plasma

IP 2010

31


2 Protein contentKjeldahl method

Determined using 10 mg of the Urokinase and multiplying the result by 6.25 to obtain the content of protein

IP 2010

3 Hepatitis B Surface antigen ELISA

Hepatitis B Surface antigen not detected IP 2010

3. HUMAN cHORiONic gONADOTROPHiNs.No Quality parameter/

MethodTest specification Reference

Pharmacopoeia1 Identification

Weight gain methodIncrease in weight of prostate gland/seminal vesicle upon the injection of hormone for 4 consecutive days when compared with International reference standard in similar condition.

IP 2010

2 Potency Weight gain method

The estimated potency is not less than 80% and not more than 125 % of the stated potency

IP 2010

4. MENOTROPiN (HUMAN MENOAPUsAL gONADOTROPHiN)1 Identification

Weight gain methodIncrease in weight of ovaries upon the injection of hormone for 3 consecutive days when compared with International reference standard in similar condition.

USP 2012



USP 2012

3 Assay For Luteinising HormoneWeight gain Method


USP 2012

5. UROfOLLiTROPiN ( fOLLicLE sTiMULATiNg HORMONE)1 Identification

Weight gain methodIncrease in weight of ovaries upon the injection of hormone for 3 consecutive days when compared with International reference standard in similar condition.

BP 2012/EP 2012



BP 2012/EP 2012

32


3 Residual Lutenising activity Ovarian ascorbic acid content depletion method (NA for recombinant based product)

Ascorbic acid depletion assay * BP 2012/EP 2012

6 REcOMBiNANT HUMAN sOMATROPiN1 Identification

SE-HPLCThe principle peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution

EP 2012/BP 2012/ USP 35

2 AssaySE-HPLC

89.0-105% of the amount of Somatropin stated potency

EP 2012/BP 2012/

3 AssaySE-HPLC

89.0-110% of the amount of Somatropin stated potency

USP 35

4 Dimer and related substances of higher molecular weight SE-HPLC

Maximum 6.0% EP 2012/BP 2012

5 Water Karl Fisher Coulometric method

Maximum 3.0% EP 2014/BP 2014/IP 2010

*Test under standardization

4. B. Newer Tests standardized/Undertaken: Few products being referred to the laboratory were be-ing released on the basis of partial testing and scrutiny of protocols. Therefore in 2013-14 the laboratory made efforts to standardize these tests so that the products could be evaluated for all the QC tests parameters as mentioned in respective pharmacopoeia. The details of the tests are provided in table 1B.

Table 1B: Quality control parameters and test specifications

s. No. Biological New Test standardizedMethod

specification Reference Pharmacopoeia

1 Recombinant Streptokinase Bulk

Identification SDS-PAGE

Main band is in same position as standard and in line with the molecular weight marker

IP 2010

33


2 Menotropin ( HMG )

Assay For Luteinising Hormone Weight gain Method


USP35/EP7.0

Water (Karl Fisher Coulometric Method)

Not more than 5% w/w EP 2012/ BP 2012

3 FollicleStimulatingHormone (Urofollitropin)

1. Identification Weight gain Method

2. Assay / Potency Weight gain Method

Increase in weight of ovaries upon the injection of hormone for 3 consecutive days when compared with International reference standard in similar condition


BP 2012

4 Recombinant FollicleStimulatingHormone (rFSH)

1. Identification Weight gain Method

2. Assay / Potency Weight gain Method

Increase in weight of ovaries upon the injection of hormone for 3 consecutive days when compared with International reference standard in similar condition.


BP2012

34


5 Recombinant Human Somatropin (Human Growth Hormone)

1. Water Karl FisherCoulometric Method

2. Identification(SE- HPLC)

3. Dimer & related substances of higher molecular weight(SE- HPLC)

4. Assay (SE- HPLC)

1. Maximum 3.0%

2. The principle peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromato-gram obtained with refer-ence solution

3. Maximum 6.0%

4. A) 89.0-110% of the amount of Somatropin stated potency

B) 89.0-105% of the amount of Somatropin stated potency

IP 2010

USP 35/EP 7.0

USP 35/EP 7.0

USP 35

E.P 7.0

The samples of enzymes and hormones received in laboratory are also sent to Centralised facilities for certain parameters, details of which are provided in table 2.

Table: 2 Tests performed by centralised facilities on Enzymes and Hormones

S.No Test Enzyme/ Hormone Centralised Facility1 Abnormal Toxicity Streptokinase, Urokinase, hCG Animal Facility

2 Infectivity testing Streptokinase, Urokinase, Heparin HCG, HMG,FSH

Immunodiagnostic Kit Lab

3 Sterility Streptokinase, Urokinase, Heparin FSH, HCG, HMG, Somatropin

Bio Assay Division

4. Water r- Streptokinase, Somatropin Viral vaccine Lab

5. Testing of Biologicals (April 2013-March 2014):

The laboratory has tested total of 80 samples of Enzymes and Hormones from April 2013-March 2014. All the samples received and tested were found to be of standard quality. Table 3 shows the batches of each product tested by the laboratory.

35


Table: 3: Batches of Enzymes and Hormones tested from Apr 2013-Mar 2014

Name of the product

Name of manufacturer/importer

No. of batches received and evaluated

No. of batches found to be of standard

No. of batches found not to be of standard

Remarks

Streptokinase Bharat Serums and Vaccines, Ambernath

2 2 - Satisfactory

BSV Biosciences, Germany 1 1 - SatisfactoryUrokinase Bharat Serums and

Vaccines, Ambernath1 1 - Satisfactory

BSV Biosciences, Germany 1 1 - SatisfactoryNanjing Nanda Pharmaceutical Co. Ltd., China

3 3 - Satisfactory

Menotropin (Human Menopausal Gonadotropin, HMG)

LG life Sciences, Korea 16 16 - Satisfactory

Ferring GmbH, Germany 2 2 - Satisfactory

BBT Biotech, GmbH, Germany

2 2 - Satisfactory

shanghai Techwell,, china 1 1 - SatisfactoryUrofollitropin (fsH)

LG life sciences, Korea 3 3 - Satisfactory


3 3 - Satisfactory

Ferring GmbH, Germany 1 1 - SatisfactoryBharat Serums and Vaccines, Ambernath

1 1 - Satisfactory

Recombinant follicle stimulating Hormone (r-fsH)


Organon, Netherland 4 4 - SatisfactoryHuman chorionic gonadotrophin (Hcg)


2 2 - Satisfactory

36


Bharat Serums and Vaccines, Ambernath

8 8 - Satisfactory

Shanghai Techwell, China 1 1 - SatisfactoryGufic Biosciences Ltd., Mumbai

1 1 - Satisfactory

IBSA Institute Biotechinique Switzerland

1 1 - Satisfactory

Ningbo Renjian Pharmaceuticals Group Co. Ltd., China

1 1 - Satisfactory

BSV Biosciences, Germany 1 1 - Satisfactorysomatropin Human Recombinant


6. Trend in volume of work as compared to previous years: The load of batches received in labora-tory increased as compared to previous years (Fig. 2)

0

5

10

15

20

25

30

35

2010-11 2011-12 2012-13 2013-14

STK

HCG

HMG

FSH

URK

SMT

ENXP

Total batches: 20 40 77 80

fig. 2 comparitive analysis of number of Batches of samples received in year 2013-2014 with previous year batches

(Abbreviation: STK- Streptokinase; HCG-Human Chorionic Gonadotropin; HMG- Human Menopausal Hormone; FSH- Follicle Stimulating Hormone; URK- Urokinase, ENX- Enoxaparin; SMT- Somatropin)

37


Table: 5: Equipment in Enzymes and Hormones Laboratory

HPLC FTIR UV-Visible Spectrophotometer

Micro Plate Reader

Micro Plate washer

Vertical Electrophoresis

pH meter Kjeldahl apparatus Vacuum oven Refrigerated centrifuge

Digital Water bath Incubator Under counter Freezer

Electronic weighing balance

Bio safety cabinets & Fume Hoods

8. Proposed target for testing new biologicals and biotherapeutics:

The laboratory is planning to take up in coming year recombinant counterparts of FSH.

9. NABL accreditation of chemical & Biological tests:

The laboratory participated in the surveillance-cum scope extension audit conducted by NABL experts on 14th & 15th September 2013. The laboratory is accredited in Chemical and Biological tests of enzymes and Hormones samples mentioned in Table 6.

Table 6: chemical and Biological Tests accredited by NABL

chemical TestsS.No Name of the product Test accredited1 Streptokinase inj pH, Clarity, Particulate matter sterptodornase activity,

Assay/ potency, 2 Streptokinase Bulk pH, sterptodornase activity, Assay/ potency,3 r-Streptokinase Inj pH, Clarity, Particulate matter, Assay/ potency4 Heparin Inj pH, Clarity, Particulate matter, Assay/ potency Anti

Factor IIa activity5 Human Chorionic

Gonadotropin (HCG)pH, Clarity, Particulate matter

6 Human Menopausal Gonadotropin (HMG)

pH, Clarity, Particulate matter

Biological TestsS.No Name of the product Test accredited1 Streptokinase Bulk & Inj Identification (Clot lysis), Streptolysin activity, Sterility,

Abnormal toxicity, BET2. r-Streptokinase Inj Identification (Clot lysis), Sterility, Abnormal toxicity,

BET3 Heparin Identification (Clot Delaying Method), Sterility, BET

7. infrastructural facilities:

The laboratory is equipped with equipments tabulated in Table 5. All equipment are placed under annual maintenance contract

(AMC) and calibrated annually by an NABL accredited laboratory or equipment specific vendors –Original Equipment manufacturer (OEM) as per Preventive maintenance schedule.

38


4. Urokinase Identification (Clot lysis), Sterility, Abnormal toxicity, BET

5. Human Chorionic Gonadotropin (HCG)

Sterility, Abnormal toxicity, BET

6. Menotropin (Human Menopausal Gonadotropin ; HMG)

Sterility, BET

7. Follicle Stimulating Hormone (FSH)

Sterility

8. r- Follicle Stimulating Hormone Sterility

10. Participation in inter-collaborative study:

The laboratory has participated in Inter laboratory Collaborative Study of BET-gel clot conducted by Quality Management Unit of NIB.

11. Preparation of in-house working Reference standard:

The laboratory has prepared Working refer-ence standard of hMG and HCG Hormones.

12. Participation in inspections:

The Laboratory In-charge inspected M/s Unimed Technology Limited manufacturing unit. The details of inspection are shown in Table 7.

Table 7: inspection of manufacturing unit

s.No inspections Details Date Technical Expert

1 Joint inspection of M/s Unimed Technology Limited for grant of License on Form 29 for manufacturing of test batches of Follitropin Beta (FSH) Inj. for the purpose of examination, test & analysis at. M/s Unimed Technology Limited, Vadodara , Gujarat

26.04.2013 Dr. J. P. Prasad

13. Trainings / seminars / conferences attended by the laboratory staff:

The laboratory scientific and technical staffs have undergone various training programme rel-evant to laboratory testing and also attended various seminars and conferences as tabulated in Table 8.

Table 8: Training attended by laboratory staffs. No. Name of the Programme Name of scientists Place Duration of

Training1. Health Safety and

Environment (HSE) based on OHSAS 18001 : 2007 and ISO 14001:2004 Environment Management System

Dr Shikha YadavDr Richa BaranwalSubhash KumarMs Aditi Saini

NIB (Training given by FICCI Quality Forum

21st May 2013

39


2. Quality Assurance of test & Calibration results

Dr Shikha YadavDr Richa BaranwalN. Nanda Gopal

NIB (Training given by FICCI Quality Forum)

9th & 10th July 2013

3. Workshop :-BIRAC -CDSA Regulatory Meet Demystifying Indian Regulations for Product approvals

Dr Shikha YadavDr Richa Baranwal

Indian Habitat Centre , New Delhi

30 &31st, July 2013

4. Second International Conference of Pharmacoeconomics and outcome research

Dr Richa Baranwal New Delhi, India 9th &10th October 2013

5. Progression & Trends in Bacterial Endotoxin Detection Technologies


Charles River Laboratories India Pvt. Ltd , Mumbai

21st & 22ndNovember 2013

6. Potency assay of FSH hormone at Bioneeds, Bangalore


Bioneeds Devarahosahally Tumkur, Bangalore,

21st- 23rd January 2014

7. Review Procedure adopted for evaluation of CMC

Dr Richa Baranwal CDL, Kasauli 7th-8th March 2014

8. Training on e-office system

EHL Staff NIB, Noida Dec, 2013

9. Bioprocessing India 2013 N. Nanda Gopal IIT, Delhi 5-7th Dec 201310. BET and Calculations in

LAL Testing”EHL Staff NIB (Seminar

by Charles River Laboratories)

20th September 2013

11. Liquid Handling Calibration device for pipette calibration and quantos

Subhash KumarMr. Mohit

NIB, Noida (Training given by Mettler Toledo, Germany )

11th March 2014

14. Miscellaneous scientific activities:

The laboratory has prepared draft monographs of Menotropin (Drug Substance and Drug Product) and submitted to Indian Pharmacopoeia Commission for incorporation in Indian Pharmacopoeia

as the monographs of these products are not available in Indian Pharmacopoeia. The laboratory has also participated in recombinant Streptokinase Bulk solution monograph test method verification along with M/s Biocon, Bangalore.

40


1. Name of Head:

Dr. Reba Chhabra, Scientist-II

2. Manpower in the Lab/Division


Dr. Charu Mehra Kamal, Scientist Grade-III

Mr. Pankaj Sharma, Junior Scientist

Dr. Sonali Agnihotri, Technical Officer, NACO

ii. Name of Technical and supportive staff

Mr. Sanjeev Kumar Sharma, Lab Technician

Mr. Rajeev Kumar, Lab Technician

Mr. Brij Bhushan, Lab Technician

Mr. Pankaj Rawat, Lab Technician, NACO

Mr. Mohit Sharma, Lab Assistant

contractual Manpower: Five

iV. Name of Research students:

Ms. Aakanksha Yadav

Ms. Nitika Sharma

Ms. Susmita Nayak

Mr. Gurjeet Singh Sandhu

3. Aims & scope of laboratory:

Immuno Diagnostic Kit Laboratory is notified as Central Drugs Laboratory (CDL) by Government of India vide Gazette No. G.F.R 601 E, dated 27th August 2002 for in-vitro diagnostic devices for HIV, HCV, and HBsAg & also Syphilis Rapid and ELISA has been certified as per CDSCO letter No. 29/Misc/4/2013-DC (52) dated 14th February,

2014. The Laboratory has been conducting Quality evaluations of indigenously manufactured and imported kits (Rapid, ELISA, CLIA, ELFA, Confirmatory, Ag/Ab & Combo kits) for HIV, HCV, HBV and Syphilis which were forwarded by Central Drugs Standard Control Organization (CDSCO). The lab has a Quality Management System in place and is NABL Accredited in accordance with the standard ISO/IEC 17025: 2005 in the field of Immunodiagnostic kits vide certificate no. T-2011 dated 05.12.2013 for Biological Testing. This ensures quality evaluation of diagnostic kits for safeguarding public health in the country.

4. scientific services undertaken, including name and no. of quality control tests performed for each biological product as per the pharmacopoeia.

4.1 The evaluation of immunodiagnostic kits- Rapid, ELISA, ELFA, CLIA, Confirmatory and Ag/Ab, Combo diagnostic kits is done with in-house reference plasma panels for Rapid & ELISA (581 members for HIV& HCV, 585 for HBsAg and 200 members for Syphilis ). Out of 581 members for HIV & HCV 100 are Reactive and 481 are Non-Reactive members, Out of 585 members for HBsAg 100 are Reactive and 485 Non-Reactive members. Out of 200 members for syphilis 100 are Reactive and 100 Non- Reactive members. For QC Evaluation of Confirmatory Assays of HIV-1/ HIV 1 & 2 /HCV, In-house reference plasma panel of 25 members out of which 23 are Positive & 2 are Negative are used and for HIV-2 assays In-house reference plasma panel of 4 members out of which 2 are Positive & 2 are Negative are used.

iV. immUNoDiAGNostiC kit LABoRAtoRY

41


iN-UsE PANEL siZE RAPiD AND ELisA

Marker True Positive(TP) True Negative(TN) TOTALHIV 100 481 581HCV 100 481 581

HBsAg 100 485 585SYPHILIS 100 100 200

cONfiRMATORY Marker True Positive(TP) True Negative(TN) TOTAL

HIV-1/ HIV-1& 2 23 2 25HIV-2 2 2 4HCV 23 2 25

524 plasma donor units have been collected from twelve licensed Blood banks /Hospitals of Delhi/NCR regions, during April 2013 to March 2014. These are aliquoted and characterized by testing with reference rapid, ELISA (based on different principles) and confirmatory assays (Western Blot, Line Immunoassay and Neutralization Assay) for HIV, HCV, HBsAg and Syphilis. For routine QC Evaluation small volume aliquot (1.0ml) is stored at 2-8°C for one week and for long term storage, bulk panel (50 ml) is stored at -20°C.

103

57

124

16 3

303

0

50

100

150

200

250

300

350

HIV- HCV HBsAg SYPHILIS (HIV-TP) COMBO TOTAL

No.

of B

atch

es E

valu

ated

MARKER

No.of Immunodiagnostic Kits Evaluated During April (2013)-March(2014)

HIV- HCV HBsAg SYPHILIS (HIV-TP) COMBO TOTAL

figure 1: No. of immunodiagnostic kits evaluated for the four markers (HiV, HcV, HBsAg, syphilis) during year 2013-14

A total of Three Hundred and Three - RAPID, ELISA, ELFA, CLIA, confirmatory kits, combo kits for HIV, HCV, Syphilis & HBsAg were evaluated using in-house reference panel consisting of 581 panel members for HIV & HCV, 585 members for HBsAg and 200 for Syphilis (Figure- 1). In-house reference plasma panel for HIV-1/ HIV 1 & 2 /HCV (25 members out of which 23 are Positive & 2 are Negative) For HIV-2 Confirmatory Assay the In-house reference plasma panel is (4 members out of which 2 are Positive & 2 are Negative.)

42


The details of month-wise evaluation of HIV, HCV, HBsAg & Syphilis ELISA and rapid kits are given below:

figure 2: Month-wise Distribution of batches of HiV, HcV, HBsAg and syphilis ELisA tested for Qc evaluation during year 2013-14

figure 3: Month-wise Distribution of batches of HiV, HcV, HBsAg, syphilis & HiV-TP combo Rapid assay tested for Qc evaluation during year 2013-14

43


figure 4: Month-wise Distribution of batches of HiV, HcV, HBsAg, and syphilis cLiA tested for Qc evaluation during year 2013-14

figure 5: Month-wise Distribution of batches of HiV, HcV, HBsAg, and syphilis ELfA tested for Qc evaluation during year 2013-14

Table 1: Manufacturer Wise Distribution of Number of HiV, HBV, HcV, syphilis and combo kits.

sr. no. cOUNTRY HiV HcV HBsAg sYPHiLis combo Kits1 INDIA 50 21 28 5 02 GERMANY 8 8 27 3 03 FRANCE 19 10 30 0 04 CANADA 2 2 1 0 35 U.K 4 1 1 1 0

44


6 JAPAN 3 0 2 0 07 CHINA 4 2 2 7 08 KOREA 8 4 1 0 09 SPAIN 5 6 20 0 010 TAIWAN 0 3 12 0 0

TOTAL(303) 103 57 124 16 3

(a) 103 HIV kits from 09 different countries were forwarded by CDSCO of which 50 kits were indig-enously manufactured and 53 kits were imported. Country-wise distribution is given in Figure 6.

5% 4%

9%

48%4%

17%

3%8%

2%

Countrywise Distribution of HIV kits Evaluated During April(2013)-March(2014)

SPAIN

CHINA

GERMANY

INDIA

UK

FRANCE

JAPAN

KOREA

CANDA

figure: 6

(b) 57 HCV kits from 09 different countries were forwarded by CDSCO for Quality Control evalua-tion of which 21 kits were indigenously manufactured and 36 kits were imported. Countrywide distribution is given in Figure 7.

45


11%

4%

12%

37%2%

18%

5% 7%

4%

Countrywise Distribution of HCV kits Evaluated During April(2013)-March(2014)

SPAIN

CHINA

GERMANY

INDIA

UK

FRANCE

TAIWAN

KOREA

CANDA

figure: 7

(c) 124 HBV kits from 10 different countries were forwarded by CDSCO of which 28 kits were indig-enously manufactured & 96 kits were imported Countrywide distribution is given in Figure 8.

16% 2%

20%

23%1%

24%

10%

1% 1% 2%

Countrywise Distribution of HBsAg kits Evaluated During April(2013)-March(2014)

SPAIN

CHINA

GERMANY

INDIA

UK

FRANCE

TAIWAN

KOREA

CANDA

JAPAN

figure: 8

(d) 16 SYPHILIS kits from 4 different countries were forwarded by CDSCO of which 5 kits were in-digenously manufactured & 11 kits were imported Countrywide distribution is given in Figure 9.

46


44%

31%

19%

6%

Countrywise Distribution of Syphilis kits Evaluated During April(2013)-March(2014)

CHINA

INDIA

GERMANY

UK

figure: 9

(e) 03 batches of HIV-TP combo kits manufactured in CANADA were forwarded by CDSCO and evaluated.

4.2 Viral Marker Testing:

In 2013-14, Five hundred and Fourteen batches/lots of Blood Products (Albumin, Factor VIII, Factor IX, Immunoglobulin (i.m, i.v), Fibrin Sealant, Coagulation Factor, and Plasma Protein Fraction etc.), Recombinant Products (Erythropoietin), and Enzymes & Hormones (Human Chorionic Gonadotropin, Urofollitropin, Human Menopausal Gonadotropin, & Urokinase) Vi-ral Vaccine (Rabies Immunoglobulin & Hepatitis B Immunoglobulin) have been tested for Viral Marker testing i.e. HIV, HBV and HCV. (Figure 10).

47


428

37 3613

0

50

100

150

200

250

300

350

400

450

BLOOD PRODUCT LAB RECOMBINANTPRODUCT LAB

ENZYMES & HORMONESLAB

VIRAL VACCINE LAB

No.

of

Pro

du

cts

Tes

ted

No. of Bio-Therapeutic Products Tested During April (2013)-March(2014)

figure: 10

TYPEs Of BiO-THERAPEUTic PRODUcTs TEsTED fOR ViRAL MARKER TEsTiNgBLOOD PRODUcTs REcOMBiNANT

PRODUcTs ENZYMEs AND HORMONEs

ViRAL VAcciNE iMMUNO DiAgNOsTic KiT

ALBUMIN ERYTHROPOIETIN HUMAN CHORIONIC GONADOTROPIN

RABIES IMMUNOGLOBULIN

PLASMA POOL

FACTOR-VIII UROFOLLITROPIN HEPATITIS B IMMUNOGLOBULIN

ABRAXANE

FACTOR-IX HUMAN MENOPAUSAL GONADOTROPIN

IMMUNOGLOBULIN (I.V; I.M)

UROKINASE

FIBRIN SEALANTCOAGULATION FACTORPLASMA PROTEIN FACTOR

48


4.3 collection of Plasma bags from Blood Banks/Hospitals of Delhi/NcR region:

HIV9%

HCV26%

HBsAg43%

SYPHILIS22%

Collection of Plasma Bags For Various Markers

HIV HCV HBsAg SYPHILIS

figure: 11

A total of 524 Reactive plasma bags for HIV, HCV, HBsAg & Syphilis were collected from 12 Blood Banks/Hospitals of Delhi/NCR regions (Figure 12).

figure: 12

49


HIVS. No.

NAME OF PRODUCT

No.of Batches Evaluated

Standard Quality Not of Standard Quality

Percentage Failure Rate

1 ELISA 37 34 03 8.10%2 RAPID 49 45 04 8.16%3 CLIA 8 8 0 ----4 ELFA 3 01 02 66.6%5 CONFIRMATORY 6 6 0 ----

HCVS. No.

NAME OF PRODUCT




1 ELISA 33 33 0 ----2 RAPID 16 15 1 6.25%3 CLIA 6 6 0 ----4 ELFA 1 1 0 ----5 CONFIRMATORY 1 1 0 ----

HBsAgS. No.

NAME OF PRODUCT




1 ELISA 64 59 5 7.8%2 RAPID 17 17 0 ----3 CLIA 31 27 4 12.9%4 ELFA 9 7 2 22.22%5 CONFIRMATORY 3 3 0 ----

sYPHiLisS. No.

NAME OF PRODUCT




1 ELISA 6 6 0 ----2 RAPID 9 8 1 11.11%3 CLIA 1 1 0 ----

4.4 Newer tests undertaken:S.NO NAME OF THE

PRODUCTNO. OF BATCHES

EVALUATEDSTANDARD

QUALITYNOT OF

STANDARD QUALITY

1. Anti HBs ELISA 8 8 02. Anti HBs CLIA 6 6 03. Anti HBc ELISA 19 19 04. Anti HBc CLIA 4 4 05. Anti HBc ELFA 3 3 0

50


6. Anti HBc (IgM)ELISA

1 1 0

7. Anti HBc (IgM)CLIA

2 2 0

8. Anti HBc (IgM)ELFA

1 1 0

9. HBeAg CLIA 2 2 010. Anti HBeAg ELISA 3 3 011. Anti HBeAg CLIA 4 4 012. Anti HBeAg ELFA 3 3 013. HIV Ag

Confirmatory1 1 0

14. HIV Ag 1 1 015. HBsAg

Quantification2 2

TOTAL 60 60 0

IN-USE PANEL SIZE FOR NEWER TESTS UNDERTAKENMarker True Positive(TP) True Negative(TN) TOTAL

Anti HBs 46 39 85Anti HBc 85 14 99

Anti HBc (IgM) 3 25 28HBeAg 5 63 68

Anti HBeAg 59 6 65HIV Ag Confirmatory 2 23 25

Combo (HIV-TP) 200 581 781Combo(HIV-HCV) 200 481 681

HIV p24 Ag 2 23 25

5. Testing of Biologicals:

5.1 108 HiV kits (53 indigenous & 55 imported) from various manufacturers were forwarded by cDscO for Qc Evaluation.

HiV- iMPORTED KiTsS. No.

Name of Manufacturer/ Importer

Name of Product No.of Batches Received and Evaluated

Standard Quality

Not of Standard Quality

REMARKS

ELISA/CLIA

RAPID CONF Received Evaluated

1 BIOKIT,SPAIN 5 0 0 5 5 5 0 -------2 M/s Intec

Products Inc.PR China

0 4 0 4 4 4 0 -------

51


3 Roche Diagnostic, Germany

5 0 2 7 7 7 0 -------

4 Dia Sorin UK 4 (Ag-Ab) 0 0 4 4 4 0 -------

5 M/s Biorad France

4 (Ag-Ab) 6 4 14 14 10 4 -------

6 Alere Medical Co.ltd,Japan 0 3 0 3 3 3 0 -------

7 Biomerieux, France

2+ 3 (Ag-Ab) 0 0 5 5 3 2 -------

8 Green Cross Medical Science,Korea

5 (Ag-Ab) 0 5 5 5 5 0 -------

9 IND Diagnostic Inc;Canada 0 2 0 2 2 2 0 -------

10 SD Standard Diagnostic Inc,Korea

0 3 0 3 3 3 0 -------

11 M/s Siemens HealthCare; Germany

1 0 0 3 1 1 0

2 Batches Testing was not taken up due to short expiry

HiV - iNDigENOUs KiTs

S. No



Standard Quality


REMARKS

ELISA/CLIA


1 Span Diagnostics LTD,SURAT

0 6 0 6 6 6 0 -------

2 Bio Standard Diagnostic Pvt Ltd,Gurgaon

3 10 0 13 13 13 0 -------

3 RFCL Limited Dehradun 1 0 0 1 1 1 0 -------

4 Reliable Pro-detect Biomedicals Pvt Ltd Shimla (H.P)

0 3 0 3 3 3 0 -------

52


5 SD BIO Standard Gurgaon

3 0 0 3 3 3 0 -------

6 Cadila Pharmaceuticals Ltd;Gujrat

0 2 0 2 2 2 0 -------

7 Meril Diagnostics pvt Ltd.Vapi,Gujrat

6 6 0 15 13 9 3

3 Batches testing was not taken up

due to Reagents

not working.

8 Transasia Bio-Medicals Ltd.Daman

3+ 3 (Ag/Ab) 0 0 6 6 6 0 -------

9 Lab Care Diagnostic (India) Pvt.LTD;Gujrat

0 3 0 3 3 3 0 -------

10 M/s Bhat Biotech Pvt ltd;INDIA

1 0 0 1 1 1 0 -------

5.2 57 HcV kits (21 indigenous & 36 imported) from various manufacturers were forwarded by cDscO for Qc Evaluation.

HcV- iMPORTED KiTs

S. No



Standard Quality


REMARKS

ELISA/CLIA


1 BIOKIT,SPAIN 6 0 0 6 6 6 0 -------2 Intec Products

Inc.PR China 0 2 0 2 2 2 0 -------


3 0 0 3 3 3 0 -------

4 Dia Sorin UK 1 0 0 1 1 1 0 -------5 Biorad France 1+4

(Ag-Ab) 3 1 9 9 9 0 -------

6 Biomerieux, France 1 0 1 1 1 1 0 -------

53



5 0 0 5 5 5 0 -------


9 General Biologicals Corp. Taiwan

3 0 0 3 3 3 0 -------

HcV iNDigENOUs KiTs

S. No



Standard Quality


REMARKS

ELISA/CLIA



3 3 0 6 6 6 0 -------



0 3 0 3 3 3 0 -------

4 SD BIO Standard Gurgaon

3 0 0 3 3 3 0 -------

5 M/s BHAT BIOTECH PVT LTD;INDIA

1 0 0 1 1 1 0 -------


3 0 0 3 3 3 0 -------


1 0 0 1 1 1 0 -------


0 3 0 3 3 3 0 -------

9 M/s Bhat Biotech Pvt ltd;INDIA

1 0 0 1 1 1 0 -------

54


5.3 125 HBsAg kits (28 indigenous & 97 imported) from various manufacturers were for-warded by cDscO for Qc Evaluation.

HBsAg iMPORTED KiTs

S. No



Standard Quality


REMARKS

ELISA/CLIA


1 BIOKIT,SPAIN

19 0 0 20 19 17 2

1 Batch testing was not taken

up due to short expiry.

