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ANNUAL REPORT2017-18

NATIONAL INSTITUTE OF BIOLOGICALSMinistry of Health and Family Welfare

Government of IndiaNOIDA

Contents

1. REPORT FROM THE DESK OF THE DIRECTOR i

2. INTRODUCTION iv

3. IMMUNODIAGNOSTIC KIT LABORATORY 3

4. MOLECULAR DIAGNOSTIC LABORATORY 11

5. BLOOD REAGENT LABORATORY 13

6. BIOCHEMICAL KIT LABORATORY 20

7. BACTERIAL VACCINE LABORATORY 26

8. VIRAL VACCINE LABORATORY 31

9. BLOOD PRODUCTS LABORATORY 35

10. RECOMBINANT PRODUCT LABORATORY 43

11. ENZYME AND HORMONE LABORATORY 51

12. THERAPEUTIC MONOCLONAL ANTIBODY LABORATORY 56

13. ALLERGEN TESTING LABORATORY 63

14. ANIMAL FACILITY 68

15. STERILITY TESTING LABORATORY 79

16. QUALITY MANAGEMENT UNIT 81

17. SAMPLE RECEIPT AND REPORT DISPATCH UNIT 88

18. TRAINING UNIT 92

19. HAEMOVIGILANCE DIVISION 106

20. INFORMATION TECHNOLOGY DIVISION 107

21. ENGINEERING DIVISION 112

22. REPORT OF THE ADMINISTRATIVE WORK 114

23. RAJBHASHA (HINDI): 119

24. EMPOWERING CONSUMERS: RIGHT TO INFORMATION ACT, 2005 124

25. AUDITORS REPORT 125-158

Annual Report 2017-18 i

National Institute of Biologicals

I am pleased to present the Annual Report of National Institute of Biologicals (NIB) for the year 2017-18, that once again highlights the crucial work being carried out by our Institute. Through the year, NIB has made significant contributions in assuring the quality of Biologicals and has also engaged as a leading scientific Institute in many activities concerned at International Level.

Being the premier Institute for assuring quality of biologicals in India, NIB is actively involved in the systematic examination of the quality of biologicals and immunobiological products, with a view to enable the release of indigenous & imported products after test and analysis as per the national requirements. This year the Institute has evaluated 1966 samples out of which, 13 batches were found to be of Not of Standard Quality (NSQ) and 02 Spurious, thus highlighting the role of Institute in protecting and promoting public health. Our core activity of Quality Control testing has been expanded to include testing services to neighbouring countries viz. Bangladesh as per the request received from their Drug Regulatory Authority for testing of Vaccines– Hepatitis A, Hepatitis B and Cell Culture Rabies Vaccine.

NIB is notified Central Drugs Laboratory (CDL) under Drugs & Cosmetics Act for Blood Grouping Reagents, Immunodiagnostic Kits, Blood Products, Recombinant Products, Biochemical Kits, Enzyme and Hormones, Bacterial Vaccines and Viral Vaccines and four Scientists of the Institute are notified Government Analysts. The Jammu & Kashmir State Government has notified NIB scientists as Government Analysts for their state vide S.R.O. 193 dated 21st April 2017.

Institute continues to contribute to the development of monographs and this year

REPORT FROM THE DESK OF DIRECTOR

11 Monographs on biologicals through review/ validation were submitted to Indian Pharmacopoeia Commission for incorporation in Indian Pharmacopoeia (IP). These monographs have been published in the 2018 edition of IP. 12 publications in various National and International journals also adds to the contribution of NIB in disseminating knowledge in the area of biologicals.

With a view to enhance the scope of NABL accreditation for the biological products including Therapeutics, Diagnostic kits, Reagents and Vaccines tested at NIB, biological tests included in the scope for accreditation have been increased to 160 from 140 and Chemical tests to 125 from 86.

In addition, to assure the safety of the employees, NIB is certified for OSHAS 18001: 2007 which provides a framework for protecting employees against possible occupational risks and reduces the likelihood of accidents in the workplace.

The outstanding performance of NIB this year, is highlighted by the active participation of the Institute in various scientific activities at International level specifically its pivotal role in the related World Health Organization (WHO) programmes as well as extending support to other international organizations of repute to establish Quality Control testing of biologicals, Laboratory Quality Management System and Haemovigilance Programme. These collaborative activities have enhanced Institute’s international visibility and standing.

NIB is designated as WHO Collaborating Centre for In-vitro Diagnostics and has been

Annual Report 2017-18ii


assigned a code WHO CC IND-148 on 9th May 2017. Designation as “Support Cell” for WHO Prequalification Programme for In-vitro Diagnostics on 22nd November 2017 is also a great accomplishment wherein NIB will be able to facilitate prequalification of indigenous products which in-turn may augment the international trade of diagnostic kits manufactured in India.

I would like to state that, NIB has hosted the 1st General Meeting of WHO-National Control Laboratory Network for Biologicals (WHO-NNB) held from 31st October to 02nd November 2017. Participants from 21 National Control Laboratories (NCLs) from different parts of the world, responsible for lot release and/or contracted for testing of WHO- prequalified vaccines, attended the meeting. Furthermore the meeting was attended by representatives from industry associations, as well as WHO. The main objective of the Network is to share quality information in order to facilitate access to vaccines through the recognition of the responsible NRA’s lot release by recipient countries. The visit of international dignitaries to NIB laboratories and their interaction with NIB scientists has opened up possibilities for linkage with these organizations for future collaborations and tie-ups. The State-of –the –art-infrastructure and world class hospitality facilities provided by NIB were highly appreciated.

The other WHO related activities include the WHO hands-on training course for 3 Indian vaccine manufacturers on “Determination of Polyribosyl- Ribitol- Phosphate (PRP) content of the Haemophilus influenza type b (Hib) capsular polysaccharide in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed Amperometric Detection (HPAEC-PAD)” held at NIB from 23rd-27th October, 2017 and also the First WHO- NIB- Vaccine Stakeholders meeting to include WHO

protocol for determination of PRP content of Hib vaccine by HPAEC-PAD in Indian Pharmacopoeia held at NIB on 27th October 2017.

The recognition of NIB scientists at various international forums is demonstrated through their active membership in various international committees like Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), International Haemovigilance Network (IHN) & Asian Harmonization Working Party Technical Committee (AHWPTC) Working Group.

The domain expertise in Quality Control of biologicals as well as in Laboratory Quality Management System (LQMS) has enabled the NIB scientists to assist the South African National Accreditation System (SANAS) for the ISO: 17025 accreditation of South African National Control Laboratory (SANCL) for Oral Polio Vaccine, Measles Vaccine and Yellow Fever Vaccine.

Further NIB has developed functional linkages in various capacities with both International and National organizations viz. WHO, NIBSC-UK, Paul Ehrlich Institut- Germany, European Directorate of Quality Medicine (EDQM)- France, National Serology Reference Laboratory-Australia, Christian Medical College- Vellore, C-CAMP- Bengaluru and IIT- Delhi, Indian Council of Medical Research (ICMR) etc. for participation in EQAS, proficiency testing and inter laboratory collaborative studies.

NIB is the National Coordinating Center for Haemovigilance Programme of India (HvPI) and the said programme was launched in December 2012 across the country. This year 08 CMEs and 02 National level workshops were conducted for creating awareness on importance of reporting adverse transfusion reactions. A total of 1312 participants which includes Blood bank officials, clinicians, nurses & blood bank technical staff

Annual Report 2017-18 iii


were trained during these CMEs/ Workshops organised by HvPI Division of NIB across the country. Due to the increase in awareness about this programme through the CMEs, the number of reporting centres have increased to 656. The reported adverse transfusion reaction reports are reviewed for its quality and significance by the Quality Panel and Signal Review Panel guided by eminent transfusion specialists. Due to the systematic and consistent efforts coordinated by NIB, for implementing the programme across the country, India has become a member of International Haemovigilance Network (IHN) and Officer In-charge HvPI- NIB is board member of IHN.

Training programmes on quality control and quality management systems for biologicals are also organized by the institute to develop skilled manpower to meet the needs of Quality Control of biologicals and immunobiologicals in the country. These training programmes are designed to cater the specific needs of the trainees viz. blood bank officials through National Health Mission, Laboratory Quality Management System (LQMS) through CDSA- DBT, Post- graduate Students through various NIPERs/ Universities of Himachal Pradesh, Silchar & Guwahati and,

technical personnel from manufacturing units. Apart from these, summer training programmes and dissertation work are also being undertaken. More than 400 personnel have been trained during this year including students, blood bank officials, and technical personnel from manufacturing units.

NIB has also initiated activities to establish well structured Research & Development Programmes in collaboration with National and International organizations that can aid in formulating regulatory recommendations for improving safety and quality of biologicals. Institutional Development Plan (IDP) in this regard has been prepared. The IDP was reviewed by the Scientific Committee for R&D activities, for its relevance to the enhancement of quality aspects and innovation. The proposed activities will be formally initiated after approval from the Ministry.

National Institute of Biologicals is making sincere efforts to live up to its mandate. I am grateful to the continuous support and guidance from Ministry of Health & Family Welfare (Government of India), Central Drugs Standards and Control Organization (CDSCO) and Industry in facilitating NIB in its endeavors for the quality service in the Healthcare Sector of the country.

Annual Report 2017-18iv


Annual Report 2017-18


Jh txr çdk’k uM~MkShri.Jagat Prakash Nadda

lEekuh; LokLF; ,oa ifjokj dY;k.k la?k dSfcusV ea=hHon’ble Union Cabinet Minister for Health & Family Welfare

Jherh vuqfç;k iVsySmt. Anupriya Patel

lEekuh; LokLF; ,oa ifjokj dY;k.k la?k jkT; ea=hHon’ble Union Cabinet Minister of State for Health & Family Welfare

Jh vf’ouh dqekj pkScShri. Ashwini Kumar Chaubey

lEekuh; LokLF; ,oa ifjokj dY;k.k la?k jkT; ea=h Hon’ble Union Cabinet Minister of State for Health & Family Welfare

Annual Report 2017-18vi


INTRODUCTION

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 Pharmacopoeias in finalizing the specifications, train personnel in the public and private sectors, prepare National Reference Standards, collaborate with other National and International Scientific Institutions/ organizations 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 calibration 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, chemicals, scientific equipment etc., is met from the grants given by the Ministry of Health & Family Welfare, Govt. of India.

SCIENTIFIC PROGRESS

Annual Report 2017-18 3


IMMUNODIAGNOSTIC KIT LABORATORY

1. Name of Head: Dr. R.K Sharma, Scientist Gr.- III

2. Manpower in the Lab/Division: I. Name of Scientific Staff

Mr. N Nanda Gopal, Scientist Gr.-III

Mr. Sanjeev Kumar, Junior Scientist (till Dec 2017)

Mr. Rajeev Kumar, Junior Scientist

II. Name of Technical staff:

Mr. Brij Bhushan, Laboratory Technician

Ms. Deepa Sharma, TO, NRL, NACO

Ms. Sweeti Dalal, Laboratory Technician, NACO (till Nov 2017)

III. Contractual Staff: Eight

3. Scientific Activities Undertaken : a) Collaboration with other

Organizations: Networking with blood banks/ hospital of Delhi/ NCR for collection of plasma bags:

DCG (I) has directed via file no Blood Bank/ Misc/NIB/2015-D dated 02.12.2015 to various blood banks/ hospitals (Table 1) to provide infectious plasma bags of HIV, HBV, HCV and Syphilis to NIB that are required for characterization and preparing performance panels in the laboratory. During the year 2017-2018 a total number of 1151 of plasma donor units were collected (Table 2) out of which 898 were reactive for HIV, HCV, HBV & Syphilis and 253 were non-reactive.

Table 1: List of Blood Banks/ Hospitals of different geographical region associated with NIB.

S. No. Name of Hospital/Blood Bank S. No. Name of Hospital/ Blood Bank

1. Apollo Hospital, New Delhi 11. Moolchand Hospital, Delhi

2. Indian Red Cross Society, New Delhi 12. Pushpanjali Hospital, Vaishali

3. G.T.B. Hospital, New Delhi 13. Kailash Hospital, NOIDA

4. AIIMS Hospital, New Delhi 14. Fortis Hospital, NOIDA

5. Safdarjung Hospital, New Delhi 15. Fortis Memorial, Gurgaon

6. Lok Nayak Hospital, New Delhi 16. Medanta Hospital, Gurgaon

7. Rotary Blood Bank, Delhi 17. Metro Heart Blood Bank, NOIDA

8. G.B. Pant Hospital, New Delhi 18. Prathma Blood Bank, Gujarat

9. Lady Harding Hospital, New Delhi 19. B. I. M. R. Hospital, Madhya Pradesh

10. Ganga Ram Hospital, New Delhi 20.Acharya Shri Chander College Medical Science, Jammu



Table 2: Total number of Plasma Bags collected from different geographical region of India

Name of Hospital/ Blood BankMarker

HIV HBsAg HCV Syphilis Non-Reactive Total

I.R.C.S, Delhi 0 0 0 0 253 253

Kailash Hospital, Delhi 9 63 26 10 0 108

Fortis Hospital, Gurgaon 3 15 7 13 0 38

Lady Harding Medical College, Delhi

10 81 23 70 0 184

G.T.B. Hospital, Delhi 27 157 140 77 0 401

Lok Nayak Hospital, New Delhi 6 30 6 0 0 42

Moolchand Hospital, Delhi 2 9 7 0 0 18

Medanta Hospital, Gurgaon 0 3 4 0 0 7

Apollo Hospital, Delhi 0 37 6 0 0 43

Prathma Blood Bank, Gujrat 3 3 2 0 0 8

B.I.M.R. Hospital, MP 3 26 3 3 0 35

Acharya Shri Chander College Medical Science, Jammu

0 3 0 0 0 3

Bangalore Blood Bank 1 4 2 0 0 7

Karnataka 2 2 0 0 0 4

Total 66 433 226 173 253 1151

b) CDL Notification:

The Institute is notified Central Drugs Laboratory (CDL) by Government of India vide Gazette No. G.S.R. 601 (E), dated 27th August 2002 for diagnostic kits of HIV-Ab, HCV-Ab and HBsAg and re-notified for these kits vide Gazette No. G.S.R. 908(E) dated 22nd December 2014. Institute is also accredited by NABL in accordance with ISO/IEC 17025:2005 for the testing of various Immunodiagnostic Kits i.e. HIV 1&/2 Antibody, HCV Antibody & HBsAg (Rapid, ELISA) and Syphilis rapid test kit in field of biological testing.

Laboratory has established Quality Management System (QMS) for conducting Quality evaluation of indigenous and imported kits (Rapid, ELISA, CLIA, ELFA, Confirmatory, Ag/Ab & Combo kits) for HIV, HCV, HBsAg & syphilis which were forwarded by offices of CDSCO and procurement division of NACO. Overall laboratory ensures the supply of standard quality immunodiagnostic kits for safeguarding the public health.



c) Government Analyst: S. No. Name of the Staff Gazette Notification No. & Date Immunodiagnostic kit Markers1. Dr. Reba Chhabra,

Scientist Grade - IGazette Notification No. S.O. 2393 (E) published on 2nd September 2015

1. Human Immunodeficiency Virus

2. Hepatitis B Surface Antigen

3. Hepatitis C Virus

4. Testing of Biologicals: 4.1 Quality Control Test/Evaluation of in-vitro

Diagnostics Kits:

During the year 2017-2018, a total of 385 immunodiagnostic kits including RAPID, ELISA, CLIA, ELFA, Confirmatory & Combo Kits for HIV, HCV, HBV, Syphilis & Dengue were evaluated in the laboratory (Table 3). Out of 385 kits, 117 (30.39%) kits for HIV, 85 (22.08%) kits for HCV, 145 (37.66%) kits for HBV, 34 (8.83%) kits for Syphilis, 3 (0.78%) kits for Dengue and 01 for HIV-Syphilis combo were evaluated.

d) Publication(s):

1. R. K. Sharma, Pallavi Kumari, Rajeev Kumar, S. K. Sharma, Brij Bhushan, Reba Chhabra and Surinder Singh. Marching Towards Chemiluminescence Immunoassay in Screening of Donors for Blood Borne Viral Infections. IOSR Journal of Pharmacy and Biological Sciences. 2018; 13(2):15-19.

2. Rajesh K. Sharma and Reba Chhabra. Brief overview on Dengue viral disease. International Journal of Biomedical and Advance Research. 2017; 8(04):129-132, doi: 10.7439/ijbar.

Table 3: Marker-wise distribution of evaluated indigenous and imported kits forwarded by offices of CDSCO in the year 2017-2018.

Name of Biologicals

TestedType of Biologicals

Number of Batches Evaluated

No. of batches found to be of Standard

Quality (SQ)

No. of batches found Not of

Standard Quality (NSQ)Imported Indigenous

HIV

RAPID 22 6 28 ----

ELISA 13 20 32 01

CLIA 40 ---- 40 ----

ELFA 6 ---- 6 ----

CONFIRMATORY 10 ---- 10 ----

HBV

RAPID 10 8 18 ----

ELISA 18 14 32 ----

CLIA 74 ---- 74 ----

ELFA 18 ---- 18 ----




Name of Biologicals

TestedType of Biologicals



Quality (SQ)

No. of batches found Not of

Standard Quality (NSQ)Imported Indigenous

HCV

RAPID 13 3 16 ----

ELISA 19 13 31 01

CLIA 28 ---- 28 ----

ELFA 4 ---- 4 ----


SYPHILIS

RAPID 9 14 23 ----

ELISA 3 3 6 ----

CLIA 5 ---- 5 ----

POOLED PLASMA 45 ---- 45

HIV-SYPHILIS COMBO

RAPID 1 ---- 1----

DENGUE ELISA 3 - - ----

4.2 List of HBV markers kits evaluated in the year 2017-2018:

Out of 145 HBV kits evaluated during

the financial year 2017-2018, 60 kits were evaluated for the following markers of HBV (Table 4).

Table 4: List of HBV markers evaluated in the year 2017-2018

S. No.NAME OF PRODUCT/

MARKERNO. OF BATCHES

EVALUATEDSTANDARD

QUALITYNOT OF STANDARD

QUALITY

1. Anti- HBs Ab 14 14 0

2. HBc IgM 16 16 0

3. Anti-HBc 13 13 0

4. HBsAg Quantification 1 1 0

5. Anti- HBe 9 9 0

6. HBe Ag 7 7 0

TOTAL 60 60 0

4.3 Inter-laboratory testing of Biologicals and Biotherapeutic Samples:

In the year 2017-2018, laboratory has tested 508 lot/batches of biologicals &

biotherapeutics for infectivity of HIV-Ab, HCV-Ab & HBsAg received from inter-laboratory (other laboratories) (Figure-1).