2 M/s Intec Products Inc.PR China

0 2 0 2 2 2 0 -------


20 0 1 21 21 19 2 -------

4 Dia Sorin UK 1 0 0 1 1 0 1 -------5 General

Biologicals Corp. Taiwan

15 0 0 15 15 15 0 -------

6 M/s Biorad France 13 0 1 14 14 13 1 -------

7 Alere Medical Co.ltd,Japan 0 2 0 2 2 2 0 -------

8 Biomerieux, France 15 0 0 15 15 13 2 -------


1 0 0 1 1 1 0 -------


11 SD Standard Diagnostic Inc,Korea

15 0 0 15 15 15 0 -------


3 0 1 4 4 4 0 -------

13 Beckman Coulter;USA 1 0 0 1 1 1 0 -------

55


HBsAg- iNDigENOUs KiTs

S. No



Standard Quality


REMARKS

ELISA/CLIA



9 3 0 12 12 9 3 -------



0 3 0 3 3 3 0 -------

4 M/s BHAT BIOTECH PVT LTD;INDIA

1 0 0 1 1 1 0 -------


3 3 0 6 6 6 0 -------


1 0 0 1 1 1 0 -------


0 3 0 3 3 3 0 -------

5.4 16 sYPHiLis Kits (5 indigenous & 11 imported) from various manufacturers were for-warded by cDscO for Qc Evaluation.

sYPHiLis - iMPORTED KiTsS. No



Standard Quality


REMARKS

ELISA/CLIA


1 M/s Intec Products Inc.PR China

0 7 0 7 7 7 0 -------


3 0 0 3 3 3 0 -------

56


3 Immucor Inc;USA 1 0 0 1 1 1 0 -------

sYPHiLis - iNDigENOUs KiTsS. No



Standard Quality


REMARKS

ELISA/CLIA


1 M/s Transasia Bio-Medicals Ltd;Daman

3 1 0 4 4 4 0 -------

2 Span Diagnostic Surat;Gujrat 0 1 0 1 1 0 1 -------

5.5 3 HiV-TP combo kits manufactured in canada was forwarded by cDscO for Quality control evaluation of which all 3 kits were imported.

cOMBO KiTs (HiV-TP)- iMPORTED KiTsS. No



Standard Quality


REMARKS

ELISA/CLIA


1 M/s Medmira Inc;Canada 0 3 0 3 3 0 3 -------

HIV HCV HBsAg SYPHILIS COMBO(HIV/TP)

KITS EVALUATED 103 57 124 16 3STANDARD QUALITY 94 56 113 15 0NOT OF STANDARD QUALITY 9 1 11 1 3

020406080

100120140

No.

of B

atch

es E

valu

ated

Quality of Evaluated Kits during April(2013)-March(2014)

KITS EVALUATED STANDARD QUALITY NOT OF STANDARD QUALITY

figure: 13

91 % HIV, 98% HCV, 91% HBsAg and 93% Syphilis kits met the specifications criteria laid down for sensitivity & specificity and were found to be of standard quality. However in HIV 8.7% (3

57


indigenous & 6 imported),HCV 1.7% (1 imported), HBsAg 8.8%(8 indigenous, 1 imported), Syphilis 6.25%(1 indigenous) and combo kits 100% imported were found not of standard quality.

6. Trend in volume of work as compared to previous year (2013-2014):

A total of 302 batches of diagnostic kits and 514 batches of (blood products, recombinant prod-ucts and Enzymes and hormones & Viral Vaccines) were tested in year 2013-14 as compared to 183 and 319 batches for the same tested in year 2012-13. Thus there was an increase of 62% in volume of work undertaken in year 2013-14.

HIV HCV HBsAg Syphilis2012-2013 65 51 57 72013-2014 103 56 124 16

0

20

40

60

80

100

120

140

Trend in Volume of Immunodiagnostic kits Evaluated During APRIL(2013)-March(2014) Compared to Previous Year

2012-2013 2013-2014

figure: 14

BLOOD PRODUCT LAB RECOMBINATPRODUCT LAB

ENZYME ANDHORMONE LAB VIRAL VACCINE LAB

2012-2013 223 53 43 02013-2014 428 37 36 13

050

100150200250300350400450

Trend in Volume of Immunodiagnos�c kits Evaluated During APRIL(2013)-March(2014) Compared to Previous Year

2012-2013 2013-2014

figure: 15

58



The Laboratory is well equipped with so-phisticated instruments required for qual-ity Control evaluation of diagnostics kits i.e. Automated ELISA System, Fully Automated CLIA System, Biosafety Cabinet-II, ELISA Reader, ELISA Washer, Rotary Shaker and temperature controlled equipment. All these are periodically calibrated and put under AMC. In-house calibration of micro pi-pettes and intermediate check of instrument is being done at regular intervals.

8. Proposed targets for testing of new Biological and Bio therapeutics being undertaken or likely to be undertaken:

The Targets proposed for 2013-2014 for QC Evaluation of additional newer biologi-cals viz. Chemiluminescent Immunoassay (CLIA) test kits for HIV, HCV, & HBV, Anti HBs ELISA test kit, Anti HBc Total (IgG & IgM) ELISA test kit, Anti HBc IgM ELISA test kit, HBe Ag-Ab ELISA test kit, HIV Ag Confirmatory, HIV Ag, HBsAg Quantifica-tion panel have been undertaken. Guidance manual on QC Evaluation of CLIA based on HIV, HCV & HBV kits is being prepared. QC Evaluation for in vitro diagnostics kits for malaria RDTs is being planned for which training from National Institute of Malaria Research (NIMR) Division of National Vec-tor Borne Disease Control Program (NVB-DCP), Collection of samples & Preparation of panels for QC Evaluation, Standardisation & Validation would be taken in phased man-ner.

9. NABL accreditation of biological and chemical tests:

Immuno Diagnostic Kit Laboratory has participated in final assessment by National Board for Testing and Calibration Laborato-ries (NABL) for testing of Rapid, ELISA and Confirmatory Immunodiagnostic Kits for HIV, HBV, HCV and Syphilis Rapid as per ISO/IEC: 17025 and has been accredited for Biological testing of Diagnostic kits vide cer-

tificate no. T-2011 dated 05.12.2013.

10. Participation in proficiency test/ EQAs:

A. iNTERNATiONAL LEVEL:

l international External Quality Assess-ment scheme (EQAs):

NIB has enrolled and participated in External Quality Assessment Scheme (EQAS) 2013 for HIV, HBV, HCV and Syphilis Serology with National Serol-ogy Reference Laboratory, (NSRL) Aus-tralia, a NATA-accredited proficiency testing provider, complying with ILAC-G13:08/2007 and also a World Health Organization (WHO) Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections. The laboratory has participated thrice i.e April, July & October in the year 2013. Certificate of successful participation in EQAS 2013 from NSRL, Australia for this laboratory has been awarded.

B. NATiONAL LEVEL:

l Under NAcP-iV program of NAcO, NiB – NRL undertakes following ac-tivities:

l Participation in National-Level EQAs for HiV sEROLOgY: Participated in HIV EQAS in two rounds i.e October and December 2013 conducted by Apex lab. NARI Pune. NIB-NRL scored 100% matching results.

l Provider of HiV Proficiency Testing Panel for HiV sEROLOgY: NIB-NRL Conducted two round of HIV EQAS in July and November 2013 & distributed HIV plasma panel of eight (8) coded well characterized samples to the 10 State Reference laboratories (SRLs) of Ut-tar Pradesh and Uttarakhand. The bulk panel was also provided to 369 linked peripheral testing centers i.e. ICTCs, PPTCTs. All the 10 SRLs scored 100% matching results.

59


HiV EQAs Results of 10 sRLs from Uttar Pradesh and Uttarakhand

S.No. Name of SRL JULY 2013Matching Results

NOVEMBER 2013 Matching Results

1 IMS, BHU, Varanasi 100% 100%2 Himalayan Institute of Medical Science, Dehradun 100% 100%3 JLN Medical College, AMU, Aligarh 100% 100%4 MLB Medical College, Jhansi 100% 100%5 CSM Medical Univ., Lucknow 100% 100%6 GSVM Medical College, Kanpur 100% 100%7 SN Medical College, Agra 100% 100%8 BRD Medical College, Gorakhpur. 100% 100%9 LLRM Medical College, Meerut. 100% 100%10 Motilal Nehru Medical College, Allahabad 100% 100%

11. Preparation and supply of Performance Panel:

In 2013-2014, the laboratory supplied NIB HIV/ HCV/ HBsAg Performance Panel each comprising of 100 Positive, 300 Negative members to 8 indigenous manufacturers. A Total Volume of 9.2 L of the performance panel was given. The Total Revenue Generated has been Rs.Ten Lacs (approx.).

S.NO NAME OF MANUFACTURER TYPE OF PANEL1. M/S TRANSASIA BIOMEDICALS LTD.,NEW DELHI HIV-1 Antibody

HCV Antibody2. M/S QUALPRO DIAGNOSTICS.,GOA HIV-1 Antibody

HBsAg3. M/S SD BIOSTANDARD DIAGNOSTICS PVT

LTD.,GURGAONHIV-1 AntibodyHCV Antibody

4. M/S BHAT BIOTECH INDIA(P)., BANGLORE HIV-1 AntibodyHCV Antibody

5. M/S MERIL DIAGNOSTICS(P)LTD.,GUJRAT HIV-1 AntibodyHCV AntibodyHBsAg

6. M/S CADILA PHARMACEUTICALS LTD.,GUJRAT HIV-1 Antibody

7. M/S PREMIER MEDICAL CORPORATION LTD.,DAMAN HIV-1 AntibodyHCV AntibodyHBsAg

8. M/S YUVRAJ BIOBIZ INCUBATOR INDIA PVT LTD.,CHENNAI

HIV-1 AntibodyHCV AntibodyHBsAg

60


12. Training/workshop/conference organized:

The Laboratory conducted the following EQAS workshops:Workshop organized No. of participants Duration Place of trainingWorkshop for distribution of HIV Proficiency Test Panel for HIV Serology (Round 1, 2013) to State Reference Laboratory of UP & Uttrakhand.

11 15.07.2013 NIB, Noida

Workshop for distribution of HIV Proficiency Test Panel for HIV Serology (Round 2, 2013) to State Reference Laboratory of UP & Uttrakhand.

12 29.11.2013 NIB, Noida

13. Participation in training / Workshop / conference:Name of the Scientist

Name of the programme Duration Place of meeting

Dr. Reba Chhabra (S-II)

One Day Awareness Training on Health Safety and Environment (HSE) based on OHSAS 18001:2007 Occupational Health and Safety Management System and IS0 14000:2004 Environment Management System.

21st May, 2013 NIB, Noida

Attended ISO 9001:2008 QMS Auditor/lead auditor training course (IRCA-UK) certified.

9th-13th April, 2013

FICCI, New Delhi

Meeting of technical specification on ARV drugs. 16th April, 2013 Safdarjung Hospital New Delhi.

IPC-USP 12th Science & Standards Symposium “partnering globally for 21st century medicine”.


ITC Maurya New Delhi.

Online Inventory Module Organized by IT Division, NIB

17th June, 2013 NIB, Noida

Panelist at Consultative meeting of IVD Industry Stake holders & at In Vitro Diagnostics in Health Care Value Chain-Opportunities & Challenges

June 2013 FICCI, New Delhi

Attended two days workshop on “Laboratory quality and Risk Management”.

2nd -4th July, 2013

New Delhi

Assuring Quality of Results in Test & Calibration 9th-10th July, 2013

NIB, Noida.

XXXV Internal Audit and Management systems certificate course as per ISO15189:2007 and NABL 112 requirement conducted by Foundation of Quality (India).

5th-8th August, 2013

New Delhi

Panelist in 6TH Medical Technology Conference “Medical Technology & its vital place in Health Care in India”

26th September, 2013

CII, New Delhi

61


Dr. Reba Chhabra (S-II)

Meeting on specifications & criteria for acceptance for test performed on Syphilis Rapid & ELISA kits

7th October, 2013

FDA Bhawan,

2nd international conference of Pharmaeconomics & outcomes research

9th-10th October, 2013

New Delhi

5th TRG meeting of lab services 24th-25th October, 2013

India Habitat Center, New Delhi

Operator Training on “Cobas S201, Cobas Taqman 48 and Cobas Ampli prep /Cobas Taqman.


NACO New Delhi

Attended 1st meeting for core committee for preparation of NLEMD

17th December, 2013

NIB, Noida.

Attended meeting of need for regulatory check for issuing commercial license to manufacturers of Malaria Rapid Diagnostic Tests

18th December, 2013

CDSCO

Attended as a member of working group 1a-IVDD, 18th AHWP Annual meeting & the 1st AHWP-RAPS Joint Conference

2nd-5th December, 2013

FDA Bhawan

27th & 28th IAEC Meeting 28th Jan, 2014 & 31st Mar, 2014

DGHS Nirman Bhawan, New Delhi.

Attended workshop on Orientation towards & Implementation of ISO 15189:2012 Quality Standard in the HIV Testing Reference Laboratories.

21st-23rd January, 2014

Kuala Lumpur; Malaysia

Attended One day expert meeting on Point Of Care (POC) HIV testing technologies.

4th February, 2014

NIB, Noida

Attended 3rd meeting of Immuno Biologicals Diagnostic kits social committee, MHD19 of BIS.

14thMarch, 2014

Jaipur, Rajasthan

Attended e-Office meeting to discuss the usage of e-office.

21stMarch, 2014 New Delhi

Attended Apex lab meeting 27thMarch, 2014

Manak Bhawan, New Delhi

Dr. Charu M Kamal (S-III)

One Day Awareness Training on Health Safety and Environment (HSE) based on OHSAS 18001:2007 Occupational Health and Safety Management System and IS0 14000:2004 Environment Management System.

21st May, 2013 NIB, Noida

62


Dr. Charu M Kamal (S-III)

Three day Regional Workshop for HIV Referral Laboratories on “Laboratory Quality Planning & Risk Management”

2nd-4th July, 2013

NARI, Pune

Assuring Quality of Results in Test & Calibration 9th-10th July, 2013

NIB, Noida

Operator Training on “Cobas S201, Cobas Taqman 48 and Cobas Ampli prep /Cobas Taqman.


Dept. of AIDS Control

Training Programme on “e-office”System 20th December, 2013

NIB, Noida.

Attended One day expert meeting on Point Of Care (POC) HIV testing technologies.

4th February, 2014

NIB, Noida.

Mr. Pankaj Kumar Sharma. Junior Scientist


17th June, 2013 New Delhi

Assuring Quality of Results in Test & Calibration organized by FICCI

9th-10th July, 2013

NIB, Noida

Workshop for EQAS Panel Distribution to UP 8 Uttrakhand.

15th July, 2013 NIB, Noida

Attended the Training “QIA Symphony RGQ Operator” Fully Automated CE IVD Workflow For molecular Diagnostics.

25th-26th September, 2013

NIB, Noida

Training Programme on “e-Office”System 20th December, 2013

NIB, Noida

Dr. S. Agnihotri, Technical Officer NACO

Laboratory Quality Planning & Risk Management 2nd-4th July, 2013

New Delhi

Three day Regional Workshop for HIV Referral Laboratories on “Laboratory Quality Planning & Risk Management”

2nd-4th July,2013

Dept. of AIDS Control

EQAS Panel Distribution for NRLs (Round 1,2013) 4th October,2013

NARI Pune

EQAS Panel Distribution for NRLs (Round 2,2013) 24th December, 2013

NARI Pune

Attended workshop on Orientation towards & Implementation of ISO 15189:2012 Quality Standard in the HIV Testing Reference Laboratories.

21st-23rd January, 2014

Jaipur, Rajasthan

Sanjeev Sharma. Technician


17th June,2013 NIB, Noida

Quality Assurance Requirements of ISO/IEC 17025 & Chemical & Biological Testing Laboratories.

9th-10th July, 2013

NIB, Noida

Rajeev Kumar Technician

Hands on workshop on chemiluminescence(CLIA) 2nd-4th May, 2013

RFCL Limited Dehradun.

Online Inventory Module Organized by IT Division, NIB.


63


Brij Bhushan Sharma, Technician

Quality Assurance Requirements of ISO/IEC 17025 & Chemical & Biological Testing Laboratories.

9th-10th July, 2013

NIB, Noida

Online Inventory module organized by IT Division, NIB.


Mohit SharmaLab Assistant

Hands on workshop on chemiluminescence (CLIA)

2nd-4th May, 2013

RFCL Limited Dehradun.

Online Inventory Module Organized by IT Division, NIB.


14. Miscellaneous scientific/Academic Activities:

l The Immuno Diagnostic Kit Laboratory participated with NIBSC Porters Bar, UK in the Col-laborative Study to assess the candidate 3rd WHO HBsAg International Standard for use in Serology Assays.

l Guidance Manual on “Quality Control Evaluation of HCV Antibody Immunodiagnostic kits” ---- NIB/IDKL/GM/02.

l Guidance Manual on “Quality Control Evaluation of HBsAg Immunodiagnostic kits”---- NIB/IDKL/GM/03.

15. TRAiNiNgs iMPARTED TO POsT gRADUATE sTUDENTs:

Four summer trainee from various universities have been deputed in the Immuno diagnostic kit laboratory for a period of 3-6 months.

Name of Summer Trainee Project TitleAakanksha Yadav Temperature Effect on the Sensitivity of Rapid &

ELISA kits to detect HCV Ab.Nitika Sharma Comparative Evaluation of HIV Rapid test kits to

heat stability testing in north India.Susmita Nayak Hands on Training Imparted on Rapid, ELISA

& Confirmatory Tests for HIV, HCV, HBsAg & Syphilis.

Gurjeet Singh Sandhu Hands on Training Imparted on Rapid, ELISA & Confirmatory tests for HIV, HCV, HBsAg & Syphilis.

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1. Name of Laboratory Head

Dr. Renu Jain, Scientist Gr. II

2. Name of scientific staff

Ms. Shalini Tewari, Scientist Gr. III (Till July, 2013)

Dr. Meena, Scientist Gr. III (With effect from April, 2013)

Dr. Gaurav Pratap Singh, Junior Scientist

3. contractual Manpower: four

4. Aim and scope:

Recombinant Product laboratory has been established for quality evaluation of re-combinant DNA derived products. During the year April 2013 to Mar 2014 it has ex-panded its scientific activities utilizing the infrastructure and scientific expertise of the laboratory, complying with the standards of ISO and NABL in assuring the quality of test results and measurement of traceability. Strengthening of activities planned for the year was achieved with the functions de-scribed as below:

4.1 conducted systematic examination of recombinant products namely on :

i) Human insulin, Insulin analogs, Gluca-gon Like Peptide (GLP) -1 peptides, Erythropoietin (EPO), Interferon beta 1a, Interferon alpha 2b, Granulocyte Col-ony Stimulating Factor (GCSF) and Teri-paratide (Parathyroid hormone, PTH) in order to facilitate release of indigenous and imported products according to the requirements prescribed under Pharma-copoeia. These were evaluated as per:

a) Insulin, Insulin analogs and GLP-1 peptide by IP 2010 (Addendum IP

2012), BP 2012, USP 35 or as per Manufacturer’s method of analysis,

b) EPO, Interferons, G-CSF and Teri-paratide (PTH) by IP 2010, BP 2012, Ch. Ph. 2010 or as per Manufactur-er’s method of analysis.

ii) Contributed regulatory scientific advice to the Indian Biotech industry in GMP assessment of the manufacturing facility.

4.2 To provide scientific expert advice on phar-macopoeial specifications for development of Biotech monographs in the r-DNA com-mittee with experts from Indian Pharmaco-poeia Commission, Stakeholders, NIB and IIT-Delhi.

4.3 To develop linkages by partnering with global standard setting agencies, stakehold-ers, Regulatory & Pharmacopeial bodies at National & International level.

4.4 To provide IP Reference Standard for Hu-man Insulin developed at NIB and with as-signed potency value in IU/mg for request from various Manufacturers and Academia as per proforma invoice raised by NIB.

4.5 To provide on job specific training to the staff in laboratory, induction training to newly recruits and for the anticipated tasks in the attributes of regulatory, pharmacopoeial, quality management system-technical re-quirements and other learning opportuni-ties.

4.6 Expansion of activities to take up testing of newer biologicals.

5. Progress of the Activities:

Lab has developed capacity to evaluate In-sulin, Insulin analogs, GLP-1 peptides, EPO, G-CSF, Interferons and Teriparatide (PTH)

V. ReComBiNANt pRoDUCt LABoRAtoRY

65


forwarded for their quality testing. A total of 465 batches have been evaluated during 2013-14 for release of test analysis reports. In addition, 17 batches for safety test for bacterial endotoxin from inter-laboratory transfer from Bacterial Vaccine Lab, Viral Vaccine Lab, Blood Products Lab and Therapeutic Monoclonal Antibody Lab were also evaluated. Details are shown in Figure 1.

0

50

100

150

200

250237

172

49

4 2 117

No.

of B

atch

es

Types of Recombinant Products Received465 Batches for Release of Test Analysis

17 Batches for NIB Interlab Transfer

figure 1. Types of Recombinant Products received for testing

5.1 Qc Testing of insulin, insulin analogs and gLP-1 Peptides:

5.1.1 Evaluation for Release of coA:

Insulin, Insulin analog and GLP-1 injections were evaluated for quality control testing of species identification, total potency, potency by soluble content, related proteins, high molecular weight proteins, metal ions, bac-terial endotoxins, sterility, colour/ clarity/ appearance, particulate analysis, dose accu-racy, osmolality and pH. Insulin bulk drug substance (API) was evaluated for identi-fication by peptide mapping, potency, high molecular weight proteins, related proteins,

bacterial endotoxin, metal ions, and loss on drying.

5.1.2 Evaluation for Monograph Verification:

API of Insulin Lispro and Insulin Aspart API were received from innovators. The tests car-ried out were identification by peptide map-ping, potency, high molecular weight pro-teins, related proteins, bacterial endotoxin, zinc metal ion, and loss on drying.

5.1.3 status of insulin samples:

Laboratory has received, tested and reported 409 batches with 19 different formulations depicted in Table 1 and Figure 2.

66


Table 1. Formulations of Insulin, Insulin Analogs and GLP-1 Peptides received for testing

s. No. category formulations Type1. insulin Regular Insulin (R) Short acting2. Isophane Insulin (NPH) Intermediate3. Biphasic Isophane Insulin (25/75) Mixture of short acting and intermediate acting 4. Biphasic Isophane Insulin (30/70) Mixture of short acting and intermediate acting 5. Biphasic Isophane Insulin (50/50) Mixture of short acting and intermediate acting 6. Insulin API Drug substance (DS)7. insulin

AnalogsInsulin Lispro Rapid acting

8. Biphasic Insulin Lispro-25/75 Mixture of rapid and intermediate acting 9. Biphasic Insulin Lispro-50/50 Mixture of rapid and intermediate acting 10. Insulin Lispro API Drug substance (DS)11. Insulin Aspart Rapid acting12. Biphasic Insulin Aspart-30/70 Mixture of rapid and intermediate acting 13. Biphasic Insulin Aspart-50/50 Mixture of rapid and intermediate acting 14. Insulin Aspart API Drug substance (DS)15. Insulin Glargine Very long acting16. Insulin Glulisine Rapid acting17. Insulin Detemir Rapid acting18. Insulin Degludec Ultra-long acting19. glucagon

LikePeptide-1

Liraglutide Long acting

0

20

40

60

80

100

120

140 130

57

42 41

66

29

166 9

112

No.

of B

atch

es

Different Formulations of Insulin, Analogs & GLP-1: 409 Batches

figure 2. formulations of insulin, insulin analogs and gLP-1 peptides

67


5.1.4 status of Label claim-Pharmacopoeia:

The product container bears claim of Pharmacopoeia mentioned as IP/ USP or no claim on the basis of which the sample is evaluated as per the methodology. Segregation of 409 batches is shown in Table 2 and Figure 3.

Table 2. Basis for testing for samples bearing no Pharmacopoeia claim

insulin and insulin analogs

Number of Batches (n= 204)

Basis of testing for batch releaseiP UsP BP Manufacturer

Human insulin

25 IP monograph for insulin preparation injectable

x x x

insulin APi 08 IP monograph for human insulin

x x x

insulin Lispro

40 x √ x Test on soluble insulin lispro content- Mfr. specifications

Lispro APi 03 IP 2014 monograph for insulin lispro

x x x

insulin glargine

29 Related proteins- IP monograph for insulin preparation injectable

USP monograph for insulin preparation injectable

x x

insulin Aspart

66 x x √ Insulin aspart in solution-Mfr. specifications

Aspart APi 01 IP 2014 monograph for insulin aspart

x x x

insulin glulisine

16 Related proteins- IP monograph for insulin preparation injectable

USP monograph for insulin preparation injectable

x x

insulin Detemir

06 x x x √

insulin Degludec

09 x x x √

gLP-1 01 x x x √

68


0

50

100

150

200

250

As per IP(Insulin)

As per USP(Lispro)

As per BP(Aspart)

As per Manufacturer Specif ications

(Glargine, Glulisine, Detemir, Degludec, Liraglutide)

As per IP for Monograph Verif ication

(Lispro, Aspart)

Pharmacopoeia Claim on Product Containers

With label claim (n=204)Without label claim (n=33)

With label claim (n=1)Without label claim (n=40)

Without label claim (n=66) Without label claim (n=61) Without label claim (n=4)

figure 3. Pharmacopoeia claim of insulin, insulin analogs and gLP-1 Peptides

5.1.5 status of Label claim-Potency:

The product container bears claim of potency strength in Insulin units. Out of 409 samples 67 samples were of 40 IU strength and 329 samples were of 100 IU strength. One batch of Liraglutide (GLP-1) was of 6 mg/ml. Eight batches of Insulin API, 03 batches of Insulin Lispro API and 01 batch of Insulin Aspart API were without assigned potency.

202 batches on further analysis were segregated into Biphasic formulations in combination of 25:75, 30:70, and 50:50, on the basis of which all the tests of potency are carried out and lations are performed. The details are shown in Figure 4.

Biphasic30-70

Biphasic25-75

Biphasic50-50

123 (Biphasic Insulin, Biphasic Aspart)

40 (Biphasic Insulin, Biphasic Lispro)

39 (Biphasic Insulin, Biphasic Lispro, Biphasic Aspart)

202 Batches of Biphasic FormulationsInsulin injections & Insulin analogs

figure 4. Biphasic formulations of insulin and insulin Analogs

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5.2 Qc Testing of Erythropoietin:

5.2.1 Lab has developed capacity to evaluate rh-EPO injections which are with or without serum albumin. The specifications are laid down in BP 2012 and Ch. Ph. 2010 and the products received in NIB were tested by parameters of identification, in vitro potency, high molecular weight proteins, bacterial endotoxin, abnormal toxicity, colour/ appearance, filling quantity, test for visible particles, pH and viral markers for HIV 1 & 2 antibody, HCV antibody and HBsAg.

5.2.2 status of Erythropoietin samples:

Laboratory has received, tested and reported 49 batches of EPO injections depicted in Figure 1. All the batches were found to be of standard quality. The samples were in varying strengths including 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10000 IU, and 20000 IU. Safety test by Abnormal toxicity on mice has been conducted after seeking ethical approval of the Institutional Animal Ethics Committee (IAEC) from time to time.

5.3 Qc Testing of g-csf and interferons (ifN β1a & ifN α2b):

5.3.1 The specifications for quality testing of rh-G-CSF are laid down in Ch. Ph. 2010 and the products received in NIB were tested by parameters of identification, in vitro potency (bioassay), high molecular weight proteins, related proteins, bacterial endotoxin, abnormal toxicity, description (appearance), osmolality, filling quantity, test for visible particles and pH.

5.3.2 For quality testing of interferon beta 1a injection, the specifications are not laid down in any Pharmacopoeia and the products received in NIB were tested as per Manufacturer’s specifications for parameters of identification, potency, purity, high molecular weight proteins, oxidized interferon, bacterial endotoxin, sterility,

osmolality, colour/ appearance and pH.

5.3.3 status of g-csf and interferons (ifN β1a & ifN α2b) samples:

Laboratory has received, tested and reported 04 batches (depicted in Figure 1) of G-CSF injections which were found to be of standard quality. The samples were in strength of 300 µg/ml and 263 µg. Safety test by Abnormal toxicity on mice has been conducted after seeking ethical approval of the Institutional Animal Ethics Committee (IAEC) from time to time. Laboratory has received and tested 01 batch of Interferon beta 1a.

5.4 Testing feasibility of Newer Biological:

5.4.1 Lab has developed capacity to evaluate Teriparatide (PTH) injection. The specifications are not laid down in any Pharmacopoeia and the products received in NIB were tested as per Manufacturer’s specifications for parameters of identification, potency, purity, bacterial endotoxin, sterility, colour/ appearance and pH.

5.4.2 Lab has developed capacity to evaluate interferon alpha 2b injection. The specifications are given in IP 2014 and the products received in NIB were tested for parameters of identification, potency, purity, related proteins, bacterial endotoxin, sterility, colour/ appearance and pH.

5.4.3 status of Teriparatide (PTH) and interferon α 2b samples:

Laboratory has received 01 batch of Teriparatide (PTH). Test for potency has been carried out to establish repeatability and reproducibility parameters using the proprietary Reference Standard from the Manufacturer and the working Reference Standard of Interferon α 2b. Laboratory has received and tested 01 batch of Interferon α 2b.

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5.5 Qc Testing on samples under NiB inter-laboratory Transfer:

Depiction of samples received under NIB inter-lab transfer for safety test by bacterial endotoxin- gel clot method is given in Table 3.

Table 3. Details of samples under NiB inter-laboratory Transfer

forwarding Laboratory sample Name No. of BatchesViral Vaccine Japanese Encephalitis Inactivated Vaccine 03

Poliomyelitis Vaccine 09Bacterial Vaccine Polysaccharide Typhoid Vaccine 02Blood Products Antihaemophilic Factor VIII 01

Rho (D) Immunoglobulin 01Therapeutic Monoclonal Antibody Rituximab 01

5.6 Reference standards used in Qc Testing:

Laboratory has maintained repository of all Reference Standards required for testing of Insulin, Insulin analogs, GLP-1 peptides, EPO, G-CSF, Interferons, Teriparatide (PTH) and these have been received from traceability of highest metrological order and from the Manufacturers. Comparative view of Certified Reference Standard & Secondary Standard are shown in Table 4.

Table 4. Repository status of Reference standards

Product type Reference standard availability at NiBiP UsP Manufacturer EDQM NiBsc

1. Human Insulin √ (IPRS effective from

Aug. 2010)

√ √ √ √

2. Bovine Insulin x x x x √3. Porcine Insulin x √ x x √4. Insulin Lispro x x √ √ x5. Insulin Glargine x x √ x x6. Insulin Aspart x x √ √ x7. Insulin Glulisine x x √ x x8. Insulin Detemir x x √ x x9. Insulin Degludec x x √ x x10. Liraglutide x x √ x x11. Exenatide x x √ x x12. Erythropoietin x x √ √ √13. G-CSF x x √ x √14. Interferon beta 1a x x √ x √15. Interferon alpha 2b x x √ x √16. Teriparatide (PTH) x x √ x x

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5.7 Release of Test Analysis Report:

The samples sent for testing were reviewed for their testing protocols, batch production protocol and certificate of analysis. Any inadequacy observed therein is communicated to the respective sample senders for its corrective action. The release of test analysis report was monitored for its turnaround time keeping a complete tracking of sample since receiving, testing and compilation of data for evaluation,

decoding and release of the report. The release status of reports is placed on NIB website on daily basis for public domain under the title “Daily Dispatch Reports”.


Testing details of biologicals with Name of manufacturer/Importer, Name of Product and No. of Batches is depicted in Table 5. After testing all the batches were found to be of standard quality.