14 4

490 508

0

100

200

300

400

500

RecombinantProducts

Laboratory

Enzymes &HormonesLaboratory

Blood ProductsLaboratory

TOTAL

No.

of s

ampl

es

No. of Inter-Laboratory samples (Total & Lab wise) tested

in 2017-18

Figure 1: Number of biologicals & biotherapeutic products tested during year April 2017-March 2018 for Viral Marker Testing

5. Preparation and Supply of National standards, Sera Panel etc.:

In the year 2017-2018, the laboratory supplied total volume of ~4.2 Liters (1.5 Liters of HIV, 1.3 liters of HCV, 1.3 liters of HBsAg and 100ml of Syphilis) Performance Panel to the following 12 indigenous manufacturers, each

comprising of 100 Positive & 300 Negative members. The Total Revenue of ~ 17,10,800 INR (Seventeen lakhs ten thousand and eight hundred rupees) has been generated. Table 5 below shows the list of Indigenous manufacturers those purchased Performance Panel from NIB.

Table 5: List of Indigenous manufacturers those Purchased Performance Panels from NIB

S. No. Name of Manufacturer Type of Panel Supplied

1. Biolab Diagnostics Pvt. Ltd., Mumbai HIV

2. Alere Medical, Gurgaon HIV, HCV, HBsAg

3. Medsource Ozone, Haryana HIV, HCV, HBsAg

4. Oscar Medicare Pvt. Ltd, New Delhi Syphilis, HIV, HCV, HBsAg

5. SD Biosensor Healthcare Pvt. Ltd., Gurugram HIV, HCV, HBsAg

6. Karwa Enterprises, Delhi HIV, HCV, HBsAg

7. Labcare Diagnostics HIV, HCV, HBsAg

8. Alere Medical, Gurgaon HIV, HCV, HBsAg



S. No. Name of Manufacturer Type of Panel Supplied

9. Nexogenix Life Sciences, Hyderabad HIV, HCV, HBsAg

10. Meril Diagnostic Ltd., Gujarat Syphilis, HIV, HCV, HBsAg

11. Premier Medical Corp. Ltd., Daman Syphilis, HIV, HCV, HBsAg

12. Avantor Performance, Dehradun Syphilis, HIV, HCV, HBsAg

6. Trend in volume of work as compared to previous year (2016-2017):

6.1 Trend in volume of work as compared to the previous year for Quality Control Testing of Immunodiagnostic kits:

A total of 385 batches of immunodiagnostic kits of HIV, HCV, HBV, Syphilis & Dengue

were evaluated in the year 2017-2018 whereas 375 batches were evaluated in the year 2016-2017, showing an increase of 2.6% samples received and evaluated in 2017-2018. The details of trend for the number of respective marker kits tested in 2017-18 as compared to that tested in 2016-17 is given below in figure 2.

HIV HBV HCV Syphilis DengueHIV

SyphilisCombo

Total

2016-17 105 158 93 19 0 0 3752017-18 117 145 85 34 3 1 385

105158

93

19 0 0

375

117145

85 343 1

385

050

100150200250300350400450

No.

of k

its te

sted

Type of immunodiagnostic kit tested

Trend of the volume of work done in 2017-18 as compared to the previous year

2016-17 2017-18

Figure 2: Trend in volume of Immunodiagnostic kits tested/evaluated during April 2017 to March 2018 as compared to the previous year (2016-2017).

6.2 Trend in volume of work as compared to the previous year for Inter-laboratory Sample Testing:

A total of 508 lot/batches of Blood Products, Recombinant Products, Enzymes and Hormones & Viral Vaccine Laboratories



Blood Products RecombinantProducts

Enzymes &Hormones Viral Vaccines

2016-17 544 3 13 242017-18 490 14 4 0

544

3 13 24

490

14 4 00

100200300400500600

No.

of i

nter

labo

rato

ry sa

mpl

es

Trend in the number of inter laboratory samples tested in 2017-18 as compared to 2016-17

2016-17 2017-18

Figure 3: Trend in volume of inter-laboratory sample tested during April 2017 to March 2018 as compared to previous year (2016 -2017).

7. Proposed targets for testing of new Biological being undertaken:

Initiation of Lot Release testing of HIV-Rapid Diagnostic Kits (RDTs).

8. Details of participation in cGMP Inspections:

Inspection of M/s Arkray Healthcare Pvt. Ltd., Surat, manufacturing facility with CDSCO team by Dr. Reba Chhabra, i/c- DD (QC) Diagnostics and Training and Sh. N. Nanda Gopal, Scientist Gr-III from 25th-26th October 2017.

9. Expert Committee Meetings: The 5th Technical Expert Committee Meeting

for In-vitro Diagnostic Kits was held at NIB on 06.07.2017.

10. Trainings/ workshops attended: Participations in training/ Workshop/ Conference

(Name of the Scientist(s), Name of the programme, Duration and place of training, etc.):

were tested for the infectivity of HIV-Ab, HCV-Ab & HBsAg in the year 2017-

18, as compared to 584 lot/batches tested in the year 2016-2017 (Figure 3).



Name of the Scientist Participated

Name of the Training/ Workshop/Conference

Duration Place of Training

Dr. R K Sharma

S-III & Head

Apex Lab meeting 23rd March, 2017

NARI, Pune

Meeting to discuss the revision of Pediatrics ARV drugs as per the availability of the formulation in market under the chairmanship of Spl. DGHS, Ministry of Health & Family Welfare, New Delhi

29th March, 2017

Nirman Bhawan,

New Delhi

22nd Asian Harmonization Working Party (AHWP) Annual Meeting & 21st AHWP Technical Committee

04th-07th Dec, 2017

Hotel The Grand,

New Delhi

5 days training program on Lot Release Testing for HIV Rapid Test

11th-15th Dec, 2017

Paul Ehrlich Institute, Langen, Germany

Mr. N Nanda Gopal

S-III

5 days training program on Lot Release Testing for HIV Rapid Test

11th-15th Dec, 2017

Paul Ehrlich Institute, Langen, Germany

Poster presentation at “4th National Summit on Public Healthcare Systems”

6th-8th July 2017

Indore, Madhya Pradesh

11. Participation in Proficiency Testing/ EQAS:

INTERNATIONAL LEVEL

International External Quality Assessment Scheme (EQAS)

Immunodiagnostic Kit Laboratory has participated in the International External Quality Assurance Scheme (EQAS) for Hepatitis Serology, HIV Serology and Syphilis Serology with 100 per cent score and got certificate. The EQAS is conducted thrice in year by National Reference Laboratory, Australia.

NATIONAL LEVEL

Provider of HIV Proficiency Testing Panel for HIV SEROLOGY: The Institute has

organized one day EQAS Workshop for distribution of HIV Proficiency Test panel (Round 2 of the Financial Year 2017-18) to SRLs of Uttar Pradesh & Uttaranchal on 20th February, 2018.

12. Outstanding achievements of the Laboratory:

Immunodiagnostic laboratory of NIB has been designated and assigned an ID as IND-148 by WHO as Collaborating Center (WHO-CC) for Quality Control of HIV, HCV, HBsAg in-vitro diagnostic assays on 09th May, 2017. WHO- pre-qualification for diagnostic kits is in progress. Further, NIB has also been recently designated as, “Support cell for WHO- Prequalification program for In-vitro Diagnostics”



1. Name of Head: Dr. R. K. Sharma, Scientist Grade-III

2. Manpower in Lab / Division I. Name of Scientific Staff:

Dr. Manoj Kumar, Scientist Grade-III

Dr. Manjula Kiran, Junior Scientist

Dr. Anoop Kumar, Junior Scientist

II. Name of Technical Staff: Nil

III. No. of Contractual Staff: 02

3. Scientific Activities Undertakena) Publication (s): Two publications

i. Anoop Kumar, Manoj Kumar, Deepika Paliwal, Aakanksha Yadav, Reba Chhabra, Surinder Singh; Methods for Hepatitis C Virus Genotyping and Diagnosis: An Update, Indian J Med Res (Accepted) [IF- 1.532][Citation-0]

ii. Manoj Kumar Rajput, Anoop Kumar, Aakanksha Yadav, Deepika Paliwal, Tripti

MOLECULAR DIAGNOSTIC LABORATORY

Sharma; Influx of recombinant insulin and its analogues for management of diabetes in India International Journal of Diabetes in Developing Countries (2017). Doi: 10.1007/s13410-017-0552-7. [IF-0.366][Citation-0]

4. Testing of Biologicals Molecular Diagnostic Laboratory (MDL) is

carrying out quality evaluation of

(i) Qualitative Molecular Diagnostic kits for HBV

(ii) Qualitative Molecular Diagnostic kits for HCV

(iii) Qualitative Molecular Diagnostic kits for HIV-1 and

(iv) Qualitative Blood donor screening multiplex kits for HBV, HCV & HIV.

During this period the laboratory had evaluated 13 batches of Molecular Diagnostic test kits, which were forwarded by office(s) of CDSCO.

Table 1: Details of batches of Molecular Diagnostic test kits evaluated (2017-18)

Name of Biologicals

tested

Type of Biologicals

No. of batches

evaluated

No. of batches

found to be of Standard

Quality

No. of batches

found not to be of

Standard Quality

No. of Inter- laboratory

sample tested

Remarks

Qualitative Molecular Diagnostic kit for HIV-1

Molecular Diagnostic

00 00 Nil Nil Nil

Qualitative Molecular Diagnostic kit for HCV


01 01 Nil Nil Nil



Name of Biologicals

tested

Type of Biologicals

No. of batches

evaluated

No. of batches


Quality

No. of batches

found not to be of

Standard Quality

No. of Inter- laboratory

sample tested

Remarks

Qualitative Blood donor screening multiplex test for HBV, HCV & HIV


12 09 01 Nil

2 Batches found invalid

Total 13 10 01 Nil 2 Batches found invalid

5. Trend in volume of work as compared to previous year

6. Proposed targets for testing of new biologicals being undertaken:

The laboratory is in the process of standardization and validation of testing procedures for quality evaluation of Viral Load monitoring Molecular Diagnostic kits for HBV, HCV and HIV. After completion of this activity such kits would be taken up for evaluation.

7. Outstanding achievements of the Lab:

The laboratory participated in HCV- NAT proficiency testing (EDQM- HCV- NAT-PT-2017) with European Directorate for the Quality of Medicines and Health Care (EDQM). The test report has been submitted to EDQM and awarded excellent results.



1. Name of Head: Mrs. Kanchan Ahuja, Scientist Grade- III

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

(w.e.f 19.07.2017)

2. Manpower in the lab/division: I. Name of Scientific Staff:

Mr. Pankaj K. Sharma, Scientist Grade-III

Ms. Vandana Tandasi, Junior Scientist

II. Name of Technical and Supportive Staff:

Mr. Subhash Kumar, Laboratory Technician

Ms. Priya Bhagat, Laboratory Assistant

Mr. Bijender Singh, Peon

III. No(s) of Contractual Staff: 04

3. Scientific Activities Undertaken: a) CDL Notification:

The Institute is notified CDL since 2002 for Blood Grouping Reagents. The Blood Reagent laboratory has the infrastructure and expertise for testing 68 different types of Blood Grouping Reagents and Gel cards.

b). Govt. Analyst:

1. Mrs. Kanchan Ahuja is a notified Government Analyst for Blood Grouping Reagents as per the Gazette Notification No. S.O.-2393 (E) published on 2nd Sept,

BLOOD REAGENT LABORATORY

2015.

2. Dr. J. P. Prasad, Scientist Grade –I & Head, Blood Products Laboratory has been declared as Government Analyst vide Gazette Notification Extraordinary Part-II, Section (3), subsection ii, published on September 2011.

c) Publication (s): Following three monographs have been published in Indian Pharmacopoeia- 2018:

Anti A1 Lectin

Anti H Lectin

Anti D (IgM)

d). Expert Committee Meetings:

Organized a meeting at NIB on 12.05.2017 with the stakeholders and representative of CDSCO for preparation of National Reference Standard for Anti A and Anti B reagents.

4. Testing of Biologicals a. A total number of 337 batches of Blood

grouping reagents and Gel cards were received for Quality Control evaluation. Out of which 119 batches were of routine blood grouping reagents, 60 were rare blood grouping sera, 157 gel cards and blood grouping cards.

TABLE -1: No. of Blood Grouping Reagents received in 2017-18

Name of the Biological No. of Batches

Evaluated

No. of batches found to be of

Standard Quality

No. batches found not to be of

Standard Quality

Anti-A 26 26 -

Anti-B 27 27 -



Name of the Biological No. of Batches

Evaluated


Standard Quality

No. batches found not to be of

Standard QualityAnti-A,B 7 7 -Anti-D (IgM) 19 19 -Anti- (IgG + IgM) Blend 18 18 -Anti-H 5 5 -Anti-A1 (Lectin) 6 6 -AHG 7 7 -BSA 3 3 -Anti-D (Verification for weak D by IAT) 1 1 -Rare Reagent 60 60 -Blood Grouping/ Rare Gel Cards 157 157 -Blood Grouping Pad 1 1 -Legal 6 2 4Anti A 02 1 1 (Spurious)Anti B 02 1 1 (Spurious)Anti- D(IgM) 01 0 1Anti D (Blend) 01 0 1Total 337 333 4

b. Collection of samples: The laboratory collected a total number of 252 left over red blood samples from Indian Red Cross Society and Sir Ganga Ram Hospital, New Delhi. These samples were grouped, sub grouped, Rh phenotyped and cryopreserved to be used for Quality Control evaluation of

Blood Grouping Reagents. In addition to the above samples, a total number of 201 red cell vials were also received from the manufacturers for Quality Control evaluation of rare blood grouping reagents. The details of the samples collected and Rh phenotyped are given in (Figure. 1 & 2).

0100200300400500 453

55 5 472

4 20 2 278

10

201

FIGURE 1: Total blood samples collected in 2017-18



0102030405060708090

R1R1 R1r R1R2 R0r R2r rr r'r R2R2 R1Rz

7685

26

8 11 123 1 3

FIGURE 2: Phenotyping of various blood samples collected

5. Preparation and supply of National Standards, Sera panel etc.-

Preparation of in-house standards: Calibration of working standards for Anti-A, Anti-B, Anti-AB, Anti-D (IgM), Anti-D (Blend), Anti Human Globulin, Anti-A1

(Lectin) and Anti-H (Lectin) was done using Secondary Standards (in -house controls) which were calibrated against International Reference Standards from National Institute of Biological Standards and Control (NIBSC, UK). Details of International Reference standards are given in (table 2).

TABLE 2

Name of Reagent International Reference Standard Source

Anti-A 03/188, version 2; 11/11/05 NIBSC, UK

Anti-B 03/164, version 2; 11/11/05 NIBSC, UK

Anti-AB 03/188, version 2; 11/11/05

03/164, version 2; 11/11/05

NIBSC, UK

Anti-D(IgM) 99/836, version 2; 20/5/05 NIBSC, UK

Anti-D(IgG+IgM) 99/836, version 2; 20/5/05 NIBSC, UK

Anti Human Globulin 96/666, version 2; 19/04/04 NIBSC, UK

6. Trend in volume of work as compared to the previous year:a. No. of samples received:

A total 337 batches were received for

evaluation, out of which 285 batches were from imported manufacturers and 52 batches were from indigenous manufacturers. Details are given in (Figure. 3).



337

52

285

0

100

200

300

400

Total samples received Indigenous manufacturers Imported manufacturers

FIGURE 3: Batches received from Indigenous & Imported Manufacturers (2017-18)

b. Trend of batches of blood grouping reagents received in the year 2017-18 and 2016-17- (Table 3)

TABLE 3

Name of the sample Total= 337(2017-18) Total= 94 (2016-17)Anti-A 26 14Anti-B 27 14Anti-A,B 7 8Anti-D (IgM) 19 7Anti- (IgG + IgM) Blend 18 17Anti-H 5 5Anti-A1 (Lectin) 6 3AHG 7 2BSA 3 0Anti-D (Verification for weak D by IAT) 1 0Rare Reagent 60 18Blood Grouping/ Rare Gel Cards 157 6Blood Grouping Pad 1 0Total 337 94

26 277

19 185 6 7 3 1

60

157

114 14 8 7

175 3 2 0 0

186 0

020406080

100120140160180

Anti-A Anti-B Anti-A,B Anti-D (IgM) Anti- (IgG +IgM) Blend

Anti-H Anti-A1(Lectin)

AHG BSA Anti-D(Verificationfor weak D

by IAT)

RareReagent

BloodGrouping/Rare Gel

Cards

BloodGrouping

Pad

FIGURE 4: No. of samples received in the lab in 2016-2017 and 2017-2018

Total= 337(2017-18) Total= 94 2016-17

( )



3048 3298 39756397

7933 80799305

10695

0

5000

10000

15000

2010-2011 2011-2012 2012-2013 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018

FIGURE 5: Cryopreservation of Red Blood Cells

7. Proposed targets for testing of new biologicals being undertaken: a. Gel card antigen profile

b. Gel Neutral

8. Trainings attended by staff of Blood Reagent Laboratory at NIB, NOIDA1. Mr. Subhash Kumar (Laboratory

Technician) and one Lab Attendant participated in an internal training on sample/spill management held on 25.08.2017 at NIB.

2. A lecture on Medical Devices Rules 2017 delivered by Dr. Eswara Reddy, Joint Drugs Controller (I), CDSCO, HQ on 13.09.2017 for all the Scientific and Technical staff including Biologists of Blood Reagent Laboratory at NIB on the Medical Devices Rules, 2017.

3. Training on e-office file tracking system (FTS) by IT CELL on 13th September, 2017 by all the regular staff at National Institute of Biologicals (NIB), NOIDA.

c. Cryopreservation of red blood cells: The laboratory strengthened the repository of cryopreserved panel cells

for routine and rare red blood cells from a total number of aliquots from 9305 to 10695. (Figure 5)

d. Inter Laboratory testing of Blood Products: The laboratory tested 94 samples of Blood Products for Anti-A

and Anti-B haemagglutination test parameter as compared to 180 batches tested in the year 2016-2017. (Figure 6)

58

143

170

220

180

94

2012-2013 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018

FIGURE 6: Interlaboratory Testing of Blood Products



9. Lab Visited by various dignitaries at Blood Reagent Laboratory1. Dr. Saber M. Hussain, Senior Scientist

in the Department of Biology at the Air Force Research Laboratory (AFRL), Wright-Patterson Air Force Base USA visited the laboratory on 09.11.2017.

2. Advanced Post Graduate Diploma students (22 Nos) of Clinical Research and Pharmacovigilance from Apollo Hospitals Educational and Research

Foundation (AHERF), New Delhi visited the laboratory on 29.11.2017.

10. Outstanding Achievements of the laboratory:a. Participation in proficiency testing:

The staff participated in external proficiency program for Anti-A, Anti-B, Anti-D (Blend), Anti-D (IgM) Anti A1 (Lectin), Anti-H (Lectin) blood grouping reagents conducted by Indian Red Cross Society, Delhi on 06th Mar 2018. The performance of the staff was found to be 100% satisfactory.