Table 5. Details of biologicals tested in Recombinant Product Lab

S. No.


Name of the Product No. of Batches Received and Evaluated

Remarks: Pharmacopoeia Label Claim on ProductBrand Name Product type

1 i. Eli Lillyii. Sanofi Aventisiii. Novo Nordiskiv. Bioconv. Shanthavi. Lupin

i. Huminsulin Rii. Insuman Rapidiii. Actrapidiv. Insugen Rv. Lupisulin R

Regular Insulin 57 IP

2 i. Eli Lillyii. Sanofi Aventisiii. Novo Nordiskiv. Bioconv. Lupin

i. Huminsulin Nii. Insuman Basaliii. Insulatardiv. Insugen Nv. Lupisulin N

NPH Insulin 42 IP

3 i. Eli Lillyii. Sanofi Aventisiii. Novo Nordiskiv. Bioconv. Torrentvi. Shanthavii. Lupin

i. Huminsulin 30/70ii. Insuman 25/75, 50/50iii. Mixtard 30, 50iv. Insugen 30/70v. Insuman Combvi. Lupisulin M30, M50

Biphasic Insulin 130 IP

4 i. MJ Biopharmaceuticalsii. Torrent

- Insulin API 08 Not mentioned

5 Eli Lilly Humalog Lispro 07 USP6 Eli Lilly Humalog Mix 25 Biphasic Lispro 17 Not mentioned7 Eli Lilly Humalog Mix 50 Biphasic Lispro 17 Not mentioned

72


8 Eli Lilly - Lispro API 03 Not mentioned9 Sanofi Aventis Lantus Glargine 29 Not mentioned10 Sanofi Aventis Apidra Glulisine 16 Not mentioned11 Novo Nordisk NovoRapid Aspart 28 Not mentioned12 Novo Nordisk NovoMix 30 Biphasic Aspart 29 Not mentioned13 Novo Nordisk NovoMix 50 09 Not mentioned14 Novo Nordisk - Aspart API 01 Not mentioned15 Novo Nordisk Levemir Detemir 06 Not mentioned16 Novo Nordisk Tresiba Degludec 09 Not mentioned17 Novo Nordisk Victoza Liraglutide 01 Not mentionedTotal (Insulin, Insulin analogs and GLP-1) = 40918 LG Life Sciences Espogen Erythropoietin 23 Not mentioned19 Shandong Kexing

Bioproducts Co. Ltd.Epocept 04 Not mentioned

20 Shenzhen Sciprogen Biopharma Co. Ltd.

Epotop 02 Not mentioned

21 CJ Cheil Jedang Corp. Ceriton 09 Not mentioned22 Biocon Erypro 01 Not mentioned23 Roche NeoRecormon 01 Not mentioned24 Harbin

PharmaceuticalsTropin 03 Not mentioned

25 Harbin Pharmaceuticals

rh-erythropoietin 06 Not mentioned

Total (Erythropoietin) = 4926 Biogen Idec Avonex IFN β 1a 01 Not mentioned27 Reliance Life Sciences Reliferon IFN α 2b 01 Not mentioned28 Beijing Four Rings Filgen G-CSF 01 Not mentioned29 Sanofi Granocyte 01 Not mentioned30 Beijing Four Rings Nfil 01 Not mentioned31 Reliance Life Sciences Religrast 01 Not mentioned32 Eli Lilly Forteo PTH 01 Not mentionedTotal (g-csf, interferons and PTH) = 07gRAND TOTAL = 465

7. Trend in Volume of Work:

The lab has infrastructure capacity building for testing 500 batches of recombinant products per

73


year and the trend since year 2009 is shown in Figure 5.

i. Five times increase in trend has been observed from the initial testing for 49 batches of Insulin.

ii. Four times increase in trend has been observed from the initial testing for 37 batches of Insulin analogs and GLP-1.

iii. 1.5 times increase in trend has been observed from the initial testing for 38 batches of cytokines and growth factors.

0

50

100

150

200

250

300

49

152

242

279

237

37

102 114

148172

38 4758 56

No.

of B

atch

es

Year-wise Receipt of Recombinant Products for Release of Test Analysis Report

Analogs & GLP-1rh-Insulin Cytokines & Growth Factors

figure 5. Trend of samples received in the Laboratory for testing since year 2009

8. infrastructural facilities- Existing and Newly Developed:

In addition the existing infrastructure is maintained through calibration and validation of equipments installed in the laboratory under annual maintenance contracts.

To strengthen infrastructure for the scientific activities, indents have been placed for purchase of additional equipments viz. water purification system for high purity grade water (18.2 MΩ) and gel dryer for SDS-PAGE gel documentation.

9. Proposed Target for Testing of New Biologicals:

Strengthening activities have been placed for nine products like Interferon alpha 2a,

Teriparatide (PTH), Rhyzodeg (Aspart and Degludec mix) and Pegylated forms of EPO, G-CSF & Interferons. Pharmacopoeial monographs for these products are not available. Feasibility will be established in phased manner and evaluation has been planned for testing of PTH drug substance and drug product.

10. NABL Accreditation of Biological and chemical Tests:

10.1 NABL Assessment:

The laboratory was assessed by NABL auditors for scope extension cum surveillance audit as per ISO 17025 on 14-15th Sept, 2013 for accreditation of biological and chemical testing of Insulin Human, Insulin Bulk, Insulin Glargine, Insulin Glulisine, Insulin Lispro, Insulin Aspart, Insulin Detemir,

74


Exenatide, Liraglutide, Erythropoietin, G-CSF and Interferon beta 1a. A total of 12 recombinant therapeutic products got accreditation as per ISO 17025 for 28 testing parameters- 21 Chemical tests and 7 Biological tests. Three laboratory scientists are approved signatories by NABL assessors for release of test reports. Reports are released using NABL symbol as per approved scope.

10.2 Notification as central Drugs Laboratory:

The laboratory was assessed by technical experts and experts from CDSCO on 31st August – 1st September, 2012 for notification as Central Drugs Laboratory and will achieve status of Central Drug Laboratory Notification for testing of Insulin, Insulin analogs, EPO and G-CSF.

11. Participation in Proficiency Testing/ inter Laboratory collaborative studies:

11.1 collaborative study with NiBsc:

i. WHO 1st international standard (is) for biosynthetic human insulin.

Period of Study- Sept., 2012 – On going

ii. 1st international standard for human pegylated g-csf

Period of Study- Nov, 2012 – June, 2013

iii. WHO 1st Replacement standard for Human c Peptide

Period of Study –Dec 2013 –Feb 2014

Overall Achievements: Established Proficiency and Competency with Knowledgepartners.

l Peg GCSF study published in WHO-Geneva Report in 2013, Reference Standard is commercially available for sale by NIBSC.

l Insulin Collaborative study Data

compilation at NIBSC continued

11.2 iLc Programme for scope of Qualitative Tests Accredited by NABL:

Inter-laboratory collaborative study was planned during Jan-Apr, 2014 for the scope of qualitative tests accredited by NABL. A total of ten laboratories have participated in the inter-lab collaborative study which includes: Pharmacopoeia Lab, Regulatory Lab and Manufacturers of Biotech products for tests on Bacterial Endotoxin by Gel clot and SDS-PAGE.

11.3 inter-lab collaboration with industry:

One batch of Human insulin was received from Torrent Pharmaceuticals Ltd. in March, 2014 for ILC study for test on Bacterial Endotoxin by Gel clot. Laboratory carried out the test as per the procedure and results were communicated to Torrent Pharmaceuticals Ltd.

11.4 collaboration with iiT-Delhi:

Chemometric tool study using Multivariate Data Analysis has been carried out in collaboration with Deptt. of Chemical Engineering of IIT, Delhi to study the consistency of Insulin drug quality. Study started from Nov, 2012 and continuing till date. Chemometric data for 800 batches of Insulin and analogs has been evaluated and data is being updated for next 733 batches for publishing in Journal of repute.

12. Preparation and supply of National Reference standard:

12.1 Reference standard for Human insulin (iPRs):

Reference Standard for Human Insulin (IPRS) prepared by NIB in 2010 and available for commercial and research use on request basis. The details of charges for supply of IPRS are available on NIB website (www.nib.gov.in). During 2013-14 Reference Standard for Human Insulin (IPRS) has been supplied to

75


Torrent Pharmaceuticals Ltd. (10 vials) and Bioscience Deptt. of S.P. University (01 vial).

12.2 guidance Document on Reference standard:

Strategy for a Guidance Document on ‘Reference Standard on Biotherapeutics’ is being formulated as per recommendations of rDNA Committee of IPC. Strategy will be formulated in consultation with Intas Biopharmaceuticals.

13. Details of Participation in cgMP inspections:

Joint inspections of facilities by experts from CDSCO and NIB as per GMP norms have been carried out for renewal of licence on Form 28D for manufacturing of rDNA products:

13.1 Torrent Pharmaceuticals, Ahmedabad on 24th May, 2013 for recombinant human insulin- NIB deputed Dr. Renu Jain as technical expert.

13.2 Cadila Healthcare Ltd., Ahmedabad for manufacturing of r-DNA products on 24th July, 2013- NIB deputed Dr. Renu Jain as technical expert.

13.3 Cadila Pharmaceuticals, Dholka, Ahmedabad for manufacturing of rh-Insulin and rh-erythropoietin products on 18-19th

Nov, 2013- Dr. Renu Jain was deputed as technical expert.

13.4 Dr. Renu Jain and Dr. Gaurav Pratap Singh were deputed by NIB for joint inspection of Cadila Healthcare Ltd., Ahmedabad for manufacturing of test batches of rh-erythropoietin, Interferon α2 b, Filgrastim and pegfilgrastim products on 19-20th Dec, 2013.

14. Training/ Workshop / conference Organized:

14.1 On the Job Orientation and induction training:

During Oct-Nov, 2013 Bench Biologists of Quality Management Unit were given orientation by guided tour to the laboratory and introduction to key personnel. Topics of training were on location of working area, characteristics of work area in terms of flow of material, personnel, product and waste segregation and disposal. Basic training was given on the topics of quality systems, documentation, SOPs on product testing, operation and maintenance of equipments, biosafety practices and material management. Bench Biologists were given practical training on various QC test parameters of Insulin, Insulin analogs and Growth Factors as per requirements of IP, USP, EP BP and Manufacturer’s method of analysis.

15. Participations in Training / Workshop / conference:

Participant’s Name Training/ Workshop/ Conference Title CategoryDr. Renu Jain 1. IPC-USP 12th Science & Standards Symposium from

16-17th Apr, 2013 by USP and IPC at ITC Maurya, New Delhi

Regulatory

Dr. Renu JainDr. MeenaDr. Gaurav Pratap Singh

1. Workshop on “Regulatory Requirements for Biopharmaceuticals-From Science to Commercialization” by DBT, CDSA and CDSCO at India Habitat Centre, New Delhi on 30th-31st July, 2013

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Dr. Gaurav Pratap Singh 3. 2nd International Conference on Pharmacoeconomics and Outcomes Research held at India Habitat Centre, New Delhi on 9-10th Oct, 2013

Regulatory

Dr. Renu JainDr. Gaurav Pratap SinghBench Biologist- Tara Chand

4. Conference on Bioprocessing India 2013 at Indian Institute of Technology, Delhi from 5th-7th December, 2013

Dr. Renu Jain 5. Workshop on Review of Stability Data submitted for Market Authorization on 12th Feb, 2014 by CDSCO at CDL, Kasauli

Dr. Renu JainBench Biologist- Shruti Dhingra

6. Awareness training on Health, Safety & Environment on 21st May, 2013 at FICCI, New Delhi

Management System Requirements

Dr. Renu Jain 7. World Accreditation Day on 15th Nov, 2013Dr. Renu Jain 8. World Quality Day on 10th June, 2013 at India Habitat

Centre, New DelhiDr. Renu JainDr. MeenaDr. Gaurav Pratap Singh

9. Training Programme on e-Office System on 27th Dec, 2013 by NIC at NIB, Noida: Sensitization programme10. Training Programme on e-Office System on 22nd March, 2014 by NIC at NIB, Noida: Specific to usage module

Dr. MeenaDr. Gaurav Pratap Singh

11. Training programme on “Physicochemical and Potency Testing” at USP, Hyderabad from 10th-18th June, 2013

Product Specific Technical Requirements of ISO 17025

Dr. Renu JainDr. Gaurav Pratap Singh

12. FICCI training programme on “Assuring Quality in Test and Calibration” at NIB, NOIDA from 9th-10th July, 2013

Dr. Meena 13. Training programme on “Fundamentals of Bioassay Practices” by USP Hyderabad on 3rd March, 2014

Dr. Renu JainDr. Gaurav Pratap SinghBench Biologist- Chanda Sinha

14. Training programme on “Liquid Handling Calibration Device and Automatic Powder and Liquid Dosing Instruments” held at NIB, NOIDA by on 11th March, 2014

16. scientific/ Academic activities:

16.1 Laboratory has contributed in development of 12 new monographs on Biotech products-Insulin Analogs, Cytokine and Growth Factors for publication in IP 2014. Out of these 4 monographs viz. Biphasic Insulin Aspart injection, Biphasic Insulin Lispro injection, Interferon alfa 2b injection and Filgrastim injection were exclusively published in IP 2014. The published monographs are:

i) Insulin Aspart

ii) Insulin Aspart injection

iii) Biphasic Insulin Aspart injection

iv) Insulin Lispro

v) Insulin Lispro Injection

vi) Biphasic Insulin Lispro injection

vii) Erythropoietin injection

viii) Erythropoietin for injection

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ix) Filgrastim injection

x) Interferon beta 1a concentrate solution

xi) Interferon alfa 2a injection

xii) Interferon alfa 2b injection

16.2 Recombinant Product Lab has also contributed in the scientific review of Post Approval Change protocols forwarded by the DDC (I) office to NIB. These Post Approval Change protocols include:

16.2.1 Extension of shelf life of drug substance & drug product, and

16.2.2 Change in the product specification of drug substance & drug product.

16.3 Publications:

a. Renu Jain, Shalini Tewari, Tara Chand, Sudha V. Gopinath, J. P. Prasad, Gaurav Pratap Singh. Development of Reference Standards on Biotherapeutics. Poster presentation at ‘Bioprocessing India 2013’. IIT Delhi 5-7th Dec., 2013: Poster# 9 92-93.

b. Renu Jain, Shalini Tewari: WHO ECBS, Geneva Report on a collaborative study for proposed 1st International Standard for pegylated G-CSF (peg G-CSF). 21-25 Oct 2013: WHO BS/2013 page 26.

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Vi. ANimAL fACiLitY

1. Name of Head:

Dr. Shikha Yadav, Scientist Grade II

2. Technical & supportive staff:

Mr. Parmender Kumar, Jr. Animal Caretaker

3. contractual staff: seventeen

4. Aim and scope:

Animal Facility performs in-vivo tests for quality control evaluation of biologicals re-ferred from laboratories of National Insti-tute of Biologicals as per Indian and other Pharmacopoeias. The Facility ensures timely availability of laboratory animals for vari-ous in vivo tests by a planned breeding pro-gram. Animal Facility ensures high quality animal husbandry and care that meets the requirements of animal welfare regulations and guidelines provided by CPCSEA. Regu-lar Institutional Animal Ethics Committee (IAEC) meetings are held to obtain ethical clearance for use of animals in QC testing.

Also, standardization of the in-vivo regula-tory tests is done for those newer biological products which are taken up by any labora-tory of NIB.

5. scientific activities undertaken during the reporting year:

institutional Animal Ethics committee (iAEc):

All the experiments involving animals are approved by the IAEC which is constitut-ed by CPCSEA. In the year 2013-14, seven IAEC meetings were organised in which 49 ongoing protocols and 2 new protocols were reviewed & approved by the committee. The

facility maintained all relevant records to ensure compliance to the approvals granted by the committee and progress under each approved protocol was put up for review by IAEC regularly in each meeting.

As per the CPCSEA requirement, IAEC members performed a detailed inspection of the Animal Facility on 11.11.2013 and re-ported that the facility had all the infrastruc-tural facilities required as per the CPCSEA norms and appreciated the automated cage and rack washers and sterilizers being used for washing and sterilizing the animal cages. They were also satisfied with the high qual-ity animal husbandry and care being pro-vided to the animals housed in the facility. The CPCSEA nominees also appreciated the maintenance of records & documentation in the facility and submitted their inspection report to CPCSEA strongly recommending the Animal Facility for further approval.

Quality control Evaluation:

In-vivo QC evaluation tests i.e Abnormal Toxicity Assay, Pyrogen Test, Potency & Identity Assays & other miscellaneous tests have been performed on a total of 1346 sam-ples of different biologicals forwarded by laboratories of NIB. A total of 622 samples were tested for Abnormal Toxicity (Table II; Fig 1), 522 samples for Pyrogen (Table III; Fig 2), 147 samples for Identity and Po-tency Assay(Table IV; Fig 3) 18 samples for Virus Inactivation Test (CCRV), 20 samples for Skin reactivity and 17 samples for safety test of BCG vaccine. A total of 9,417 animals were used to conduct these in vivo QC tests, details of which are provided in Table I.

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Table 1: Details of Animal census and No. of Animals Used During 2013-14

S.No Species Strain Census (31.03.2014)

Animals Used (2013-14)

1. Mice Swiss Albino 1191 51622. Guinea Pigs Duncan Hartley 331 13083. Rabbits New Zealand

White72 90

4. Rats Wistar Rats 1050 320S.D. rats 644 2537

TOTAL 3288 9,417

The details of various in vivo tests performed are as follows.

i. Abnormal Toxicity Assay- is conducted to determine the presence of any toxic substance in bio-logical products intended for parenteral administration. Five mice (17-22 gm) and two Guinea pigs (250-350 gm) are used per test for most products. However for Erythropoietin, Granulocyte- Colony Stimulating Factor, Human Chorionic Gonadotropin, Urokinase and Streptokinase only 5 mice are used. A total of 622 samples were tested for abnormal toxicity in 2013-14 in which 3110 mice and 1086 guinea pigs were used. The details of number of samples of various products are provided in Table II; Fig 1.

Table ii: Details of different products tested for Abnormal Toxicity (2013-14)

Laboratory Name of product No. of Samples 2013-14

No.of Mice

No.ofGuinea pigs

Blood Products

Human Albumin 283* 1415 566Dried Human Antihemophilic Fraction. (Factor VIII) 43 215 86Human Specific Immunoglobulin (I/M) (SPIG-IM) 30 150 60Human Normal Immunoglobulin (I/M) (IGIM) 07 35 14Plasma Protein Fraction (PPF) 2 10 04

Enzymes & Hormones

Human Chorionic Gonadotropin (hCG) 15 75 -Streptokinase (STK) 1 5 -Urokinase (URK) 5 25 -

Recombinant Products

Erythropoietin (EP) 54 270 -Granulocyte- Colony Stimulating Factor (G-CSF) 4 20 -

Bacterial Vaccine

Polysaccharide Typhoid Vaccine (Typhim) 1 05 02Hib Conjugate Vaccine (Hib) 0 - -

Viral Vaccine Human Rabies Immunoglobulin (RIg) 07 35 14Human Hepatitis B Immunoglobulin (HBIg) 09 45 18Cell Culture Rabies Vaccine (CCRV) 13 65 26Live Attenuated Measles Vaccine (LAMV) 59 295 118

80


Live Attenuated MMR Vaccine (MMR) 56 280 112Live Attenuated Rubella Vaccine (LARV) 30 150 60Japanese Encephalitis Vaccine (JEV) 3 15 6Total 622 3110 1086

*Including 6 repeat tests

0

50

100

150

200

250

300

Hum

an A

lbum

in

Fact

or V

III

SPIG

-IM IGIM PP

F

hCG

STK

URK EP

G-CS

F

Typh

im Hib

Rig

HBIg

CCRV

LAM

V

MM

R

LARV JE

V

283

43 307 2 15 1 5

54

4 1 0 7 9 13

59 5630

3

Fig 1: NUMBER OF SAMPLES TESTED FOR ABNORMAL TOXICITY (2013-14)

ii. Pyrogen Test – is conducted to detect the presence of any pyrogenic substance in the drug in-tended for parenteral administration and is prescribed in the Indian Pharmacopoeia and other Pharmacopoeias. A total of 522 samples were tested for presence of pyrogens in 2013-14 using rabbits, details of which are provided in Table III; Fig 2.

Table iii: Details of different products tested for Pyrogen Test (2013-14)

Laboratory Name of product No. of samples 2013-14 Blood Products

Dried Human Antihemophilic Fraction (Factor VIII) 46Albumin 278Normal Immunoglobulin (I/V) (IGIV) 95Normal Immunoglobulin (I/M) (IGIM) 8Human Specific Immunoglobulin (I/M) (SPIG-IM) 30Human Specific Immunoglobulin (I/V) (SPIG-IV) 1Plasma protein Fraction (PPF) 2Factor-IX 21Fibrinogen -

Viral Vaccine Human Rabies Immunoglobulin (RIg) 6Human Hepatitis B Immunoglobulin (HBIg) 12Cell Culture Rabies Vaccine (CCRV) 20

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Bacterial Vaccine

Haemophilus influenza type b Vaccine (Hib) -Typhim 1Meningococcal polysaccharide Vaccine (MPV) 2Total 522

0

50

100

150

200

250

300

Fact

or V

III

Albu

min

IGIV

IGIM

SPIG

-IM

SPIG

-IV PPF

Fcat

or-IX

Fibr

inog

en Rig

HBIg

CCRV Hi

b

Typh

im

MPV

46

278

95

830

1 221

0 6 12 200 1 2

Fig 2: NUMBER OF SAMPLES TESTED FOR PYROGEN TEST (2013-14)

iii identity and Potency Assay- is done to establish the identity and determine the strength and activity of the products before their use in humans. A total of 147 samples were tested for potency in 2013-14.

The identity and potency assay was standardised for r-FSH and batch release initiated for r-FSH, FSH activity of Urofollitropin and LH activity of Menotropin (HMG). The standardization of assay for residual LH activity of urofollitropin has been initiated. In house working reference standards were prepared for hCG and HMG hormones for use in identity and potency assay.

The details of number of animals used for

various products is as follows:

HCG: 32 Female rats, r-FSH: 30 Female rats, Urofollitropin-FSH: 30 Female rats, Menotropin-LH: 36 Male rats, Menotropin-FSH: 36 Female rats.

A total of 2857 rats and 1872 mice were used for identity and potency assay of various products in 2013-14.With constant support of IAEC, an effort was made to reduce the animal usage for which whenever 2 or more batches of hormones or vaccines were received together assay was put up with a common control/reference group. The details of different products tested for Potency assay are provided in Table IV; Fig 3.

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Table iV: Details of different products tested for Potency Assay (2013-14)

Laboratory Name of Product No.of samples 2013-14

No. of AnimalsRats Mice

Enzyme & Hormone

Human Chorionic Gonadotropin (hCG) 21 560 -r-FSH 25 600 -HMG-LH 21 612 -HMG-FSH 21 522 -Urofollitropin (FSH) 8 195 -Urofollitropin Residual Luteinizing Hormone

2 48 -

Viral Vaccine

RIg* 6 - 540Japanese Encephalitis Vaccine (JEV) 3 - 140CCRV* (Potency Assay) 16 - 1,192Inactivated Polio Vaccine* 6 320 -Total 147 2,857 1872

*Tested by Viral vaccine lab

0

5

10

15

20

25

hCG

r-FS

H

HMG-

LH

HMG-

FSH

Uro

folli

trop

in F

SH

Uro

folli

trop

in R

LH

CCRV JE

V

Rig

Polio

Vac

cine

21

25

21 21

8

2

16

3

6 6

Fig No. 3: NUMBER OF SAMPLES TESTED FOR POTENCY TEST (2013-14)

Miscellaneous Tests performed in Animal facility:

Name of test No. of Samples No. Of AnimalsSkin Reactivity for BCG Vaccine 20 120 G. PigsVirulent Mycobacterium of BCG Vaccine 17 102 G.PigsVirus Inactivation for CCRV Vaccine 18 180 MiceTotal: 37 222

6. Trends in Volume of Work as compared to Previous Years:

As compared to previous year, there has been a considerable increase of 298 % in the total number of samples referred to the Animal Facility for various in-vivo QC tests. In this year, a total of 1346

83


samples were received for testing from various laboratories of NIB as compared to 452 samples received in 2012-13. Also the number of animals issued for these tests has increased considerably from 2802 in 2012-13 to 9,417 in 2013-14.The trends in the volume of work since 2009 have been provided in Figure 4 and Figure 5.

27 0 0

166 12717

191 172

31

223 190

29

622522

147

0100200300400500600700

Abno

rmal

Tox

icity

Test

Pyro

gen

Test

Iden

�ty

& P

oten

cyTe

st

Fig 4: TRENDS IN SAMPLES RECEIVED FOR QC EVALUATION

2009-10 2010-11 2011-12 2012-13 2013-14

188

1860 22222802

9417

0

2000

4000

6000

8000

10000

2009-10 2010-11 2011-12 2012-13 2013-14

Fig 5: TRENDS IN NUMBER OF ANIMAL ISSUED FOR QC EVALUATION

84


7. infrastructural facilities:

The Animal Facility designed by National Institute of Health, USA has a total area of 4700 sq meter with approx 1200 sq. meter on each floor and additional support area of 1100 sq meter on ground floor. The animal rooms occupy about 50-60 % of the total area. 10-12% each is for washing area and storage. Quarantine and corridors occupies 12-15% area whereas 4-5% is for utilities.

The ground floor of animal facility has a hos-pital room well equipped with surgical table, designated quarantine rooms and sick bays for housed animals. Separate receiving and storage areas have been designed for dry and fresh feed, bedding material and storage of cages and racks. Cold room (2-8º C) has been provided for storage of carcass of dead animals and animal tissue waste. The wash-ing and sterilization is done by mechanical washers and autoclaves equipped with mi-croprocessor control system. In addition ground floor has staff room, locker rooms, showers and toilets for the animal care staff.

First floor has rooms designated for holding experimental animals of different species i.e mice, rat, guinea pig and rabbit as well as for holding animals for different experiments.

The second floor of the animal facility has designated breeding rooms, stock rooms and quarantine rooms for mice, rats, guinea pigs and rabbits.

The animals are being maintained under controlled environmental conditions as specified in CPCSEA guidelines with tem-perature maintained between 22-25±2OC, relative humidity between 45-65%, timer controlled 10:14 hr light dark cycle and 12-15 air changes per hour with 100% fresh air.

8. Proposed Target for testing of new biologicals:

As central facility, Animal Facility will take

up mandatory in vivo testing required for new products taken up by various laborato-ries of NIB.

9. National Accreditation Board for Testing and calibration Laboratories (NABL) Accreditation of Biological Tests:

Animal Facility participated in the Surveil-lance-cum scope extension audit conducted by NABL experts on 14th & 15th September 2013.

10. Participation in Trainings/Workshops/conference:

Dr. shikha Yadav, scientist grade ii:

• AttendedTrainingon‘HealthSafetyandEnvironment (HSE) based on OHSAS 18001: 2007 and ISO 14001:2004 Envi-ronment Management System’ on 21st May 2013 organised by FICCI at NIB, Noida.

• Delivered talk on “Minimizing Pain &Distress in Laboratory Animals” in 8 day Internship program of students from DUVASU, Mathura organised by Na-tional Institute of Animal Welfare, Min-istry of Environment & Forest, Ballab-garh, on 18th June 2013.

• Attended Training on ‘Quality Assur-ance of test & Calibration results’ on 9-10th July 2013 organised by FICCI at NIB, Noida.

• Nominated by CPCSEA ,Delhi to per-form Inspection of Animal Facility of Ram-eesh Institute of Vocational & Technical Education, Greater Noida on 26th July 2013

• Attended Workshop:-‘BIRAC -CDSARegulatory Meet Demystifying Indi-an Regulations for Product approvals: Regulatory requirement for Biopharma-ceuticals from science to commerciali-zation” on 30-31st July 2013 at Indian Habitat Centre, Delhi.

85


• Attended “Certificate course in Labo-ratory Animal Science” meeting the requirements of Federation of Eu-ropean Laboratory Animals Scien-tists association (FELASA) Category C certification jointly organized by TANUVAS,CPCSEA,NIAW and LASA India from 14-23rd September 2013 at Madras Veterinary College, Chennai.

• Attended workshop on ‘Progression &Trends in Bacterial Endotoxin Detec-tion Technologies’ organised by Charles River Laboratories, India on 21-22nd November 2013 at Mumbai.

• Delivered lecture on “PerioperativeCare & Analgesia” in International Course on Laboratory Animals(ICLAS) on 25.November.2013 organised by IGIB, Delhi with Utrecht University ,Netherlands

• Deliveredtalkon“PainManagementinLaboratory Animals” on 20th December 2013 in two week training for B.Pharma students of NGSPM Nashik at NIAW, Ballabgarh, Ministry of Environment & Forest.

• Attended training on e-office on 26thDecember 2013 at NIB.

• Attended Training on Potency assay ofFSH hormone on 21-23rd January 2014 at Bioneeds, Bangalore.

• Delivered talk on “CPCSEA guidelinesfor laboratory Animal Facility & SOPs required” in 5 day training program for CPCSEA nominees organised by NIAW,

MoE &F on 5th February 2014 during visit at NIB.

• Attended workshop on “Review ofstability data submitted for market authorization” ,organised by CDSCO on 12.2.14 in Delhi

• Attended “National Symposium onAnimals and Alternatives in Life Science Research” at Banaras from 16-18th February 2014.

• Nominated as Member on IAEC’s ofDabur Research Foundation, Ghaziabad and Curadev Pharma Pvt Ltd, Noida by CPCSEA, Delhi.

Mr. Parmender Kumar, Jr. Animal caretaker:

• Sensitizationofsupportstaffoftheroutefor transportation of Biomedical Animal House waste to hold Area.

11. Training imparted:

• OrganizedonedayTrainingsfor47nosCPCSEA Trainees at Animal Facility, NIB in collaboration with National Institute of Animal Welfare, Ministry of Environment and Forests, Ballabgarh in 4 batches, details of which are provided below.

s.No. Date of Training No. of Trainees1 28.05.2013 072 12.06.2013 093 18.06.2013 114 05.02.2014 20

Total 47

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1. 1. Name of Head: Sh. A.K. Sahu, Scientist Grade-II (till 30th

December, 2013) Sh. Neeraj Malik, Scientist, Grade-III (w.e.f.

7th January, 2014)

2. Manpower in the Lab/ division:


Mr. Subhash Chand, Junior Scientist

ii. Name of Technical and supportive staff:

Mr. Kallol Saha, Lab. Technician

iii. contractual Manpower: four

3. Aim and scope:

The Sterility Test Laboratory of Bio-Assay Division is a Central Facility equipped to test the various Biologicals referred to it for sterility testing and NABL Accredited in accordance with the standard ISO/IEC 17025;2005 in the field of biological Testing. The various laboratories of the Institute which are currently referring its samples are Recombinant Products, Blood Products,

Enzyme and Hormones, Viral Vaccine and Bacterial Vaccine Laboratories.

The products referred are tested by Direct Inoculation or Membrane Method (Closed Sterility Test Method) as per IP, USP, EP and other pharmacopoeia and as advised by the referring laboratory.

4. scientific activities undertaken during the reporting year:

Performed sterility test by Direct Inoculation or Membrane filtration method as per IP, USP, EP and other pharmacopoeia, for different Biologicals products referred.

Each Sterility test is supported by the Growth promotion test for media used in sterility test and Control test as per the Pharmacopoeia.

An environmental Monitoring Programme initiated for the Microbial monitoring of Clean Rooms to check the bioburden of clean rooms and other classified area of NIB. The different microbial strains isolated & characterised for their morphological & biochemical properties.

Vii. steRiLitY LABoRAtoRY, Bio-AssAY DiVisioN

5. Testing of biological:

Name of manufacturer/ importer

Name of the product No. of batch received and evaluated


No. of batches not found to be of standard

Remarks

Novo novardis,Eli Lilly

Recombinant Products (Insulin, Interferon, Erythropoietin, GSF )

400 400 Nil

Baxter, CSL Behring, Biotest,El-shaddai Biologicals Ltd.,BPL, Bharat Serum

Blood Products (Albumin, Human Normal Immunogllobulin, Antithrombin, coagulation Factor, etc)

556 556 Nil

LG Life Sciencies ltd, Enzymes & Hormones(Steptokinase, hCG, FSH, HMG, urokinase, Heparin)

68 68 Nil

87


Serum Institute of India, Sanofi Pasteur

Bacterial Vaccines (BCG, Meningococcal polysaccharide Vaccine, HibPro, Typhim Vi)

7 7 Nil

Chiron behring vaccine Pvt ltd, Serum Institute of India, GSK, Biologicals Evans.

Viral Vaccines and Immunosera(Cell Culture Rabies Vaccine, MMR, Measles, Rubella, JEV, IPV, HPV, Hep. B Immunoglobulin & Rabies Immunoglobulin)

101 101 Nil

Total 1132 1132 NiL

400, 35%

556, 49%

68, 6%7, 1%101, 9%

Samples Tested for Sterility (FY 2013-14)

RP BP E&H BV VV

“graphical representation of Different product types referred for sterility test in financial Year 2013-14.”

6. Trend in volume of work as compared to previous year 2011-12, including examination of technical dossiers in the following figures 35 & 36:

6952 44

7057 50

81

5269 72

126

155

163

5772

122

91 87

123105

78

116

61 57

020406080

100120140160180

No. o

f sm

ples

Month

Sample Received in Year 2012-13 & 2013-14

Samples Received in Year 2012-13 Samples Received in Year 2013-14

88


0

200

400

600

800

1000

1200

145

428

598

897

1132

2009-10 2010-11 2011-12 2012-13 2013-14

“graphical representation of the samples tested in sterility Lab from 2009-2014”

7. infrastructural facilities- existing and newly developed: Existing facilities:

• Sterilitytestarea(ModuleNo.L0013,L0014,L0015A)• Growthpromotiontest(L0044A)• MediaPreparation&pouring(L0042andL0040))• WalkinIncubatorsRoom(L0017)• EnvironmentalMicrobiologyLab(L0018)

8. Proposed targets for testing of new Biological and Biotherapeutics being undertaken or likely to be undertaken:

As per the different Product referring Laboratories.

9. NABL accreditation of biological and chemical tests:

NABL Accredited in accordance with the standard ISO/IEC 17025 : 2005 in the field of biological Testing(Certificate no. T-2011).

10. Participation in Proficiency Test/ EQAs:

intra Laboratory comparison: Sterility test as per the pharmacopoeia prescribed, for positive and negative media controls. Positive controls include the different dilution of reference culture strains.

11. Detail of participation in cgMP inspection: As per QA programme.

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12. Any other relevant information to be published in the annual report, such as training imparted to post graduate and other students:

Training is imparted in Six Months Dissertation Program for one student. Detail of training Im-parted to Students:

s. N. Name of student Duration /Topic 1. Mr. Prashant Sharma 10th Jan- July, 2013.

Morphological & Biochemical characterisation of Microflora isolated from Clean Rooms in An Environmental Monitoring Programme.

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Viii. ALLeRGeN testiNG LABoRAtoRY

1. Name of Laboratory Head:

Dr. G.R.Soni, Scientist Grade-I (Up to 20.12.2013)

Dr. Achla Prasad, Scientist Grade-II (w.e.f. 20.12.2013)


Name of scientific staff:

Dr. Sanjay Mendiratta, Jr. Scientist

contractual Manpower: Three

3. Aim and scope:

Recognition of the importance of standardization of diagnostic and therapeutic extracts has steadily gained ground over the past decades. Optimal safety of immunotherapy was originally the main driving force behind the efforts to improve standardization.

The number of patients suffering from allergy and asthma is increasing rapidly in both the urban and rural regions of India. According to World Allergy Organization 20-30% of people in India are suffering from one or more allergic diseases and about 25 percent of population, including children, suffers with respiratory allergy. Because the prevalence of allergy has increased to such an extent, allergy must be regarded as a major healthcare problem. For identification of offending allergens in these patients, various diagnostic tests are performed which is followed by administration of immunotherapy with the causative allergens. Both, the diagnostic efficiency as well as therapeutic efficacy of these procedures depends on the bio-potency of these allergen extracts.

Presently, in India, patients are diagnosed and treated with crude, aqueous allergen

extracts, which have not been properly characterized or standardized, because procedures and reagents are not available for their quality control. Moreover, there is no monograph available on Allergens except European Pharmacopoeia which may not be applicable in Indian context. Therefore, there is an urgent need to undertake a systematic and comprehensive work to develop techniques, prepare reference reagents and generate parameters for their quality control.

Considering the above facts and in view of the mandate of National Institute of Biologicals (NIB), work on allergens is undertaken to i) identify, isolate, purify and characterize major and minor allergens of clinically important indigenous allergen extracts, ii) prepare their database(s), and iii) develop methods and reagents for their quality control. This will enable us to lay down quantitative limits for their quality control. The preparation of in-house reference allergen extracts along with allergen standardization shall also help in ensuring uniform bio-potency in allergen extracts marketed by various manufacturers in India. This will facilitate availability of allergen extracts of appropriate bio-potency for better patient care in our country i.e. the diagnosis and immunotherapy of allergy patients. To begin with two clinically important allergens, namely cockroach (P. americana) and Moth, were selected in a consultative meeting of experts held at NIB.

4. scientific services undertaken, including name and no. of quality control tests performed for each biological product as per the pharmacopoeia.

There is no monograph available in Indian Pharmacopoeia on allergens.

Project entitled “Development of Techniques and Reagents for Quality Control of Clinically Important Indigenous Allergen Extracts” was

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undertaken for standardization of Allergen extracts in India. The proposed work was undertaken in collaboration with Metro Hospital Noida. The ethical clearance has been obtained from fourth IHEC meeting held on Mar 25th, 2014.

Standardization of tests like Protein estimation, Carbohydrate estimation, SDS-PAGE, ELISA &Western Blotting etc. is being done as per published literature.

5. immunochemical Tests with Allergen Extracts:

5.1 Preparation of cockroach Extracts: A total of six Cockroach Whole body extracts

(E1, E3,E5,E7,E8,E9) were prepared using ammonium bicarbonate precipitation, defatting with diethyl ether, extraction in NH4HCO3, dialysis (Mol. cut off 3.5kD), filtration and lyophilization. The freeze dried extracts were further used for performing various immunochemical assays.

5.2 Protein Estimation in the extract of Periplaneta americana (Cockroach): Protein content in all of six extracts were determined using standardized Modified Lowry method with BSA as standard. Figure 1 below represents standard curve for determination of protein content in extract E3& E5.

figure 1: The figure shows the standard curve generated by using different concentrations

of BsA as standard showing linear relationship between concentration and absorbance. concentration of extract sample was determined from the standard curve.

5.3 Estimation of carbohydrate content in the extract of Periplaneta american (cockroach):

The anthrone reaction is the basis of a rapid and convenient method for the determination of carbohydrates, either free

or present in polysaccharides. Carbohydrates are first hydrolysed into simple sugars using sulphuric acid. In hot acidic medium glucose is dehydrated to hydroxymethyl furfural. This compound forms with anthrone a green coloured product with an absorption maximum at 630 nm.

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Anthrone method for estimation of carbohydrate content was standardized and validated. A total of 41 experiments were performed for estimation of carbohydrate

content and repeated five times to validate the results for each extract (n=6). The glucose was used as standard at 10, 20, 30, 40, 50µg/ml concentrations.

figure 1: The figure shows the standard curve generated by using different concentrations of glucose as standard showing linear relationship between concentration and absorbance. concentration of extract sample was determined from the standard curve.

5.4 sDs PAgE analysis of allergen extract: The allergen extracts of Periplaneta americana were subjected to Sodium Dodecyl Sulfate Poly Acrylamide Gel Electrophoresis (SDS-PAGE) to study their protein profile and determine molecular weights. (Figure 3). SDS-PAGE was run with different percentages of resolving acrylamide gel viz. 7.5, 10, 12, 15 % and best

resolution was obtained with 10% resolving gel. SDS-PAGE was performed with different protein contents /well (10 µg, 20µg, 30 µg, 40 µg, & 60 µg,) to determine optimal concentration of protein for obtaining best resolution. A protein content of 40ug/well was found to give optimal band resolution in the gel.

93


figure 3: Protein profile of different extracts of Periplaneta americana ( E1, E3, E5, E7,E8 & E9) using 40ug protein /well along with molecular weight markers.

5.5 ELisA for determination of specific igE in sera samples: Indirect ELISA tests (n=28) were per-formed to determine specific IgE for Cockroach allergens in sera of 54 normal healthy volunteers and 10 Cockroach Skin Prick Test (SPT) positive patients. The major findings of ELISA tests are summarised below:

l Experiments performed: n= 28

l Cockroach Extracts used: E1 and E5

l Optimal Ag coating conc. 1µg/100 µl/well

(in ten experiments)

l Screening of Normal healthy volunteers NHV 25, 27, 51 found reactive

(NHV): 1 to 54

l Screening of Cockroach SPT positive: CP 5,6, &7 found non- reactive

cP 1 to 10

5.6. Western Blotting:

Western Blotting (also called Immunoblotting) is a technique used for analysis of individual proteins in a protein mixture. Standardization of western blotting was undertaken to identify major allergen/s and minor allergens in the cockroach

extract/s. Major allergens are defined on the basis of frequency of recognition by serum IgE antibodies; that is, a frequency of greater than 50% justifies a designation as a major allergen. Due to limited patient sera, commercial sera with cockroach specific IgE were procured from Plasma International lab, USA for preliminary standardization.

94


The key findings of Western Blot are summarized below:• Number of Experiments n=6• ExtractTested: E1,E3,E5,E7,E8• SPT+veSampleTested: CP2,CP5,CP10(n=3)• CommercialseraTested: CS1,CS2,CS3(n=3)• Seradilutionstried: 1:3,1:5,1:10,1:20• Optimizedseradilution: Samples-1:3;CS1-1:10• CurrentStatus: Standardized

Identification of major and minor allergens for Indian population will be undertaken with SPT positive patient sera.

figure 4: Results of Western Blot obtained with three commercial sera positive for cockroach igE.

5.6 isolation and purification of Major allergen using fPLc:

Upon identification of major and minor allergen Isolation and purification of atleast one major allergen will be undertaken using FPLC.

6. Testing of Biologicals: Testing parameters under standardization.

7. Trend in volume of work as compared to previous year:

7.1 Six more cockroach extracts were prepared

7.2 In addition to Protein estimation & SDS Page following immunochemical tests were also performed and standardised on all six extracts. • Carbohydrateestimation• ELISAfortotalIgEactivityincontrol

& patient sera• WesternBlotting

Correspondence with CDSCO for constitution of an expert committee on Allergen Standardization is in process to oversee and formulate quality control of

95


allergens used in allergy diagnostics and therapeutics in India.

8. infrastructural facilities- existing and newly developed: Allergen Lab is a new lab established to develop quality control mo-dalities for Allergen immunodiagnosis and therapy. Preliminary testing parameters, as per published literature have been initiated/ standardized. The test parameters and other modalities in this regard will be finalized in consultation with an expert committee being constituted by DCG(I). Necessary commu-nication with DCG(I) in this regard has been done by NIB.

9. Proposed targets for testing of new Biological and Bio therapeutics being undertaken or likely to be undertaken:i. Expansion of network for sera collectionii. Identification of Major and Minor Aller-

gens iii. Standardization of isolation and purifi-

cation of at-least one Major allergen us-ing FPLC

iv. Initiation of work on Moth allergens w.e.f Sept 2014

v. Capacity building through expert com-mittee meetings and relevant exposure of lab staff

vi. Interaction with manufacturers of aller-gen diagnostics kits & allergen extracts (therapeutic & diagnostic)

10. Participation in training/ Workshop/ conference:

Dr. Achla Prasad:

• Deputed for Training at NationalReference Centre of Respiratory Allergy, Asthma & Applied Immunology, Department of Respiratory Allergy & Applied Immunology, Vallabhbhai Patel Chest Institute, New Delhi for the period Dec 02 to Dec 06, 2013 in the field of “Allergy Diagnosis and Management”.

• Deputedfor4-daysTrainingprogramonLaboratory Management System (LMS) ISO/IEC 17025 conducted by FICCI (Nov, 5-8, 2013).

• Proposal for International Training onAllergen Standardization submitted.

• TrainingprogramoneOfficesystemonDec. 23, 2013 at NIB, NOIDA

Dr. sanjay Mendiratta:

• DeputedforTrainingatNationalRefer-ence Centre of Respiratory Allergy, Asth-ma & Applied Immunology, Department of Respiratory Allergy & Applied Immu-nology Vallabhbhai Patel Chest Institute, New Delhi for the period Dec 02 to Dec 06, 2013 in the field of “Allergy Diagnosis and Management”.

• TrainingprogramoneOfficesystemonDec. 23, 2013 at NIB, NOIDA.

11. Miscellaneous scientific/ Academic Activities, including interaction with manufacturer or importer of biological:

1. Expert committee being constituted by DCG (I) for scientific deliberations re-garding QC of allergens in India.

2. Correspondence with manufacturers/importers of allergens and diagnostic kits being done through DCG (I) Viz. i. All Cure Pharma (P) Ltd.ii. Alcit India (P) Ltd.iii. Cure Well India Ltd.iv. Creative Drugs Industries.

Allergen Kits in india:v. Lilac Medicare, Mumbai vi. Omega Dx (Asia) Pvt. Ltd, Mumbaivii. CPC Diagnostics Pvt. Ltd., Chennaiviii. M/s Phadia GmbH, Germanyix. M/s Merck Specialties Pvt Ltd.

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1. Name of Head:

Dr Reba Chhabra, Scientist Grade II

2. Manpower in the Lab/ Division:


Ms Ajanta Sircar, Scientist Grade III

ii. Name of Technical & supportive staff: Brij Bahadur, Lab Technician

iii. contractual Manpower: four

3. Aim and scope:

The Biochemical Kit Laboratory has been engaged in the evaluation of Self-Monitoring of Blood Glucose (SMBG) devices such as Glucometers - Blood Glucose test Strips with a mandate to evaluate the intrinsic quality in terms of accuracy/specificity so that diagnostic accuracy and reliability of the values reported by such test devices could be assured. The laboratory also has the capacity to evaluate related product such as fully automated analyzer based Glucose reagent. The laboratory has referred to the Clinical Laboratory Standards Institute (CLSI) guidelines, International Standards Organization (ISO) 15197 guidelines and the WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002 for developing the experimental design, data generation and statistical analysis for evaluating the recommended QC parameters; precision, accuracy, linearity, and range. The particulars of testing and the ‘Acceptance criteria’ based upon calculation of ‘Allowable

Total Error’ limits have been vetted by an experts group constituting members from the CDSCO, members coordinating the program related to systemic disorders and health care in the ICMR, members who are experts in the field, members from WHO, IPC and members from the industry. The offices of the DCG(I) and the ADC(I) have been forwarding batches of the said products to the Biochemical Kit Laboratory for evaluation since November 2010.

Standardization of Laboratory Reference Method for evaluation of newer biological products such as HbA1c Test Kits, point of care devices and Reagent Kits for cardiac parameters; Cholesterol, Triglycerides, LDL and HDL has been completed. Method validation for QC testing of the same is awaited pending availability of survey sample.

Currently, the major functions of the laboratory are:

a) Evaluation of ‘point of care’ testing devices as Glucometers + strips

b) Quality control testing of Biochemical Kits (fully automated analyzer based Glucose Re-agents)

• Scientificservicesundertaken:Batchesoffully automated analyzer based Glucose reagent and Blood glucose Test strips were tested for parameters as shown in following table. The methodology for the same was developed as per the source shown in the column ‘Reference’.

iX. BioChemiCAL kit LABoRAtoRY

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Product Evaluated Parameters tested ReferenceFully automated analyzer based Glucose Reagent

Linearity and Range

Allowable Total Error Limits

Clinical Laboratory Standards Institute Guideline No.EP6-A, Vol23, No.16Clinical Laboratory Standards Institute Guideline No.EP5-A2, Vol 24, No.25

Clinical Laboratory Standards Institute Guideline No.EP9-A2, Vol 22, No.19

Blood Glucose Test Strips + Glucometers

Intermediate Precision

Repeatability

System Accuracy

Bias

ISO Guideline No. 15197

WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus


s No. Name of Manufacturer/ importer Name of Product No. of batches received evaluated



remarks

1 M/s Biotest Medical Corp., Taiwan / M/s Microgene Diagnostics Systems Pvt. Ltd, New Delhi, India

Smartest Persona Glucose Monitoring System Test Strips

1 1 -

2 M/s OK Biotech Co. Ltd., Taiwan / M/s Soyuz Healthcare Pvt Ltd., New Delhi, India

Easy Prik Basic Blood Glucose Test Strips

1 1 -

3 M/s OK Biotech Co. Ltd., Taiwan / M/s Microgene Diagnostics Systems Pvt. Ltd, New Delhi, India

OK Biotech Blood Glucose Test Strips

1 1 -

4 M/s Major Biosystem Corp., Taiwan / M/s Aspen Diagnostics Pvt. Ltd., Delhi, India

Glucochek Blood Glucose Test Strips

4 4 -

5 M/s Bioonime Cormporation, Taiwan / M/s Morepen Laboratories Ltd., Delhi, India

Dr. Morepen Gluco-One Pro Blood Glucose Test Strips

1 1 -

6 M/s Tianjin Empecs Medical Devices Co. Ltd, China / M/s Morepen Laboratories Ltd., Delhi, India

Dr. Morepen Gluco-One Blood Glucose Test Strips

1 1 -

7 M/s TaiDoc Technology Corp., Taiwan / M/s Morepen Laboratories Ltd., Delhi, India

Dr. Morepen Gluco-One Blood Glucose Test Strips

1 1 -

8 M/s Infopia Co. Ltd., Korea/ M/s Morepen Laboratories Ltd., Delhi, India

Dr. Morepen Easy Gluco Blood Glucose Monitoring System BG-01

1 1 -

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9 M/s TaiDoc Technology Corp., Taiwan / M/s Accurex Biomedical (p) Ltd., Tarapura, India

Clever Chek Blood Glucose Test Strips

1 1 -

10 M/s TaiDoc Technology Corp., Taiwan / M/s Saify Traders, Indore, India.

Smartcare Blood Glucose Test Strips

1 1 -

11 M/s TaiDoc Technology Corp., Taiwan / M/s Medsource Ozone Biomedicals (p) Ltd., Delhi, India.

U-Right TD-4285 Blood Glucose Test Strips

1 1 -

12 M/s TaiDoc Technology Corp., Taiwan / M/s Wockhard Ltd., Mumbai, India.

Sugarchek Glucose Test Strips

1 1 -

13 M/s HMD Biomedical Inc. Taiwan / M/s El- Shaddai Biologicals, Chennai, India

El – Sure Smart Blood Glucose Test Strips

1 1 -

14 M/s B Braun Medical Industries, Malaysia / M/s B Braun Medical (India) Pvt. Ltd, Mumbai, India

Omnitest EZ Blood Glucose Test Strips

1 1 -

15 M/s EPS Biotechnology Corp., Taiwan / M/s Easymax Lifecare Pvt. Ltd., Chennai, India

EasyMax Glucose Test Strips

1 1 -

16 M/s Abbott Diabetes Care Ltd., UK / M/s Abbott Healthcare Pvt. Ltd., Mumbai, India

FreeStyle Optium H Blood Glucose Test Strips

1 1 -

17 M/s Abbott Diabetes Care Ltd., UK / M/s Abbott Healthcare Pvt. Ltd., Mumbai, India

FreeStyle Optium Blood Glucose Test Strips

1 1 -

18 M/s Bayer Healthcare LLC, USA/ M/s Bayer Pharmaceuticals Pvt. Ltd., Thane, India

Breeze 2 Blood Glucose Test Strips

1 1 -

19 M/s Bayer Healthcare LLC, USA/ M/s Bayer Pharmaceuticals Pvt. Ltd., Thane, India

Ascencia Entrust Glucose Test Strips

1 1 -

20 M/s Roche Diagnostics Inc., U.S.A/ M/s Roche Diagnostics India Pvt. Ltd., Mumbai, India

Accu Chek Sensor Comfort Blood Glucose Test Strips

1 1 -

21 M/s Roche Diagnostics, GmbH, Germany/ M/s Roche Diagnostics India Pvt. Ltd., Mumbai, India

Accu Check Active Test Strips

5 5 -

22 M/S Roche Diagnostics, GmbH, Germany/ M/s Roche Diagnostics India Pvt. Ltd., Mumbai, India

Accu Check Integra Blood Glucose Test Strips

1 1 -

23 M/S Roche Diagnostics, GmbH, Germany/ M/s Roche Diagnostics India Pvt. Ltd., Mumbai, India

Accu Check Go 1 1 -

24 M/s Life Scan Scotland Ltd., UK/ M/s Johnson& Johnson Ltd., Chennai, India

One Touch Ultra Blood glucose Test strips

3 3 -

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25 M/s Life Scan Scotland Ltd., UK/ M/s Johnson& Johnson Ltd., Mumbai, India

One Touch Ultra Blood glucose Test strips

2 2 -


One Touch Horizon Blood glucose Test strips

1 1 -


One Touch Horizon Blood glucose Test strips

1 1 -


One Touch Select Blood glucose Test strips

3 3 -


One Touch Select Blood glucose Test strips

1 1 -

30 M/s Life Scan LLC, Rico, USA/ M/s Johnson& Johnson Ltd., Chennai, India

One Touch Sure Step Blood glucose Test strips

1 1 -

31 M/s Life Scan LLC, Rico, USA/ M/s Johnson& Johnson Ltd., Mumbai, India

One Touch Sure Step Blood glucose Test strips

2 2 -

32 M/s Arkray factory Ltd., UK/ M/s Arkray Healthcare Pvt. Ltd., Mumbai

Arkray Glucocard sensor test strips

1 1 -

33 M/s Arkray Inc. USA / M/s Arkray Healthcare Pvt. Ltd., Mumbai

Arkray Glucocard sigma test strips

1 1 -

34 M/s Del Bio, Inc., Taiwan / M/s Omron Healthcare India Pvt. Ltd., Gurgoan, India

Omron Blood Glucose Test

3 3 -

35 M/s Del Bio, Inc., Taiwan / M/s Delta India Electronics (p) Ltd., New Delhi, India

Dia-Chek Blood Glucose Test Strips

1 1 -

36 M/s Acon Biotech (Hagzou) Co. Ltd., PRC/ M/s Kriya Design Technologies Pvt. Ltd., Chennai, India

On Call Plus Blood Glucose Test Strips

1 1 -

37 M/s Bioptik Technology Inc., Taiwan/ M/s Aspen Diagnostics Pvt. Ltd., New Delhi

Easy Touch Blood Glucose Test Strips

3 3 -

100


China, 1Korea, 1

Taiwan, 21

Germany, 5

USA, 8

UK, 14

PRC, 2Malaysia, 1

GLOBAL DISTRIBUTION OF BLOOD GLUCOSE TEST STRIPS EVALUATED AT NIB

5. Trend in volume of work as compared to the previous year (2012-2013), including examination of technical dossiers:

• Since November 2012, the laboratoryhas additional manpower (two Bench Biologists & two Lab Attendants) and is in a position to evaluate up to 120 batches of Blood Glucose Test Strips and 120 batches of Glucose Reagent. But only 54 batches of Blood Glucose Test Strips were received and evaluated during this financial year.

• The Laboratory has completedstandardization of ‘Reference Method’ for glycosylated hemoglobin A1c (HbA1c) and for Cholesterol, Triglycerides, HDL-Cholesterol and LDL-Cholesterol. IQC for these methods demonstrate ‘Process In- Control’ with the ‘Precision’ values falling within acceptable limits of variation.

• For these parameters, the laboratoryhas also participated in inter-laboratory comparison (ILC) and successfully implemented the use of the statistical tool of calculating Z- score (a robust statistical technique taught vide a training program by FICCI) for analyzing the data. BKL has also successfully participated in the

ACBI- CMC Vellore, External Quality Assurance program for validating the ‘Accuracy’ of these methods and completed one year cycle.

• Apart from the routine testing, thelaboratory has also completed a study on effect of different storage conditions on the concentrations of Cholesterol, Triglycerides, HDL-Cholesterol and LDL-Cholesterol in serum samples, in order to explore the possibilities of preparation and long-term shelving of a Serum Panel for Lipid profile.

6. infrastructure facilities- existing and newly developed:

The laboratory is equipped with the instrument; a fully automated biochemical analyzer and other basic facilities like under- counter Freezers, a Bio-safety Cabinet, Electronic pH meter, a Fume Hood, and a walk- in Cold Room/ -20°C Freezer for storing patient samples and Biochemical Kits and reagents.

7. Proposed target for testing of new Biologicals:

Standardization of ‘Reference Method’ for quantitative ELISA based kits for PSA

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(Prostate specific antigen) and CA125 (Breast Cancer Antigen) is proposed for the coming year. The laboratory would like to participate in External Quality Assurance program conducted by any authorized body.

8. NABL accreditations of Biological and chemical tests:

BKL has been assessed and accredited in accordance with the standard ISO/IEC 17025:2005 for QC testing of its two products viz. Blood Glucose Test Strips and Fully Automated Analyzer based Glucose Reagent.

9. Participation in proficiency testing/ EQAs:

The laboratory is presently enrolled into the ACBI/ CMC External Quality Assessment Scheme (EQAS) - 2014 for Chemistry and HbA1c, conducted by the Department of Clinical Biochemistry, Christian Medical College, Vellore.

10. Training/ workshop/ conference organized:

Trained a B Tech (Biotechnology) 3rd year student on aspects of QC Testing of Blood Glucose Test Strips between 28.5.2013 to 12.7.2013.

11. Participation in Training / Workshop / conference:

• NameoftheTraining: Quality Assurance Requirements of ISO/IEC

17025 & chemical and Biological Testing Laboratories.

Trainee : Ms. Ajanta Sircar, S-III & In-charge, BKL Date : 9-10 July, 2013 Venue : NIB, NOIDA Organizers : FICCI

• NameoftheTraining:

Online Inventory module

Trainee : S-III & Lab. Tech Date : 17th Jun 2013 Venue : NIB, NOIDA Organizers : NIB

• NameoftheTraining: e-Office System (e-file, e-Tour, CAMS, KMS) Trainee : Ms. Ajanta Sircar, S-III , & In-charge, BKL Date : 26th Dec 2013 & 21st Apr, 2014 Venue : NIB, NOIDA Organizers : NIB

• NameoftheTraining: Liquid handling calibration device &

Automatic powder and liquid dosing instruments.

Trainee : Lab. Tech. & Bench Biologist

Date : 11th March, 2014 Venue : NIB, NOIDA Organizers : Mettler Toledo

• NameoftheTraining: Awareness training on Health safety and

Environments. Trainee: Lab. Tech. & Bench Biologist Date : 21st May, 2013 Venue : NIB, NOIDA Organizers : NIB

12. Miscellaneous scientific/ Academic Activities, including interactions with manufacturer or importer of biologicals:

The BKL was a participant in a meeting of the “Experts Committee to examine the ‘Specifications’ and ‘criteria for acceptance’ for tests performed on ‘Blood Glucose Tests Strips’ and ‘Analyzer based Glucose Reagent’ held on the 5th of July 2013 at CDSCO, FDA Bhavan, Kotla Road, New Delhi- 110002

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1. Name of Head:

Mr. A. K. Sahu - Scientist Grade-II (till 30.12.2013)

Mr. N. Malik - Scientist Grade-III (w.e.f. 07.01.2014)

2. Manpower in the lab/division:


Ms. Gurminder Bindra (Scientist Gr. III)

Ms. Shalini Tewari (Scientist Gr. III)

Dr. Manjula Kiran (Junior Scientist)

Mr. Subhash Chand (Junior Scientist)

ii. Name of Technical & supportive staff:

Mr. Jaipal Meena - Lab Technician

iii. contractual Manpower: Eight

3. Aim and scope:

Viral Vaccine Laboratory has been established with the aim to evaluate and ensure that the vaccines and antisera produced, distributed and imported into the country are safe, efficacious and potent. The scope is:

• To develop linkage with other national/international institutions and keep abreast with worldwide scientific research and technological developments in production and quality control of viral vaccine and antisera with a view to advising on the suitability of their adoption.

• To develop technical guidelines/ manualson standards to be used by manufacturers and to undertake research on various immunobiologicals using multidisciplinary integrated approach.

• Providing training facilities in qualitycontrol testing of viral vaccine and antisera for personnel of related institutions including testing and manufacturing units and six month dissertation project for post graduate students (M.Sc. & B. Tech) of various universities is also formed as an indispensable part of its activities.

4. scientific services undertaken:

Viral Vaccine laboratory is currently involved in the quality evaluation of Human Rabies Immunoglobulin (HRIg), Hepatitis B Immunoglobulin (HBIg; I/V, I/M) for batches forwarded by the office of DCG (I).

The Laboratory has standardised the quality control testing of Live attenuated MMR vaccine, Live attenuated Measles vaccine, Live attenuated Rubella vaccine, Cell Culture Rabies Vaccine (CCRV). QC Tests for Japanese Encephalitis vaccine (JEV), Inactivated Polio Vaccine (IPV) and Human Papilloma virus vaccine (HPV) are under standardization.

The test parameters for the various biologi-cals carried out in the lab as per the pharma-copoeia/WHO-TRS are enlisted in the table below.

X. ViRAL VACCiNe LABoRAtoRY

103


Name of the product Quality control testHuman Rabies Immunoglobulin (HRIg)

1. Potency2. Sterility3. Abnormal Toxicity4. Pyrogen5. Total Protein

6. Protein composition7. Molecular size distribution8. pH 9. Viral marker

Human hepatitis B Immunoglobulin (HBIg) for I/M Administration

1. Potency 2. Sterility3. Abnormal toxicity4. Pyrogen 5. Total protein

6. Protein Composition7. Molecular size distribution8. pH9. Viral Markers

Human hepatitis B Immunoglobulin (HBIg) for I/V Administration

1. Potency 2. Sterility3. Abnormal toxicity4. Pyrogen 5. Total protein

6. Protein Composition7. Molecular size distribution8. pH9. Osmolality10. Viral Markers

Live attenuated MMR (Measles, Mumps, rubella) vaccine

1. Identification2. Potency3. Stability

4. Sterility5. Abnormal Toxicity6. Moisture content

Live attenuated Measles vaccine



Live attenuated Rubella vaccine



Cell Cultured Rabies vaccine (CCRV)

1. Potency2. Virus inactivation3. Sterility4. Abnormal toxicity

5. Pyrogen6. Bacterial endotoxin7. Moisture content

Japanese Encephalitis Vaccine

1. Potency2. Sterility3. Abnormal Toxicity

4. Bacterial Endotoxin Test5. Free Formaldehyde 6. Aluminium content

Inactivated polio vaccine (IPV)

1. Potency by D Antigen assay 2. Rat Potency assay3. Sterility 4. Free Formaldehyde

5. Protein content6. Bacterial Endotoxin7. Volume checking

Human Papilloma virus vaccine (HPV)

1. Identity HPV-16 L1 VLP2. Identity HPV-18 L1 VLP3. Potency HPV- 16 LI VLP4. Potency HPV- 18 LI VLP5. Potency (In- Vivo)

6. Sterility7. Volume8. Aluminium Content9. Bacterial Endotoxin

104


5. Testing of Biologicals:Name of the product

Name of manufacturer/ Importer

Name of the product


No. of batches found to be standard

No. of batches not found to be standard

Remarks

PAFC, China

Human Rabies Immunoglobulin

03 received in Mar 13 03 evaluated in Apr 13

03 Nil

Regu

lato

ry sa

mpl

es

Kamada Ltd., Israel

02/02 02 Nil

CSL Behring, Germany

02/02 02 Nil

Biotest Pharma Gmbh Germany

Human hepatitis B Immunoglobulin, I/V

03/03 03 Nil

Chengdu Rongsheng China, Harbin Pacific China Human hepatitis B

Immunoglobulin, I/M

02/02 02 Nil

CSL Behring GmbH, Germany

01/01 01 Nil

Green Cross Corp. Korea

03/03 03 Nil

Name of manufacturer/ Importer

Name of the product


No. of batches found to be Remarksstandard not standard

Serum Institute of India, Pune

MMR Vaccine • singledose• tendose

22 received from Apr 13 to Mar 14

25 evaluated of 42 received from Apr 12 to Mar 13

25 Nil

Service Samples


Live Attenuated Measles Vaccine • singledose• tendose


• 42evaluatedof42received from Apr 12 to Mar 13

• 09evaluatedof53received from Apr 13 to Mar 14

51 Nil

Service Samples & 10 batches under parallel testing with CDL Kasauli

105



Live Attenuated Rubella Vaccine• singledose• tendose


30 evaluated of 30 received from Apr 12 to Mar 13

30 Nil Service Samples & 10 batches under parallel testing with CDL Kasauli

Biological E., Hyderabad

Japanese Encephalitis Vaccine

NIL Standardization started for previously received 03 batches

Chiron Behring Vaccines Pvt Ltd, Ankleshwar

Cell cultured Rabies Vaccine (CCRV)

18 18 Nil 4 Batches are under Parallel Testing with CDL Kasauli

Zydus Cadila, Ahmedabad

20 batches received and are under standardization

- 3 Batches are under Parallel testing with CDL Kasauli


10 batches received and are under standardization -

- 3 Batches are under Parallel testing with CDL Kasauli

Glaxo Smithkline, Belgium.