Group photo of the meeting held with stakeholders on 12.05.2017 for National Reference Standard of Anti A and Anti B Reagents

Mr. Pankaj K. Sharma, receiving a momento being a trainer in the collaborative training program by National Health Mission (NHM) on “Training of Trainers for Strengthening of Blood services & e- Rakt Kosh meeting held on 5th – 7th Sep 2017



Participants performing Hand-on training on Laboratory Quality Management System (LQMS) at BRL held on 5th – 7th Sep 2017

Ms. Vandana Tandasi receiving a certificate from Dr. Reba Chhabra for being a trainer in the LQMS training

Students of National skill development performing Hands-on Training Program on Quality Control of Biologicals for M.Sc. Biotechnology, Microbiology and Biochemistry students of University of Jammu, Himachal Pradesh from 03.01.2018 to 23.01.2018



1. Name of Head: Ms. Ajanta Sircar, Scientist Grade III

2. Manpower in the Lab/ Division: I. Name of Scientific Staff:

Mr. Tara Chand, Scientist Grade III

BIOCHEMICAL KIT LABORATORY

Dr. Ashwini Kumar Dubey, Scientist Grade III

II. Name of Technical Staff:

Ms. Girija L.V., Laboratory Technician,

III. Nos. of Contractual staff: Four

3. Scientific Activities Undertaken: a) Collaboration with other organizations:

S. No.

Title Collaborating Institutes Period of Study

Status

1. Performance Validation of indigenously manufactured Glucose Sensing Devices developed with ICMR support

ICMR, New Delhi and

Biochemical Kit Laboratory, National Institute of Biologicals, NOIDA

09 Months Ongoing

b) CDL Notification:

The Institute is notified Central Drug Laboratory (CDL) for Glucose Test Strips and Fully automated analyzer-based Glucose Reagents vide Gazette Notification G.S.R. 908 (E) dated 22nd December 2014.

c) Govt. Analyst:

1. Ms. Ajanta Sircar, Head, Biochemical Kit Laboratory is appointed as Government Analyst by the Central Government for the whole of India in respect of the classes of drugs (i.e. Glucose test strips and fully automated analyzer-based glucose reagents) vide Gazette Notification S.O. 2393 (E) dated 02nd September 2015.

2. Ms. Ajanta Sircar, Head, Biochemical

Kit Laboratory, is also declared as Govt. Analyst by the Govt. of Jammu & Kashmir for the class of drugs (i.e., Glucose test strips and fully automated analyzer based glucose reagents) vide S.R.O. 193 dated 21st April 2017.

d) Publication (s):

Ajanta Sircar, Tara Chand, Aalapti Singh and Sunita Koholi. Control Testing of Batches of ‘Blood Glucose Test Strips’- made for use with Glucometers as a closed system; at the National Institute of Biologicals, NOIDA, INDIA: An overview of the procedure, profile of samples tested and the findings. IOSR- Journal of Pharmacy and Biological Sciences, Vol. 12, Issue 4, Ver. VIII (Jul– Aug 2017), PP 01-11.



4. Testing of Biologicals:

Name of Biologicals Tested

Type of Biologicals No. of batches

evaluated

No. of batches found

to be of Standard Quality

No. of batches

found not to be of

Standard Quality

No. of Inter-

Laboratory sample tested

Biochemical Kit Glucose Test Strips 183 183 Nil Nil

Biochemical Kit Fully automated analyzer based glucose reagents

24 19 5 Nil

Representation of ‘Standard Quality’ (SQ) & ‘Not of Standard quality’ (NSQ) batches of Blood Glucose Test Strips (183) & Glucose Reagents (24) evaluated at BKL, NIB during 01.04.17 to 31.03.18

0

50

100

150

200

Glucose Test Strips Glucose Reagent

183 SQ

19 SQ

0 NSQ

5 NSQ

No

. o

f B

atc

hes

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

In the financial year 2017-18, a total of 207 sample batches (183 batches of Blood Glucose Test Strips and 24 batches of Glucose Reagent) were received and evaluated. With the present staff strength, the laboratory has a capacity to test 150 batches of Glucose Reagent samples in a year. However the number of batches received is way less than its capacity and the laboratory hopes to receive more batches for effectively utilizing its capacity.

6. Proposed target for testing of new Biologicals being undertaken:

6.1 New types of products: The laboratory is evaluating newer technology-based products that entail the use of Smartphone/ Mobiles. Products such as ‘GlucoMe’, Dnurse SP1 Blood Glucose Meter for Smart Phone have been tested and/or are under testing at the laboratory. These are small external devices that fit easily to a smartphone and function as a glucose meter together with a specific ‘App’ on the phone. These devices have a clinical decision supporting website and 3-4 blood



glucose readings/day for any type 1 diabetes patient can be downloaded for analysis of the glycaemic pattern/ trends which helps patients and clinicians for treatment decision. The App also provides an e-Log book where blood glucose data can be saved and printed later or can be emailed to health care providers. In addition, these apps have graphical displays to see and interpret blood glucose entries and thus motivate patients to regulate calorie intake/ blood glucose testing frequency; resulting in better glucose control. Integrated insulin calculators also help patients on multiple daily injections; review their bolus insulin dose and improve glycaemic control without increasing severe hypoglycaemia in insulin-requiring patients with diabetes.

The other innovative products evaluated at Biochemical Kit Laboratory for blood glucose parameter is (i) CLEVER CHEK TD-3250 Blood Glucose plus Blood Pressure Monitor which is designed for monitoring of multiple parameters such as blood glucose & blood pressure and (ii) Easy Mate I GCHb which is designed for monitoring of multiple parameters such as blood glucose, cholesterol & haemoglobin.

As recommended by the Biochemical Kit Laboratory Technical Expert Committee, an Ion exchange HPLC based HbA1c testing platform is being procured for use as Laboratory Reference Method. Following Reference Method validation, batches of rapid test kits for HbA1c will be taken up for evaluation.

7. Training/ Workshop/ Conference organized, Lectures delivered in conference/ seminar/ symposium:

S.

No.

Name of the Scientist

Title Date Venue Conference Organizer

1. Mr. Tara Chand, Scientist

Gr - III

“Overview of self - monitoring of blood glucose systems evaluated at NIB”

10 - 13 May 2017

Sher-i Kashmir Institute of Medical Sciences, Srinagar, (J & K)

2nd J&K Medical Science Congress 2017 and 1st Annual conference of metabolic syndrome-prediabetes-polycystic ovary syndrome (MPPCOS) society

Sher-i Kashmir Institute of Medical Sciences, Srinagar,

(J & K)

8. Participation in Training/ Workshop/ Conference: S.

No.Name of the Scientist Area of Training Period Venue Trainer

1. 1. Mr. Tara Chand,

Scientist Gr-III

2. Mr. Ashwini Kumar Dubey, Scientist Gr-III

Equipment operation training for “Roche Cobas C111 Biochemistry Analyser”

07 - 12 Apr 2017

Biochemical Kit Laboratory, NIB, NOIDA

M/s Roche Diagnostics India Pvt. Ltd.



S. No.

Name of the Scientist Area of Training Period Venue Trainer


Scientist Gr-III


Equipment operation training for “Roche Cobas C311 Biochemistry Analyser”

07 - 12 Apr 2017



3. 1. Mr Tara Chand, Scientist Gr-III

2. Mr Ashwini Kr. Dubey, Scientist Gr.- III

Equipment operation training for “ Roche Cobas b221 Blood Gas Analyzer”

29 - 30 May 2017




Scientist Gr-III


Equipment operation training for “Alinity C” Biochemistry Analyzer

12 - 14 Sep 2017


M/s Abbott Healthcare Pvt. Ltd. USA


Scientist Gr-III


Equipment operation training for Qaaf Healthcare International’s product Cooey Blood Glucose Meter, for Smartphone

26 Sep 2017


M/s Qaaf Healthcare International, Delhi, India


Scientist Gr-III

2. Dr. Ashwini Kumar Dubey, Scientist Gr-III

Equipment operation training for Dnurse SP1 glucometer devices for Smartphone

26 Oct 2017


M/s Jana Care Pvt. Ltd., India


Scientist Gr-III


Equipment operation training for “Alinity C” Biochemistry Analyzer

07- 08 Dec 2017


M/s Abbott Healthcare Pvt. Ltd. India


Scientist Gr-III


Equipment operation training for “Vitros 250” Biochemistry Analyzer

19-26 Dec 2017


M/s Ortho Diagnostics Pvt. Ltd., India




Collaboration with ICMR: With a view to develop low cost indigenous devices, ICMR has aided the development of glucose sensing devices since 2010, and now three prototypes have been developed. These products are now readying for the manufacturing process and so their performance needs to be independently validated following standard norms and regulation as an integral part of the process. The Biochemical Kit Laboratory is in a very prestigious collaboration with the Division of Innovation and Translational Research - Indian Council of Medical Research (ICMR), New Delhi for guiding the manufacturer with respect to product design, sensitizing them about the Device’s Test parameters, and their specifications and limits of acceptance. Biochemical Kit Laboratory, NIB will also guide the different clinical data generation centers at Pondicherry, Mysore, Chennai and New Delhi for harmonizing their glucose estimation methodologies for ease of corroboration of test results through all the centers. Before these indigenously developed products are licensed to manufacture on a commercial scale, they will be required to be tested at NIB, NOIDA. This collaboration of the indigenous manufacturers with the Biochemical Kit Laboratory, during product development stage, will sensitize them regarding the Quality parameters and develop their preparedness for going to the next level.

The activities planned through this collaboration are-

• Biochemical Kit Laboratory, NIB, NOIDA to conduct ICMR- funded

Workshops for the Manufacturers and the Collaborating Centers for sensitizing them about the requirements of ISO 15197

• Biochemical Kit Laboratory to provide technical assistance to establish a uniform ‘Internal Quality Control Program for Glucose estimation’ in the four clinical data generating centers at Pondicherry, Mysore, Chennai and New Delhi with a view to harmonize the data generated by all the four centers.

• ICMR to fund recruitment of Technical Staff for this project and purchase of IQC materials and other laboratory consumables/ services for enabling the IQC Program in Biochemical Kit Laboratory and all the participating laboratories.

• Testing of the indigenous Glucose sensing devices/ test strips and other materials/ and execution of the test protocols, at Biochemical Kit Laboratory and all the four clinical data generating centers at Pondicherry, Mysore, Chennai and New Delhi.

• Collection, collation and analysis of the data generated by all the four participating centers for conclusively commenting on the quality of performance of the indigenously developed glucose sensing devices.

Workshops conducted for the indigenous manufacturers; Achira Labs Pvt. Ltd., Bengaluru and Raffles Diagnostics, Mysuru at Bengaluru and Mysuru The workshops for the Manufacturers (Achira Labs Pvt. Ltd., Bengaluru and



Raffles Diagnostics, Mysuru) for sensitizing them regarding the requirements of ISO 15197 has been conducted at Bengaluru and Mysuru on the 18th and 19th Sept., 2017 by Ms. Ajanta Sircar, Scientist – III & Head, Biochemical Kit Laboratory, NIB and together with the ICMR Scientists, Dr. Chander Shekhar, Additional Director General, ICMR & Head (Innovation & Translational Research, Intellectual Property Rights) and Dr. Neeta Kumar Scientist E, ICMR. The R & D Team of Achira Labs Pvt.

Ltd., JP Nagar, Bangalore and Raffles Diagnostics, Mysore were sensitized about the protocols and requirements of ISO 15197. The demonstration of the QC protocols by the NIB team together with Hands- on training to the technical staff of the Manufacturers was given. The Hand-outs/ Training materials were also distributed to the 2 manufacturers. The manufacturers also availed this opportunity to discuss problems related to performance of their devices with NIB Scientist.

Figure 1: Dr. Chander Shekhar, Additional Director General, ICMR & Head (Innovation & Translational Research, Intellectual Property Rights), Dr. Neeta Kumar, Scientist E, ICMR and Ms. Ajanta Sircar, Head & Scientist –III,

Biochemical Kit Laboratory, NIB during a ICMR- NIB collaborative workshop at Achira Labs, Bengaluru

Figure 2: Ms. Ajanta Sircar, Head & Scientist –III Biochemical Kit Laboratory & technical team, NIB giving a demonstration of QC protocol at Achira Labs, Bengaluru, as a team with Dr. Chander Shekhar, Additional Director

General, ICMR & Head (Innovation & Translational Research, Intellectual Property Rights).



I. Polysaccharide

1. Name of Head: Dr. Akanksha Bisht, Scientist Grade-III

2. Manpower in the Lab/Division: I. Name of Scientific staff:

1. Mr. Harit Kasana, Junior Scientist

2. Mr. Ajay Kumar Ade, Junior Scientist

3. Mr. Paras Jain, Junior Scientist, (July 2017 onwards)

II. No(s) of Contractual Staff: Three

3. Scientific Activities Undertaken:a) Collaboration with other organizations:

World Health Organization (WHO) Hands-on training course on “Determination of Polyribosyl-ribitol-phosphate (PRP) content of the Haemophilus influenza type b (Hib) capsular polysaccharide in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed

BACTERIAL VACCINE LABORATORY

Amperometric detection (HPAEC-PAD)” from 23-27 October 2017 at Bacterial Vaccine Lab - NIB:

Bacterial vaccine laboratory has conducted World Health Organization (WHO) Hands-on training course on “Determination of Polyribosyl-ribitol-phosphate (PRP) content of the Haemophilus influenza type b (Hib) capsular polysaccharide in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed Amperometric detection (HPAEC- PAD)” from 23rd-27th October 2017 at NIB, to six participants from three Indian vaccine Manufacturers i.e. Shantha Biotechnics, Bharat Biotech and Zydus Cadila. Training was facilitated by National Institute of Biologicals, (MOH&FW) and Istituto Superiore Di Sanita (ISS) National Center for the Control and Evaluation of Medicines, Rome, Italy. Training was successfully completed and appreciated by the expert.



b) Contribution in development of Monographs: Preparation of IP Monograph for inclusion of WHO protocol for Determination of PRP content of Hib in liquid vaccine presentations by HPAEC- PAD – Bacterial Vaccine Lab, NIB

First Stakeholder’s Meeting regarding inclusion of WHO protocol for Determination of PRP content of Hib in liquid vaccine presentations by HPAEC- PAD in Indian Pharmacopoeia was organized by Bacterial Vaccine Lab of NIB on 27 October 2017 at NIB. Meeting was attended by representatives of WHO, Instituto Superiore Di Sanita (ISS, Rome), DCG (I), Indian Pharmacopoeia Commission and six Indian Vaccine Manufacturers. It was decided in the meeting that the Bacterial Vaccine Laboratory of NIB will be the nodal agency to co-

ordinate in this regard between the various stakeholders including the WHO and ISS Rome as mentioned above. As a follow up of this meeting NIB has received from Dr. Mike Ward, Co-coordinator- Regulatory Systems Strengthening (RSS) Team, Essential Medicines and Health products (EMP) Department, WHO Headquarter, Geneva a Method Validation Report “Saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations by High Performance Anion Exchange Chromatography coupled with Pulsed Amperometric Detection” prepared by Dr. Christina von Hunolstein and Luisa Ralli of National Centre for the Control and Evaluation of Medicines at Istituto Superiore di Sanita Rome, Italy. This study may be completed so as to include this WHO protocol in IP 2019 and 2020 Addendum.



4. Testing of Biologicals:Name of the Biologicals

Tested

Type of Biologicals

No. of batches

evaluated

No. of batches


Quality

No. of batches found not

to be of Standard

quality

*No. of Inter

Laboratory sample tested

Remarks

Haemophilus influenza type b (Hib) TT conjugate vaccine

Bacterial

vaccine

05 batches

These service samples are being tested for standardization of QC parameters of final product.

02

Service samples received through CDSCO

Hib Pentavalent vaccine batches (Determination of PRP content by HPAEC-PAD)

Bacterial

vaccine 10 batches

Oral Cholera vaccine

Bacterial

vaccine

02 batch

* The lab performs tests for Aluminium content, Free Formaldehyde, Thiomersal for polysaccharide as well as other vaccines.


6. Proposed target for testing of new Biologicals being Undertaken: Oral Cholera vaccine



7. Participation in Training/ workshop/ conference (Name of the Scientist(s), Name of the programme, duration and place of training, etc.):

Name of the Scientist (s) Name of the Programme Duration Place of Training

1. Dr. Akanksha Bisht

2. Mr. Harit Kasana,

3. Mr. Ajay Kumar Ade

4. Mr. Paras Jain

Ion Chromatography HPAEC-PAD Application Workshop

12th & 13th July 2017

NIB, NOIDA.

1. Mr. Harit Kasana,

2. Mr. Ajay Kumar Ade

3. Mr. Paras Jain

Analytical training of NIB scientist for Hikojima Oral Cholera vaccine (HILLCHOL) testing.

06-08 Nov, 17 Hilleman Laboratories, New Delhi

8. Outstanding achievements of the lab:

The 1st General Meeting of WHO-National Control Laboratory Network for Biologicals was held at National Institute of Biologicals (NIB) during 31st October -2nd November, 2017 in which 39 personnel from 21 countries across the globe participated in the meeting.

This meeting at NIB primarily focus on the networking of National Control Laboratories for testing Vaccine for WHO supply.

II. Bacillus Calmette Guerin (BCG) Vaccine Laboratory

1. Name of Head: Dr. Akanksha Bisht, Scientist Grade-III

2. Manpower in the Lab/Division: I. Name of Scientific staff:

Mr. Harit Kasana, Junior Scientist

II. Name of supportive staff:

Mr. Suraj, Peon

III. No(s) of Contractual Staff: Two

3. Scientific Activities Undertaken:a. Collaboration with other

organizations:

1. Request for NIB assistance to NCL South Africa to establish testing for Virulent mycobacteria in BCG Vaccine: -

A request has been received from the Director, NCL for Biologicals Products, South Africa via email dated 27-07-2017 and 02-08-2017 to train their Veterinarian in Virulent Mycobacteria parameter of BCG vaccine, especially in the interpretation of the autopsy results, i.e. to recognize the signs of tuberculosis. It is pertinent to mention here that the Director of NCL of South Africa Dr. Derek Litthauer along with his colleague Dr. Quinton Meyer visited the BCG Vaccine testing laboratory and the Animal House of NIB in this regard during the 1st General meeting of the WHO- National Control Laboratory for Biologicals (WHO- NNB) held at NIB from 31st October – 2nd November 2017.



2. Seeking possibility for training on BCG Vaccine potency testing by WHO East Mediterranean Regional office (EMRO) Egypt:-

A request has been received on 19-02-2018 via email from Dr. Houda Langar, Regional Advisor, Vaccines Regulations and Productions (VRP) WHO EMRO region Egypt to explore the possibility to organize for two Egyptian NRA staff a training on BCG Vaccine potency (Assay) and media preparation for the testing. Dr. Houda has requested NIB to provide the modality, cost and any additional information required in this regard.

Dr. Houda Langar has been requested by NIB to send a formal request in this regard on the WHO EMRO region letter head, so that the same can be put up for obtaining prior approval of Ministry of Health & Family Welfare and Ministry of External Affairs, Govt. of India before further proceeding in this regard.

b. CDL Notification:

Institute is notified CDL for the Bacillus Calmette Guerin (BCG) Vaccine. (Ref. Gazette Notification No: G.S.R. 250 (E)- Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017).

4. Testing of Biologicals:Name of the

Biologicals TestedType of

BiologicalsNo. of

batches evaluated


StandardQuality

No. of batches found not to

be of Standard quality

Remarks

Bacillus calmette Guerin (BCG) vaccine

Bacterial

vaccine

05 batches All parameters have been standardized and verification studies performed

Service samples received through CDSCO




1. Name of Head: Mr. Jaipal Meena, Scientist Grade III

2. Manpower in the lab/division: I. Name of Scientific Staff

Ms. Archana Sayal, Junior Scientist

Mr. Anirban Mukherjee, Junior Scientist

II. Name of Technical Staff :

Mr. Sukhen Majhi, Laboratory Technician

III. No(s) of Contractual Staff: Nine

VIRAL VACCINE LABORATORY

3. Scientific Activities Undertaken: CDL Notification: Institute is notified CDL

for the Cell Culture Rabies Vaccine, Live attenuated Measles Vaccine, Live Attenuated Rubella Vaccine. (Ref. Gazette Notification No: G.S.R. 250 (E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017).

4. Testing of Biologicals

Name of Biologicals

Tested

Type of Biologicals

No. of Batches

Evaluated

No. of Batches found

to be of Standard

quality

No. of Batches

found not to be of

Standard quality

No. of Inter-laboratory

sample tested

Remarks

Rabies immunoglobulin

Immuno-globulin

11 11 Nil 1111 Batches tested

Measles Vaccine Viral

Vaccine02 02 Nil 0

Standardized

Rubella Vaccine Viral

Vaccine01 01 Nil 0

Standardized

MMR vaccine Viral

Vaccine0 0 Nil 0

StandardizedCCRV Viral

Vaccine17 17 Nil -

17 batches released

MR Vaccine Viral

Vaccine05 05 Nil 0

Standardized

Rotavirus Vaccine Viral

Vaccine05 - - -

Standardized

Inactivated Polio Vaccine

Viral

Vaccine03 03 Nil -

Standardized



Name of Biologicals

Tested

Type of Biologicals

No. of Batches

Evaluated

No. of Batches found

to be of Standard

quality

No. of Batches

found not to be of

Standard quality

No. of Inter-laboratory

sample tested

Remarks

Human Papilloma Vaccine

Viral

Vaccine03 03 - -

Under Standardization

Hepatitis A Vaccine

Viral

Vaccine04 04 - -

04 batches released

Hepatitis B Vaccine

Viral

Vaccine 9 9 - -09 batches released

Varicella Vaccine Viral

Vaccine01 - - -

Under Standardization

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

No.Name of the product

No. of batches evaluated for the period

2016-17 2017-18

1. Human Rabies Immunoglobulin 15 batches 11 batches

2. Live attenuated MMR vaccine 5 batches 0

3. Live attenuated Measles vaccine 4 batches 2 batches

4. Live attenuated Rubella vaccine 3 batches 1

5. Cell Cultured Rabies Vaccine 10 batches 17 batches

6. Live attenuated Measles and Rubella Vaccine 05 batches 5 batches

7. Japanese Encephalitis Vaccine 1 batch 0

8. Human Papilloma Virus vaccine 03 batches 3 batches

9. Inactivated Polio Vaccine 05 batches 3 batches

10. Rotavirus Vaccine 5 batches 5 batches

11. Hepatitis A Vaccine 05 batches 04 batches

12 Hepatitis B Vaccine 0 batches 9 batches

13 Varicella Vaccine0 batches

01 batch under standardization

14 Samples for Moisture Content 215 batches 276 batches tested



0

3

6

9

12

15

18

11

17

2 1

5

9

4 3 31

Pro

du

cts


Number of Vaccines & Sera samples evaluated in the period 2017-2018

2

98

111

164

Number of Batches Evaluated for Moisture Content in 2017-18

Recombinant Product Viral Vaccine Enzyme & Hormone

Monoclonal Antibody Blood Products

6. Proposed targets for testing of new biologicals being undertaken:S. No. Product/ test Timeline

1 Japanese Encephalitis Vaccine (JEV) Dec 20182 Varicella Vaccine Dec 2018

7. Participations in training/workshop/conference (Name of the scientist, name of programme, duration and place of training etc.):

• Name of programme: Hands on training on “Potency assay of Hepatitis A and Hepatitis B Vaccine” imparted by Scientists from Bangladesh (Mrs. Shayla, Mrs. Zebun Nahar)



• Duration of training: 11-09-17 to 13-09-17 (Three Days)

8. Outstanding achievements of the Lab: Mr. Jaipal Meena, Scientist Gr III, Head

Viral Vaccine Laboratory visited as Technical Expert of South African National

Accreditation System, the accreditation body of South Africa. The visit from 02.04.17 to 07.04.17 was for Assessment of South African National Control Laboratory (SANCL) for ISO17025 accreditation for Oral Polio Vaccine, Measles Vaccine and Yellow Fever Vaccine.



1. Name of Head: Dr. J. P. Prasad, Scientist Grade-I

2. Manpower in the Lab/ Division I. Name of the Scientific staff:

i. Ms. Sudha. V. Gopinath, Scientist Grade-III

ii. Ms. Madhu Y, Scientist Grade-III

iii. Dr. Varun Singh, Junior Scientist

iv. Mohd. Daud Ali, Junior Scientist

II. Name of the Technical Staff : NIL

III. No. of Contractual Staff: Eight

3. Scientific activities undertakena) Collaboration with Other

organizations

The method verification and Monograph development for Anti-D Immunoglobulin (Monoclonal) in collaboration with the product Manufacturer and Indian Pharmacopoeia Commission (IPC) has been communicated to IPC. The product, manufactured indigenously, is the only monoclonal version of Anti-D IgG available in the world indicated to be used in Rh Negative rhesus negative mothers with no Anti-D antibodies in their serum who have just delivered rhesus positive infants. As claimed by the manufacturer, its effect in decreasing the incidence of haemolytic disease of the new-born due to Rh incompatibility has been dramatic.

BLOOD PRODUCTS LABORATORY

b) CDL Notification

Institute is notified Central Drugs Laboratory vide Gazette of India Extraordinary Part II Section 3-Subsection (i) No. 684 published in December 2014 for the following products:

i. Human Albumin

ii. Human Normal Immunoglobulin (Intravenous & Intramuscular)

iii. Human Coagulation Factor VIII

iv. Human Coagulation Factor IX

v. Plasma Protein Fraction

vi. Fibrin Sealant Kit

vii. Anti- Inhibitor coagulant Complex

c) Government Analyst:

1. Dr. J. P. Prasad, Scientist Grade –I & Head, Blood Products Laboratory has been declared as Government Analyst vide Gazette No. S.O 2393(E) for testing of plasma derived products published on September 2015

2. Dr. J. P. Prasad, Scientist Grade –I & Head, Blood Products Laboratory has been declared as Government Analyst vide Gazette Notification Extraordinary Part-II, Section (3), subsection ii, published on September 2011. (FOR BLOOD REAGENTS)



d) Contribution and development of monographs

i. Monograph for total protein estimation in Human Albumin, immunoglobulin and plasma Protein Fractions:

The monograph on total protein estimation in human albumin, immunoglobulins and plasma protein fraction has been published as Method G in the general Chapter of Total protein estimation in Indian Pharmacopoeia 2018.

ii. Acceptance criteria for Clottable protein in Fibrin Sealant kit

The proposed acceptance criteria for Clottable protein in monograph for Fibrin Sealant kit also published in Indian Pharmacopoeia 2018.

iii. The following are proposed for inclusion

a. Inclusion of automated validated one stage clotting assay for potency of Human Coagulation Factor VIII.

b. Inclusion of Haemolysis in the test for Anti-A & Anti-B Haemagglutinins based on observations in few batches of indigenously manufactured

Human Normal Immunoglobulins for intravenous use.

c. Deletion of test for Abnormal Toxicity in relevant Monographs for Blood Products to harmonize with European and British Pharmacopoeia and also in consideration with 3Rs global concept.

d. Revision in Reagents and Buffers, referred in Assay for Thrombin in monograph for Fibrin sealant kit have been submitted to Indian Pharmacopoeia Commission, Ghaziabad for review.

e) Publications:

1. S. V. Gopinath, J.P. Prasad. Intravenous Immunoglobulin Preparations: Quality Assurance Measures and Proposed Strategies for Improving Its Safe and Judicious Use in India. Applied Clinical Research, Clinical Trials and Regulatory Affairs. Volume 5, Issue 1, 2018.

2. Charu Arora, J. P. Prasad, et.al, A comparative study between various compendial biuret estimation methods with respect to the estimation of protein in human biologicals. Indian Journal of Pharmaceutical sciences. Accepted

4. Testing of BiologicalsName of

Biologicals tested

S. No. Type of Biologicals No. of batches

evaluated

No. of batches


Quality (SQ)

No. of batches found to be Not-of Standard Quality (NSQ)

No. of inter-

laboratory sample tested

Blood Products

1 Human Albumin 234 231 03 -

2 Plasma Protein Fraction 03 03 0 -

3 Human Normal Immunoglobulin IV

51 50 01 -



Name of Biologicals

tested

S. No. Type of Biologicals No. of batches

evaluated

No. of batches


Quality (SQ)

No. of batches found to be Not-of Standard Quality (NSQ)

No. of inter-


4 Human Normal Immunoglobulin IM

12 12 0 -

5 Specific Immunoglobulin IV

(Hepatitis B Immunoglobulin, Anti-D Immunoglobulin)

02 02 0 -

6 Specific Immunoglobulin IM

(Tetanus Immunoglobulin)

24 24 0 -

7 Specific Immunoglobulin IM (Anti-D Immunoglobulin IM)

25 25 0 -

8 Specific Immunoglobulin IM (Hepatitis B immunoglobulin)

15 15 0 -

9 Specific Immunoglobulin IM (Rabies Immunoglobulin)

11 11 0 -

10 Human Coagulation Factor VIII (Plasma derived)

50 48 02 -

11 Human Coagulation Factor VIII rDNA

34 34 0 -

12 Human Coagulation Factor IX 12 12 0 -

13 Human Coagulation Factor IX rDNA

05 05 0 -

14 Human Prothrombin Complex 01 01 0 -

15 Fibrin Sealant Kit 34 34 0 -

16 FEIBA (Anti-inhibitor coagulant complex)

10 10 0 -

Total 524 518 06 -

One legal sample of Human Coagulation Factor VIII have been received, tested and reported during this period.

5. Preparation and supply of National Reference Standards (NRS) The laboratory has initiated preparations for developing two National Reference Standards as given

below:



a) First National Reference Standard for total protein estimation of Human albumin

Selection of candidate material for preparation of National Reference Standard for total protein estimation in Human albumin is in progress. The standard procedure for lyophilization of selected candidate reference material is also under evaluation to establish a suitable method. Before declaring as a National Reference Standard for total protein estimation in Human albumin solution, this standard will be assigned a value through collaborative study with national and international laboratories.

b) First National Reference Standard for Potency assay of Human Coagulation Factor VIII

The indigenous biopharmaceutical companies are dependent upon the Primary Reference Standards which are, many a times of limited supply, and as a standard procedure the companies

have to develop in-house standards calibrated against the primary standard. NIB being the nodal laboratory for quality control of biologicals aims to develop National Reference Standard through collaborative studies for supply to the indigenous manufacturers thereby facilitating easy availability of such traceable standards. The development of NRS for Factor VIII with a harmonized Unitage that has to be used by all the indigenous manufacturers instead of their own in-house standard which will assure uniformity in potency labelling of each batch of this product.

The two proposals have been approved by the scientific expert committee for Blood Products in the meeting held at NIB on 2nd February 2017 and further preparations in this regard is being taken up. The laboratory is exploring contributor (manufacturer) for candidate reference material to go ahead with the proposed project.

6. Trend in volume of work as compared to previous years Fig.1 Quantum of batches received and tested in last five years (2013 – 2018)

480

500

520

540

560

580

600

620

2013-2014 2014-2015 2015-2016 2016-2017 2017-2018

Number of Batches received and evaluated during last Five Years (From 2013 to 2018)

Fig.1 above shows the trend in quantum of batches of various plasma derived products received and tested in last five years at NIB.



Fig 2. Quality Control testing of various Blood Products in last eight years (From 2010 to 2018)

Page 46 of 133

Fig 2. Quality Control testing of various Blood Products in last eight years (From 2010 to

2018)

7. Proposed target for testing of new biologicals 7.1 The laboratory has initiated establishing of Quality Control testing of Anti-Thymocyte

Globulin (rabbit), which is imported in to the country for immunosuppressive therapy

in kidney transplantation for treatment of patients with kidney failure. Anti-

Thymocyte Globulin (rabbit) is indicated for the prophylaxis and treatment of acute

rejection in patients receiving a kidney transplant. Thymoglobulin is to be used in

conjunction with concomitant immunosuppression. The method verification and

establishment for testing of this product is targeted to be completed by September

2018. Further a product specific monograph will be prepared and proposed for

publication in Indian Pharmacopoeia.

7.2 Human Coagulation Factor VII is used for treatment of Factor VII deficient patients.

Factor VII deficiency is an inherited bleeding disorder that is caused by a problem

with Factor VII. Because the body produces less Factor VII than it should, or because

the Factor VII is not working properly, the clotting reaction is blocked prematurely

and the blood clot does not form. Factor VII deficiency is an autosomal recessive

disorder, which means that both parents must carry the defective gene in order to pass

it on to their child. It also means that the disorder affects both males and females.

Factor VII deficiency is very rare, but like all autosomal recessive disorders, it is found

more frequently in areas of the world where marriage between close relatives is

common. With the time, the plasma derived factors are replaced gradually with

recombinant (rDNA) products in the market with an aim to provide safe and virus free

products to patients. The laboratory is in process to establish Quality Control testing

of recombinant Human Coagulation Factor VII to extend its mandatory services for

testing of such imported batches in the country. Since the product is non-

pharmacopoeial, the compliance is assessed as per the drug product specification

0

100

200

300

400

500

600

700

2010-2011 2011-2012 2012-2013 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018

179 208 219

534

593 609573

524

177205 217

520564 593 570 518

2 3 2 14 29 16 3 6

Number of Batches received and evaluated Number batches found SQ Number of Batches found NSQ

7. Proposed target for testing of new biologicals7.1 The laboratory has initiated establishing

of Quality Control testing of Anti-Thymocyte Globulin (rabbit), which is imported in to the country for immunosuppressive therapy in kidney transplantation for treatment of patients with kidney failure. Anti-Thymocyte Globulin (rabbit) is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Thymoglobulin is to be used in conjunction with concomitant immunosuppression. The method verification and establishment for testing of this product is targeted to be completed by September 2018. Further a product specific monograph will be

prepared and proposed for publication in Indian Pharmacopoeia.

7.2 Human Coagulation Factor VII is used for treatment of Factor VII deficient patients. Factor VII deficiency is an inherited bleeding disorder that is caused by a problem with Factor VII. Because the body produces less Factor VII than it should, or because the Factor VII is not working properly, the clotting reaction is blocked prematurely and the blood clot does not form. Factor VII deficiency is an autosomal recessive disorder, which means that both parents must carry the defective gene in order to pass it on to their child. It also means that the disorder affects both males and females. Factor VII deficiency is very rare, but like all autosomal recessive

Fig 2 below gives the results of Quality Control testing and number of batches found not of standard quality in last eight years at NIB. During the reporting period 2017 -2018, six batches of various blood products are found NSQ due to high value

in assay for Pre-kallikrein activator (PKA) in Human Albumin batches, low potency in Human Coagulation Factor VIII batches and Haemolysis observed in test for Anti-A & Anti-B Haemagglutinins in Human Normal Immunoglobulin for Intravenous use.



disorders, it is found more frequently in areas of the world where marriage between close relatives is common. With the time, the plasma derived factors are replaced gradually with recombinant (rDNA) products in the market with an aim to provide safe and virus free products to patients. The laboratory is in process to establish Quality Control testing of recombinant Human Coagulation Factor VII to extend its mandatory services for testing of such imported batches in the country. Since the product is non-pharmacopoeial, the compliance is assessed as per the drug product specification submitted by the manufacturer. The method qualification for testing of this product is targeted to be completed by December 2018.

8. Details of participation in cGMP inspections:8.1 Subject Expert for Joint Investigation:

Dr. J.P. Prasad, Scientist-I & Head nominated as subject expert for joint investigation of M/s. Virchow Biotech, Hyderabad, Telengana, from 4th to 6th April 2018.

8.2 Subject Expert for Joint Inspection: Mrs. Y. Madhu, Scientist-III nominated as subject expert for joint inspection of following government approved (in Form 37 of Schedule A of Drugs & Cosmetics Rules 1945) private testing laboratories to observe the compliance of Schedule L-1 of Drugs & Cosmetics Rules 1945:

a. M/s Vatsa Testing Laboratory, G.T. Road, Murthal, Sonepat, on 10th & 11th October, 2017.

b. M/s Hi-Tech Lab Ltd., 1-2, DLF Industrial Area, Phase-I, Faridabad, on 12th & 13th October, 2017.

c. M/s Choksi Laboratories Ltd., Plot No. 362, Industrial area, Phase-II, Panchkula, on 20th & 21st November, 2017.

d. M/s Pharmaffiliates Asia, Plot No. 225, Industrial Area, Phase-II, Panchkula, on 23rd & 24th November, 2017.

8.3 Two scientists Dr. Varun Singh and Mohd. Daud Ali of the laboratory along with Dr. D. Roy, Consultant (Regulatory) visited M/s. Intas Pharmaceuticals, Ahmedabad as observers for Anti-Complementary Activity test in Human Normal Immunoglobulins for intravenous use.

9. Meetings organized:9.1 The Laboratory has organized a meeting

on development of National Reference Standards for Total protein estimation in Human Albumin and potency assay for Human Coagulation Factor VIII on 12th Apr, 2017, at NIB, NOIDA.

9.2 The Laboratory has organized Third Subject Expert Committee meeting to discuss and strengthen the laboratory activities on 22nd March, 2018, at NIB, NOIDA.

10. Participation in training/ workshop/ conference10.1 Dr. J. P. Prasad was appointed

as an examiner by controller of Examination, Banaras Hindu University, Varanasi to evaluate Ph. D Thesis entitled “Characterization



of Thioredoxin Reductase in Filarial Parasite” , June 2017.

10.2 Dr. J. P. Prasad was appointed as an expert by controller of Examination, Banaras Hindu University, Varanasi to conduct Viva of Ms. Savitri Tiwari, Department of Biochemistry for award of Ph. D in Biochemistry on 15.09.2017.

10.3 Dr. J. P. Prasad delivered lecture on Quality Control of Blood Products in All-India Pharma festival “SPIRIT’18– Innovation is Tradition”, All India Student’s Conclave & A National Seminar, held during 3rd – 4th February, 2018 at IIT, BHU, Varanasi.

10.4 Dr. J. P. Prasad attended Expert Working Group Meeting on Blood & Blood Related Products at Indian Pharmacopoeia Commission, Ghaziabad on 28.02.2018.