Human Papilloma Virus vaccine (HPV)

4 batches received and are under standardization

-

Serum Institute of India, Pune.

Inactivated Polio Vaccine (IPV)

08 batches received from Apr13 to Mar 14

17 batches under standardization (9 batches received from Apr 12 to Mar 13)

-

6. Trend in volume of work as compared to previous year (2012-13), including examination of technical dossiers:

s. No. Name of the product

No. of batches evaluated for the period2012-13 2013-14

1. Human Rabies Immunoglobulin 07 batches 07 batches

2. Human hepatitis B Immunoglobulin, I/M & IV

12 batches 09 batches

3. Live attenuated MMR vaccine NIL 25 batches

4. Live attenuated Measles vaccine NIL 51 batches

106


5. Live attenuated Rubella vaccine NIL 30 batches

6. Cell Cultured Rabies Vaccine 02 batches 18 batches

7. Japanese Encephalitis Vaccine NIL Standardization started for previously received 03 batches

8. Human Papilloma Virus vaccine NIL Standardization started for previously received 04 batches

9. Inactivated Polio Vaccine NIL Standardization started for previously received 09 batches

107



The viral vaccine laboratory is well equipped for the quality control testing of viral vaccines and the immunoglobulins with dedicated modules and capacity to augment more vaccines.

108


8. Proposed targets for testing of new biologicals and Biotherapeutics being undertaken or

likely to be undertaken:

The proposed target for the standardization of newer vaccines is as below:s. No. Product/test Timeline

1 Inactivated Polio vaccine (IPV) Dec 2014

2 Japanese Encephalitis Vaccine (JEV) Mar 2015

3 Human Papilloma Vaccine (HPV) Jun 2015

4 Rotavirus vaccine Dec 2015

9. NABL accreditation of biologicals and chemical tests:

Viral Vaccine Lab has got assessed for NABL accreditation in Sep 2013 for CCRV, MMR, Measles, Rubella vaccine, Hepatitis B Immunoglobulin and Rabies Immunoglobulin testing.

Product NABL accredited tests

Biological chemical Hepatitis B Immunoglobulin 1) Sterility 1) Molecular size distribution

2) Abnormal toxicity 2) Assay for Protein

3) Pyrogen 3) pH

Rabies Immunoglobulin 1) Sterility 1) Molecular size distribution

2) Abnormal toxicity 2) Assay for Protein

3) Pyrogen 3) pH

4) Identification & Potency: Serum virus neutralization test

Cell culture rabies vaccine 1) Sterility 1) Moisture content

2) Bacterial endotoxin test 2) pH

3) Virus inactivation test

4) NIH potency

5) Abnormal toxicity

6) Pyrogen

109


MMR vaccine 1) Sterility 1) Moisture content

2) Identification

3) Potency

4) Stability

5) Abnormal toxicity Measles vaccine 1) Sterility 1) Moisture content

2) Identification

3) Potency

4) Stability

5) Abnormal toxicityRubella vaccine 1) Sterility 1) Moisture content

2) Identification

3) Potency

4) Stability

5) Abnormal toxicity

Inspection of Viral Vaccine Lab for notification as CDL was done in Dec 2013, where parallel testing (with CDL, Kasauli) for CCRV, Measles and Rubella vaccines is recommended.

WHO-NRA assessment for the LA and LR of viral vaccines is also scheduled for the end of the year 2014

10. PARTiciPATiON iN TRAiNiNg/WORKsHOP/cONfERENcE

NAME OF STAFF

TITLE VENUE DATE

Ms. Gurminder Bindra

Workshop on review of Stability data submitted for Market Authorization

Metropolitan, New Delhi 12.02.2014

WHO workshop on implementation of guidelines for lot releases of vaccines

Radisson, Ghaziabad 12.11.2013-14.11.2013

QC testing of Inactivated Polio Vaccine Serum Institute of India, Pune

22.04.2013- 26.04.2013

Ms. Shalini Tewari

Workshop on Review procedure adopted for evaluation of CMC as per module III of CTD and regulatory decisions taken thereof

CDL, Kasauli

07.03.2014- 08.03.2014

Fundamentals of Bioassay practices Novotel Convention Centre, USP, Hyderabad

03.03.2014

Potency testing of Japanese Encephalitis Vaccine

Biologicals E Ltd., Hyderabad

18.11.2013-22.11.2013

2nd international conference of pharmacoeconomics and outcomes research, organized by ISPOR-India chapter


09.10.2013-10.10.2013

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Ms. Shalini Tewari

BIRAC-CDSA regulatory meet demystifying Indian regulations for product approvals


30.07.2013-31.07.2013

Mr. Subhash Chand

The Vaccine India Summit 2014 Hyderabad 04.03.2014-06.03.2014


12.07.2013-19.07.2013

Mr. Jaipal Meena

QC testing of MMR vaccine Serum Institute of India, Pune

27.01.2014- 31.01.2014


12.07.2013-19.07.2013

Quality system managenemnt and internal quality audit as per IS/ISO 17025

FICCI, New Delhi

15.05.2013-18.05.2013

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Xi. BACteRiAL VACCiNe LABoRAtoRY (BCG)

1. NAME Of THE HEAD

Sh. A.K.Sahu - Scientist Grade-II (19th March2013 - 30th December 2013)

Sh. Neeraj Malik - Scientist Grade-III (7th Jan 2014 – Onwards)

2. MANPOWER iN THE LAB/DiVisiON:


Mr. Harit Kasana, Jr. Scientist

ii. contractual Manpower: four

3. AiM AND scOPE:

Bacterial Vaccine Laboratory is involved in Quality Control testing of Bacterial Vaccine viz. BCG and Polysaccharide vaccines. The laboratory has standardized all parameters for complete testing on BCG vaccine (Freeze-Dried) final product which include Identification, Count of Colony forming unit, Stability, Sterility, skin reactivity, Virulence and Moisture content from

various manufacturer of BCG vaccine, as per compendial procedures

Bacillus Calmette-Guerin (BCG) vaccine, one of the most widely used vaccine, is currently given at the birth to children in over 100 countries to prevent the milliary tuberculosis.

4. scientific services undertaken, including name and number of quality control test performed for each biological product as per pharmacopoeia, newer tests undertaken, interesting observations if any:

i. The standardization of QC parameters for final product of BCG vaccines has been performed as per Indian Pharma-copoeia (IP), European Pharmacopoeia (EP) and WHO, TRS 979, (2013).

ii. Standardization of the method for Iden-tification of BCG vaccine by multiplex PCR technique.


Name of the Manufacturer/ importer

Name of the product




Remarks


BCG Vaccine 14

All parameters have been standardized and are under validation.

These service samples have been received for validation and parallel testing

BCG Vaccine Laboratory, Guindy Chennai

BCG Vaccine 03

Green Signal biopharma private Ltd, Tamil- -Nadu

BCG Vaccine 08

6. Trend in volume of the work as compared to the previous year (2013-2014), including examination of the technical dossier:

112


05

1015202530

Year wise

No.

of b

atch

es re

ceiv

ed B

CG

va

ccin

e

Trend in the number of batches received for QC evaluation

2011-2012

2012-2013

2013-2014

0

1

2

3

4

5

2 5 8 11 14 17 20 23 26 29 32

Lesi

on d

iam

eter

in m

m

Test No.

Trend analysis of vaccine Vs reference in skin reactivity test

Neat Vaccine

1:10 dilution vaccine

1:100 dilution vaccine

Neat Reference

1:10 dilution reference

1:100 dilution reference

7. infrastructural facilities – existing and newly developed:

The laboratory is equipped with instruments viz. biosafety cabinet, Walk in Incubator & Walk in Cold room (+2-8°C), autoclave, Inspissator and other basic facilities. All the equipments are under annual maintenance contract (AMC) and calibrated as per schedule according to NABL requirements.

113


LJ Medium Flask (Culture)

Excessive Dermal Reactivity Test

8. Proposed target for testing of new Biologicals and Biotherapeutics being undertaken or likely to be undertaken:

BCG for Immunotherapy by December 2014.

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9. 9. NABL Accreditations of Biological and chemical tests:

Bacterial Vaccine Laboratory (BCG) is NABL accredited laboratory in accordance with the standard ISO/IEC 17025:2005 for chemical and Biological testing as per certificate number T-2010 (chemical) and T-2011 (Biological) for the following test:

i. Identificationii. Moisture Contentiii. Sterilityiv. Excessive dermal reactivityv. Virulence/safety

Bacterial Vaccine Laboratory has undergone CDL inspection by team of experts on December 12, 2013.

10. Participation in proficiency testing/EQAs:

Not available at present. The lab is ready to participate in PT as and when available at National /International level.

11. Preparation and supply of National standard(s), sera Panel:

The lab will take up the feasibility study for the reference standard preparation in collaboration with manufacturers and IPC.


Name of the Scientist

Name of the programme Duration Place of training/ Workshop

Mr. Neeraj Malik Visit of BCG vaccine facility at Serum Institute of India, Pune

18-19th Oct 2013 Pune

Mr. Neeraj Malik Workshop on implementation of WHO Guidelines for lot release of vaccines

12-14th November 2013

Delhi

Mr. Harit KasanaMs. SuchitraMs. Gunjan

Awareness training on Health Safety and Environment based on OHSAS 18001:2007, Ocupational Health and safety Management System and ISO 14001:2004 Environment Management System

21st May 2013 NIB, Noida

Mr. Harit KasanaMs. SuchitraMs. Gunjan

Operator Training on Cobas s201, Cobas TaqMan48 and Cobas Ampliprep/Cobas TaqMan

28-30th October 2013

NIB, Noida

Mr. Harit Kasana The Vaccine India Summit, 2014 4-6th March 2014 Hyderabad

13. Miscellaneous scientific/academic activities, including interaction with manufacturer or importer of Biologicals, if any:

Interaction with Indian Pharmacopoeia Commission, Ghaziabad for Expert Committee meeting on Biologicals (Vaccines) scheduled for 19th March 2014 attended by Mr. Neeraj Malik.

14. Any other revelant information to be published in the Annual Report, such as training imparted to Post graduate and other students:

S. No. Name of the Student Dissertation Topic1. Lavanyam Pathania (B.Tech, Biotechnology,

Shoolini University, Solan)Identification of BCG vaccine strains by conventional method and Multiplex PCR technique

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1. Name of Head:

Sh. A.K. Sahu, Scientist Grade-II (19th March 2013 - 30th December 2013)

Sh. Neeraj Malik, Scientist Grade-III (7th Jan 2014 – Onwards)

2. Manpower in the Lab/Division:

i. Name of scientific staff:

Mrs. E. Madhu, Scientist Grade-III

Mrs. Vandana Tandasi, Junior Scientist

ii. contractual Manpower: six

3. Aim and scope:

Bacterial Vaccine Laboratory is a newly started laboratory and involved in standardization of quality control testing of various polysaccharide vaccines for their batch release testing. The laboratory

has standardized various parameters for Haemophilus influenza type b (Hib) TT conjugate vaccine, Meningococcal Quadrivalent/ Bivalent vaccines and Typhoid Vi Polysaccharide Vaccine, as per the specifications of Indian Pharmacopoeia. The lab has also started standardizing the different parameters for quality control testing of Meningococcal A Conjugate Vaccine.

4. scientific services undertaken, including name and number of quality control tests performed for each biological product as per Pharmacopoeia, newer tests undertaken, interesting observations, if any:

Standardization of Hib polysaccharide conjugate vaccine: 02 batches of Hib –TT conjugate polysaccharide vaccines were received for standardization purpose.

Xii. BACteRiAL VACCiNe LABoRAtoRY (poLYsACChARiDe)


Name of the Manufacturer/ importer

Name of the product




Remarks

Bio-Med Private Ltd

Hib TT conjugate

02 These service samples have been received for standardization purpose


The laboratory is equipped with instruments viz. biosafety cabinet, weighing balance, pH Meter, UV-Vis Spectrometer, Refrigerated centrifuge, Fume Hood, HPLC & FPLC and other basic facilities. All the equipments are under annual maintenance contract (AMC)

and calibrated as per schedule according to NABL requirements. The lab is soon going to procure the HPAEC PAD.

7. Proposed target for testing of new Biologicals and Biotherapeutics being undertaken or likely to be undertaken:

Standardization of Meningococcal A Conjugate Vaccine by December 2014.

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8. NABL accreditation of Biological and chemical tests:

Bacterial Vaccine Laboratory (Poly) is NABL accredited laboratory in accordance with the standard ISO/IEC 17025:2005 for chemical and Biological testing as per certificate number T-2010 (chemical) and T-2011 (Biological) for the following test:

i. Hib TT conjugate vaccine 1. Identification 2. Antimicrobial preservative

(Thiomersal) 3 Residual Moisture content 4. Abnormal Toxocity 5. Sterility

6. Pyrogen 7. pH

ii. Meningococcal Polysaccharide vaccine 1. Identification 2. Residual Moisture content 3. Abnormal Toxocity 4. Sterility 5. Pyrogen

iii. Typhoid Vi Vaccine 1. pH 2. Antimicrobial preservative (Phenol) 3. Abnormal Toxicity 4. Sterility 5. Pyrogen


S. No.

Name of the scientist

Name of the Programme Duration Place of training

1 Mrs. E. Madhu

2013 ICP-USP 12th Science and Standards Symposium-16th & 17th April 2013

(2 Days) 16th -17th April 2013

ITC Maurya, New Delhi

FPLC training for Molecular size distribution of Meningococcal Polysaccharide Vaccine by Dr Arshad Jawed, Applictaion Specialist, G. E. Healthcare

1 day22.04.2014

NIB, NOIDA

Awareness Training on Health & Safety and Environment

(1 Day)21st May 2013

NIB, NOIDA

Physicochemical & Potency Testing (12 Days) 10.06.2013- 21.06.2013

U.S.P., Hyderabad

BIRAC-CDSA Regulatory meet-Demystifying Indian Regulations for product approvals

(2 Days)30-31st July 2013

New Delhi

FPLC training for molecular size estimation on Matrix washing, test runs demonstration to check the UV-RID connections and signal, Column preparation, column packing, column performance tests, running sample, result analysis and report generation by Dr Arshad Jawed, Applictaion Specialist, Life sciences, G. E. Healthcare.

(2 Days)25.09.2013-26.09.2013

NIB, NOIDA

IRCA – UK Certified training course on ISO 14001: 2004 Environmental Management System

(4 Days)21.10.2013 to 25.10.2013

FICCI, New Delhi

E office training at NIB (1day) 27.12.2013 NIB, NOIDA

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2 Mrs. Vandana Tandasi

2013 ICP-USP 12th Science and Standards Symposium-16th & 17th April 2013

(2 Days)16th -17th April 2013

Hotel ITC Maurya, New Delhi

FPLC training for Molecular size distribution of Meningococcal Polysaccharide Vaccine by Dr Arshad Jawed, Applictaion Specialist, Life sciences, G. E. Healthcare

1 day22.04.2014

NIB, NOIDA

Awareness Training on Health & Safety and Environment

1 Day21st May 2013

NIB, NOIDA

FPLC training for molecular size estimation on Matrix washing, test runs demonstration to check the UV-RID connections and signal, Column preparation, column packing, column performance tests, running sample, result analysis and report generation by Dr Arshad Jawed, Applictaion Specialist, Life sciences, G. E. Healthcare.

2 Days25.09.2013-26.09.2013

NIB, NOIDA

E office training at NIB (1day)27.12.2013

NIB, NOIDA

10. Miscellaneous scientific/Academics activities including interactions with manufacturer or importer of biologics, if any:

Interaction with Indian Pharmacopoeia

Commission, Ghaziabad for Expert Committee meeting on Biologicals (Vaccines) scheduled for 19th March 2014 attended by Mrs. Y. Madhu.

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Xiii. theRApeUtiC moNoCLoNAL ANtiBoDY LABoRAtoRY

1. Name of Head:

Dr. G. R. Soni, Scientist Grade – I


i. Name of scientific staff:

Dr. R. K. Sharma, Scientist Grade – III

Mrs. Rashmi Srivastava, Scientist Grade - III

ii. Name of Technical and support staff:

Mr. P. S. Chandranand, Lab Technician

iii. contractual Manpower: Two

3. Aim and scope of the Laboratory:

Monoclonal antibodies (Mabs) are routinely used in biochemistry, molecular biology and medical research but the greatest achievement has been their use as therapeutic agents for the treatment of human diseases like cancer, leukaemia, asthma, arthritis, psoriasis, Crohn’s disease and transplant rejection etc. Research is going on to cure more diseases including rare diseases of the many parts of the globe by Mabs. These are generated by recombinant DNA (rDNA) technology, hybridomas technology, B lymphocyte immortalisation or other technologies (e.g. phage display technology, genetically engineered animals).

Over the two decades manufacturers using advance state of art facility to improve the engineering technologies, for ensuring safety, purity, potency and efficacy of the therapeutic antibodies. These developments, produced highly purified, safe and efficacious therapeutic monoclonal antibodies for the patient with lesser side effects.

The use of monoclonal antibodies (Mabs) for cancer therapy has achieved considerable

success in recent years and is now one of the most successful and important strategies for treating patients with haematological malignancies and solid tumours. Therefore, monoclonal antibodies have finally come of the age as most successful therapeutic molecules and generating a market value of US $44.6 billion in 2011 and global Mab market is expected to rise at a Compound Annual Growth Rate (CAGR) of 5.3 to nearly US $58 billion in 2016 (bcc Research).

India is a major importer of therapeutic monoclonal antibodies such as Trastuzumab, Panitumumab, Ranibizumab, Eculizumab, Certolizumab, Golimumab, Canakinumab, Catumaxomab, Ustekinumab, Tocilizumab, Ofatumumab, Denosumab, Belimumab, Ipililumab, Brentuximab and Pertuzumab, etc. A few Indian biopharmaceutical industries have developed biosimilar and started marketing of these antibodies for patient care, i.e. M/s Biocon Ltd, Banglore, M/s Dr. Reddy Lab, Hyderabad, M/s Intas Biopharmaceuticals ltd, Ahmedabad. Some companies Mab’s are in pipeline, i.e., Reliance life science, Mumbai, Avesthagen, Bangalore, Bharat Serum and Vaccines Ltd, Mumbai, Serum Institute of India, Pune, Zydus Biologics Centre, Ahmedabad, Lupin Biotech Research, Pune, Natco pharma – Hyderabad and Mabpharm – Goa.

In view of the above fact National Institute of Biologicals has set up the Therapeutic Monoclonal Antibody Laboratory for Quality Control Testing of therapeutic monoclonal antibodies.


Total nineteen types of Therapeutic Monoclonal Antibodies are approved by the Drugs Controller General (I) for marketing

119


in India. Table -1. Out of these, laboratory has received Rituximab and Trastuzumab as a service sample from the manufacturers through O/o DCG(I) for standardization of quality control testing. Laboratory has received three service samples of Rituximab of different firms and one of Trastuzumab from M/s Roche. The laboratory has started the testing for the same with coordination with the other laboratory. As no monographs are available in any of the pharmacopoeia for doing the quality control testing, therefore testing is carried out of the Reditux (Rituximab) and Herceptin (Trastuzumab) as per specifications validated and approved by the DCG(I) during the marketing authorization in their respective CTD III module of therapeutic antibody.

Table:1 - Therapeutic Monoclonal Antibody approved by Dcg(i)

Sl. No. Name of Antibody1 Rituximab2 Trastuxumab3 Bevacizumab4 Panitumumab5 Infliximab6 Etanercept7 Canakimumab8 Itolizumab9 Basiliximab10 Omalizumab11 Cetuximab12 Ranibizumab13 Tocilizumab14 Natalizumab15 Denosumab16 Nimotuzumab17 Gemtuzumab ozogomicin18 Daclizumab19 Abciximab

Rituximab:

Rituximab is a monoclonal antibody consisting of 1328 amino acid residues, with a molecular weight of 144,544 Daltons, that targets the CD20 antigen, a specific protein found on the surface of normal and malignant B lymphocytes. It is used in treatment of Non-Hodgkin Lymphoma, Chronic lymphocyte leukaemia and Rheumatoid Arthritis.

The standardization / validation of pH, Osmolality, Total Protein, Molecular size distribution by HPLC have been performed. Other tests including Bacterial Endotoxin, Particulate matter and sterility were performed by other labs of the Institute. Standardization / Validation of functional assay like potency of Rituximab has been started. Master cell bank preparation of WIL-2S cell line is under process. Isoelectric focusing and ion charge variation studies are being planned by using capillary electrophoresis and ion exchange chromatography. Draft monograph of drugs substance and drug product of Rituximab has been prepared and submitted to Indian Pharmacopoeia Commission for their further necessary action.

Trastuzumab:

Trastuzumab is a recombinant humanized therapeutic monoclonal antibody having chemical formula C6470H10012N1726O2013S42 which is directed against the human epidermal growth factor receptor 2 (HER2) and has been shown to inhibit the proliferation of tumour cells. Its main use is to treat certain breast cancers like Adjuvant breast cancer, Metastatic breast cancer and Metastatic gastric cancer.

Laboratory has started standardization / validation of pH and estimation of protein for Trastuzumab as per draft monograph of Indian Pharmacopeia / manufacturer protocol. Other test like Bacterial Endotoxin test is being performed by other laboratory. Draft monograph of Trastuzumab has been preprared and sent to Indian Pharmacopeia Commission for examination and necessary action. Laboratory has also prepared draft guidance manual for assuring quality of Trastuzumab.

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Apart from the above mentioned activities laboratory has also prepared following SOP’s as per format suggested by Quality management Unit of NIB and:

- Receipt and storage of Internal Reference Standard (IRS) and Reference Standard

- Aliquoting of sample and storage of aliquots

- Revival, viability count, sub-culture and cryopreservation of WIL-2S cell line used for bioassay of Rituximab.

- Determination of potency of Rituximab by Complement Dependent Cytotoxicity (CDC) in WIL-2S cell line.

- Preparation of Master Cell Bank (MCB) and Working Cell Bank (WBC) of WIL-2S cell line.

- Test for identity of Rituximab by Capillary Zone Electrophoresis (CZE).

5. Estimation of Potency of Anti-D immunoglobulin using fAcs (Assay under standardization): Dr. sanjay Mendirattta

Assessment of the level of anti-D is important for monitoring alloimmunized Rh D-negative antenatal patients and immunized volunteers, and for ensuring the potency of therapeutic products. Anti-D-specific immunoglobulin preparations are routinely used for the prophylaxis of Rh(D) immunization of Rh-negative women after delivery. The clinical use of anti-D immunoglobulin for prevention

of haemolytic disease of the newborn necessitates estimation of its potency. Flow cytometry (FACS) has found many applications in immunohaematology with the simplest technique being equivalent to a direct antiglobulin test, e.g. to detect an antibody bound to red blood cells in vivo Van der Meulen et al. (1980) described the use of flow cytometry for measuring the relative amounts of anti- D present on red cells. The technique is based on binding of immunoglobulin to D-positive cells, with subsequent use of a secondary fluorescence-labelled anti-human immunoglobulin G (IgG) fragment and read-out by FACS. Each sample of anti-D immunoglobulin is assayed against the International Reference Preparation, calibrated in international units (IU), which allows a specification to be given in IU/ml. Thus flow-cytometric method which indicates that FACS is suitable for estimation of potency.

figure 1a & 1b: fAcs based display of density plot for standardizing assay for potency estimation of Anti-D immunoglobulin (Assay under standardization):

The cell population was gated according to their forward- and side-scatter characteristics, but the small extent of debris was excluded. The median fluorescence intensity (MFI) was measured for all events and analyzed in each sample, whereas a marker was set in the negative control. We observed a decreasing shift in signal of positive response as we moved from higher concentration to lower concentration.

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figure1a: Representative image for Potency estimation of Anti-D igg using flow cytometry

MFI=6598 MFI=2959

Standard Concentration = 0.6 IUStandard Concentration = 1.2 IUNegative Control

MFI= 179

MFI=1511 MFI= 849

Standard Concentration = 0.3 IU Standard Concentration = 0.15 IU

MFI= 324

No Sample Only D+ IgG (Fab)2

figure 1b: Representative image for Potency estimation of Anti-D igg using flow cytometry

D-ve +Sample Concentration = 0.15IU

MFI= 202

Sample Concentration = 0.3IU Sample Concentration = 0.15IU

MFI= 2142MFI= 3704

Sample Concentration = 1.2IU Sample Concentration = 0.6IU

MFI= 6447 MFI= 5255

Negative Control for D-Ve

MFI= 156

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6. Training / Workshop / conference / Meetings / Lecture attended by:

Dr. R. K. sharma:

1. 12th USP Science & Standards Symposium at ITC Mourya, New Delhi on 16 & 17th April 2013.

2. Biologicals & rDNA products committee meeting at IIT, Delhi on 26th April 2013.

3. Conference of Bioprocessing India 2013 at IIT, Delhi on 5 to 7th December 2013.

4. Review procedure adopted for evaluation of CMC at CDL, Kasauli on 6 & 7th March 2014

Mrs. Rashmi srivastava:

1. BIRAC-CDSA Regulatory Meet Demystifying Indian Regulations for product approvals at India Habited Center on 30 & 31st July 2013.

2. Training on Potency testing of Reditux (Rituximab) by CDC assay at Dr Reddys Laboratories, Hyderabad from 2nd to 13th September 2013.

3. Training program on Fundamentals of Bio-assay Practices at USP Hyderabad on 3rd March 2014.

4. Training on e-office system at NIB, Noida 23 – 27th December 2013

Mr. P. s. chandranand:

1. 12th USP Science & Standards Symposium at ITC Mourya, New Delhi on 16 & 17th April 2013.

2. One day orientation program on UPLC(H) at Waters India, New Delhi pn 26th April 2013.

3. BIRAC-CDSA Regulatory Meet Demystifying Indian Regulations for product approvals at India Habited Center on 30 & 31st July 2013.

4. Training on Potency testing of Reditux (Rituximab) by CDC assay at Dr Reddys Laboratories, Hyderabad from 2nd to 13th September 2013.

5. Demonstration program on liquid handling calibration device by Mettler Toledo at NIB, Noida on 11th March 2014.

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1. Name of Head:

Dr. G. R. Soni, Scientist Grade-I (upto 07.07.2013)

Dr. Reba Chhabra, Scientist Grade-II (since 08.07.2013)

2. Manpower in the Lab / division:


Dr. Manoj Kumar, Jr. Scientist

ii. contractual Manpower: Two

3. Aim and scope:

Nucleic acid based testing (NAT) laboratory has been established for performance evaluation of molecular diagnostic test kits intended to be used for viral load monitoring for disease prognosis and blood donor screening for transfusion-transmitted viruses such as Hepatitis-B virus (HBV), Hepatitis-C virus (HCV) and Human Immunodeficiency virus (HIV). Molecular diagnostics improve patient care by providing clinically actionable information. The diagnostics are valued

based on how well the information provided improves clinical decisions. A molecular test narrows window period with very high sensitivity and accuracy. The serological tests generally show false positive results due to presence of antibodies generated during previous infections, but molecular test detects nucleic acid present inside the viruses. Therefore, there is no chance of false positive results when the viruses have been cleared. Government of Delhi has passed a bill to make molecular testing mandatory in all its blood banks.


The lab has developed plasma panels for performance evaluation of quantitative molecular diagnostic test kits intended to be used for viral load monitoring for HBV, HCV and HIV-1. Each NAT positive plasma panel represents a dynamic range of viral load i.e. viral load in each panel varies from few copies to billion copies. During the year 2013-14, the laboratory has evaluated 49 batches of molecular diagnostic test kits.

XiV. NUCLeiC ACiD testiNG LABoRAtoRY

Table: Details of batches of molecular diagnostic test kits evaluated in year 2013-14.

Name of manufacturer/importer Name of the product

No. of batches evaluated



Remarks

1 2 3 4 5 6

M/s Roche Molecular Inc. USA Molecular Diagnostic test kit

28 28 0

M/s QIAGEN GmbH, Germany 18 18 0

M/s Abbott Molecular Inc. USA 03 03 0

Total 49 49 0

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5. Proposed target for testing of new Biologicals:

The laboratory is planning to start testing of molecular diagnostic test kits intended to be used for blood donor screening for HBV, HCV and HIV-1.

6. Participations in Training /Workshop /conference:

Name of scientific staff

Name of programme Duration Place

Dr. Reba Chhabra Refer Immuno- diagnostic Kit Lab section

Dr. Manoj K Rajput 1. IPC-USP 12th Science & Standards symposium2. Operator Training on Cobas s201, Cobas s201, Cobas TaqMan 48 and Cobas Ampliprep Cobas TaqMan3. Operator training on QIAsymphony RGQ System4. Quality Assurance of test & Calibration results5. Health Safety and Environment (HSE) based on OHSAS 18001 : 2007 and ISO 14001:2004 Environment Management System

16-17 April 201328-30th Oct 2013

25-26th Sept 20139-10th July 201321st May 2013

ITC Maurya, New DelhiNAT Lab. NIB

NAT Lab. NIBNIB

NIB

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1. Name of Head:

Dr. Renu Jain-Quality Manager

2. Manpower in the Unit:

Ms. Sudha V Gopinath - Deputy Quality Manager

Ms. Y Madhu - Deputy Quality Manager

Mr. P.S Chandranand - Deputy Quality Manager

3. contractual Manpower: Three

4. Aim and scope:

The unit is coordinated by Scientists & technical persons of the Institute who are given additional responsibilities to function as Quality Manager, Deputy Quality Managers along with Technical Managers and have also been strengthened by additional manpower working in the capacity as Bench Biologists. The unit has facilitated the Institute’s Mandate in obtaining the Status of Accreditation for laboratories in chemical and biological testing in June, 2011 as per the Scope complying with the requirements of ISO 17025: 2005, and the period of renewal has been granted for two years i.e. from Dec. 2013 - Dec., 2015

The Objective of Quality Management system with continuous improvement has strengthened in the following areas:

i. Surveillance Audits and renewal of a creditation by NABL.

ii. Notification of Laboratories as Central Drugs Laboratory.

4.1 On-site External Assessments:

4.1.1 Annual surveillance Audit by NABL:

Assessment by NABL Team of Assessors –was held for Scope Extension cum Surveillance Audit in testing -biological and chemical parameters in September 14th – 15th 2013 (Table 1). The Institute has obtained the renewal of accreditation in Dec. 2013 for the following ten product testing laboratories:

i. Bacterial Vaccine Laboratory, ii. Biochemical Kit Laboratory, iii. Blood Grouping Reagent Laboratory , iv. Blood Product Laboratory, v. Enzyme & hormone Laboratory , vi. Immunodiagnostic Laboratory , vii. Recombinant Product Laboratory , viii. Sterility test Laboratory, ix. Viral Vaccine Laboratory, x. Animal Facility

Approved signatory status is granted to those laboratory Heads and Technical Managers of the laboratory to release test reports using NABL symbol who are sufficiently qualified and experienced and have been assessed by accrediting body to be fully competent in technical and quality management aspects as per the defined Scope of the laboratory.