10.5 Dr. J. P. Prasad invited as an external expert for the interview held on 23rd March 2018 for recruitment of temporary positions in projects at CSIR – IGIB, New Delhi.

10.6 Dr. J. P. Prasad delivered lecture on ‘Quality Control Testing of Various Plasma Derived Products’ at Initiative on Hemophilia Care III held on 17th April, 2017 at India Habitat Centre, New Delhi.

10.7 All laboratory staff attended lecture on ‘Enhancing Performance for Global Organizational Success’ delivered by Mr. R. N. Kumar, Faculty (Behavior Science), Administrative Training Institute, Mysore on 1st April, 2017.

10.8 All laboratory staff attended

lecture on ‘Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India-2016’ lecture delivered by Dr. A Ramakishan DDC (I), CDSCO on 27th May, 2017.

10.9 All laboratory staff attended lecture on ‘Data Integrity & Analytical Platforms’ lecture given by M/s Waters, India, on 3rd June, 2017.

10.10 The laboratory actively participated in an interactive session with a delegation comprising Drug Controller of Royal Government of Bhutan and Regulatory Officer visited the Institute on 24th May, 2017 with an objective “To Explore Possibilities for Testing of Biologics and TTI Test Kits” at NIB and to make it as an Appellate Laboratory and to identify areas of institutional linkages between Drug Regulatory Authority of Bhutan and NIB, Ministry of Health & Family Welfare, Government of India.

10.11 The junior laboratory staff attended internal training on MS Word, Excel and Power Point to enhance the skill in use of computers for preparation of various laboratory quality documents and data analysis held on 5th – 7th April, 2017 at NIB, NOIDA.

10.12 The laboratory staff attended orientation program on ‘Health and Safety’, on 28th April, 2017 at NIB, NOIDA.

10.13 The laboratory staff attended lecture on ‘Bioinformatics, Data Integrity and Management’, on 09th May, 2017 at NIB, NOIDA.



10.14 All laboratory staff attended Fire training and Mock Drill demonstration, held in May, 2017 at NIB, NOIDA.

10.15 The scientific staff of the laboratory attended lecture on ‘Data Integrity: Regulatory perspectives and Challenges & Analytical Techniques in Biopharma’, held on 03rd June, 2017 at NIB, NOIDA.

10.16 The scientific staff of the laboratory attended and actively participated in an interactive session on US Pharmacopoeia Global Perspectives in Compendia Standards”, held on 22nd July, 2017 at NIB, NOIDA.

11. Outstanding achievements of the laboratory 11.1 Experts from M/s Bio Pharma,

Ukraine visited NIB in October 2017 to discuss the technical aspects of the test for Pre-Kallikrein Activator (PKA). The technical experts discussed

in detail and appreciated the work done by Blood Product Laboratory and concurred to the findings of the laboratory for their blood product.

11.2 The laboratory has organized two meetings of the Scientific Expert Committee for Blood Products on 12th April 2017 and 22nd March 2018 to finalize strategies to strengthen the Scientific Activities of the laboratory wherein the initiatives taken by the laboratory were appreciated by the experts.

11.3 The laboratory has contributed for publication of an alternate method for total protein estimation in IP 2018 in General Chapter for Human Albumin, Human Plasma Protein Fraction, Human Normal Immunoglobulin for intravenous use and Human Normal Immunoglobulin (IM) Monographs. Also for revision of acceptance criteria for Clottable protein in Fibrinogen in Monograph for Fibrin Sealant Kit.



1. Name of Head Dr. Charu Mehra Kamal, Scientist Grade II

2. Manpower in the Laboratory/ Division

I. Name of Scientific Staff

Ms. Gurminder Bindra, Scientist Grade III

Dr. Meena Kumari, Scientist Grade III

Dr. Sanjay Mendiratta, Junior Scientist (w.e.f 12th May 2017)

II. Name of Technical Staff

Ms. Poonam, Laboratory Technician (w.e.f 13th Feb 2018)

Mr. Mohit Lal, Laboratory Technician (w.e.f 13th Feb 2018)

III. No(s) of Contractual staff 06

3. Scientific Activities Undertaken : a. Collaboration with other

organisations:

i. Collaborative studies with National Institute for Biological Standards and Control (NIBSC)

• Report published for establishment of the 1st WHO International Standard for Insulin, Human Biosynthetic. In this Phase I repeat study, the objective was assignment of Insulin content to the candidate standard received from NIBSC-UK April 2017.

• Expert Committee on Biological

RECOMBINANT PRODUCT LABORATORY

Standardization, WHO has published report for WHO International Collaborative Study of the Proposed 2nd International Standard for Parathyroid Hormone 1-34, Recombinant Human, 17 – 20 October 2017. Out of 12 participant laboratories in eight countries, Recombinant Product Laboratory was one of the study participant.

b. Central Drugs Lab Notification

The Institute is notified Central Drugs laboratory (CDL) vide The Gazette of India, Extraordinary, notification No. GSR 908 (E)-Part II-Sec 3 (i) on Dec 22, 2014 for class of products mentioned in Table 1.

Table 1: CDL Notified recombinant products

S. No Name of Product Type of Product1. Recombinant Insulin Anti-Diabetic2. Recombinant Insulin

Analogues3. r-Erythropoietin (EPO) Growth factors4. r-Granulocyte colony

stimulating factors (G-CSF)

c. Government Analyst: Names of scientist to be notified as Government Analyst by CDSCO have been proposed from laboratory

d. Development of Monographs: Contribution by laboratory towards development of monographs is given in Figure1



Contribution to Pharmacopoeial Monographs

Monograph IP 2018 (effective from 1st July 2018)

Interferon beta 1a injection Teriparatide Teriparatide for Injection

Peg Filgrastim

Revised Monographs for IP 2018 (effective from 1st July 2018)

Figure 1: Contribution of NIB in Development of IP Monographs

e. Publication(s):

1. Collaborative study to evaluate the inter laboratory reproducibility for Gel Electrophoresis by SDS PAGE on human Erythropoietin drug samples. Chanda Sinha, Meena Kumari, Shagun Wadhwa, Zafar Abbas, Y Madhu, Renu Jain, G. R. Soni, Surinder Singh & Participants of the Study. International

Journal of Medical Health Sciences Oct 2017,Vol-6;Issue-4

2. Role of NIB in connecting science to patients by assuring safe and quality anti diabetic products, the same has been communicated and accepted in Indian Journal of Medical Sciences. March 2018

4. Testing of Biologicals (Table 2):Name of

Biologicals testedType of

BiologicalsNo. of

Batches Evaluated

No. of Batches

Found to be of Standard

Quality (SQ)

No. of Batches Found Not to

be of Standard Quality (NSQ)

No. of Inter


Remarks

Insulin RegularInsulin BiphasicInsulin NPHInsulin Bulk

Anti Diabetic -

Insulin

48150 24 2

224 Nil Nil Medical supplies: 10

Legal:03

Degludec /AspartGlargineAspartLisproGlulisineDetemirDegludecLiraglutideDegludeg/ Liraglutide

Anti Diabetic–

Insulin Analogues

16 58 645822 613 1 0

238 Nil Nil Legal: 04



Name of Biologicals tested

Type of Biologicals

No. of Batches

Evaluated

No. of Batches

Found to be of Standard

Quality (SQ)

No. of Batches Found Not to

be of Standard Quality (NSQ)

No. of Inter


Remarks

Filgrastim

Peg Filgrastim

Erythropoietin

Interferon Alpha 2b

Interferon beta 1a

Peg Interferon Alpha 2b

Peg Interferon beta 1a

Growth Factors

2

3

18

0

1

0

2

26 Nil Nil

Legal samples: 02

Medical supplies: 01

Teriparatide

GLP - Dulaglutide

Small Peptides

1

2

3 Nil Nil --

TOTAL 491

5. Preparation and supply of National Standards, Sera Panel etc. Reference Standard Program

The effective implementation of IP monographs on rDNA Biotherapeutic products which are published in IP requires

suitable use of Reference Standards. For this, steps have been taken to develop National Reference Standards for Filgrastim, Peg Filgrastim, Insulin Lispro and Insulin Glargine. The road map of Reference Standard program which has been initiated is given in Table 3 and present status is given in Table 4



Table 3: Roadmap for National Reference Standard development for rDNA products initiated by NIB (N=04)

Reference Std-IPRS Potency Standard Physico-chemical Standard

2016-2018 2017-2019

FILGRASTIM

LISPRO

PEG FILGRASTIM

GLARGINE

Table 4. Development of Reference Standards

S. No. Name of the Study Collaboration Study Period Status

1 National Reference Standard preparation of Insulin Lispro

6 Laboratories

(NIB, Insulin Stakeholders, Pharmacopoeia Labs)

2016-2018 Final Unitage assigned, Certificate of Analysis and Safety data Sheet finalized in a meeting held with all collaborative laboratories. The Lispro Reference Standard will be shortly released.

2 National Reference Standard preparation of Insulin Glargine

13 Laboratories

(NIB, Insulin Stakeholders, Pharmacopoeia Labs)

2017-2019 Consent for participation in collaborative study received from 06 laboratories.

3 National Reference Standard preparation of Filgrastim

6 Laboratories

(NIB, Filgrastim Stakeholders, & Pharmacopoeia Labs)

2016-2018 Candidate selection has been done & communicated to respective stakeholders for material donation

One of the stakeholder has agreed to donate the study material

4 National Reference Standard preparation of Peg Filgrastim

10 Laboratories

(NIB, Peg Filgrastim Stakeholders, & Pharmacopoeia Labs)

2016-2018 Monograph published in IP Addendum 2015 has been revised by NIB. Queries being addressed by NIB in the published monograph

6. Trend in Volume of Work as Compared to the previous year i. Trend in Test and Analysis of

Recombinant Biotherapeutic products

The laboratory has capacity and

infrastructure to test 500 batches on the basis of complete testing of recombinant products per year and laboratory has received 491 batches in 2017-18. The expansion in volumes showing the trend since 2009 is given in Figure 2.



0100200300400500600

86

292

403485 465 500 493 505 491

Trend of total number of Recombinant Biotherapeutic products from 2009-2018

Figure 2: Trend for Total No. of batches of Recombinant Biotherapeutic Products from 2009-2018

ii. Trend in different types of Recombinant Biotherapeutic Products (Figure 3)

0

50

100

150

200

250

300

49

152

242

297

237

259271

191

224

37

102114

148

172

209194

292

240

3847

58 56

23 28 22 27

No.

of B

atch

es

rH -Insulin Analogues & GLP-1 Growth Factors

Trend of different types of Recombinant Biotherapeutic products from 2009-2018

Figure 3: Trend of different types of Recombinant Biotherapeutic Products from 2009-2018

iii Source of Recombinant Biotherapeutic products: Imported vs Indigenous (Figure 4)

0

100

200

300 224197

27

240 226

14 27 7 19

No

. o

f B

atc

hes

rh Insulin Analogs & GLP-1 Growth Factors & Peptides

Figure 4: Source of Recombinant Biotherapeutic Products in 2017-2018



7. Proposed Target for Testing of New Biologicals and being undertaken7.1 Quality control testing for Interferon

beta 1a, Peg Interferon beta 1b & Insulin Glargine (300 IU) which were proposed target in previous year has been established by laboratory.

7.2 Laboratory is currently in the process of establishing three new products namely Peg Erythropoietin, Darbepoetin and

Faster Acting Insulin Aspart (Fiasp).

8. Details of Participation in cGMP Inspections

Joint Inspections of Biotherapeutic Manufacturing Units in India were carried out with CDSCO and state FDA along with experts from NIB. Inspections of the manufacturing units carried out for recombinant bio therapeutics are as under (Table 5):

Table 5. NIB Experts in Joint in cGMP Inspections of Biotech Facilities in India

S. No. Date of CDSCO Audit

Place Purpose of Audit

NIB Scientist rDNA Product

1 06th & 07th

July 2017

A Joint inspection with CDSCO at M/s Cadila Healthcare Ltd., Ahmedabad

Revalidation of Certificate of Pharmaceutical Product as per WHO GMP scheme

Dr. Charu M. Kamal, Scientist Grade II & Dr. Meena Kumari, (Scientist Grade III)

r-DNA based products.

2 9th and 10th Nov 2017

Joint Inspection with CDSCO of M/s Shri Krishna Analytical Services, New Delhi

Private Drug Testing Laboratories

Dr Charu Mehra Kamal (Scientist Grade-II)

Laboratories approved in Form 37 of Schedule A of Drugs and Cosmetics Rule, 1945

9. Meeting Organized: Scientific Meeting for Discussion on

preliminary report on Reference Standard Preparation on Insulin Lispro, 26th May 2017 (The meeting was held as a result of Inter-collaborative study implementing the documentary standards of IP Insulin Lispro DS, DP and biphasic Insulin Lispro). Preliminary report on Lispro RS preparation was finalized, the Certificate of Analysis and the data labels were freezed, and the Lispro RS was assigned a property value.



10. Participations in Training/ Workshop/ Conference (Name of the Scientist (s), Name of the programme, duration and place of training, etc.): Table 6

S. No. Name of the Scientist (s) Name of Programme Duration Place

1. One day training programme was attended by All lab staff including bench biologists hired through outsource agency

Enhancing Performance for Global Organization Success

1st April 2017

NIB, NOIDA

2. One day training was attended by lab staff on bioinformatics application

Applications of bioinformatics tools in the current, proposed R & D and ongoing areas of work

9th May 2017

NIB, NOIDA

3. One day training was attended by lab staff

Talk on Guidelines on similar biologics: regulatory requirements for marketing authorization in India.-2016

27th May 2017

NIB, NOIDA

4. Ms. Gurminder Bindra UPLC /H class and Empower software

18th April 2017

Waters India Ltd., New Delhi

5. All lab staff Talk on Data integrity: Regulatory perspective and challenges., Analytical techniques in Biopharma

03rd June 2017

NIB, NOIDA

6. Dr Charu M. Kamal 6th Health care access summit on putting “Policies into Practices: Best Practices in Non communicable Diseases (NCD)

9th June 2017

OPPI, Delhi

7. Dr Charu M. Kamal

Dr. Meena Kumari

Training on r-DNA products for characterization by LC-MS

19th to 21st July 2017

M/s Waters (I) Pvt. Ltd., Bengaluru

8. All lab staff US Pharmacopoeia Global Perspective in Compendial standards

22th July 2017

NIB, NOIDA

9. Ms. Gurminder Bindra

Dr Sanjay MendirattaHands on training programme on UPLC

21st to 23rd August 2017

M/s Waters (I) Pvt. Ltd., Bengaluru



S. No. Name of the Scientist (s) Name of Programme Duration Place

10. Dr. Meena Kumari, Hands on training programme on Establishment of new method for assay of Filgrastim

22nd - 23rd August, 2017

USP Hyderabad

11. Ms. Gurminder Bindra Internal training on Documentation Control (SOP Review and Amendments)

24th August 2017

NIB, NOIDA

12.Dr. Sanjay Mendiratta

Internal training on Sample / spill management

25th August 2017

NIB, NOIDA

13. Dr. Charu M. Kamal

Dr. Meena Kumari

Dr. Sanjay Mendiratta

Short course on Upstream Processing, Analytical Characterization, Quality by Design & Process Analytical Technology

5th–7th December 2017

IIT, Delhi

10.1 A meeting for scientific discussion on development of Filgrastim Reference Standard (RS) and to analyze the data of Filgrastim RS candidate selection was held on April 06, 2017 at Indian Pharmacopeia Commission (IPC), Ghaziabad

10.2 The meeting of ‘Expert Working Group on Biologicals and rDNA Products’ was held on 22nd December, 2017 at RS Iyer Hall, IPC-Ghaziabad with Expert Working Group Members, NIB Representatives and IPC Representatives. During the meeting, development of IP Reference Standards for rDNA Products and the associated challenges faced by IPC were also discussed. The meeting agenda points for general chapters for certain test procedures and product specific monographs for next IP Edition/Addendum were also discussed.

11. Outstanding achievements of the Laboratory:11.1 Poster Presentation on “Role of NIB

in connecting science to patients by assuring safe and quality anti diabetic products” by Ms. Gurminder Bindra, Scientist Grade III in 2nd JK Medical Science Congress 2017 & 1st Annual Conference of MP PCOS Society on 10- 13 May 2017 at Srinagar, India.

Authors: Gurminder Bindra, Charu M Kamal, Meena Kumari, Shruti Dixit, Vandana Saklani, Pretty Sharma, Renu Jain, Surinder Singh

11.2 RPL staff contributed significantly in the publication of product specific monographs in Indian Pharmacopoeia 2018 which will be effective from July 2018 viz.

• Teriparatide DS • Teriparatide DP • Interferon beta 1a injection



1. Name of the Head : Dr. Charu Mehra Kamal,

Scientist Grade-II (Since 12.7.2017)

Dr. Richa Barnawal,

Scientist Grade-III (Till 11.07.2017)

2. Manpower in the Laboratory: I. Name of Scientific Staff:

Dr. Birendra Kumar, Junior Scientist (Since 16.05.2017)

II. Name of Technical & Support Staff:

Sh. Brij Bahadur, Laboratory Technician

Sh. Rajeev Srivastava, Laboratory Assistant

III. Contractual Manpower: FOUR

3. Scientific Activities UndertakenA. Collaboration with other organisation:

The laboratory participated in “International Collaborative Study for development of 4th International Reference Standard of Streptokinase” with NIBSC, UK. The study was for potency assay for preparation of 4th International Reference Standard of Streptokinase for Quality Control aspects. The data of the study is under analysis and preliminary report will be sent by the NIBSC, UK for opinion to the laboratory.

B. CDL Notification:

The Institute is notified Central Drugs Laboratory (CDL) vide the Gazette of

ENZYME AND HORMONE LABORATORY

India, Extraordinary, Notification No. : G.S.R. 250 (E) - Part-II - Section 3 - Sub- Section (i) dated 15th March, 2017 for class of products mentioned in Table – 1

Table – 1 CDL notified Enzyme and Hormone products.

S. No Name of Products

(a) Streptokinase (Natural and Recombinant)

(b) Human Chorionic Gonadotropin (hCG)

(c) Human Menopausal Gonadotropin (hMG)

C. Development of Monograph:

The laboratory has reviewed three monographs of Follitropin (Follicle Stimulating Hormone) received from IPC for incorporation in Indian Pharmacopoeia. The laboratory sent the comments to IPC for further discussion in meeting of Expert Committee of rDNA product (Table 2).

Table 2: Contribution of Enzyme and Hormone Laboratory in Monograph preparation:

S. No.

Name of Monograph

Prepared / Reviewed and comments sent to IPC

Publish status

1. Follicle Stimulating Hormone

Reviewed and comments sent to IPC

Published in IP 2018

2. Follicle Stimulating Hormone Concentrated Solution

-do-

3. Recombinant Follicle Stimulating Hormone injection

-do-



E. Publication(s):

The laboratory has submitted an abstract entitled “Therapeutic Gonadotropins Used in Infertility Treatment: Quality Control, a Critical Component to Ensure Their Safety and Effectiveness in Patients”, which has been published in Conference Souvenir cum Abstract Book for 1st Annual conference of the Metabolic Syndrome-Pre-diabetes –PCOS Society (M P PCOS CON 2017) in tandem with 2nd J & K Medical Science

Congress (JK MSC 2017) at Srinagar from 10-13 May 2017 following KJK MSC 2017.