4.1.2 Notification of Laboratories as central Drugs Laboratory:

Assessment was held on 12th Dec., 2013 (Table 1) for declaration of NIB as Central Drugs Laboratory for Quality evaluation of Viral and Bacterial Vaccines, namely –

i. Live Attenuated Measles Vaccine ii. Live Attenuated Rubella Vaccine iii. Cell Culture Rabies Vaccine iv. BCG Vaccine v. Human Rabies Immunoglobulin vi. Hepatitis B Immunoglobulin (Human)

IV/ IM

XV. sUppoRt seRViCesQUALitY mANAGemeNt UNit

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The assessment team comprised of two Technical experts from National Institute of Virology, Pune and CDL, Kasauli and two Regulatory experts from CDSCO. Recommendation report has been given to NIB for the compliance.

TABLE 1 :- EXTERNAL AssEssMENTs ON-siTE AT NiB 2013- 14S. No.

Function for Assessment / Review

Assessment Team Period of Assessment

Areas Audited Audit Outcome

1 Annual Surveillance Audit for renewal of Accreditation as per– ISO 17025: 2005

National Accreditation board for testing and Calibration laboratories-Gurgaon

Lead Assessor -01Technical Assesors-04

Dr. YKS Rathore- CRCL, New DelhiDr. KS Grover-MumbaiDr. KM Chacko-SriRam Instt, DelhiDr. Kishore Shenoy P, BangaloreDr. Alka Beotra-National Dope Testing Lab, New Delhi

Sept. 14-15, 2013

Biological testingChemical testing Labs:BRL, BPL, E&H, IDKL,RPL, STR, AF, BKL, BVL and VVL

QMU, SRRDU and Stores & Purchase

Verification Audit was completed at NABL

Renewal of Accreditation granted for Dec.,13- Dec.,15

2 Notification –Central Drugs Laboratory

National Regulatory Agency –CDSCO-HQrs New Delhi

Technical expert -02Regulatory Expert –CDSCO- 02Dr. Kavita Lole – NIV,Pune

Mr. Sameer Rai Bhalla – CDL, Kasauli

Mr. Yogesh Shelar – FDA Bhawan, New Delhi

Mr. Ankit Sharma- CDSCO, Ghaziabad

Dec. 12, 2013

QMS-ISO 17025Quality Manual

Products : 6

Labs: 02BVL, VVL

Recommenda- tion report given to NIB for its compliance

4.2 Accreditation mechanism:

a) NABL operates its accreditation process through empanelled Lead Assessors and Technical Assessors covering all fields as specified in the scope of NABL.

b) Accreditation granted is valid for a period of 2 years. Annual surveillance is conducted to evaluate the continued compliance of the ac-credited laboratories to the requirements of NABL for maintaining accreditation. This is

renewed on the basis of re-assessment con-ducted and successive decision on renewal.

c) Recommendations from Assessment Team of NABL, Accreditation Committee forms the basis for accreditation decisions. Mem-bers of the committees are drawn from Na-tional Metrology Institute, Standards Bod-ies, Experienced Assessors (including those from accredited laboratories), Academic institutions, important professional bodies, Regulatory bodies etc.

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d) The applicant laboratory must comply with all requirements of ISO/ IEC 17025: 2005 and with the relevant NABL specific criteria and other requirements.

4.3 inter Laboratory collaborative study:

4.3.1 According to one of the recommenda-tions by NABL Assessors, conducting an ILC study is important for NIB to maintain its accreditation status in the years to come, & comply to the requirement of “Assuring the quality of test and calibration results” (under subclause 5.9 – ISO 17025).

study was designed in three phases with timelines from January, 2014 – April, 2014

• Phase1-Confirmationoftheparticipant response form by email for the test, and the test protocol for BET Gel clot & Gel electrophoresis (SDS-PAGE)

• Phase2-

a) Dispatch of the study material (by NIB)

b) Reporting of results (by collaborating laboratory)

• Phase3 -Compilationof the results and preparation of preliminary report by NIB

The following ten laboratories across the country had participated:-

a) Pharmacopoeia testing labs - 2

b) Biotech Manufacturer’s testing lab - 7

c) Academia/ Contract testing lab – 1

4.3.2 Request for Inter-laboratory Collaborative study participation by External laboratories - NIB has participated in an ILC study con-ducted by M/s Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat for two tests –Sterility Test and Bacterial Endotoxin Test. Samples have been received in March, 2014 and study is in progress.

4.4 implementation of Management systems - isO 14001:2004 Environment Management system (EMs) & OHsAs 18001:2008 Occupational Health & safety Management system at NiB:

Awareness training on Health Safety & Envi-ronment as per International Standards was organized by FICCI Quality Forum (FQF), New Delhi in May, 2013 with an objective to certify NIB for ISO 14001:2004 Environ-ment Management System (EMS) & OHSAS 18001:2008 Occupational Health & Safety Management System. Consultancy has been awarded to FICCI Quality Forum for its ef-fective implementation on 10th March, 2014.


5.1 Preparation & Review of sOPs and Policies for the system procedures as under:

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5.1.1 Preparation of new sOPs and Policies:

s. No. Title of sOP/ Policy implementing Unit sOP/ Policy id1 Procedure for product identification,

packing traceability and status labellingQuality Management Unit NIB/QMU/SOP/38/R0

2 Route for transportation of biomedical laboratory waste to hold Area & vendor pick up point

Institutional Biosafety Committee

NIB/IBSC/SOP/01

3 Route for transportation of biomedical animal house waste to hold area

Institutional Biosafety Committee

NIB/IBSC/SOP/02

4 Personnel – Skill and Competency Quality Management Unit NIB/QMU/PL/02/R0

5.1.2 Review of sOPs – The written procedure of Quality Management Unit & other laboratories were reviewed for its period of validity & change control system.

5.2 Trainings:

The management has formulated the goals with respect to the training. A training Calendar has been prepared for identifying training needs and providing training of personnel. The training programme is relevant to the present and anticipated tasks of the laboratory with respect to technical and management requirements and On-Job-specific activities. The unit has been able to impart trainings through a planned training programs described as under:

5.2.1 Trainings on Management system requirements (Table 2):

Trainings have been imparted by National Institute of Training for Standardization -Bureau of Indian standards (BIS-Noida) and FICCI Quality Forum (FQF), New Delhi to enhance core competencies to the following :-

• ScientificandTechnicalpersonshavebeentrained who are working in the areas of product testing in labs, engineering unit, Stores and Purchase. And Quality Management Unit.

5.2.2 Trainings to Bench biologists of QMU:

Sensitization for revision of SOPs of Quality system, Preparing for the Audits and Internal Audit Plans and assisting in a team, assuring quality in test and calibration results, handling calibration device & Automatic powder and liquid dosing instruments.

Table 2:- Participation in Trainings/ workshop/ conference (Name of scientists, Name of pro-grammes duration and place of training etc.)

Name of Scientist/ Attended By

Name of Programme Duration Place of Training

Management Systems – Quality, Energy, Environment Health & Safety

Dr. Reba Ms. Sudha

ISO 9001: 2008 Quality Management Systems Auditor/ Lead Auditor Training Course, N=2


FICCI Quality Forum, New Delhi

Mr. Jaipal MeenaMr. PK Mohapatra

Laboratory Quality System, Management & Internal Audit as per ISO/ IEC 17025, N=2

15th-18th May, 2013

FICCI Quality Forum, New Delhi

NIB Staff (Labs, Engineering, Administration, Stores, QMU)

Awareness Training on Health, Safety & Environment (HSE) based on OHSAS 18001: 2007 and ISO 14001: 2004 Environment Management System, N=50

21st May, 2013

NIB, Noida

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NIB Laboratory Staff

Assuring quality in test and calibration results, N=23

9th-10th July, 2013

NIB, Noida

Mr. Mukesh KumarMr. Chandrapal

Energy Management System ISO 50001, N=2 3rd-5th October, 2013

FICCI Quality Forum

Ms. Y Madhu Mr. R.P. Joshi

ISO 14000 Lead Auditor: Environment Management System Course Certificate by Nigel Bauer, UK, N=2

21st-25th October, 2013

FICCI Federation House, New Delhi

Dr. Achla Prasad ISO/ IEC 17025: 2005 Laboratory Management System, N=1

5th-8th November, 2013

FICCI Federation House, New Delhi

Regulatory system Requirements in Biologicals


IPC-USP 12th Science & Standards Symposium, N=24


ITC Maurya, New Delhi


Workshop on Regulatory Requirements for Biopharmaceuticals from Science to Commercialization, N=11

30th-31st July, 2013

India Habitat Centre, New Delhi

Dr. J.P. PrasadDr. RenuDr. RajeshMr. Nanda GopalDr. GauravBench Biologist- RPL

Conference on Bioprocessing India 2013, N=6 5th-7th December, 2013

IIT, New Delhi

Dr. Renu JainDr. Shikha YadavMs. Gurminder Bindra

Review of Stability Data submitted for Market Authorization, N=3

12th February, 2014

Hotel Metropolitan, New Delhi

Dr. Renu JainDr. Rajesh SharmaMs. ShaliniMs. Y MadhuDr. Richa

Review Procedure adopted for evaluation of CMC, N=5

7th-8th March, 2014

CDL, Kasauli

global Learning Opportunities

Dr. Reba ChhabraDr. Renu JainDr. J.P. PrasadBench Biologists- QMU

World Accreditation Day, N=6 10th June, 2013


NIB Laboratory Staff-Immunodiag- nostic Lab, Other Lab representatives

Interactive session on Medical Devices and IVDs, N=24

2nd and 4th July, 2013

NIB, Noida

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2nd International Conference of Pharmacoeconomics & Outcome research, N=10

9th – 10th October, 2013


Dr. Renu JainMs. Y Madhu Bench Biologist –QMU

World Quality Day, N=3 15th November, 2013

India Habitat Centre

5.3 Equipment Maintenance program:

The unit organizes a planned program for Equipment which includes annual maintenance programs, validation by Preventive maintenance and Calibration to be carried out by NABL certified agency. The category of equipment included are all temperature controlled, mass/ volume, UV-Vis Absorbance, potentiometer measurements, Centrifuge, Telethermometers, mercury based thermometers. Intermediate Checks by Trained Personnel are carried out for Equipment which have been calibrated by external agency at periodic intervals. Authorized list of Equipment usage is being updated timely with the AMC and Calibration done and due date.

5.4 Annual internal quality Audit:

The unit has planned a calendar schedule to conduct Internal Audit of the quality sys-tem which includes product testing labo-ratories, Stores /Purchase unit, Sample Re-ceipt and Report dispatch unit. The Audit is based as per the operating procedure of Internal audit prepared by the quality man-agement unit, with evidence of Witness for the On-site testing , documentation on as-sessment sheet and the Audit observations with their recommendations and the non-conformances.

a) Audit was carried out for 8 laboratories namely Biochemical Kit, Blood Grouping Reagent, Blood Product, Enzymes & Hor-mones, Immunodiagnostic Kit, Recombi-

nant Product, Sterility and Animal Facility. The Audit was performed by NIB Internal auditors with a defined Audit schedule from a period of June 24th – 25th, 2013. The ac-tivity audited was mainly on the ISO 17025 requirements with its 25 sub-clauses which includes activities of organization, qual-ity system and technical requirements along with the witness of the on- site- testing. The details of the Auditors name, Auditee, the area, date and time were described in the Audit plan.

b) Audit activity was concluded with an out-come of 11 non conformities. After the compilation of report, review of the non-conformances observed was done, correc-tive actions were monitored, followed by a management review meeting.

5.5 Management Review Meeting:

A review of the management system was conducted in Aug. 14th, 2013 using a formal agenda whose action was to be taken in time bound manner and are based on the Input and Output Reviews. Record of the Manage-ment Review meeting, Minutes and the Ac-tion taken Report (ATR) are circulated.

Review included information on:(a) The suitability of policies and procedures,(b) Reports from managerial and supervisory

personnel,(c) The outcome of Internal Audits,(d) Corrective and Prevention Actions,(e) Assessments by External bodies,(f) The results of inter-laboratory comparisons

or proficiency tests,(g) Changes in the volume and type of the work,

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(h) Customer feedback,(i) Complaints,(j) Recommendations for improvement,(k) Other relevant factors, such as quality control

activities, resources and staff training.

6. Others:

National Institute of Biologicals has facilitat-ed the visit of Scientific & Technical persons from areas of Regulatory, Vaccine manufac-turing, Quality forums, foreign delegates to the laboratory & Animal House (Table 3).

Table 3: INTER-RLEATIONSHIP WITH REGULATORY AND ACCREDITATION BODIES FOR GLOBAL STANDARD PRACTICES

s.No Visitor Organization/Designation

National Visitors

VisitPeriod2013-2014

Prospects

1 Mr. S.Ramedeo Abbott Lab, India July 04,2013

Knowledge partners for Medical devices and diagnostic kits

2 Mr. S.Ravi

3 Mr. Rajesh Pandepa

4 Mr. Shivkumar

5 Mr. Ankul Bhutt

6 Ms. Sonal Ramdev

7 Mr. Basudev Bhatacharya FICCI Quality Forum, New Delhi

July 10,2013

Management system requirements

8 Dr. S.K. Gupta Scientist G, National Institute of Immunology, New Delhi

July 15,2013

Scientific Advisory Meeting

9 Dr. Sunil Gupta Director, CRI, Kasauli

10 Dr. Vijay Chaudhary Prof.-Biochemistry, University of Delhi

11 Mr. Mritunjay KumarFICCI Quality Forum, New Delhi

Sept 06,2013

To understand the scope for Implementation of EHS 14 K and 18 K12 Mr. R.K. Arora

13 Dr.Y.K.S Rathore NABL Assessors Sept 14,15,2013

NABL Surveillance Audit for Renewal of Accreditation as per ISO 17025

14 Dr.K.S. Grover

15 Dr.K.M. Chacko

16 Dr.Kishore Shenoy P

17 Dr.Alka Beotra

18 Ms. Shakuntala D.Gamlin

Joint Secretary, MOHFW Sept 19,2013

Team Visit of the Health Ministry

19 Dr. L. Swasticharan DGHS, New Delhi

20 Mr. Rajeev Kanaujia CDB, MOHFW, New Delhi

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21 Dr. Sharma Former President RanbaxyAdvisor Ranbaxy

Oct 15,2013

Advisor Ranbaxy

22 Dr. S.K. Jain H.O.D Biotech Deptt.Jamia Hamdard University

Dec 05,2013

Collaborations for academic avenues

23 Dr. Kavita Lole Scientist Expert NIV, Pune -CDL Assessor

Dec 12,2013

CDL notification of Vaccine testing labs

24 Mr. Yogesh Shelar Drug Inspector, FDA Bhawan, New DelhiCDL Assessor

25 Mr. Sameer Rai Bhalla Technical Officer CDL Kasauli-CDL Assessor

26 Mr. Ankit Sharma Drug Inspector CDSCO-zone office Ghaziabad CDL Assessor

27 Mr. Patitapaban Dash Institute of Cost Accountants of India, New Delhi

Dec 16,2013

Review of Costing charges for testing biological products

28 Ms. Preeti Jain

29 Mr. M.L. Mehta

30 Mr. J.P Singh

31 Ms. Nisha Devan

32 Dr. Himasahu Gadgil Intas Pharmaceuticals Limited, Ahmedabad, Gujarat

Jan 28,2014

Collaborations in Recombinant products and MAbs

33 Dr. Pranjal Bordili34 Dr. Susobhan Das35 Dr. Ashok Sagal Institute of Cytology &

Preventive Oncology Jan 31,2014

To understand the state of Art facility for Lab infrastructure36 Dr. Veena Singh

37 Dr. G.P. Sharma Director, Food Research & Standardization Laboratory, MOHFW, Ghaziabad

Feb 03,2014

To understand the state of Art facility for Lab infrastructure

38 Dr. A. Ramkishan Deputy Drug Controller (India), FDA Bhawan, New Delhi

March 19,2014

Visit for Regulatory perspectives

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Table 3 (contd.)

s.No Visitor Organization /Designationinternational Visitors

VisitPeriod2013-2014

Prospects

1 Dr. Phillippe Auclair Abbott Lab, Belgium July 02,2013

Knowledge partners for Medical devices and diagnostic kits2 Dr. Petra Kaars Wiele Abbott Lab, Germany

3 Dr. Lotfi Larbi Tunisian Delegates Nov 07,2013

Delegation from Tunisia

4 Dr. C.Ben Rayhama

5 Dr. Lotfi Sallami

6 Mrs. Nadia Fenina

7 Dr. Lamine Tarhouni

8 Mrs. Rim Boufika

9 Mr. Bechir Tarhouni Taniha

10 Mr. Raj Kumar

11 Ms. Marouani Fanny Cosmetic organicsParis

Nov 29,2013

Team Visit to explore the Areas of collaboration12 Mr. Satish Kaul

13 Mr. Pawan Raj Pal

14 Dr.Nata Menabde WHO RepresentativeSEARO

Dec 06,2013

Strengthening Vaccine testing facilities for NRA Assessments15 Dr.Madhur Gupta Technical Officer WHO-

New Delhi

16 Dr.Nora Dellepiane Scientist-WHO Headquarters, Geneva

Aprl.01,2014

Strengthening Vaccine testing facilities for NRA Assessments

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MANPOWER AVAiLABiLiTY

1. Shri Ashis Barua JTO & Oi/c SRRD

2. Shri Pawan Kumar Data Entry Operator

3. Contractual Manpower: Five

AiM AND scOPE Of sRRDU SRRDU was set up as an independent unit in

2008 to:• receiveallsamplesofBiologicalssentfor

quality analysis by the Drugs Regulatory authorities and rejecting samples which did not meet the statutory requirements or required criteria

• upload sample details in the sampletracking module

• assigncodenumbertosamplesreceivedfor quality testing/analysis and send them to respective laboratories for testing

• de-code the samples on receipt of testreport of majority of critical tests from the laboratories for final test report of the products

• sendthefinalQualityAnalysisreporttothe sample sender for product release

• store all samples received for qualitytesting as per their recommended storage temperature

• discardallsamplesoneyearpostexpirystored in the cold room

• receive and dispose all complaintspertaining to testing procedures, staff

etc. as per the GOI rules.

BiOLOgicALs TEsTiNg AT A gLANcE

As already brought out in the previous year’s annual report the Institute had been receiving samples of various categories of biological products like Immunodiagnostic Kits, Molecular Kits, Blood Products, Blood Reagents, Recombinant Products (insulin), Enzymes & Hormones, Viral Vaccines, Bacterial Vaccines and Biochemical Kits viz. Glucose and Blood Glucose Test strips and testing them as per the Compendial Procedures. During the year 2013-14 the Institute received as many as 1820 batches of these biologicals for testing. A summary breakdown of the samples received for testing (product wise) during the year under report is in Table – 1.

TABLE – 1: PRODUcT WisE sAMPLEs RE-cEiVED fOR TEsTiNg

s.No. categories of Biologicals Received1 Immunodiagnostic Kits 3352 Recombinant Products 4653 Blood Products 5604 Blood Reagents 1465 Enzyme & Hormones 896 Biochemical Kits 607 Molecular Kits 488 Viral Vaccines 829 Bacterial Vaccines 25

10 Monoclonal antibody 10

Total: 1820

sAmpLe ReCeipt & RepoRt DispAtCh UNit

The different types of Biological products which were tested in the institute during the year 2013-14 are as under:

s.No. Major Products Types of Products

1 Immunodiagnostic kits HIV, HBsAg & HCV (ELISA/CLIA/ELFA); HIV, HBsAg & HCV (Rapid); HIV, HBsAg & HCV (Confirmatory); Syphilis (RPR); TPHA; Combo Kits; HBeAg; Anti HBc IgM; Anti HBs; Anti-HBc; Anti HBe

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2 Molecular Diagnostic Kits

HIV-1; HBV and HCV

3 Blood Grouping Reagents Anti-A; Anti-B; Anti-AB; Anti-A1 (Lectin); Anti-H (Lectin); Anti-D (IgG/IgM) Monoclonal; Anti-D (IgG/IgM) (Mono-Mono Blend); AHG (Anti Human Globulin); Anti-IgG-C3d Polyspecific (Green); BSA (Bovine Serum Albumin); Rare Blood Grouping Sera; Bulk/Concentrate Bulk (Anti-A, Anti-B, Anti-D (IgM), Anti-D Totem); AHG Coombs Test Card; Blood Grouping Kits; Gel cards; Sub-Grouping Cards and New Born Cassette

4 Blood Products Human Albumin (4.5%, 5%, 20%, 25%); Normal Immunoglobulin I/V & I/M; Anti-D Immunoglobulin I/V & I/M; Coagulation Factor VIII; Recombinant Factor VIII; Factor IX; Anti-Inhibitor Coagulant Complex; Fibrin Sealant; Tetanus Immunoglobulin; Anti Thrombin-III; Anti-human Lymphocyte IgG (Rabbit)

5 Recombinant Products Soluble insulin; Isophane insulin; Biphasic isophane insulin; Insulin Lispro; Insulin Lispro & Insulin Lispro Protamine suspension Mixed in 25/75 and 50/50; Insulin Aspart; Insulin aspart & insulin aspart protamine suspension Mixed in 30/70 & 50/50; Insulin Glargine; Insulin Glulisine; Insulin Detemir; Exenatide; Glucagons like Peptide; rh. Erythropoietin inj.; Interferon beta 1a; Rh. GCSF; Rh. Insulin bulk and Rh. EPO bulk

6 Enzyme & Hormone Streptokinase injection & Bulk; Enoxaparin Sodium API; Menotropin; Human Chorionic Gonadotropin; Urofollitropin/Follicle Stimulating Hormone (Normal/Recombinant); Human Growth Hormone inj.; Somatropin inj.

7 Biochemical Kits/Strips Glucose Estimation Kit; Blood Glucose Test Strips

8 Viral Vaccines Hepatitis B Immunoglobulin I/V & I/M; Rabies Immunoglobulin

sAMPLE TRAcKiNg sOfTWARE

The sample tracking software is developed by NIC and was fully operational during the year 2013-14. All samples received in the Institute during the year and accepted for testing were uploaded in the software for (a) tracking by the sample sender and the manufacturer/ importer online (b) coding & decoding the samples (c) reporting test results and (d) batch release. The batch release informa-tion was also put up in the Institute web site for information of all concerned.

AccREDiTATiON

The sample receipt unit is the main entry point for receipt of all samples to the Institute for testing. This unit is accredited by NABL.

REcORD MANAgEMENT (ARcHiViNg)

During the year 2013-14 action was taken to re-cord all files after completion of testing activi-ties. The files were documented and classified for traceability. Precedent Book for keeping note of important rulings and decisions and Record re-tention schedule have been maintained to ensure that files are neither prematurely destroyed nor kept for periods longer than necessary. All records are under the custody of Oi/c SRRD Unit to which the Archive unit is attached.

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Meeting of the general / governing Body

The 23rd Meeting of the Governing Body and the 7th Meeting of the General Body were held on 13.11.2013.

Meeting of the standing finance committee

The 22nd Meeting of the Standing Finance Committee of the Institute was held on 10.09.2013.

Engineering Activities

Detailed information on engineering and construction activities undertaken during the year, 2013-2014:

civil Engineering Works undertaken:

1. Total engineering support for operation & maintenance of services in the Laboratories, Guest Hostel, Hostel, Staff Quarters, Library, Cafeteria and related facilities of the Institute.

2. Complete overhauling of Centralized Water Softening Plant of the Institute.

3. Conversion of bituminous road portion in to the concrete road.

4. Furnishing of Director’s PS Room and Haemovigilance Unit.

5. Participation in inspection of SS furniture procured for Laboratories and Guest House Furniture.

6. Assigned the work for Upgradation of Conference Hall and D.G.Room Acoustic Treatment to CPWD.

7. Administration of AMC Contracts for Housekeeping, Horticulture and Pest Control Services in the entire campus.

8. Construction of a new NIB signboard at rear entry gate.

9. Stack, noise and effluent monitoring through M/s National Productivity Council New Delhi.

E-Office:

The Institute has implemented the e-Office, one of the initiatives in the area of e-Governance. It is a suite of applications developed by the National Informatics Centre (NIC) comprising of File Management System (eFile), Leave Management System (eLeave), Knowledge Management System (KMS) Personnel Information System (PIS), Tour Management System (eTour) Collaboration and Messaging Services (CAMS), and other eServices such as Pay Slip, GPF Statements and online forms etc. The NIC has also provided the on-site support for six months for training, handholding and smooth implementation of the project. Initially, the Institute has started the work with Leave Management System (eLeave) which was successfully implemented. Entries in the Personnel Information System (PIS) with minimum data was also started by the Administration. The information in respect of active and closed files was also obtained from various Divisions / Sections / Laboratories so that all files get migrated into eFile. Two officials of the Institute also deputed for Capability Building Programme on e-Office for Master Trainers during Feb. 12-18, 2014. The Institute intends to make significant progress to achieve a paper-free office in all its Divisions / Sections / Laboratories in the next two years.

BUDgET & fiNANcE

During the year 2013-14 Budget Estimate (BE) allocation was for Rs. 25.00 Crore and the Revised Estimate (RE) Rs. 25.00 Crore. The Institute generated a revenue of Rs. 3.28 Crore from various sources, i.e., Fee for testing of various biologicals products, and Fee for Training Programs, Rents received from Hostel & Guest Houses and interest on the Saving Bank Account etc.

RepoRt of the ADmiNistRAtiVe WoRk

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Particulars Amount ( Rs. in crore)

Budget Estimate (BE) 25.00

Revised Estimate(RE)/Final Estimate 25.00

Expenditure incurred during the year 25.05

Details of the expenditure incurred on various heads may be viewed for the Annual Accounts of the Auditors given in this Report.

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cOMPOsiTiON

cOMPOsiTiON Of THE gENERAL BODY

secretary Health & family WelfareMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi.

chairman

secretary Department of Bio-Technology New Delhi

Member

Dr. V. M. Katoch, secretary, DHR & Dg, icMR Ansari Nagar, New Delhi – 110029

Member

Additional secretary (Health) Ministry of Health & Family Welfare Nirman Bhavan, New Delhi – 110011

Member

Additional secretary & f.A. Ministry of Health & Family Welfare Nirman Bhawan, New Delhi – 110011

Member

Director general of Health service Ministry of Health & Family Welfare Nirman Bhawan, New Delhi – 110011

Member

Drug controller general (india) Directorate General of Health Services F. D. A. Bhawan, Kotal Raod New Delhi - 110002.

Member

Joint secretary Ministry of Health & Family Welfare Nirman Bhawan, New Delhi – 110011.

Member

secretary Health & Family Welfare, H. Block Secretariat Govt. of Andhra Pradesh Hyderabad, Andhra Pradesh

Member

secretary Health & Family Welfare Department Government of West Bengal Writers Building, Kolkata.

Member

chairman Serum Institue of India Ltd. 212/2 Hadapsar Pune - 411 028

Member

Director Pasteur Institute of India Coonoor – 643 103 (The Neelgiris)

Member

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The chairman cum Managing Director National Dairy Development Board Anand, Gujrat

Member

Managing Director Haffkine Bio-Pharmaceutical corpn. Ltd., Acharya Donde Marg Parel, Mumbai.

Member

Director, NiB Member secretary

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COMPOSITION OF THE GOVERNING BODY

Secretary (Health & Family Welfare) Ministry of Health & Family Welfare Nirman Bhavan, New Delhi – 110011

Chairperson

Secretary (DBT), Govt. of India Block No.2, C.G.O. Complex Lodhi Road, New Delhi – 110003.

Member

Dr. V. M. Katoch, Secretary, DHR & DG, ICMRAnsari Nagar, New Delhi – 110029

Member

Director General of Health Services Directorate General of Health Services, Nirman Bhavan, New Delhi – 110011

Member

Additional Secretary (Health) Ministry of Health & Family WelfareNirman Bhavan, New Delhi – 110011

Member

Additional Secretary & F.A. Ministry of Health & Family WelfareNirman Bhawan, New Delhi – 110011

Member

Drugs Controller General of India Directorate General of Health Services, Nirman Bhavan, New Delhi – 110011

Member

Joint Secretary (HFW) Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi – 110011

Member

Director, NIB Member Secretary

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COMPOSITION OF THE STANDING FINANCE COMMITTEEAdditional Secretary Ministry of Health & Family WelfareNirman Bhawan, New Delhi

Chairman

The Addl. DG, ICMR or his nominee Indian Council of Medical ResearchAnsari NagarNew Delhi - 110029

Member

Joint Secretary Min. of Health & Family WelfareNirman BhawanNew Delhi - 110011

Member

Drugs Controller General (I) or his nominee (Not below the rank of Asstt. Drugs Controller (I))FDA BhawanNew Delhi - 110002

Member

Director (IFD) Min. of Health & Family WelfareNirman BhawanNew Delhi - 110011

Member

Director, NIB Member Secretary

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PERSONNEL

A. (scientific & Technical)

S.No Name Designation1 Dr. Suridner Singh Director, I/c. NIB 2 Dr. G.R. Soni Scientist Grade-I3 Dr. Reba Chhabra Scientist Grade-II4 Dr. Achla Prasad Scientist Grade-II5 Dr. Renu Jain Scientist Grade-II6 Dr. J. P. Prasad Scientist Grade-II7 Dr. Shikha Yadav Scientist Grade-II (Vet.)8 Sh. Ashis Barua Jr.Training Officer9 Sh. A. K. Sahu Scientist Grade-II10 Sh. Neeraj Malik Scientist Grade-III11 Dr. Charu Mehra Kamal Scientist Grade-III12 Mrs. Ajanta Sircar Scientist Grade-III13 Mrs. Sudha V Gopinath Scientist Grade-III14 Mrs. Kanchan Ahuja Scientist Grade-III15 Dr. R. K. Sharma Scientist Grade-III16 Mrs. Gurminder Bindra Scientist Grade-III17 Mrs. Shalini Tewari Scientist Grade-III18 Mrs. Rashmi Srivastava Scientist Grade-III19 Mrs. Richa Barnawal Scientist Grade-III20 Mrs. Madhu E. Scientist Grade-III21 Dr. Meena Kumari Scientist Grade-III22 Sh. Pankaj Kumar Sharma Jr. Scientist23 Sh. N. Nanda Gopal Jr. Scientist24 Dr. Manoj Kumar Jr. Scientist25 Sh. Harit Kasana Jr. Scientist26 Sh. Subhash Chand Jr. Scientist27 Dr. Gaurav Pratap Singh Jadaun Jr. Scientist28 Dr. Manjula Kiran Jr. Scientist29 Mrs. Vandana Tandasi Jr. Scientist30 Sh. Sanjeev Kumar Sharma Lab Technician31 Sh. Kallol Saha Lab Technician32 Sh. P.S. Chandranand Lab Technician33 Md. Daud Ali Lab Technician34 Ms. Girija L.V. Lab Technician35 Sh. Jaipal Meena Lab Technician36 Sh. Subhash Kumar Lab Technician(PWD)

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37 Sh. Rajiv Kumar Lab Technician38 Sh. Brij Bhushan Lab Technician39 Sh. Brij Bahadur Lab Technician40 Sh. Mohit Sharma Lab Assistant41 Sh Rajiv Kumar Shrivastava Lab Assistant42 Sh. Prdeep Lab Assistant43 Ms. Priya Bhatt Lab Assistant44 Sh. Parminder Kumar Junior Animal Care Taker

B. (Administration, finance & Accounts and Procurement)

s.No Name Designation45 Sh. P.C.P. Mahapatra Administrative Officer 46 Sh. S. K. Sharma Budget & Finance Officer47 Sh. P.K. Mohapatra Section Officer (Admn.)48 Sh. Jagdish Prasad Pant Administrative Assistant49 Sh. Deepak Mahajan Computer Officer50 Sh. Pawan Kumar Sharma Data Entry Operator51 Sh. Manmeet Singh Steno. Grade-B52 Sh. R.K. Arora Steno Grade-III53 Sh. Pradeep Kumar UDC54 Sh. Upender Nath Sharma UDC55 Sh. Dhirender Singh UDC56 Sh. Ramesh Chand Dalai Stores Clerk57 Sh. Partho Pratim Mandal Stores Clerk58 Sh. Pradeep Kumar LDC59 Sh. Prem Chand Gupta LDC60 Ms. Savita Rai Receptionist61 Sh. H.P. Vashist Electrician62 Sh. Gobind Singh Rawat Staff Car Driver Grade-II63 Sh. Ravi Dutt Staff Car Driver Grade-II64 Sh. Harinder Singh Staff Car Driver Grade-II65 Sh. Leela Kishan Staff Car Driver Grade-II66 Sh. Bijender Singh Group ‘D’ Official67 Sh. Suraj Pal Group ‘D’ Official68 Sh. Subhash Chand Group ‘D ’Official69 Sh. Rakesh Group ‘D’ Official70 Sh. P.C. Diwan Group ‘D’ Official71 Ms. Shobha Group ‘D’ Official72 Ms. Rajinderi Devi Group ‘D’ Official

144


C. (Engineering & Technical)

S.No NAME DESIGNATION73 Sh. Mukesh Kumar Assistant Engineer(Electrical)74 Sh. R.P. Joshi Assistant Engineer (Civil)75 Sh. Subhash Chand Junior Engineer (Electrical)76 Sh. Chander Pal Junior Engineer(Mechanical)77 Sh. Amarjit Singh Junior Engineer(Mechanical)78 Sh. H.P. Vashisth Electrician

145


Empowering Consumers: Right to Information Act, 2005

In terms of Section 4(1) (b) and 4(2) of the Right to information Act, 2005, the Institute has nominated the following officers as CPIO and Appellate Authority under the RTI Act, 2005:

1. Dr. G.R. Soni, Scientist Gr.-I - Appellate Authority

2. Sh. S.K. Sharma, BFO - Central Public Information Officer

During the year (2013-14), the Institute received the following applications to obtain various types of information under the RTI Act:-

financial Year Number of applications received

Transferred to other organization

Reply sent Outstanding

2013-14 18 --- 16 2

146


AUDiTORs REPORT

147


iNDEPENDENT AUDiTOR’s REPORT

Report on the financial statements

We have audited the attached financial statements of National Institute of Biologicals (“NIB”), which comprise the Balance Sheet as at 31st March 2014 and the Income & Expenditure Account along with the Receipts & Payment Account for the year ended, and a summary of significant accounting policies and other explanatory information.

Management’s Responsibility for the financial statements

Management is responsible for the preparation of these financial statements that give a true and fair view of the financial position and financial performance of NIB in accordance with accounting princi-ples generally accepted in India. This responsibility includes the design, implementation and mainte-nance of internal control relevant to the preparation and presentation of the financial statements that give a true and fair view and are free from material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audit. We con-ducted our audit in accordance with Standards on Auditing issued by the ICAI. Those standards re-quire that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materials misstatements.

An Audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatements of the financial statements, whether due to fraud or error in making those risk assessments, the auditor considers the internal control relevant to the NIB’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances but not for the purpose of expressing an opinion on the effective-ness of the entity’s internal control. An audit also includes evaluating the appropriateness of account-ing principles used and reasonableness of the accounting estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Report on Other Legal and Regulatory Requirements

1. Attention is invited to:

Note No. 2 regarding non-consideration of bank balances by NIB;

Note No. 3 regarding Non provision of Leave Encashment, Gratuity and Bonus;

148


Note No. 10 regarding non-confirmation of balances;

Note No. 14 regarding weak/inadequate Internal Control system at NIB; and

Note No. 18 regarding long outstanding advances to the parties.

2. We report that:

a) We have obtained all the information and explanations, which to the best of our knowledge and belief were necessary for the purpose of our audit;

b) In our opinion, the Balance Sheet & Income & Expenditure dealt with by this report complies with the Accounting Standards issued by the Institute of Chartered Accountants of India;

c) In our opinion proper books of accounts have been maintained by the institute so far as it appears from our examination of books; and

d) In our opinion the Balance Sheet and the Income & Expenditure Account dealt with by this report are in agreement with the books of accounts.

Opinion

Subject to our observations/comments in Para 1 of “Report on Other Legal and Regulatory Require-ments” above, in our opinion and to the best of our information and according to the explanations given to us, the accounts and the Schedules annexed together with the significant accounting policies and notes thereon exhibit a true and fair view:

a) In the case of Balance Sheet, of the state of affairs of NIB as at 31st March 2014; and

b) In the case of the Income & Expenditure Account, of the Excess of Expenditure over Income for the year ended 31st March 2014.

for P A R Y & co. chartered Accountants (firm Registration No. 007288c)

Sd/cA Yogesh Malik Partner (M. No. 074635)

Place: Noida Date: 25.07.2014

149


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SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2014 (Amount in Rs)

Balance as at the beginning of the year 2,079,540,512.76 2,079,082,669.76 Add: Expenses incurred for HSCC - 376,182.00 Add: Security Deposits (Electricity) - 645,068.00 Add: Increase in Stock of Fuel for Boillers & D.G Set 2,263,456.00 -

Less: Previous Year's Advance adjusted towards purchase of Fixed Assets

1,830,563.00 -

Less: Prior Period Adjustments-ETP 761,809.00 - Less: Sale of Vehicles - 2,079,211,596.76 563,407.00 2,079,540,512.76

Add: Capital Assets Fund Balance at the beginnig of the year 54,312,717.00 32,365,043.00 Addi�on during the year 10,004,144.00 16,114,532.00 Transfer from WIP 325,000.00 64,641,861.00 5,833,142.00 54,312,717.00

Add: Grant u�lised for advances of previous year 6,361,050.00 5,641,955.00 Add: Grant U�lised for Advances during the Current Year against goods & services 27,183,577.00 5,748,610.00

BALANCE AS AT THE YEAR END 2,177,398,084.76 2,145,243,794.76

A. CURRENT LIABILITIES1. Sundry Creditors a) HSCC 17,663,227.00 17,667,334.00 b) Goods 7,449,339.00 25,112,566.00 7,099,855.00 24,767,189.00

2. Advances Received -Advance Sale of Refrence standards 177,600.00 50,779.00 -Grant Received in Surplus from GOI - 2,620,152.94 -Receipts payable to MOH & FW, GOI 3,292,663.00 1,390,355.00 -Earnest Money Deposit 205,500.00 3,675,763.00 728,200.00 4,789,486.94

3.Statutory Liabili�es -TDS (Professional) 34,064.00 39,321.00 -TDS (Contractors) 239,835.00 273,899.00 141,073.00 180,394.00

4. Other Current Liabili�es -Security deposit/Reten�on Money 1,676,829.00 1,184,483.00 -Salary Payable 4,372,938.00 4,015,646.00 -Expenses Payable 767,935.00 - -TDS Payable to NIB GPF 8,625.00 6,826,327.00 - 5,200,129.00 B. PROVISIONS 1. For Gratuity 4,700,933.00 4,848,851.00 2. Accumulated Leave Encashment 5,069,841.00 9,770,774.00 5,309,617.00 10,158,468.00 TOTAL 45,659,329.00 45,095,666.94

For Previous Year ended on 31.03.2013

Ministry of Health & Family Welfare

For Current Year ended on 31.03.2014 SCHEDULE 2 -CURRENT LIABILITIES AND PROVISIONS

SCHEDULE 1 -CORPUS/CAPITAL FUND For Previous Year ended on 31.03.2013

NATIONAL INSTITUTE OF BIOLOGICALS

For Current Year ended on 31.03.2014

152

Annual Report 2013-2014SC

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153


SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2014 (Amount in Rs)

SCHEDULE 4 -CURRENT ASSETS , LOANS & ADVANCES

A. CURRENT ASSETS 1. Cash balances in hand 13,267.00 11,350.00 2. Balance with Banks : - Saving Accounts 52,696,507.13 55,353,244.13 3. Stamps in hand 6,854.00 52,716,628.13 9,775.00 55,374,369.13 TOTAL (A) 52,716,628.13 55,374,369.13 B. LOANS, ADVANCES AND OTHER CURRENT ASSETS 1. Loans(a) Staff Advances - Computer Advance 70,200.00 74,000.00 - Scooter Advance 18,000.00 4,000.00 - House Building Advance 742,230.00 924,230.00 - Tour Advance 12,800.00 31,570.00 - Department Advance - 70.00 - Motor car Advance - 10,800.00 - LTC Advance 32,300.00 5,400.00 - Fes�val Advance 28,500.00 904,030.00 42,375.00 1,092,445.00

(b) Other En��es engaged in ac�vi�es of NIB - Advance to DAVP 56,424.00 56,424.00 - Advance to SPX Process - 1,830,563.00 - Advance to Star Catalyst 1,063,405.00 - - Advance to CPWD 5,000,000.00 - - Advance to NICSI 1,760,694.00 - - Advance to DGS&D (Computer) 1,588,237.00 - - Advance to Forbes Marshall 477,557.00 - - Advance To H.N. Traders 731,535.00 - - Advance to IOCL 13,303.00 40,059.00 - Advance to HSCC (ETP) 569,091.00 569,091.00 - Advance to HSCC (Other work) 648,934.91 11,909,180.91 648,934.91 3,145,071.91

2. Advances and other amount recoverable in cash or in kind or for value to be received: a) On capital Account -Advance to HLL Life Care Ltd against Equipments 29,506,638.00 18,435,704.00 -Advance to HLL Life Care Ltd for Consultancy 663,502.00 201,802.00

b) Deposits -Bank Deposit for sales tax registra�on 25,000.00 25,000.00 -Security Deposit with Balmer Lorrie 200,000.00 - -Security Deposit with Reliance - 4,500.00 -Security Deposit with PVVNL 5,287,079.00 3,701,518.00 -Security Deposit with Padam Petroleum 25,000.00 25,000.00 -Security Deposit with NOIDA 930,750.00 930,750.00 -Service tax recoverable - 56,868.23 -CENVAT Recoverable 1,649,890.00 38,287,859.00 202,102.00 23,583,244.23

3. Claim Receivable 845.00 226,494.00 4. Receivable from IPC - Haemovigilance 102,492.00 - 5. Sundry Debtors 52,787.00 - 6. Pre-paid Expenses 90,247.00 309,490.00 7. Stock-Fuel for Boillers & D.G Set 4,504,104.00 2,240,648.00 8. TDS Receivable (2013-14) 27,527.00 - 8. Grant Receivable from GOI (2013-14) 526,679.29 - TOTAL (B) 56,405,751.20 30,597,393.14 TOTAL (A+B) 109,122,379.33 85,971,762.27

For Current Year ended on 31.03.2014 For Previous Year ended on 31.03.2013

154


SCHEDULES FORMING PART OF INCOME & EXPENDITURE FOR THE YEAR ENDED AS AT 31st MARCH 2014 (Amount in Rs)

1. Receipts from Tes�ng -Sample tes�ng receipts 25,458,851.00 15,256,453.00 2. Receipts from Sales -Sale of Refrence Standards 695,000.00 360,000.00 -Sale of Waste Oil - 334,101.00 -Sale of Vehicle - 695,000.00 59,052.00 753,153.00

TOTAL 26,153,851.00 16,009,606.00

SCHEDULE 6 - GRANTS/SUBSIDIES (Irrevocable Grants & Subsidies Received)

Grant Received During the year 247,380,000.00 195,000,000.00 Grant unu�lized b/f from the previous year 2,620,152.94 - Grant Adjusted towards Revenue Expenditure: Current Year Expenditure 217,396,326.23 Less: Expenses Adjusted from current year income 32,792,663.00 184,603,663.23 151,101,910.25 (taken to income & expenditure Account)

Less: Prior Period Expenses paid during the Year 438,958.00 147,753.00 Less: Grant u�lized for purchase of fixed Assets 3,146,113.00 16,114,532.00 Less: Transfer from WIP - 5,833,142.00

Less: Grant u�lized for advances against Fixed Assets/ Goods/Services/Deposits for C.Y 27,183,577.00 6,393,678.00

Less: Current Year income transferred to MOH & FW 29,500,000.00 17,523,000.00 Less: Current Year Income Payable to MOH & FW 3,292,663.00 1,390,355.00 Less: Amount Recoverable from MOH & FW of Previous Year - 276,658.81 Less: Expenses incurred for HSCC - 376,182.00 Less: Payable for Fixed Assets 98,402.00 - Less: Increase in Stock of Fuel for Boillers & D.G Set 2,263,456.00 -

Add: Advance of Previous year u�lized against goods & Services - 6,777,364.00

Grant payable/Receivable from Govt. of India (Refer schedule-4) -526,679.29 2,620,152.94

SCHEDULE 7 - INTEREST EARNED For Current Year

ended on 31.03.2014


1) On Saving accounts: 4,825,438.00 1,534,682.00 2) On Loans To Employees/Staff 374,806.00 307,265.00 TOTAL 5,200,244.00 1,841,947.00

SCHEDULE 8 - OTHER INCOME For Current Year

ended on 31.03.2014


a) Usage receipts for Hostel, Guest House & Conference Hall 1,331,085.00 990,450.00 b) Sale of Tender Forms 24,638.00 29,308.00 c) Training Fees 18,000.00 10,000.00 d) Other Income 34,484.00 1,012.00 e) License Fees 30,361.00 31,032.00 TOTAL 1,438,568.00 1,061,802.00



For Current Year ended on 31.03.2014

SCHEDULE 5 - RECEIPTS FROM TESTING & SALES For Current Year ended on 31.03.2014

155


SCHEDULES FORMING PART OF INCOME & EXPENDITURE FOR THE YEAR ENDED AS AT 31st MARCH 2014 (Amount in Rs)

a) Salary and Wages 48,117,386.00 46,858,513.00 b) Allowances and Bonus 213,810.00 233,161.00 c) Consultant payment - - d) Consultants/Cont. Emp.Payment 27,576,054.00 14,505,994.00 e) Consultancy to HLL - - f) Employer's Contribu�on to NPS/ other Fund 909,369.00 797,267.00 g) Staff Welfare expenses 308,463.00 410,067.00 h) Expenses on Employee's Re�rement and Terminal Benefit 3,933,335.00 4,471,984.00 i) Others -Medical Reimbursement 1,340,631.00 892,453.00 -LTC Expenses 950,717.00 1,106,341.00 -Liveries 26,536.00 1,694.00 -Reimbursement of Tu�on Fees 956,914.00 1,136,320.00 TOTAL 84,333,215.00 70,413,794.00

a) Electricity and Water Charges 43,188,947.00 30,847,481.00 b) Purchase of office consumables 981,190.00 457,818.00 c) Office Maintenance 5,658,343.00 4,090,380.00 d) Rent, Rates and Taxes 124,412.00 270,952.00 e) Vehicles Running and Maintenance 636,448.00 703,842.00 f) Postage, Telephone and Communica�on Charges 684,523.00 618,181.00 g) Prin�ng & Sta�onary 1,089,517.00 744,017.00 h) Travelling and Conveyance Expenses 1,198,002.00 1,329,500.00 I) Expenses on Seminar/Workshops 548,244.00 260,605.00 j) Auditor's Remunera�on 45,025.00 42,079.00 k) Professional Charges 566,327.00 424,391.00

l) Adver�sement and Publicity 630,072.00 1,201,532.00 m) Other Expenses: - Miscellaneous Expenses 24,946.00 140,456.25 - Security Services expenses 7,212,116.00 5,036,839.00 - Honorarium (others) 102,000.00 121,400.00 - House Keeping Charges 6,873,254.00 5,899,338.00 - Hiring of Vehicles 1,397,973.00 699,042.00 - Hindi Promo�on 6,635.00 2,000.00 - Bank Charges - 1,312.00 - Internet Access Charges 644,241.00 251,126.00 - Travelling (others) 388,766.00 334,696.00 - Newspapers & Periodicals 147,057.00 188,784.00 - Other Office Expenditure 195,559.00 - - Service Tax Unrecoverable 56,868.23 - TOTAL 72,400,465.23 53,665,771.25

a) Repair & maintenance - Lab Equipments 8,081,108.00 7,475,379.00 b) Opera�on & Maintenance - Electrical 2,163,641.00 2,141,702.00 c) Opera�on & Maintenance - DG Sets 3,010,138.00 1,259,001.00 d) Opera�on & Maintenance - HVAC Plant 4,107,226.00 4,161,847.00 e) Opera�on & Maintenance - Boiler 1,057,523.00 962,927.00 f) Opera�on & Maintenance - Water Supply system 2,507,719.00 1,084,148.00 g) Opera�on & Maintenance - Incinerator - - h) Opera�on & Maintenance - Air Compressor 15,449.00 37,079.00 i) Opera�on & Maintenance - Cold Room 2,278,514.00 2,090,685.00 j) Opera�on & Maintenance - BMS 1,123,224.00 782,216.00 k) Opera�on & Maintenance - Li�s 564,027.00 520,373.00 l) O & M Acces Control System 958,018.00 586,037.00 m) Purchase of Lab Consumable 9,534,087.00 5,256,085.00 n) Purchase of Lab Chemicals 1,718,332.00 1,799,745.00 o) Purchase of Kits & Reagents 7,505,975.00 7,498,001.00 p) Consump�on of Fuel for Boillers & D.G Set 15,968,365.00 10,233,023.00 q) Bio-Waste Disposal Charges 69,300.00 47,452.00 TOTAL 60,662,646.00 45,935,700.00

For Current Year ended on

31.03.2014

SCHEDULE 9 - ESTABLISHMENT EXPENSES


31.03.2014


SCHEDULE 11 - LAB SERVICES - OPERATION & MAINTAINANCE EXP



31.03.2014 SCHEDULE 10 - OTHER ADMINISTRATIVE EXPENSES


156


(Amount in Rs) RECEIPTS Current Year Previous Year PAYMENTS Current Year Previous Year

1. Opening Balance 1. Expenses -Cash in Hand 11,350.00 19,188.00 -Establishment Expenses 84,363,617.00 69,797,678.00 -Bank Balance 55,353,244.13 47,876,374.13 -Administra�ve Expenses 71,100,837.00 53,665,771.25 -Stamps in Hand 9,775.00 5,024.00 -Lab Services- O&M Exp 62,926,102.00 43,653,706.00

-Prior Period Expenses 438,958.00 147,753.00 2. Grants Received -From Government of India 247,380,000.00 195,000,000.00 2. Payments made against funds

-Advance to HLL Lifecare Limited (Net) 11,532,634.00 5,711,154.00 3. Interest Received: -Advance to IOCL - 37,456.00 -On Bank deposits 4,825,438.00 1,534,682.00 -Advance to Star Catalyst 1,063,405.00 -

-Interest Recovered from Scooter, HBA & Computer advance

374,806.00 307,265.00 -Advance to CPWD 5,000,000.00 - -Advance to NICSI 1,760,694.00 -

4. Other Income -Advance to DGS&D (Computer) 1,588,237.00 - -Receipts from Hostel/Guest houses 1,331,085.00 990,450.00 -Advance to Forbes Marshall 477,557.00 - -Sale of Tenders Forms 24,638.00 29,308.00 -Advance To H.N. Traders 731,535.00 - -Sample tes�ng receipts 25,458,851.00 15,256,453.00

-Sale of Reference Standards 695,000.00 360,000.00 3. Expenditure on Fixed Assets & Capital Work-in-Progress

-Training fees 18,000.00 10,000.00 -Building - 213,224.00 -Licence Fee 30,361.00 31,032.00 -Machinery & Equipment 7,146,759.00 6,862,882.00 -Misc. Receipts 34,484.00 1,012.00 -Computers & Computer So�ware 699,385.00 6,141,862.00 -Sale of Vechile - 59,052.00 -Furniture & fixture 1,768,761.00 509,556.00 -Sale of Waste Oil - 334,101.00 -Office Equipments 339,239.00 2,258,998.00

-Books 50,000.00 117,000.00 5. Other Receipts -Tools - 11,010.00 Recovery from Staff Advances -Computer Advance 83,800.00 98,982.00 4. Refund of surplus money/Loans -Scooter Advance 10,000.00 26,500.00 -To the Government of India 29,500,000.00 17,523,000.00 -House Building Advance 182,000.00 501,000.00 -Last Year Receipts Paid to Ministry 1,390,355.00 672,732.00 -Tour Advance 278,999.00 - -Motor car Advance 10,800.00 43,200.00 5.Other payments -LTC Advance 618,622.00 49,600.00 Advances disbursed during the year -Fes�val Advance 64,500.00 50,625.00 -Scooter Advance 24,000.00 - -Departmental Advance 70.00 2,430.00 -Fes�val Advance 50,625.00 75,000.00

-Advances to Contractors U�lized during the year 1,857,319.00

383,575.25

-Computer Advance 80,000.00

84,000.00 -Advance Received for Reference Standards 126,821.00 - -Tour Advance 260,229.00 31,570.00

-Service Tax Utlised during the year - 258,936.00 -LTC Advance 645,522.00 -

-EMD received during the year - 312,300.00 -Advance utlised for Reference Standards - 45,200.00

-Security Deposit/Reten�on Money Received during the year 492,346.00 566,367.00

-Security Deposit (Travelling)200,000.00 -

-Net Claims received during the year 225,649.00 - -Security Deposit (Electricity) 1,585,561.00 645,068.00 -Net Increase in payment of Statutory dues 93,505.00 91,896.00 -EMD released during the year 522,700.00 - -Creditors for Fixed Assets/Capital Goods 98,402.00 - -Net Increase in Claims Recoverable - 94,831.00 -TDS Payable to NIB GPF 8,625.00 - -Receivable from IPC - Haemovigilance 102,492.00 -

-TDS Receivable 27,527.00 - -Net Service Tax paid during the year 1,447,788.00 - -Increase in Debtors 52,787.00 - -Payment made for Expense Payable 4,107.00 376,182.00 -Claims paid during the year - 149,320.00 -CGHS - 30.00 -Grant u�lised for advances of previous year 100,449.00 -

6.Closing Balances -Cash in Hand 13,267.00 11,350.00 -Bank Balance 52,696,507.13 55,353,244.13 -Stamps in Hand 6,854.00 9,775.00

TOTAL 339,698,490.13

264,199,352.38

TOTAL 339,698,490.13

264,199,352.38

As per our report of even date a�ached.

For P A R Y & CO.Chartered Accountants(FR No. 007288C)

CA Yogesh MalikSd/- Sd/- Sd/-

Sd/-

S.K. Sharma Dr. G.R. SoniPartner (Budget & Finance Officer) (Sc. Gr.-I/Dy. Director(Admn. i/c)M. No. 074635

Place: Noida Dr. Surinder SinghDate:25.07.2014 (Dy Director(QC)/Director-i/c)

NATIONAL INSTITUTE OF BIOLOGICAL(Ministry of Health & Family Welfare)

RECEIPTS AND PAYMENTS ACCOUNT FOR THE YEAR ENDED 31ST MARCH 2014

FOR NATIONAL INSTITUTE OF BIOLOGICALS

157


AMOUNT (Rs.)PARTICULARSRECEIPTSGrant unu�lized b/f from the previous year 2,620,152.94 Grant in Aid Received From Ministry 247,380,000.00 TOTAL RECEIPTS (A) 250,000,152.94 LESS:- EXPENDITURE INCURRED & PROVISION

Establishment Expenses 84,333,215.00 Administra�ve Expenses 72,400,465.23 Lab Services-Opera�on & Maintainance Exp 60,662,646.00 Grant Utlized for Payment of Prior Period Expenditure 438,958.00 Increase in Stock of Fuel for Boil lers & D.G Set 2,263,456.00 Payment made for Fixed Assets during the year:Addi�ons in Fixed Assets 10,329,144.00 Less: Transfer from WIP-ETP 325,000.00 Less: Advance of Previous year u�lized against goods & Services 6,759,629.00 3,244,515.00 Advance against Fixed Assets, Goods & Services (Net) 27,183,577.00

TOTAL CURRENT YEAR EXPENDITURE / UTILISATION (B) 250,526,832.23

GRANT RECEIVABLE FROM GOI (2013-14) (B-A) 526,679.29

NATIONAL INSTITUTE OF BIOLOGICALSMinistry of Health & Family Welfare

DETAILS OF GRANT UTILISATION FOR THE FINANCIAL YEAR 2013-14

FOR YEAR 2013-14

158


schedule -12(forming part of financial statement as on 31-3-2014)

(A) sigNificANT AccOUNTiNg POLiciEs

1. Basis of Accounting

The financial statements have been prepared as prescribed by ICAI in accordance with generally accepted accounting principles. The National institute of Biologicals (here and after referred as NIB) adopts accrual system of accounting however, the incomes i.e. receipts from sale of reference standard, sample testing charges, training fee received, rent received from hostel/guest house and interest on advances are recognized on Cash basis.

The accounting policies adopted and applied in the preparation of financial statements by the NIB are consistent with those used in the previous years.

2. fixed Assets and Depreciation

a) Fixed assets are stated at cost less accumulated depreciation.

b) Depreciation has been provided to the extent of 95% on S.L.M on the basis of rates as prescribed in schedule XIV of the Companies Act 1956. The depreciation rates applied on various assets is given below –

fiXED AssETs RATEs Of DEPREciATiON cHARgEDMachinery & Equipment - 4.75%Office Equipment - 7.07%Building - 1.63%Furniture & Fixtures - 6.33%Typewriter - 13.91%Vehicles - 9.50%Air Conditioner - 13.91%Computer & Computer Software - 16.21%Cycle Rickshaws - 9.50%Tools - 4.75%Books - 40.00%

c) In respect of additions to fixed assets made during the year, depreciation has been provided for the full year and in respect of sale/disposal of fixed assets, no depreciation has been provided but it has no financial implication due to this deviation from the prescribed provisions of the ICAI.

d) The depreciation has been charged to the grant (Corpus Fund/Capital Fund) and is recognized in the Income & Expenditure account over the useful life of the asset as a contra item as per AS-12 Prescribed by ICAI.

3. grant in Aid

a) The grants in aid received from Ministry of Health & family Welfare, Government of India is accounted for on accrual basis. Accordingly, any deficit/surplus of grant has been shown as Grant receivable/payable to the MOH & FW.

159


b) The grants utilized for the purchase of fixed assets and have been shown under the head of Capital Assets Fund.

c) Further grants utilized for advances against Fixed Assets, goods & services have also been shown under the head of Corpus/Capital Fund.

4. inventory Valuation

Stock of Diesel has been valued at cost based on First in First out (FIFO) method.

5. Employee Remuneration & Benefits

All Retirement and other Terminal Benefits such as Gratuity, Leave Encashment and Bonus etc are not accounted on year to year basis and the same are recognized in the year of occurrence of event.

6. Revenue Recognition

a) Income and expenditure are accounted for on accrual basis, as they are earned or incurred however, the incomes i.e. rent received from hostel/guesthouse, sample testing charges, sale of reference standard, bank interest and interest on staff advances are accounted on Cash basis; except in case of Government Authorities.

b) From 2013-14 onwards, Consultancy charges paid for procurement of Fixed Assets is considered as revenue expenditure.

7. Provision

A provision is recognized, when an enterprise has a present obligation as a result of past event; it is probable that an outflow of resources will be required to settle the obligation, in respect of which a reliable estimate can be made. Provisions are not discounted to present value and are determined based on best estimate required to settle the obligation at the balance sheet date. These are reviewed at each balance sheet date and are adjusted to reflect the current best estimates.

8. contingent Liabilities and contingent Assets

A disclosure for a contingent liability is made when there is a possible obligation that may, but probably will not, require an outflow of resources. Where there is a possible obligation or a present obligation but the likely hood of outflow of resources is remote, no provision or disclosure is made.

160


(B) NOTEs ON AccOUNTs

1. During the year NIB has opted for Voluntary Compliance and Encouragement Scheme (VCES). NIB has paid Service Tax on rent received from guest house/hostel amounting to Rs. 1,44,698.00 for previous years as well as current year due to non-collection of service tax from parties. Due to which income is understated to this extent.

2. The following balances which are lying with the Bank as on 31.03.2014 are not considered in the Books of NIB. Further, Income is unaccounted to the extent interest received on following accounts:

in RupeesS. No. Account Type interest not recognized Balance as on

31.03.20141. NIB-Haemovigilance A/c 14,616.00 12,202.00

2. NIB-Pension A/c 13,136.00 3,13,771.00

3. NIB-NPS A/c 11,268.00 1,66,101.00

4. NIB-UPSAC A/c 112.00 1,07,702.00

NIB-Workshop A/c 13,397.00 2,04,306.75

Total 52,529.00 8,04,082.75

Due to non-consideration of above mentioned figures, Income and Assets are understated to the extent of Rs. 52,529.00 and Rs. 8,04,082.75 respectively. Further, amount payable to ministry does not include respective amounts.

3. Provision for Leave Encashment and gratuity to the extent of Rs. 434.42 lakhs has not been made during the year, as exact liability has not been ascertained by approved actuary. Similarly, the provision on account of bonus payable during the year has not been made as the exact liability has not been ascertained.

4. Sundry Creditors includes a sum of Rs 1,76,67,334.00, which is payable to M/s HSCC(I) Ltd, on account of construction of Laboratory, Animal House include consultancy fee. This amount is payable from the last 7 years, due to some defects intimated and yet to be rectified.

5. All liabilities are recognized to the extent information available.

6. NIB has transferred all the receipts earned during the year from its various operations, except Rs. 32,92,663.00 which is shown as “Receipts Payable to MOH & FW” under the head of “Current Liability”.

7. NIB has maintained Fixed Assets detail in Soft format only. Further, physical verification of fixed assets & Store is yet to be carried out.

8. The depreciation of Rs.9,88,55,335.00 has been charged to the Income & Expenditure account. Since the Institute is fully aided by the Government of India, therefore depreciation is charged to the Grant (Corpus Fund/Capital Fund) and is recognized in the Income & Expenditure account over the useful life of the asset as a contra item.

161


9. During the year Rs. 3,25,000.00 has been capitalized from work-in-progress on account of Effluent Treatment Plant (ETP) and balance amount of Rs.4,36,809.00 which relates to Technical-study & advertisement expenditure has been adjusted from Corpus Fund.

10. Party’s balances including Balance with HLL & HSCC are subject to confirmations. Further, the interest receivable/ due from HSCC is not recognized in the books of NIB due to non-confirmation of balance. Interest received amounting to Rs. 4,107.00 on HSCC savings account is recognized as income and the same is reduced from amount payable to HSCC.

11. During the Financial Year 2013-14, NIB has transferred Rs. 21,97,000.00 to “NIB Pension Fund Account”, shown as an expense in the books of NIB. This amount has been kept in a separate bank account and balance of that bank is not recognized in the books of NIB along with the interest thereon.

12. Purchase of Diesel to the extent utilized during the year has been recognized as expenditure and the balance amount is shown as stock (as ascertained by the management of Institute) forming part of current assets.

13. TDS Recoverable from Government authority is recognized in the books of accounts for the F.Y. 2013-14.

14. Internal Control System is to be strengthened.

15. NIB has not gathered any information from suppliers/service providers about their status under Micro, Small and Medium Enterprises (Development) Act, 2006. Therefore, the required information, regarding the dues outstanding to Micro, Small and Medium Enterprises as on 31.03.2014 and interest payable, if any, are not recognized and reported.

16. NIB has made Cash payment of Rs.94,282.00 on account of VAT on sale of Tender Forms, Sale of Reference Standards etc instead of utilizing VAT Credit for payment of VAT. Further, the amount of VAT Credit cannot be quantify, due to non-availability of Information.