4. Testing of Biologicals: The details of Biologicals and number of

batches evaluated for Quality Control testing during the reporting year are summarized in the Table 3. All batches reported were of Standard Quality. Total 23 batches of Enzymes and Hormones were evaluated in the laboratory and CoA released for all products.

Table 3: Testing of Biologicals

Name of Biologicals Tested

Type of Biologicals

No. of Batches

evaluated


Quality

No. of batches found not to be of Standard

Quality

Streptokinase Inj. Enzyme 1 1 None

Heparin Inj. 7 7 None

Human Chorionic Gonadotropin (HCG) Inj.

Hormone 2 2 None

Menotropin (HMG) Inj.

Hormone 2 2 None

Follitropin Inj. 9 9 None

Somatropin Inj. (recombinant)

2 2 None

5. Preparation and supply of National Reference Standard: The Study protocol for preparation of NRS of Somatropin has been initiated.

6. Trend in volume of work as compared to the previous year:A. Quality evaluation of Biologicals: The

laboratory has a testing capacity of 120

batches of Enzymes and Hormones per year, however the laboratory received 23 batches of Enzymes and Hormones which were evaluated. The trends of samples received for QC evaluation as compared to previous year: Product wise/Total sample are shown in Figure 1.



2

8

1

65

3

1 1

15

2 2

0

9

21

0 0

7

0

2

4

6

8

10

12

14

16N

o.

of

Sa

mp

les

Trend analysis of sample recieving during 2016-2017 and 2017-2018

Apr. 2016- March 2017 Apr. 2017- March 2018

B. Interlaboratory Sample testing: The laboratory has tested 53 samples of Blood Product Laboratory, 11 sample of Therapeutic Monoclonal Antibody Laboratory and 56 sample of Viral

Vaccine Laboratory for safety test by Bacterial Endotoxin –Gel Clot Method. The trend of samples received from various laboratories for BET testing by gel clot method is shown in fig.

43

0 0 0

19

0 0 0 0 0

36

59

3

11

5 5

40

51

0

5

10

15

20

25

30

35

40

45

50

No.

of

Sam

ple

s

Total Samples - 2016-2017 = 62 , 2017-2018 = 120

Trend analysis of sample recieving for BET test by

Interlaboratory during 2016-2017 and 2017-2018

Apr. 2016- March 2017 Apr. 2017- March 2018



C. Establishment of potency assay of Urokinase as per manufacturer’s method: During this year, the laboratory has standardized the potency assays of Urokinase by manufacturer’s method.

D. Method & Protocols presentation in IAEC: The methods and protocols for testing of different test parameter (such as Potency test of Hormone, Streptolysin Activity of Streptokinase, Pyrogen and Abnormal Toxicity test of enzyme and hormone samples) were presented by Dr. Charu M. Kamal, Enzyme and Hormone Laboratory in IAEC meeting held on 23.08.2017, 12.12.2017 and 22.03.2018 at NIB.


hCG Pregnancy test kit: The laboratory is planning to undertake the Quality evaluation of hCG Pregnancy test kit. In this regard, two officials of laboratory were trained in the

laboratories of HLL Lifecare Ltd. and AIIMS.

8. Details of participation in cGMP Inspections:

Dr. Charu M. Kamal, participated in Joint Inspection of M/s Shri Krishna Analytical Service, New Delhi (Private Drug Testing Laboratory) with CDSCO official on 9-10 Nov 2017 for approval of Form 37 of schedule A of Drugs and Cosmetics Rule, 1945.

9. Participations in Training/Workshop/Conference (Name of the Scientist (s), name of Programme, duration and place of training etc.)

The laboratory staff attended Training/Workshop/Conference time to time organised by Institute and also by other institute. The Training attended by laboratory staff is tabulated in Table 4

Table 4 Training attended by laboratory staff:

S. No.

Name of Scientists Name of the Programme Duration Place

1. One day training programme attended by all lab staff

Enhancing Performance for Global Organization success

1st Apr 2017 NIB, NOIDA

2. Mohit Kumar (Biologist) Post Training Exercise on MS Word, Excel and Power point

05th to 07th Apr 2017

Bioinformatics Lab, NIB, NOIDA


Talk on guidelines on similar biologics: regulatory requirements for marketing authorization in India- 2016

27th May 2017 NIB, NOIDA



S. No.

Name of Scientists Name of the Programme Duration Place


Talk on Data integrity: Regulatory perspective and challenges., Analytical techniques in Biopharma

03rd Jun 2017 NIB, NOIDA

5. Dr. Birendra Kumar Hands on training programme on establishment of new method for assay of Filgrastim

22nd -23rd Aug 2017

NIB, NOIDA


Talk on Management Requirement as per ISO 17025: 2005

26th Aug 2017 NIB, NOIDA


Talk on Technical Requirement as per ISO 17025: 2005

9th Sep 2017 NIB, NOIDA

8. Dr. Charu M. Kamal

Dr. Birendra Kumar

Brij Bahadur

Short course on Upstream Processing, Analytical Characterization, Quality by Design and Process Analytical Technology

5th – 7th Dec 2017

IIT, Delhi



1. Name of Head: Mr. Subhash Chand, Scientist Gr. III

2. Manpower in the lab/division:I. Name of Scientific Staff:

Dr. Richi V. Mahajan, Junior Scientist

Mr. P. S Chandranand, Junior Scientist (till 27.11.2017)

Ms. Apoorva Anand, Junior Scientist

(w.e.f 28th June 2017)


Sh. Mohammed Imran, Laboratory Technician. (w.e.f 20th Feb 2018)

III. No(s) of Contractual Staff Eight

3. Scientific Activities Undertaken: a. Collaboration with other organization:

(i) To develop technical expertise in cutting

THERAPEUTIC MONOCLONAL ANTIBODY LABORATORY

edge technologies for characterization of Therapeutic Monoclonal Antibodies with C-CAMP Bengaluru, TMA Laboratory has proposed for characterization of 04 batches of the Trastuzumab for analysis of peptide mapping and glycan analysis on 08.06.2017. The results for peptide mapping analysis were communicated to NIB on 14.06.2017.

(ii) The Research Council meeting was held from 27th-29th Nov, 2017 at IMTECH, Chandigarh. Director, NIB presented a brief overview of scientific activities at NIB and gave a possible roadmap for collaboration between CSIR-IMTECH and NIB. The MoU for collaboration between CSIR-IMTECH and NIB on physiochemical characterization of monoclonal antibodies, development of reference standards and monographs is under process.

Research council meeting at CSIR IMTECH, Chandigarh on 27th to 29th Nov., 2017



a. CDL Notification: The CDL Notification of TMA Laboratory will be taken up after NABL Accreditation as per ISO17025: 2005. The laboratory initiated for NABL Accreditation and had been included in the revised NIB Scope for NABL On Site Assessment 2018 to be held in June 2018.

b. Development of Monograph: The meeting of ‘Expert Working Group on Biologicals and rDNA Products’ was held on 22nd Dec, 2017 at RS Iyer Hall, IPC-Ghaziabad with Expert Working Group Members, Representatives from NIB & IPC. The progress made by Indian Pharmacopeia in the field of biologics and list of new monographs and general chapters included in IP 2018 was shared by IPC. Development of IP Reference Standards for rDNA Products including Therapeutic Monoclonal Antibodies (mAbs) and the associated challenges faced by IPC were also discussed.

e. Publication (s): i) Research Article

• Sandra Prior et al. participants of the Study. “International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab mAbs 2017. DOI: 10.1080/19420862.2017.1386824.

• Subhash Chand, Birendra Kumar, Vivek Morris Prathap, Surinder Singh & Richi V. Mahajan “Quality assurance of Rituximab (anti-CD 20) antibodies by potency testing: Determining the System Suitability Criteria and Sample Acceptance Criteria.” Current Science.

(Accepted).ii) Book Chapter Richi V Mahajan, Subhash Chand,

Mahendra Pal Singh, Apurwa Kestwal and Surinder Singh. “Advances in Production of Therapeutic Monoclonal Antibodies- A handbook on high value fermentation products”: Scrivener Publishing (9781119460015) (Accepted).

iii) Abstract Published

• Subhash Chand, Priyanka Pandey, P.S. Chandranand & Richi V. Mahajan. “Charge Heterogeneity pattern of Trastuzumab: Targeted therapy for metastatic Breast Cancer” was published in the “2nd JK Medical Science Congress and 1st Annual Conference of Metabolic Syndrome-Prediabetes-PCOS Society” conference proceedings.

• Subhash Chand, Nripendra N. Mishra, Richi V. Mahajan & Surinder Singh. “Regulation of Biosimilars in India: Role of National Institute of Biologicals (NIB).” Journal of Proteins and Proteomics 2018; Vol. 9 (Supplementary): 29-30.

• Utpreksha Vaish, Nripendra N. Mishra, Richi V. Mahajan, Anu Prakash, Subhash Chand, Surinder Singh. “Method validation of CDC bioassay for assuring efficacy of Anti- CD20 monoclonal antibody Biosimilars.” Journal of Proteins and Proteomics 2018; Vol. 9 (Supplementary): 90. Poster presentation at ICABB-2018, Jaypee Institute of Information & Technology (JIIT), NOIDA.



Name of Biologicals

Tested

Type of Biologicals

No. of Batches

Evaluated

No. of Batches


quality

No. of Batches

found not to be of

Standard quality

No. of Inter-


Remarks

Bevacizumab Therapeutic Monoclonal Antibodies (mAbs)

17 15 02 NAAll the samples were tested as per manufacturer’s drug product release specifications & method of analysis protocol due to non-availability of Pharmacopoeial monograph.

Rituximab 02 02NA

NA

Dulaglutide

Recombinant product(Inter laboratory sample received)

--- --- --- 01

Total 19 17 02 01

5. Preparation and supply of National Standards, Sera panel etc:

4. Testing of Biologicals

Roadmap (2018-2023) for preparation of Reference Standard for TMA Laboratory is prepared and incorporated into the Institutional Development Program (IDP) of

NIB which has been presented in Governing Body meeting of NIB.

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

18

19

20

21

FY 2016-17

FY 2017-18

21

19

Financial Year

Num

ber o

f bat

ches

eva

luat

ed

Figure1. Quality testing of therapeutic monoclonal antibodies in FY 2017-18



0

5

10

15

20

Bevacizumab Rituximab Adalimumab Trastuzumab Dulaglutide

17

20 0 10

11

64

0

Name of the product

Num

ber

of b

atch

es e

valu

ated

FY 2016-17 FY 2017-18

(Inter Laboratry sample received)

7. Proposed targets for testing of new biologicals being undertaken:S. No. Product/test Timeline

1 Etanercept Aug. 2018

2 Ranibizumab Oct. 2018

3 Ramucirumab Dec. 2018

4 Pertuzumab March 2019

8. Participations in training/workshop/conference (Name of the scientist, name of programme, duration and place of training etc.):8.1 Scientific Presentations given by NIB Scientist

S. No. Name of the Scientist Name of the Programme Duration Place of Conference

1.

Mr. Subhash Chand, Scientist-III & HOD

An oral presentation on “Charge Heterogeneity pattern of Trastuzumab: Targeted therapy for metastatic Breast Cancer” at “2nd JK Medical Science Congress and 1st Annual Conference of Metabolic syndrome-Prediabetes-PCOS Society”

10th to 13th May 2017

Srinagar, J & K.



S. No. Name of the Scientist Name of the Programme Duration Place of Conference

2. Participated in a Multi-Stakeholder Round table on “Unblocking India’s Potential in Biomedical Science & Innovation to Improve Healthcare in India and for the World” organised by Patient Safety and Access Initiative of India Initiative foundation

04th Aug 2017 Indian Habitat Center (IHC), New Delhi.

3. Participated as a speaker in “Wellness India 2017 Expo- Conference Session on Medical Biotech: The future of Healthcare”

30th Aug 2017 Pragati Maidan, New Delhi

4. Invited as a Panellist for Panel Session on ‘Ensuring uniformity of GMP inspections in biologics manufacturing’

19th & 20th Sep 2017

BioPharma India, Mumbai

5. Delivered a lecture on ‘Quality Evaluation of Therapeutic proteins & mAbs’

26th Mar 2018 University of Delhi South Campus (UDSC)

An oral presentation on “Charge Heterogeneity pattern of Trastuzumab at “2nd JK Medical Science Congress on 10th to 13th May 2017 at Srinagar, Jammu & Kashmir



“Wellness India 2017 Expo - Conference Session on Medical Biotech: The future of Healthcare”, on 30th Aug 2017 at Pragati Maidan, New Delhi

Ensuring uniformity of GMP inspections in biologics manufacturing’ in Biopharma India 2017 conference on 19th & 20th Sep, 2017 in Mumbai

8.2 Participation of NIB Scientist in training/ workshops/ conferences

S. No. Name of the Scientist Name of the Programme Duration Place of training

1. Mr. Subhash Chand, Scientist-III & Mr. P.S Chandranand, Junior Scientist

Characterization of mAbs using LC-MS/MS

6th to 9th

Jun 2017

C-CAMP & WATERS India, Bengaluru

2. Mr. Subhash Chand, Scientist-III & Dr. Richi V. Mahajan, Junior Scientist

WHO Ist World Conference on “Access to Medical Products and International Laws for Trade and Health in Context of the 2030 Agenda for Sustainable Development”. NIB Scientists participated as Rapporteurs

21st Nov 2017 Hotel Taj Mahal, New Delhi



S. No. Name of the Scientist Name of the Programme Duration Place of training

3. Dr. Richi. V Mahajan, Junior Scientist & Dr. Nripendra Nath Mishra, Bioassay Expert

Bioassay Training with Practical session on using appropriate statistical concepts

23rd to 24th

Nov 2017

USP India, Hyderabad

4. Ms. Apoorva Anand, Jr. Scientist, Ms. Anu Prakash, Bench Biologist

Analytical Characterization of Biosimilars: Concepts and Case Studies

6th & 7th

Dec 2017

IIT, Delhi

5. Dr. Richi V. Mahajan, Jr. Scientist

3rd IIMA International Conference on Advances in Healthcare Management Services (ICAHMS 2017)

08th to 10th

Dec 2017

IIM, Ahmadabad

9. Outstanding achievements of the Lab:i. Therapeutic Monoclonal Antibody

Laboratory collaborated with NIBSC, UK for the preparation of “1st WHO reference reagent for the biological activity of Rituximab-like antibodies”. Experimentation for the collaborative work has been successfully completed and results have been submitted to NIBSC, UK. Out of 16 participants worldwide, only 06 participants were having valid results for all 09 performances for CDC assay. NIB is one among 06 participants who have all 09 valid assays with % CV< 10%. The study has been published in mAbs Journal, entitled “International standards for monoclonal antibodies to support pre- and post- marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab”. The said

standard has been commercialized by NIBSC in collaboration with WHO as 1st International Standard for the biological activities of Rituximab; NIBSC Code: 14/210.

ii. Publications: 02 Research Articles accepted; 01 book chapter published & 03 Abstracts published in International & National reputed Journals / Books.

iii. Mr. Subhash Chand, Scientist-III & Head TMA Laboratory has been nominated as an expert member in below mentioned Expert Committees:

• Implementation Committee for establishing a Virology BSL2+ at CSIR-IMTECH, Chandigarh.

• ‘Bioassay Expert Committee’ at IPC, Ghaziabad for establishment of in-vitro cell culture lab in “Advanced level research centre”, IPC



1. Name of Head: Dr. Achla Prasad, Scientist Grade-I

2. Manpower in the Laboratory: i. Name of Scientific Staff:

Ms. Shalini Tewari, Scientist Grade-III

Dr. Sanjay Mendiratta, Junior Scientist (Till 09.05.17)

ii. Number of Contractual Staff : Three

3. Scientific Activities Undertaken:a. Collaboration with other

organisations:

i. The Allergen Testing Laboratory has two committees of subject experts viz. National Expert Committee approved by Honourable Health Minister and Core committee of NIB, constituted to undertake work on modalities of Quality Control of Allergens for the first time in India. Members of the committee are from different medical colleges/ hospital/ academia/ Govt. institutions/ CDSCO/ IPC etc.

ii. The work on project entitled “Development of Techniques and Reagents for Quality Control of Clinically Important Indigenous Allergen Extracts (Cockroach and Moth)” in collaboration with Metro Hospital, NOIDA, is being continued.

iii. Collaboration for obtaining the two Moth species viz. Helicoverpa armigera and Corcyra cephalonica with Entomology Department of Indian

ALLERGEN TESTING LABORATORY

Agriculture Research Institute (IARI) Delhi was initiated.

iv. Collection of Spodoptera litura & P. americana was initiated from Department of Zoology, Delhi University

b. Development of Monographs: The Allergen Testing Laboratory contributed in the development of first general monograph on “Allergen Products” in Indian Pharmacopoeia 2018. Volume III, Page No. 4067-4069

4. Testing of Biologicals:a. Laboratory has undertaken Quality

Control activities as per IP-2018 for Cockroach and Moth Allergens

b. Laboratory prepared 14 SOPs for the various test procedures, equipment etc used in Quality Control of Allergens.

c. As per IP-2018, following four tests are to be performed to initiate Quality Control of Allergens in India: (i) Sterility (ii) Protein content (Modified Lowry’s method) (iii) Protein profile (SDS-PAGE) (iv) Potency (SPT to be done by manufacturer)

d. Obtained raw material (Whole Body Powder-WBP) of Moth from three indigenous allergen manufacturers and prepared allergen extracts from each WBP. Performed protein estimation, carbohydrate estimation and SDS-PAGE of all the three Moth allergen. From SDS-PAGE profiling of above three moth extracts and communication with the manufacturers, it was apparent that all



three were using different raw material though Moth extracts prepared from WBP from two vendors showed similar SDS-PAGE profile (Fig 1). The issue of raw material used for allergen extract manufacturing is being considered for Quality Control aspect in consultation with CDSCO. In this regard NEC recommended following three species of moth or any other taxonomically identified prevalent species in the area:

• Helicoverpa armigera

• Spodoptera litura

• Corcyra cephalonica

Fig 1: SDS-PAGE Profile of Moth allergen extracts prepared from raw material obtained from three

indigenous allergen manufacturers

e. To maintain the quality of the starting raw material for preparation of insect Allergens, proper identification of insect (s) is crucial. In this regard help was sought from Entomology Department at IARI and further work is in progress. Cockroach (P. americana) and Moth (S. litura) were procured from Zoology Department, Delhi University and lyophilized. These were used to prepare

extracts and subjected to protein estimation and SDS-PAGE profiling.

f. Service samples of Cockroach and Moth allergens finished product received from different manufacturers without any claim of protein content. Protein estimation by Modified Lowry method was performed on these samples which gave erroneous results. When SDS-PAGE was performed, the protein bands did not appear in the gels stained with Coomassie Brilliant Blue.

g. In a meeting convened at FDA Bhawan on 07.11.2017 manufacturers informed that Phenol is added to during allergens manufacturing at buffer extraction step which interferes with Lowry’s method. Hence Allergen Testing Laboratory undertook protein estimation using different methods for protein estimation viz (i) Bicinchoninic Acid (BCA) Method (ii) Bradford Method and (iii) Base catalyzed Hydrolysis and Ninhydrin (BHN) Method (WHO Method).

h. BHN method involves time consuming cumbersome steps like heating, neutralization which may lead to variation in results, hence it was decided by all present not to adopt BHN method.

i. Hence Standardization and Validation of Bradford Method was undertaken using (i) in-house protocol & reagents (ii) PEI protocol (Kit Method).

j. The proposed collaborative work with PEI was initially to resolve the issue of estimation of protein content in allergen samples with Phenol, which will help in finalising the batch/ lot release modalities for allergens in Indian scenario which may be extended



iii. Expert Meetings Held:

1. 9th Meeting of National Expert Committee on 25.04.17A consolidated list of indigenous allergens was prepared by Allergen Testing Laboratory, NIB using duly authenticated lists of allergens obtained from each of four indigenous manufacturers. The purpose is to prepare a list of commercially available indigenous allergens manufactured by only licensed indigenous manufacturers and approved by CDSCO and to generate a database for “Common Allergens of India”.

New allergen will be included in this list only after manufacturer establishes their respective allergenicity through published data in India

The committee opined that Botanical/Zoological names with species along with common names are to be provided by the manufacturer for compilation of consolidated indigenous allergen list. The proper identification and authentication is an important aspect of Quality Control.

2. 10th Meeting of National Expert Committee on 31.08.17Manufacturing license to indigenous manufacturers should be granted only for allergens prepared from taxonomically identified starting material from Indian origin source. Identification to be done from an Institute of Indian Council of Agricultural Research (ICAR) or a Government recognized institute

Approved proposal for preparation of reference reagent for SDS-PAGE of Cockroach allergens (P. americana) at Allergen Testing Laboratory.

Following three species of Moth were approved for allergen manufacture & QC work Helicoverpa armigera Spodoptera litura Corcyra cephalonicaFinalization of batch release specifications for protein content and SDS-PAGE profile of allergens.

for allergen Quality Control in respect of updating monograph, conducting research, preparing QC Reagents and capacity building.

5. Trend in volume of work as compared to previous year:i. Allergen database for “Common

Allergens of India” was developed by IT Cell of NIB in coordination with Allergen Testing Laboratory. This software comprises a list of total 430 indigenous allergens out of which 302 allergens have been approved by National Expert Committee. Further work is in progress.

ii. Preparation of checklist for onsite inspection of Allergen Products Manufacturing facilities: Dr. Achla Prasad, Scientist Gr.-I & Head of Laboratory along with Ms. Shalini Tewari, Scientist-III, Dr. D. Roy, Regulatory Consultant of NIB and Prof. M.K. Agarwal member of NEC visited one of the facility for onsite evaluation of manufacturing practice required to be followed for manufacturing under the provision of Drugs and Cosmetics Act and Rules. A checklist to verify the compliance as per Schedule M Part I A of the Drugs Rules has been prepared.



3. Meeting with stakeholders at CDSCO-HQ on 07.11.17

Manufacturers were asked to generate the data of testing of their mother stock solution of allergens and share it with State FDA, CDSCO and NIB for each product for next two years so as to have data bank of approximately three batches of each product. Dr. Naveen Arora a NEC expert from IGIB- Delhi and NIB were requested to find out the method of protein estimation where there is no Phenol interference so that manufacturers can send the samples of their mother solution to NIB for data collection and verification with CoA of manufacturer.

It was also requested that firm shall submit Bio potency testing of one or two batches or shall submit the Indian literature about allergen product to CDSCO and NIB (indicating that it is potent and useful allergen in India) in coming two years.

4. Interactive Core Committee Meeting on 01.02.2018

The major issues of interaction were as bottlenecks in adopting recommended QC parameters in Indian scenario of Allergen manufacturing wherein interference of Phenol with protein estimation by Lowry’s method as mentioned in IP Monograph 2018 along with regulatory aspects. Head of Batch Control and Allergen Analytics, Paul Ehrlich Institut (PEI) - Germany suggested that the issue of Phenol interference may be resolved by using Bradford Method I as per PEI Protocol.

5. Meeting with stakeholders at CDSCO-HQ on 21.03.18

It was decided that manufacturers should preferably forward 5 sealed vials of bulk Cockroach and Moth allergen extract samples, preferably of 3 consecutive batches each, along with claim of protein content, SDS- PAGE profile (if available) and protocol to NIB for testing of protein content, SDS- PAGE pattern and sterility from the mother stock solution prepared by manufacturer by validating analytical methods present in IP- 2018 or alternative validated method to see the interference of Phenol in testing.

After validation, NIB will communicate the testing method to CDSCO, IPC and manufacturer for proper standardization of allergen. It was also decided that NIB will not charge any fee for testing up to one year. After validation, NIB will communicate the testing method to CDSCO, IPC and manufacturer for proper standardization of allergen. After one year, manufacturers will continue to send each batch to be manufactured to NIB for batch release with reasonable fees as to be fixed by NIB in near future which will be decided later

6. Proposed targets for testing of new biologicals:

Laboratory is working in coordination with CDSCO to take up quality evaluation of indigenously manufactured cockroach and moth allergen extracts.

7. Details of Participation in cGMP inspections:

Dr. Achla Prasad, Scientist Grade-I & Head of Laboratory participated as Subject Expert in following three GLP Inspections which are conducted as Joint inspection by CDSCO (North Zone) as per Schedule L1 of Drugs and Cosmetics Rules, 1945



GLP CDSCO:

S.No.

Zone State Name of Firm with Address Drug Inspector

Date of Inspection

1

North Zone

Haryana

M/s Shagun Testing Laboratories, SCO No. 32, Sec-12 A, Gurgaon.

Sh. Kailash Chander Malik

09-10/10/2017

2 M/s Mankind Research Centre, Mankind Pharma Ltd., Plot No. 191-E, Sector-4-II, IMT Manesar, Distt. -Gurgaon.

12-13/10/2017

3 M/s Kamal Enviro & Food Labs Pvt. Ltd., 254, Sector-6, IMT, Manesar, Distt. - Gurgaon.

16-17/10/2017

OECD-GLP-DBT (NGCMA)

S. No. Name of scientist Duration Place of Inspection

1.Dr. Achla Prasad

1-2/12/2017 Indian Institute of Toxicology, Pune

2. 29-30/01/2018 GLR Laboratories Pvt Ltd. Chennai

8. Participations in Training/Workshop/Conference:S. No. Name Name of the programme Duration Place of Programme

1. Dr. Achla Prasad Quality Control of Indigenous Allergens: Limitations and Possible Ways Forward

Mar 16-18, 2018

51st ICAAICON 2018 Lucknow

9. Outstanding achievements of the lab:

a. Allergen Testing Laboratory is the first of its type in the country to undertake Quality Control testing, analysis of allergen products and contributing significantly towards improving modalities for the same. Ensuring availability of quality allergens for patient care will help in reducing debilitating impact of allergies and improving quality of life of allergy patients.

b. Consolidated recommendations of two Committees on Allergens have been communicated to DCG (I)/ CDSCO for further notifications by their office to manufacturer/importers for compliance.

c. Publication of the first general Monograph on Allergen Products in Indian Pharmacopoeia 2018 edition.

d. Preparation of draft checklist for onsite inspection of Allergen Products Manufacturing facilities



1. Name of Head: Dr. Shikha Yadav, Scientist Grade- II, Vet

2. Manpower in the/Division:i. Name of Scientific Staff:

Dr. Suresh Kumar, Scientist Grade- III, Junior Vet

ii. Name of Technical Staff:

Mr. Prdeep, Laboratory Assistant

Mr. Parminder Kumar, Junior Animal Care taker

Mrs. Shobha, Peon

iii. No(s) of Contractual Staff: Fourteen

Animal Facility is a central support unit for all laboratories of NIB which performs in-vivo tests for Quality Control evaluation of biologicals received in the institute. The facility also ensures timely availability of laboratory animals for various in-vivo tests by a planned breeding program and the staffs of the facility ensure high quality animal husbandry and care that meets the requirements of animal welfare regulations and guidelines provided by The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA). Animal Facility also provides good quality laboratory animals to other research and education institutes as well as industry at reasonable rates.

3. Scientific Activities Undertaken:a) Collaboration with other

organizations:• Collaboration with IIT, Delhi: Dr.

Archana Chugh, Associate Professor, IIT, Delhi has collaborated with Dr. Shikha

ANIMAL FACILITY

Yadav for the project titled “Corneal delivery of antifungal-peptide conjugate encapsulated nanoparticle formulation in an experimental animal model of Fusarium solani”.

• Collaboration with CSIR-IGIB, Delhi: Dr. Shikha Yadav has collaborated with Dr. Vijay Pal Singh, IGIB, Delhi for project titled “Evaluation of A1 and A2 variants of β-casein in cow milk as factors causing allergic airway disease in murine model”.

• Collaboration with JIIT, NOIDA: Dr. Shikha Yadav has collaborated with Dr. Vibha Rani, JIIT, NOIDA for project titled “Identification and characterization of mi RNA relevant to cardiac disease.

• Collaboration with SRM University: Dr. Suresh Kumar has collaborated with Prof. Samuel Raj, SRM University for project titled “Synergy combination study of novel compound JS-2-02 with standard care therapy against Mycobacterium tuberculosis.

b) Publication(s):

• Suresh Kumar1, Vijay K. Bharti2, Prdeep Kumar1 and Ramendra Pati Pandey3 2018. Proposed Deletion of Abnormal Toxicity Test And 3R Initiatives for

Other Safety Test of Biologicals. Source Journal of Pharmaceutical Sciences. Volume 1, 1-1

1National Institute of Biologicals, Ministry of Health & Family Welfare, Govt. of India, India 2Defence Institute of High Altitude Research (DIHAR), DRDO, Ministry of Defence, India 3Department of Medicine, University of Sao Paulo, Brazil

• Suresh Kumar1, Mahendra Pal Singh1 , Vijay K. Bharti2 , Ramendra Pati Pandey3



2018 Quality control of vaccines- A journey from classical approach to 3Rs.- Microbiol Curr Res. 2018; 2(2):14-30.

1National Institute of Biologicals, Ministry of Health & Family Welfare, NOIDA, Uttar Pradesh, India 2Defence Institute of High Altitude Research (DIHAR), DRDO, Ministry of Defence, India 3Department of Medicine, University of Sao Paulo, State of Sao Paulo, Brazil

4. Testing of Biologicals: In-vivo QC evaluation tests i.e. Abnormal

Toxicity Test, Pyrogen Test, Potency & Identity Assays & other miscellaneous tests have been performed on a total of 927 samples of different biologicals forwarded by the laboratories of NIB. A total of 386 samples were tested for Abnormal Toxicity, 450 samples for Pyrogen, 66 samples for Identity and Potency Assay, 25 samples for miscellaneous tests. A total of 7891 animals were used to conduct these in-vivo QC tests, 148 were used for research and 2991 were sold to other institutes, details of which are provided in Table I.

Table I: Details of Animals used & supplied in 2017-18

S. No. Species Strain

Animal Provided in the Year 2017-18

QC Testing ResearchSold to outside

institutes

1. MiceSwiss Albino 5622 - 625

BALB/c 360 92 721

2. RatsSD Rats 741 56 1009

Wistar Rats 320 - 630

3. Guinea Pigs Duncan Hartley 792 - 6

4. Rabbits New Zealand White 56 - -

Total 7891 148 2991

Grand Total 11030

4.1 Approval of protocols by IAEC: All the experiments involving animals have to be approved by the IAEC, constituted by CPCSEA. In the year 2017-18, four IAEC meetings were organized in which 45 ongoing protocols and 12 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.

4.2. Abnormal Toxicity Test is conducted to determine the presence of any toxic substance in biological products intended for parenteral administration and are prescribed in the Indian and other Pharmacopoeia. The details of number of samples of various products and number of animals used are provided in Table II.



Table II: Details of different products tested for Abnormal Toxicity (2017-18)

Laboratory Name of ProductNo. of

Samples

2017-18

No. of Animals used

Mice G. Pigs

Blood Products

Human Albumin 231 1155 462

Dried Human Antihemophilic Fraction (Factor VIII)

46 230 92

Human Specific Immunoglobulin (I/M) (SPIG-IM)

46 230 92

Human Normal Immunoglobulin (I/M) (IGIM) 12 60 24

Plasma Protein Fraction (PPF) 3 15 6

Human Rabies Immunoglobulin (RIg) 10 50 20

Enzymes & Hormones

Human Chorionic Gonadotropin (hCG) 2 10 -

Streptokinase (STK) 3 15 -

Vaccines

Hib Conjugate Vaccine (Hib) 10 50 20

Human Hepatitis B Immunoglobulin (HBIg) 15 75 30

Cell Culture Rabies Vaccine (CCRV) 08 40 16

Total 386 1930 762

4.3 Pyrogen Test is conducted to detect the presence of any pyrogenic substance in the Biological products including vaccines intended for parenteral administration and are prescribed in

the Indian and other Pharmacopoeia. The details of number of samples of various products are provided in Table III.

Table III: Details of different products tested for Pyrogen Test (2017-18)

Laboratory Name of Product No. of samples 2017-18

Blood Products Human Albumin 229

Dried Human Antihemophilic Fraction (Factor VIII) 44

Normal Immunoglobulin (I/V) (IGIV) 39

Normal Immunoglobulin (I/M) (IGIM) 12

Human Specific Immunoglobulin (I/M) (SPIG-IM) 41

Plasma Protein Fraction (PPF) 03

Factor-IX 13



Laboratory Name of Product No. of samples 2017-18

Viral Vaccine Human Rabies Immunoglobulin (RIg) 10

Human Hepatitis B Immunoglobulin (HBIg) 17

Cell Culture Rabies Vaccine (CCRV) 27

Human Hepatitis B Vaccine (HBV) 05

Hib Conjugate Vaccine (Hib) 10

Total 450

4.4 Identity and Potency Assay is done to establish the identity and determine the strength and activity of the products

before their use in humans. The details of different product tested for Potency assay are provided in Table IV.

Table IV: Details of different products tested for Potency Assay (2017-18)

Laboratory Name of ProductNo. of samples

(2017-18)

No. of Animals used

Rats Mice

Enzyme & Hormone

hCG 2 48 -r-FSH* 8 279 -HMG-LH* 6 234 -HMG-FSH 6 180 -

Blood Products

Human Rabies Immunoglobulin (RIg)

11 - 1740

Viral VaccineCell Culture Rabies Vaccine 20 - 1632Inactivated Polio Vaccine 4 320 -Human Papilloma vaccine 3 - 120Hepatitis B Vaccine (HBV) 1 - 110

Recombinant Product

Recombinant Erythropoietin (r EPO) 5 - 250

Total 66 1061 3852*Includes repeat testing

4.5 Miscellaneous tests performed in Animal Facility (Table V)

Name of testNo. of Samples No. of Animals used

Mice G. Pigs

Virulent Mycobacterium of BCG Vaccine 5 - 30

Virus Inactivation Test 20 200

Total: 25 200 30



5. Trend in volume of work as compared to the previous years:

Quality Control Testing: The details of the trend in the volume of work in terms of

samples received for in-vivo quality control tests since 2009-2018 has been provided in Figure 1 and trend in terms of number of animals provided from Animal Facility is provided in Figure 2.


As a central facility, Animal Facility will take

up mandatory in-vivo testing required for new products taken up by any laboratory of NIB.



7. Participations in Training/Workshop/Conference

7.1 Dr. Shikha Yadav, Scientist Grade II & Head, Animal Facility

• Attended conference on “Implementation of 3Rs in Academic Research & Regulatory Testing” organized by CPCSEA, Ministry of Environment, Forests and Climate control in Delhi on 9th January 2018.

• Invited as an expert member of Initial Screening Committee (ISC) by Secretary, Technology Development Board (TDB), Department of Science & Technology, GoI for screening a project Proposal on “Establishment of Specific Pathogen Free Laboratory Animal Breeding & Testing Facility” from RCC Laboratories India Pvt. Ltd, Hyderabad on 23rd May 2017 in Delhi.

• Attended seminar organized by “The Jackson Laboratory”, USA on mouse colony management and breeding, health status and its impact of research and basics in mouse genetics on 30th May 2018 at NCBS, Bangalore.

• Attended IAEC meeting of Curadev Pharma, Greater NOIDA on 16th June 2017 where she has been nominated as member of Institutional Animal Ethics Committee (IAEC) by CPCSEA, Ministry of Environment, Forest & Climate Change.

• Invited as Guest Faculty for the only FELASA (Federation of European Laboratory Animal Science Association) Accredited Certificate Course in Laboratory Animal Science (CCLAS)

in India, conducted by Tamilnadu Veterinary and Animal Sciences University (TANUVAS) from 13-23rd Sep 2017, to deliver lecture on ‘Severity evaluation’ on 21.09.2017 and as expert for the ‘Evaluation of case studies and final evaluation of candidates’ on 22.09.2017 and 23.09.2017.

• Posters presented in International Conference on “ Recent Advances in 3 R’s and Laboratory Animal Science” at JNU, Delhi on 25-26 November 2017–

• “Evaluating the effects of feeding different β-casein variants of cow milk (A1/A1, A1/A2 and A2/A2) on airway hyperresponsiveness in murine model” Shikha Yadav, Amit, Dheeraj Sarkar, Nakul Dev S Yadav, Mohammed Faruq, VP Singh, Pankaj Sharma

• “Development of murine model of fungal keratitis” Harsha Rohira, Sujithra Shankar, Sushmita G Shah, Shikha Yadav, Aruna Poojary, Saurabh Saraswat and Archana Chugh

• Invited as resource person to deliver a talk on “Anesthesia & Analgesia in Laboratory Animals” in National Workshop on Laboratory Animal Experimentation: Handling & Injection Procedures organized by Centre of Medical Biotechnology, MDU, Rohtak , Haryana on 17th March 2018.

• Invited to deliver a talk on “Implementing Refinement in Animal Experiments- Severity Assessment, Clinical Score Sheets and Humane



End Points” on 29th March 2018 in a workshop on Basic Bio-methodology of Laboratory Animals, which is being organized at CSIR- IMTECH, Chandigarh, Haryana.

7.2 Dr. Suresh Kumar, Scientist Grade- III

• Co-chaired a session during seminar on “Laboratory animal health and quality improvement through improvised sanitation, hygiene and sterilization procedures”, organized jointly by NCLAS, NIN (ICMR), CPCSEA and Laboratory Animal Scientists Association, India (LASA) to commemorate the World Laboratory Animal Day at NIN, Hyderabad on 24th April 2017.