17 Electricity expenses for current year is understated by Rs. 6,85,650.00 because of adjustment of Security Deposit (Electricity) of previous year.

18. The advances to contractors & suppliers includes the following:

S. No. Party’s Name Amount in Rs Remarks1. Directorate of Advertising

& Visual Publicity (DAVP)56,424.00 Outstanding since 1st April 2007

2. M/s HSCC (I) Ltd. 12,18,025.91 Amount was provided for Effluent Treatment Plant (ETP) & other work. This amount is outstanding for more than 4 years which is resulting into financial loss to the Government as NIB is not getting any interest on these advances; however no action is taken till date. Further, as per the information provided by the management, now this ETP is un-viable due to design defect.

162


3. M/s HLL Lifecare Limited 3,01,70,140.00 In the current year part of the equipments & consultancy has been adjusted against advances. NIB generally maintains such balance with HLL on regular basis for procurement of Lab Equipments. According to the CAG Report this advance payment is in excess of actual requirement which is resulting into financial loss to the Government as NIB is not getting any interest on these advances.

19. Previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary.

for P A R Y & cO. fOR NATiONAL iNsTiTUTE Of BiOLOgicALschartered Accountants

(fR No. 007288c)

Sd/- cA Yogesh Malik Sd/- Sd/-Partner s.K. sharma Dr. g.R soni(M. No. 074635) (Budget & finance Officer) (sc. gr.-i/ Dy. Director (Admn.) i/c)

Sd/-Place: Noida Dr. surinder singhDate: 25.07.2014 (Dy. Director(Qc)/Director-i/c)

163


iNDEPENDENT AUDiTOR’s REPORT

The Members, General Provident Fund,

National Institute of Biologicals, Ministry of Health & Family Welfare Government of India, A-32, Sector-62 (Institutional Area) Noida-201307

1. We have audited the attached Balance Sheet of the National Institute of Biologicals, General Prov-ident Fund as at 31st March 2014 and Income & Expenditure Account along with Receipts & Payment Account for the year ended on that date annexed thereto. These Financial Statements are the Responsibility of the “NIB-GPF” Management. Our Responsibility is to express an opinion on these Financial Statements Based on our Audit.

2. Attention is invited to- i. Note no (1) regarding the effect of change in the value of bonds.

3. Further we report that: a) We have obtained all the information and explanations which to the best of our knowledge

and belief were necessary for the purpose of our audit. b) In our opinion proper books of accounts as required by law have been kept by the Institute so

far as it appears from our examination of books. c) The Balance Sheet and the Income & Expenditure Account dealt with by this report are in

agreement with the books of accounts.

4. Subject to Para – 2, in our opinion and to the best of our information and according to the expla-nations given to us, the said accounts exhibit a true and fair view.

a) In the case of Balance Sheet of the state of affairs as at 31st March 2014; and b) In t he case of the Income & Expenditure Account Excess of Income over Expenditure for the

year ended 2014.

for P A R Y & cO. chartered Accountants (fRN 007288c)

Sd/-cA Yogesh Malik Partner (M. No. 074635)

Place: Noida Date: 25.07.2014

164


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BGPF

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Mr.S

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831.

00

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Dr.

Reba

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BGPF

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Dr.

R.K.

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3

68,9

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9

5,00

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-

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3

5,94

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49

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11NI

BGPF

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Mr.

Neer

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865.

00

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400.

00

-

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-

3

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58,1

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0

12NI

BGPF

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Dr.J

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13

NIBG

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645.

00

45,6

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14NI

BGPF

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Mr.

P.K.

Mah

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3

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0

1

20,0

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0

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-

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3

3,39

8.00

47

2,28

1.00

15NI

BGPF

/21

Mr.

Ashi

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3

88,9

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3

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7

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46,

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690,

893.

00

16

NIBG

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3 M

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on L

akra

, S.T

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5

45.0

0

-

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-

-

-

-

-

54

5.00

17NI

BGPF

/24

Mr.

Deep

ak M

ahaj

an, C

.O.

3

92,2

38.0

0

7

2,00

0.00

-

-

-

-

-

3

7,51

8.00

50

1,75

6.00

18NI

BGPF

/25

Mr.J

.P. P

ant,

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n. A

ssist

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5

39,9

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0

7

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00

1

50,0

00.0

0

-

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-

4

5,29

5.00

52

7,26

2.00

19NI

BGPF

/26

Mr.P

arde

ep K

umar

, U.D

.C.

5

70,3

64.0

0

1

97,0

00.0

0

-

-

-

-

-

5

8,77

8.00

82

6,14

2.00

20NI

BGPF

/27

Mr.

Man

mee

t Sin

gh, S

teno

882

,585

.00

120

,000

.00

-

-

345

,000

.00

-

-

6

1,12

5.00

71

8,71

0.00

21NI

BGPF

/28

Mr.H

.P.V

ashi

st, E

lect

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1,

122,

277.

00

125

,000

.00

-

-

-

-

-

103

,402

.00

1,35

0,67

9.00

22NI

BGPF

/29

Mr.

Pard

eep

Kum

ar, L

.D.C

.

839

,880

.00

144

,000

.00

3

6,00

0.00

-

-

-

-

81,

552.

00

1,10

1,43

2.00

23NI

BGPF

/30

Mr.

Dhin

rend

ra S

ingh

, U.D

.C.

9

58,2

90.0

0

1

00,5

00.0

0

-

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1

00,0

00.0

0

-

-

79,

358.

00

1,03

8,14

8.00

24NI

BGPF

/31

Mr.

U.N.

Shar

ma,

U.D

.C.

7

74,0

90.0

0

1

64,0

00.0

0

-

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-

-

-

7

4,95

8.00

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013,

048.

00

25

NIBG

PF/3

2 M

r. G.

S. R

awat

, Driv

er

1

67,3

95.0

0

8

0,00

0.00

-

-

1

50,0

00.0

0

-

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6

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.00

104,

346.

00

26

NIBG

PF/3

3 M

r.P.C

. Gup

ta,

LDC

1

27,5

98.0

0

4

8,00

0.00

-

-

-

-

-

1

3,36

3.00

18

8,96

1.00

27NI

BGPF

/34

Mr.B

ijend

er S

ingh

, Peo

n

164

,194

.00

18,

000.

00

-

-

171

,000

.00

-

-

1,3

87.0

0 12

,581

.00

28

NIBG

PF/3

5 M

r. Ra

kesh

, Peo

n

7

0,30

5.00

7

2,00

0.00

-

-

6

5,00

0.00

-

-

3

,855

.00

81,1

60.0

0

29NI

BGPF

/37

Ms.

Sho

bha,

Peo

n

153

,849

.00

72,

000.

00

-

-

80,

000.

00

-

-

9,8

18.0

0 15

5,66

7.00

30NI

BGPF

/39

Mr.

Subh

ash

Chan

d, P

eon

3

79,3

34.0

0

6

7,80

0.00

-

-

2

25,6

00.0

0

-

-

22,

904.

00

244,

438.

00

31

NIBG

PF/4

0 D

r. Ac

hla

pras

ad, S

c.-I

I

2,08

8,88

0.00

1

80,0

00.0

0

-

-

-

-

188

,910

.00

2,45

7,79

0.00

32NI

BGPF

/41

Ms.

Kan

chan

Ahu

ja, S

c II

I

1,61

1,69

5.00

2

70,0

00.0

0

-

-

-

-

151

,962

.00

2,03

3,65

7.00

33NI

BGPF

/45

Dr.

Renu

jain

, Sc.

-II

1,

613,

116.

00

300

,000

.00

-

-

-

-

1

54,4

79.0

0 2,

067,

595.

00

34

NIBG

PF/4

6 M

r. Su

raj P

al, P

eon

88,

771.

00

48,

000.

00

2

4,00

0.00

-

-

-

1

0,33

3.00

17

1,10

4.00

35NI

BGPF

/47

Ms.

Mad

hu E

rmill

i, Sc

III

723

,434

.00

96,

000.

00

-

-

-

-

6

6,68

0.00

88

6,11

4.00

36NI

BGPF

/49

Mr.

Ravi

Dut

t, Dr

iver

7

7,31

3.00

9

6,00

0.00

11,

000.

00

-

-

-

11,

808.

00

196,

121.

00

37

NIBG

PF/5

0 M

r. Ha

rinde

r Si

ngh,

Driv

er

2

17,5

12.0

0

9

6,00

0.00

-

-

1

75,0

00.0

0

-

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8

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.00

146,

735.

00

38

NIBG

PF/5

1 D

r. R.

N.Pr

asad

, DD(

QC)

1,82

1.00

-

-

-

-

-

-

1,82

1.00

39NI

BGPF

/52

Mr.

S.K.

Sha

rma,

Lab

. tec

h.

2

67,2

29.0

0

7

2,00

0.00

10,

000.

00

-

-

-

27,

367.

00

376,

596.

00

40

NIBG

PF/5

3 M

r.P.C

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an, P

eon

52,

766.

00

66,

000.

00

2

4,20

0.00

3

9,30

0.00

-

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5

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.00

108,

918.

00

41

NIBG

PF/5

5 M

r. R.

K. A

rora

, Ste

no

68,

238.

00

14,

400.

00

-

-

65,

000.

00

-

-

2,8

45.0

0 20

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.00

42

NIBG

PF/5

6 D

r. Su

rinde

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ngh,

DD(

QC)

142

,926

.00

72,

000.

00

-

-

-

-

1

5,82

8.00

23

0,75

4.00

43NI

BGPF

/57

Mr.

A.K.

Sah

u, S

c.-I

I

332

,540

.00

92,

500.

00

10

0,00

0.00

-

5

57,0

70.0

0

-

3

2,03

0.00

-

44NI

BGPF

/58

Mr.P

.S.C

hand

rana

nd, L

.T.

1

08,2

50.0

0

8

0,00

0.00

-

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-

12,

608.

00

200,

858.

00

45

NIBG

PF/6

1 M

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ukes

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mar

, A.E

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1,

289,

816.

00

120

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.00

-

-

-

-

1

17,8

69.0

0 1,

527,

685.

00

46NI

BGPF

/62

Mr.

R.P.

Josh

i, A.

E.(C

ivil)

146

,573

.00

60,

000.

00

-

-

-

-

1

5,57

9.00

22

2,15

2.00

47NI

BGPF

/64

Mr.L

eela

Kish

an, D

river

518

,156

.00

72,

000.

00

-

-

-

-

4

8,47

3.00

63

8,62

9.00

48

NIBG

PF/6

5 M

r. M

VR. D

. Pra

sad,

S.C

lerk

500

.00

-

-

-

-

-

-

500

.00

49NI

BGPF

/66

Mr.R

.C.D

alai

, S. C

lerk

286

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.00

84,

000.

00

-

-

-

-

2

8,90

3.00

39

9,62

1.00

50NI

BGPF

/67

Mr.

Subh

ash

Chan

d, J

.E.

1

12,3

18.0

0

4

8,00

0.00

-

-

1

00,0

00.0

0

-

-

8

,757

.00

69,0

75.0

0

51NI

BGPF

/69

Mr.

S.K.

Sha

rma,

B.F

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1,

128,

265.

00

400

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.00

-

-

50,

000.

00

-

-

115

,704

.00

1,59

3,96

9.00

52NI

BGPF

/70

Mr.M

anpa

l, Jr

. Acc

ount

ant

1

25,1

47.0

0

-

-

-

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-

10,

888.

00

136,

035.

00

53

NIBG

PF/7

2 M

r. Ja

ipal

Mee

na, L

ab.T

ech.

4

4,38

4.00

3

6,00

0.00

-

-

-

-

5

,557

.00

85,9

41.0

0

54NI

BGPF

/73

Ms.

Girij

a L.

V., L

ab.T

ech.

2

8,84

2.00

2

4,00

0.00

-

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-

-

3

,640

.00

56,4

82.0

0

55NI

BGPF

/74

Md.

M.L

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1

62,8

85.0

0

9

5,00

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0

13

0,00

0.00

-

-

6

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86,8

39.0

0

56NI

BGPF

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Ms.

Parm

inder

Kuma

r,Jr.

Anim

al Ca

re Ta

ker

2

19,6

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21,

933.

00

301,

540.

00

57

NIBG

PF/7

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Kum

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Sc.

6

66,8

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00

-

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65,

483.

00

877,

325.

00

58

NIBG

PF/7

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Gopa

l, Jr

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101

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24,

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00

-

-

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9,9

54.0

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5,36

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59NI

BGPF

/79

Mr.

Vije

nder

Kum

ar M

eena

, Jr.S

c.

5,

934.

00

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5,

934.

00

60

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Kum

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harm

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2

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11.0

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6

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0.00

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23,

369.

00

319,

480.

00

61

NIBG

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Mah

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1

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62

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SCH

EDU

LES

FOR

MIN

G P

ART

OF

BALA

NCE

SH

EET

AS A

T 31

st M

ARCH

201

4SC

HED

ULE

- 1

: Li

st o

f Mem

bers

Who

Con

trib

uted

tow

ards

sub

scri

ptio

n of

"N

IB-G

PF"

G P

F AC

COUN

TS B

ALAN

CE S

UMM

ARY

AS O

N 31

.03.

2014

NA

TION

AL IN

STIT

UTE

OF B

IOLO

GICA

LSM

inist

ry o

f Hea

lth &

Fam

ily W

elfa

re

167


(Am

ount

in R

s)

Sl.N

o G

PF A

/c

No.

N

ame

& D

esig

nati

on O

peni

ng B

alan

ce a

s on

1.0

4.20

13(A

)

Sub

scri

ptio

/

Cont

ribu

tion

.(B

)

Rec

over

y

(C)

Adv

ance

(D)

Wit

hdra

wal

(E)

F.S

ettl

e

(F)

Pre

viou

s Ye

ar

Adju

stm

ents

(E

xces

s/Sh

ort)

(G)

Int

eres

t @

8.7

0%

(H)

Bal

ance

as

on 3

1.03

.201

4(A

)+(B

)+(C

)-(D

)-(E

)-(F

)-(G

)+(H

)

1NI

BGPF

/01

Dr.

G.R.

Son

i, Sc

.-I

6

79,3

40.0

0

5

95,0

00.0

0

-

-

-

-

-

8

6,94

3.00

1,

361,

283.

00

2

NIBG

PF/0

4 M

s Su

dha

V.Go

pina

th, S

c II

I

923

,574

.00

60,

000.

00

1

0,00

0.00

-

75,

000.

00

-

-

8

2,38

1.00

1,

000,

955.

00

3

NIBG

PF/0

5 M

r. R.

Ram

an, S

r.Acc

ount

ant

44,

707.

00

1

,500

.00

4,0

00.0

0

-

-

5

0,55

7.00

-

35

0.00

-

4NI

BGPF

/06

Ms.

G.B

indr

a, S

c II

I

2,42

7,18

1.00

2

28,0

00.0

0

-

-

-

-

-

2

21,9

09.0

0 2,

877,

090.

00

5

NIBG

PF/0

7 M

r. P.

P. M

onda

l, St

ore

Cler

k

378

,030

.00

70,

000.

00

-

-

-

-

-

36,

477.

00

484,

507.

00

6

NIBG

PF/0

8 M

s.Aj

anta

Sirc

ar, S

c II

I

325

,332

.00

20,

944.

00

-

-

-

-

-

29,

272.

00

375,

548.

00

7

NIBG

PF/0

9 M

s.Sh

alin

i Tew

ari,

Sc I

II

1,

048,

185.

00

84,

000.

00

-

-

-

-

-

95,

151.

00

1,22

7,33

6.00

8NI

BGPF

/10

Mr.S

.Kan

nan,

JS

26,

831.

00

-

-

-

-

-

-

-

26,8

31.0

0

9NI

BGPF

/12

Dr.

Reba

Chh

abra

, Sc.

-II

1,

103,

797.

00

72,

000.

00

-

-

-

-

-

99,

423.

00

1,27

5,22

0.00

10NI

BGPF

/13

Dr.

R.K.

Shar

ma,

Sc

III

3

68,9

54.0

0

9

5,00

0.00

-

-

-

-

-

3

5,94

1.00

49

9,89

5.00

11NI

BGPF

/14

Mr.

Neer

aj M

alik

, Sc.

III

33,

865.

00

20,

400.

00

-

-

-

-

-

3

,908

.00

58,1

73.0

0

12NI

BGPF

/15

Dr.J

.P.P

rasa

d, S

c.-I

I

1,25

9,12

9.00

3

40,0

00.0

0

40,

000.

00

1

80,0

00.0

0

-

-

-

1

15,9

24.0

0 1,

575,

053.

00

13

NIBG

PF/1

7 M

r.Kal

lol S

aha,

Lab

. Tec

h.

1

39,9

77.0

0

1

35,0

00.0

0

-

-

2

40,0

00.0

0

-

-

10,

645.

00

45,6

22.0

0

14NI

BGPF

/20

Mr.

P.K.

Mah

apat

ra, S

.O (

A)

3

18,8

83.0

0

1

20,0

00.0

0

-

-

-

-

-

3

3,39

8.00

47

2,28

1.00

15NI

BGPF

/21

Mr.

Ashi

s Ba

rua,

J.T

.O.

3

88,9

00.0

0

3

25,0

00.0

0

-

-

7

0,00

0.00

-

-

46,

993.

00

690,

893.

00

16

NIBG

PF/2

3 M

r. Am

on L

akra

, S.T

.A.

5

45.0

0

-

-

-

-

-

-

-

54

5.00

17NI

BGPF

/24

Mr.

Deep

ak M

ahaj

an, C

.O.

3

92,2

38.0

0

7

2,00

0.00

-

-

-

-

-

3

7,51

8.00

50

1,75

6.00

18NI

BGPF

/25

Mr.J

.P. P

ant,

Adm

n. A

ssist

ant

5

39,9

67.0

0

7

2,00

0.00

20,

000.

00

1

50,0

00.0

0

-

-

-

4

5,29

5.00

52

7,26

2.00

19NI

BGPF

/26

Mr.P

arde

ep K

umar

, U.D

.C.

5

70,3

64.0

0

1

97,0

00.0

0

-

-

-

-

-

5

8,77

8.00

82

6,14

2.00

20NI

BGPF

/27

Mr.

Man

mee

t Sin

gh, S

teno

882

,585

.00

120

,000

.00

-

-

345

,000

.00

-

-

6

1,12

5.00

71

8,71

0.00

21NI

BGPF

/28

Mr.H

.P.V

ashi

st, E

lect

rian

1,

122,

277.

00

125

,000

.00

-

-

-

-

-

103

,402

.00

1,35

0,67

9.00

22NI

BGPF

/29

Mr.

Pard

eep

Kum

ar, L

.D.C

.

839

,880

.00

144

,000

.00

3

6,00

0.00

-

-

-

-

81,

552.

00

1,10

1,43

2.00

23NI

BGPF

/30

Mr.

Dhin

rend

ra S

ingh

, U.D

.C.

9

58,2

90.0

0

1

00,5

00.0

0

-

-

1

00,0

00.0

0

-

-

79,

358.

00

1,03

8,14

8.00

24NI

BGPF

/31

Mr.

U.N.

Shar

ma,

U.D

.C.

7

74,0

90.0

0

1

64,0

00.0

0

-

-

-

-

-

7

4,95

8.00

1,

013,

048.

00

25

NIBG

PF/3

2 M

r. G.

S. R

awat

, Driv

er

1

67,3

95.0

0

8

0,00

0.00

-

-

1

50,0

00.0

0

-

-

6

,951

.00

104,

346.

00

26

NIBG

PF/3

3 M

r.P.C

. Gup

ta,

LDC

1

27,5

98.0

0

4

8,00

0.00

-

-

-

-

-

1

3,36

3.00

18

8,96

1.00

27NI

BGPF

/34

Mr.B

ijend

er S

ingh

, Peo

n

164

,194

.00

18,

000.

00

-

-

171

,000

.00

-

-

1,3

87.0

0 12

,581

.00

28

NIBG

PF/3

5 M

r. Ra

kesh

, Peo

n

7

0,30

5.00

7

2,00

0.00

-

-

6

5,00

0.00

-

-

3

,855

.00

81,1

60.0

0

29NI

BGPF

/37

Ms.

Sho

bha,

Peo

n

153

,849

.00

72,

000.

00

-

-

80,

000.

00

-

-

9,8

18.0

0 15

5,66

7.00

30NI

BGPF

/39

Mr.

Subh

ash

Chan

d, P

eon

3

79,3

34.0

0

6

7,80

0.00

-

-

2

25,6

00.0

0

-

-

22,

904.

00

244,

438.

00

31

NIBG

PF/4

0 D

r. Ac

hla

pras

ad, S

c.-I

I

2,08

8,88

0.00

1

80,0

00.0

0

-

-

-

-

188

,910

.00

2,45

7,79

0.00

32NI

BGPF

/41

Ms.

Kan

chan

Ahu

ja, S

c II

I

1,61

1,69

5.00

2

70,0

00.0

0

-

-

-

-

151

,962

.00

2,03

3,65

7.00

33NI

BGPF

/45

Dr.

Renu

jain

, Sc.

-II

1,

613,

116.

00

300

,000

.00

-

-

-

-

1

54,4

79.0

0 2,

067,

595.

00

34

NIBG

PF/4

6 M

r. Su

raj P

al, P

eon

88,

771.

00

48,

000.

00

2

4,00

0.00

-

-

-

1

0,33

3.00

17

1,10

4.00

35NI

BGPF

/47

Ms.

Mad

hu E

rmill

i, Sc

III

723

,434

.00

96,

000.

00

-

-

-

-

6

6,68

0.00

88

6,11

4.00

36NI

BGPF

/49

Mr.

Ravi

Dut

t, Dr

iver

7

7,31

3.00

9

6,00

0.00

11,

000.

00

-

-

-

11,

808.

00

196,

121.

00

37

NIBG

PF/5

0 M

r. Ha

rinde

r Si

ngh,

Driv

er

2

17,5

12.0

0

9

6,00

0.00

-

-

1

75,0

00.0

0

-

-

8

,223

.00

146,

735.

00

38

NIBG

PF/5

1 D

r. R.

N.Pr

asad

, DD(

QC)

1,82

1.00

-

-

-

-

-

-

1,82

1.00

39NI

BGPF

/52

Mr.

S.K.

Sha

rma,

Lab

. tec

h.

2

67,2

29.0

0

7

2,00

0.00

10,

000.

00

-

-

-

27,

367.

00

376,

596.

00

40

NIBG

PF/5

3 M

r.P.C

.Diw

an, P

eon

52,

766.

00

66,

000.

00

2

4,20

0.00

3

9,30

0.00

-

-

5

,252

.00

108,

918.

00

41

NIBG

PF/5

5 M

r. R.

K. A

rora

, Ste

no

68,

238.

00

14,

400.

00

-

-

65,

000.

00

-

-

2,8

45.0

0 20

,483

.00

42

NIBG

PF/5

6 D

r. Su

rinde

r Si

ngh,

DD(

QC)

142

,926

.00

72,

000.

00

-

-

-

-

1

5,82

8.00

23

0,75

4.00

43NI

BGPF

/57

Mr.

A.K.

Sah

u, S

c.-I

I

332

,540

.00

92,

500.

00

10

0,00

0.00

-

5

57,0

70.0

0

-

3

2,03

0.00

-

44NI

BGPF

/58

Mr.P

.S.C

hand

rana

nd, L

.T.

1

08,2

50.0

0

8

0,00

0.00

-

-

-

-

12,

608.

00

200,

858.

00

45

NIBG

PF/6

1 M

r. M

ukes

h Ku

mar

, A.E

.(E)

1,

289,

816.

00

120

,000

.00

-

-

-

-

1

17,8

69.0

0 1,

527,

685.

00

46NI

BGPF

/62

Mr.

R.P.

Josh

i, A.

E.(C

ivil)

146

,573

.00

60,

000.

00

-

-

-

-

1

5,57

9.00

22

2,15

2.00

47NI

BGPF

/64

Mr.L

eela

Kish

an, D

river

518

,156

.00

72,

000.

00

-

-

-

-

4

8,47

3.00

63

8,62

9.00

48

NIBG

PF/6

5 M

r. M

VR. D

. Pra

sad,

S.C

lerk

500

.00

-

-

-

-

-

-

500

.00

49NI

BGPF

/66

Mr.R

.C.D

alai

, S. C

lerk

286

,718

.00

84,

000.

00

-

-

-

-

2

8,90

3.00

39

9,62

1.00

50NI

BGPF

/67

Mr.

Subh

ash

Chan

d, J

.E.

1

12,3

18.0

0

4

8,00

0.00

-

-

1

00,0

00.0

0

-

-

8

,757

.00

69,0

75.0

0

51NI

BGPF

/69

Mr.

S.K.

Sha

rma,

B.F

.O.

1,

128,

265.

00

400

,000

.00

-

-

50,

000.

00

-

-

115

,704

.00

1,59

3,96

9.00

52NI

BGPF

/70

Mr.M

anpa

l, Jr

. Acc

ount

ant

1

25,1

47.0

0

-

-

-

-

-

10,

888.

00

136,

035.

00

53

NIBG

PF/7

2 M

r. Ja

ipal

Mee

na, L

ab.T

ech.

4

4,38

4.00

3

6,00

0.00

-

-

-

-

5

,557

.00

85,9

41.0

0

54NI

BGPF

/73

Ms.

Girij

a L.

V., L

ab.T

ech.

2

8,84

2.00

2

4,00

0.00

-

-

-

-

3

,640

.00

56,4

82.0

0

55NI

BGPF

/74

Md.

M.L

. Dau

d Al

i, La

b.Te

ch.

1

62,8

85.0

0

9

5,00

0.00

-

48,0

00.0

0

13

0,00

0.00

-

-

6

,954

.00

86,8

39.0

0

56NI

BGPF

/75

Ms.

Parm

inder

Kuma

r,Jr.

Anim

al Ca

re Ta

ker

2

19,6

07.0

0

6

0,00

0.00

-

-

-

-

21,

933.

00

301,

540.

00

57

NIBG

PF/7

6 D

r. M

eena

Kum

ari,

Jr.

Sc.

6

66,8

42.0

0

1

20,0

00.0

0

25,

000.

00

-

-

-

65,

483.

00

877,

325.

00

58

NIBG

PF/7

8 M

r. Na

nda

Gopa

l, Jr

. Sc.

101

,415

.00

24,

000.

00

-

-

-

-

9,9

54.0

0 13

5,36

9.00

59NI

BGPF

/79

Mr.

Vije

nder

Kum

ar M

eena

, Jr.S

c.

5,

934.

00

-

-

-

-

-

-

5,

934.

00

60

NIBG

PF/8

0 M

r. Pa

nkaj

Kum

ar S

harm

a, J

.S.

2

36,1

11.0

0

6

0,00

0.00

-

-

-

-

23,

369.

00

319,

480.

00

61

NIBG

PF/8

2 S

h. P

. C..P

Mah

apat

ra, A

O

1,

749,

124.

00

355

,000

.00

-

-

-

-

1

68,7

04.0

0 2,

272,

828.

00

62

NIBG

PF/8

3 D

r. Vi

jay

laxm

inag

439

,776

.00

-

-

-

-

-

3

8,26

1.00

47

8,03

7.00

63

NIBG

PF/8

4 D

r. S

S Ne

gi, J

r Sc

113

,616

.00

-

-

-

1

13,6

16.0

0

-

-

-

T

otal

31

,380

,116

.00

6,5

60,0

44.0

0

3

04,2

00.0

0

417

,300

.00

2,0

41,6

00.0

0

721

,243

.00

-

2,8

77,3

32.0

0

37,9

41,5

49.0

0

954,

712.

00

417,

300.

00

-304

,200

.00

1,

067,

812.

00

39,0

09,3

61.0

0 T

OTA

L SU

BSCR

IPTI

ON

CAR

RIE

D F

OR

WAR

DED

TO

BAL

ANCE

SH

EET

AD

D :

ADVA

NCE

AD

JUST

ED S

HO

WN

SEP

ARAT

ELY

OPE

NING

ADV

ANCE

01.

04.2

013

ADD

: ADV

ANCE

GIV

EN D

URIN

G TH

E YE

AR

LES

S: R

ECO

VERY

OF

ADVA

NCES

DUR

ING

THE

YEAR

SCH

EDU

LES

FOR

MIN

G P

ART

OF

BALA

NCE

SH

EET

AS A

T 31

st M

ARCH

201

4SC

HED

ULE

- 1

: Li

st o

f Mem

bers

Who

Con

trib

uted

tow

ards

sub

scri

ptio

n of

"N

IB-G

PF"

G P

F AC

COUN

TS B

ALAN

CE S

UMM

ARY

AS O

N 31

.03.

2014

NA

TION

AL IN

STIT

UTE

OF B

IOLO

GICA

LSM

inist

ry o

f Hea

lth &

Fam

ily W

elfa

re

168

Annual Report 2013-2014S

CH

EDU

LE -

2 :

Exce

ss o

f In

com

e/Ex

pend

itur

e fo

r th

e ye

ar

As

on

31

.03

.20

14

A

s on

3

1.0

3.2

01

3

Ope

ning

Bal

ance

As

on

1

,030

,224

.22

9

62,5

34.2

2 Ad

d/Le

ss:

Inco

me/

Expe

nditu

re f

or t

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(A

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L IN

STI

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ICA

LSC

hart

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Acc

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Gen

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Pro

vide

nt F

und

(FR

No.

00

72

88

C)

CA

Yog

esh

Mal

ikSd

/-Sd

/-

Sd/-

Sd/-

Par

tner

S.K

. Sha

rma

Dr.

G.R

. Son

iM

. No.

07

46

35

(Bud

get

& F

inan

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er)

(Sc.

Gr.

-I/D

y. D

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c)

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oida

Dr.

Sur

inde

r S

ingh

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e :2

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01

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y.D

irec

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)/D

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OF

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LOG

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ND

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ENTS

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UN

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R T

HE

YEA

R E

ND

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1S

T M

AR

CH

20

14

Gen

eral

Pro

vide

nt F

und

173


NATiONAL iNsTiTUTE Of BiOLOgicALs Ministry of Health and Welfare

general Provident fund

scHEDULE - 5

(FORMING PART OF THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 31ST MARCH 2014)

A. sigNificANT AccOUNTiNg POLiciEs

1. Method of accounting:

The accounts have been prepared under the Historical cost convention on accrual basis.

2. Revenue Recognition:

The Revenue has been recognized on accrual basis, except Bank interest.

3. fixed Assets:

There are no fixed assets.

4. investments:

Investments are stated at cost and are held in the name of the “National Institute of Biologicals General Provident Fund” (herein after referred to as “NIB – GPF”).

B. NOTEs TO AccOUNTs

1. Investment in the bonds have been stated at the cost therefore the effect of the change in the value of the bond as on date of balance sheet has not been considered.

2. Interest on Investments amounting to Rs. 32,82,030.00 includes Rs. 1,81,000.00 in respect of interest for the year 2012-13.

3. TDS Recoverable from Government authority as recognized in the books of accounts for the F.Y. 2013-14.

4. The accounting standards issued by ICAI wherever applicable have been complied to the extent possible.

174


5. The previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary to confirm to the current period presentation.

for P A R Y & cO. fOR NATiONAL iNsTiTUTE Of BiOLOgicALs

chartered Accountants general Provident fund

(fRN. 007288c)

Sd/-cA Yogesh Malik Sd/- Sd/-Partner s.K. sHARMA D.R g.R soni(M. No. 074635) (Budget & Finance Officer) (Sc.Gr.-I/ Dy. Director (Admn.) I/c)

Sd/-Place: Noida Dr. surinder singhDate: 25.07.2014 (Dy. Director(QC)/Director-i/c)

annual report 2013-14 - national institute of …nib.gov.in/annual_report/nib annual report...

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