• Delivered a lecture on “Biomedical Waste Management Rules 2016” to B. Tech Students from VIT, Vellore at NIB on 29th May 2017.

• Delivered a lecture on “Biomedical Waste Management Rules 2016” at ICAR- National Research Centre on Equines, Sirsa Road, Hisar on 13th October 2017.

• Provided internal training at NIB on

• “Handling of Biologicals and Spills” to SRRDU Staff on 16th June 2017 & Contractual Staff on 25th May 2017

• “Chemical handling, storage and spill management” to Staff of different laboratories at NIB on 25th August 2017.

• “Biosafety Practices” to regular Staffs at NIB on 23rd November 2017.

• Invited as an Expert Member in the Expert Committee Meeting to discuss

on Alternative to Animals held on 11th

October 2017 at National Institute of Pathology, Safdarjang Hospital, New Delhi and also delivered the presentation on “Cell- based assay for neurological disorders.”

• Delivered a lecture on “Biosafety and Importance” for post graduate students from University of Jammu and Himachal Pradesh at NIB on 4th January 2018.

8. Outstanding achievements of the lab:8.1 The annual inspection of the Animal

Facility was done by IAEC on 12th December 2017 as per the CPCSEA requirement. The CPCSEA nominees submitted the inspection report to CPCSEA and strongly recommended the Animal Facility for further approval as it was an excellent facility meeting all CPCSEA requirements.



8.2 Dr. Shikha Yadav, Scientist Grade-II & Head, Animal Facility:

• Selected by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) - International’s council on Accreditation in June, 2017 as an Ad hoc Specialist (Site Visitor) wherein she will be assisting AAALAC International in conducting and evaluating site visits/audits of Animal Facilities for accreditation purposes.

• Nominated as Technical Expert in Project Evaluation Committee (PEC) by Secretary, Technology Development Board (TDB), Department of Science & Technology, GOI for evaluation of the project entitled “Establishment of Specific Pathogen Free (SPF) Laboratory Animal Breeding and Testing facility”

submitted by RCC Laboratories India Pvt. Ltd. on 16th November, 2017 at Hyderabad company site office.

• Dr Shikha Yadav, Scientist and Head, Animal Facility, was Co-organizing Secretary of an International Conference on “Recent Advances in 3R’s and Laboratory Animal Science”, jointly organized with Jawaharlal Nehru University and CSIR - IGIB, Delhi at Convention Centre, JNU on 25th to 26th November 2017. Invited speakers and more than 300 participants from all over India and 10 different countries such as USA, UK, Australia, Japan, Korea, Sudan, Sri Lanka, Netherland, Singapore, Denmark came together for sharing and advancing knowledge about recent advances in 3R’s and Laboratory Animal Science in this conference



Inauguration Session- Prof Rana P Singh (SLS, JNU), Prof. M. Jagadesh Kumar, Vice Chancellor (JNU), Shri Gowri Shankar, Deputy Secretary, CPCSEA, Prof S.K Goswami, Dean, School of Life Sciences (JNU), Dr Arvind Ingle,

President, LASA and Dr Shikha Yadav, NIB, NOIDA

Lamp Lighting ceremony by invited speakers- Dr Noriyuki Kasai, Tohoku University (Japan) Dr Patricia Turner,

University of Guelph (Canada), Dr Elisabet Berggren EURL-ECVAM (Europe) and Dr Tharanga (Sri Lanka).



Invited Speakers - Dr James R. Swearengen, Global Director & Dr Kathryn Bayne, CEO, AAALAC

International, USA.

Honoring the invited speakers of the conference

• The conference was preceded by two pre-conference workshops on “Experimental Design” by NC3Rs, UK in forenoon and “Hygiene in Laboratory Animal Facilities” by Tecniplast, Italy in afternoon on 24th November 2017 at CSIR Institute of Genomics and Integrative Biology, Mathura Road, Delhi which was attended by around 100 participants from all over India.

Dr Mark J Prescott, Director of Policy and Outreach and Dr Nathalie Percie du Sert, Head of Experimental

Design, National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), United

Kingdom conducted workshop on “Experimental Design”

8.3 Dr. Suresh Kumar, Scientist Grade- III & Incharge, Animal Facility

• Invited as external expert in the CSIR- Assessment Committee constituted in the area of Bioscience & Biotechnology at CSIR- Central Leather Research Institute, Adiyar, Chennai (Tamil Nadu) on 8th February 2018 for the assessment of Scientists.

• Conducted the Annual Inspection of Animal Facility of Department of Pathology Pt. B. D. Sharma PGIMS, Rohtak on 3rd March 2018.

• Invited as external expert in the CSIR- Assessment Committee constituted in the area of Bioscience & Biotechnology at CSIR- Indian Institute of Chemical Biology, Salt Lake, Kolkata 13thMarch



2018 for the assessment of Scientists.

• Reviewed a manuscript titled “Study on the development of region specific hybrid goat and their performance evaluation under high altitude condition” received on 11th July 2017 from Defense Life Science Journal which was published by Defence Scientific Information & Documentation Centre (DESIDOC) of Defence Research & Development Organization (DRDO).

8.4 Details of Animals Provided to Research & Education Institutes and Industry in 2017-18

In the year 2017-18, Animal Facility provided a total of 2991 good quality laboratory animals to research and education institutes as well as industry in Delhi and neighboring states as compared to 1154 animals provided in 2016-17.( Fig :3)

2016-172017-18

11542991

Figure 3 : No of Animals Provided to Other Institutes

Number of Animals sold

8.5 Commitment of NIB for implementation of 3R’s

As commitment towards the 3R’s, the scientists of Animal Facility and laboratories worked in close coordination to reduce the number of animals used in the Quality Control testing by testing more than one batch of same product at the same time with a common reference or control group. This enabled us to save a large number of laboratory animals in the year 2017-18, the details of which are provided below;

S. No. Details of QC TestNumber of

Animals Saved

1.

Potency Assay for Rabies Immunoglobulin (RIg)

240 mice

2. NIH Potency assay for Rabivax 808 mice

3 Potency assay for various hormones 133 rats

Total 1181



1. Name of Head : Dr. J. P. Prasad, Scientist, Grade- I

2. Manpower in the Lab/ Division:I. Name of Scientific staff :

Sh. Kallol Saha, Laboratory Technician

II. Name of Technical and Support Staff:

Sh. Narender Kumar, Laboratory Assistant

STERILITY TESTING LABORATORY

III Number of Contractual Staff : Two

3. Scientific Activities Undertaken: Working on Molecular characterization

of environmental isolates. Environment monitoring of classified area and isolation of microbes followed by biochemical and molecular characterization using DNA extraction, RT- PCR, Gel electrophoresis and DNA Sequencing.

4. Testing of biologicals:Name of

LaboratoryType of Biologicals No. of

batch evaluated


Quality

No. of batches found to be NOT

of StandardQuality

Recombinant Products

Insulin, Interferon, Erythropoietin, GSF

485 485 Nil

Blood Products Albumin, Human Normal Immunoglobulin, Antithrombin, coagulation Factor

515 515 Nil

Enzymes & Hormones

Streptokinase, hCG, FSH, HMG, Urokinase, Heparin

27 27 Nil

Viral

Vaccines

Cell Culture Rabies Vaccine, MMR, Measles, Rubella, HPV, Hepatitis B Immunoglobulin & Rabies Immunoglobulin

34 34 Nil

Therapeutic Monoclonal Antibody

Trastuzumab & Bevacizumab 14 14 Nil

485, 45%515, 48%

27, 3%34, 3%14, 1%

1075 Samples Tested For Sterility (FY 2017-18)

RP BP E&H VV TMAb.

“Graphical representation of different product types referred for Sterility test in Financial Year 2017-18.”



5. Trend in volume of work as compared to previous year (2016-17) including examination of technical dossiers:

0

200

400

600

800

1000

1200

1400

145

428

598

897

11321222 1181 1222

1075

No. of

Sam

ple

s

Graphical representation of the biological samples tested for sterility

2009-10

2010-11

2011-12

2012-13

2013-14

2014-15

2015-16

2016-17

6. Participation in Training/ Workshop/ Conference (Name of the Scientist(s), Name of the programme, Duration and place of training, etc.):

Mr Kallol Saha along with two staff hired through outsource agency participated in One Day seminar on Next Generation DNA Sequencing organized by Thermo Fisher Scientific at Hotel Pullman, New Delhi.


Upgradation of Sterility Testing Laboratory area as per WHO & ISO guidelines.



1. Name of Head : Dr. J. P. Prasad- Quality Manager

2. Man power in the Unit : i. Mr. Subhash Chand – Deputy Quality

Manager

ii. Mr. P. S. Chandranand- Deputy Quality Manager

iii. Mr. Sanjeev K. Sharma- Deputy Quality Manager (Since 03.02.2017-03.01.2018)

iv. Md. Daud Ali-Deputy Quality Manager (Since 03.06.2017- till date)

3. Contractual Manpower: 03 (Three)

4. Aims and scope of the Unit: Quality Management Unit of NIB takes

care of the quality evaluation of various biologicals being tested at NIB. It serves as a management tool with elements of:

a) An appropriate infrastructure, encompassing the organizational structure, procedures, processes, personnel and resources;

b) Systematic action necessary to ensure adequate confidence that quality evaluation at NIB will satisfy given requirements for quality as per the various pharmacopoeial guidelines/ or manufacturer’s protocol.

The unit ensures inter-relationship between the laboratories and other technical & administrative departments for compliance of technical and management requirements. In addition, it ensures the vertical relationship between pharmacopoeial body

QUALITY MANAGEMENT UNIT

and the regulatory system. The objective of Quality Management Unit is continuous improvement in the following areas:

i. Maintenance, Sustenance & Enhancement of Scope for NABL accreditation in accordance to ISO/ IEC 17025: 2005 requirements & OHSAS 18001:2007

ii. Periodic Assessment by Accreditation/ Certification body (e.g. NABL)

iii. Preparation & Upgradation of Quality System Documentation

iv. Equipment Maintenance

v. Internal Quality Audit as when required.

vi. Management Review Meeting as when required.

vii. Assuring the Quality of Test Results

viii. Implementation of Integrated QHSE Management System (as per the ISO 9001:2015, ISO 14001:2015 & BS OHSAS 18001:2007)

5. Enhancement of Scope for ISO/IEC 17025: 2005 Requirements

The scope of Accreditation has been enhanced in discipline of Chemical & Biological tests in seven different categories namely:

i. Biotechnology Derived Products

ii. Immunological Products

iii. Enzymes

iv. Vaccines

v. Hormones

vi. Other Specified Tests which include Biochemical Kits

vii. Biopharmaceuticals



Laboratory / Unit Name No. for different types of products AccreditedBiochemical Kit 02Blood Grouping Reagent 19Immunodiagnostic Kit 22Blood Product 21Enzyme & Hormone 09Recombinant Product 28Bacterial Vaccine 03Viral Vaccine 09Therapeutic Monoclonal Antibody 04Molecular Diagnostic Kit 03Total 120

The NABL Reassessment of NIB laboratories in accordance to ISO/IEC 17025:2005 for the year 2018-2020 is applied to enhance the scope of

120 products and 285 tests (Biological=125 & Chemical=160) dated 17.11.2017

NOTE: 07 new products are added in the scope of NABL accreditation in accordance to ISO/IEC 17025:2005 from two laboratories viz. Therapeutic Monoclonal Antibody & Molecular Diagnostic Kit

Previously 91 products were accredited for the Year 2016-2018 that included 226 tests (Biological=86 & Chemical=120). The trend Chart is depicted at Table 1 and Graph 1-3

Table 1: Enhancement in application of Scope of Accreditation for Biological & Chemical tests & products as per ISO/IEC 17025: 2005 (2011-2020)

AreasPeriod

2011-2013 2013-2015 2016-2018 2018-2020Laboratories 7 10 10 12Products 19 61 91 120Biological Tests 12 36 140 160Chemical Tests 16 34 86 125

Total Tests 28 70 226 285

Graphs depicting Enhancement of NABL Scope:

0

2

4

6

8

10

12

2011-2013 2013-2015 2016-2018 2018-2020

Period

710 10

12

No. of

Labora

tori

es

1. Trend for No. of Laboratories

0

50

100

150

2011-2013 2013-2015 2016-2018 2018-2020

Period

1961

91120

No. of

Pro

ducts

2. Trend for Type of Products



12

36

140

160

16

34

86

125

0 50 100 150 200 250 300

2011-2013

2013-2015

2016-2018

2018-2020

3. Trend for No. of Tests (Biological & Chemical)

Chemical Biological

Total =28

Total =70

Total =226

Total =285

6. Quality System Documentation6.1 Review & Revision of Standard

Operating Procedures (SOPs) and Manuals

Alert Calendar (Jan-Dec 2018) for timely revision/ review of SOPs is issued

to all areas of Diagnostic, Therapeutic, Vaccine Laboratories and Support/Facilitating Units

6.2 Presently the Quality Management System of NIB is strengthened with quality documentation procedures as summarized below (Table 2):

Table 2:

S. No. Laboratory / Unit NameNumber of

Manual / SOPsManual N = 5

1. Quality Manual-Apex Quality document 01

2. Biosafety Manual 01

3. Purchase Manual 01

4.

BS OHSAS 18001:2007 Manual

• Level I Document

• Level II Document

02

Management & Technical System procedures

5.Standard Operating Procedures(SOPs) of various Product Testing Laboratories

661

6. QMU Approved Formats 704



6.3 Equipment Maintenance

Authorized list of equipment usage is being updated timely with the details of preventive maintenance e.g. AMC/ Calibration done with due date. An Alert Calendar for Fixed and Moveable Equipment for year 2018 has been released to all users of the laboratory and the Stores & Purchase Unit which includes activity for: a) AMC, b) Validation and c) calibration. These services are rendered by OEMs of the equipment and NABL accredited agencies under seven categories viz., Temperature Controlled, Mass/ Volume, UV – Vis Absorbance, Potentiometer Measurements, Centrifuge, Tele-thermometers, and Mercury Based Thermometers etc.

7. Annual Internal Quality Audit : The annual internal quality audit were

conducted as per the requirements of ISO/IEC 17025:2005 & BS OHSAS 18001:2007 by the Quality Management Unit.

7.1 The Internal Audit as per ISO/IEC 17025:2005 was held on 29th -31th Aug 2017 for

a) Product Testing laboratories (N=10) namely Biochemical Kit, Blood Grouping Reagent, Immunodiagnostic Kit, Blood Product, Enzyme & Hormone, Recombinant Product, Bacterial Vaccine (BCG & Polysaccharide), Viral Vaccine. Therapeutic Monoclonal Antibody Lab & Molecular Diagnostic Kit Lab were added to the scope of internal audit.

b) Support Units (N=2) namely Sterility, and Animal Facility

c) Technical Units (N=3) Quality Management Unit, Sample Receipt & Report Dispatch Unit, Stores & Purchase Unit.

7.2 The internal audit as per the requirements of BS OHSAS 18001:2007 was held on 6th Nov 2017. The internal audit for OHSAS Standard ensures that OH&S management system is conducted at planned interval for the section Administration, Guest House, Hostel, Canteen, Institutional Bio-safety Committee (IBSC), QMU & Engineering Section. The unit had planned a calendar schedule to con1duct Internal Audit of the quality system on the month of November 2018.

8. Management Review Meeting A review of the management system was

conducted on March 9th, 2017(ISO 17025: 2005) & 23rd Nov 2017 (OHSAS 18001: 2007) using a formal agenda whose action were to be taken in time bound manner.

9. Scientific Services Undertaken I. Trainings

A Training Calendar has been prepared in coordination with the Training Unit, NIB, for identifying training needs and providing training to the 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. Scientific and technical persons working in the areas of product testing laboratories, Engineering unit, Stores and Purchase and Quality



Table 3: Internal Trainings/ workshop/ conferences Organized at NIB:Name of Scientist/

Attended By Name of Programme Duration Organizer

Management Systems – LQMS, Quality, Health, Safety & Environment (QHSE)All Staff(N=121)

Orientation program on Health and Safety

1 day(28-04-2017)

Quality Management Unit

Scientific Staff(N=63)

Bioinformatics, Data Integrity And Management

1 day(09-05-2017)


All Staff(N=167)

Fire Training & Mock Drill Demonstration

1 day(23-05-2017)

Quality Management Unit & Engineering Div.


Guidelines on similar biologics: regulatory requirements for marketing authorization in India-2016

1 day(27-05-2017)



Data Integrity : Regulatory perspectives and Challenges & Analytical Techniques in Biopharma

1 day(03-06-2017)


Administrative Staff(N=17)

Internal training on MS Word, Excel, PowerPoint to enhance the skill in use of computers.

3 day(12th to 14th Jun,17)


Scientific Staff(Laboratory Block)(N=114)

Training & Mock Drill for Evacuation Plan in Emergency condition

1 day(15-06-2017)

Quality Management Unit & Engineering Div.


US Pharmacopeia Global Perspectives in Compendia Standards

1 day(22-07-2017)



Writing of amendments and revision of SOP’s

1 day(24-08-2017)



Chemical handling, storage and spillage management

1 day(25-08-2017)

Quality Management Unit & IBSC


ISO 17025:2005 Training(Management & Technical Requirements)

2 day(26-08-2017 & 09-09-2017)



Biosafety Practices1 day(27-09-2017) Quality Management

Unit & IBSCScientific Staff(N=19)

Training on “Biosafety Practices”Mock drill for Chemical Spill

1 day(31-01-2018)

Management Unit, have been trained in technical and management areas, as

enlisted below in Table 3 (Total No. of Internal training=13)



10. Visit of Dignitaries:S. No. Date of Visit Name Designation

1. 07.04.2017 Alok Kumar MD NHM (UP)

2. 07.04.2017 Dr. William Kilembe Project Director and study physician at Zambia Emory HIV Research Project (ZEHRP), Lusaka (Africa)

3. 07.04.2017 Dr. Mohammad Kyar African Union Commission

4. 07.04.2017 Prof. Gilbert Kolwar Professor, Strathmore University, Kenya

5. 07.04.2017 Philip Rice Wellcome Trust

6. 07.04.2017 Prof. Omu Anzala Professor of Virology and Immunology,

KAVI- ICR, Kenya7. 24.05.2017 Kinga Jamphel Drug Regulatory Authority Bhutan

8. 24.05.2017 Jigme Tanzin Regulatory Office Bhutan

9. 16.06.2017 Tentin Dorji &

Rinchen Waydi

Royal Centre for Disease Control

Department of Public Health

Ministry of Health, Bhutan10. 04.07.2017 Dr. J. P. Meshram Deputy Director Health (CG)

11. 21.07.2017 Dr. I.S. Chaitanya Kumar Asst. Professor, Transfusion Medicine

State Programme Officer12. 12.08.2017 Sh. Sudhir Kumar Joint Secretary-Regulation

Ministry of Health & Family Welfare

Govt. of India 13. 06.09.2017 Dr. Shravan Subramanyam MD, Roche Diagnostics

14. 07.11.2017 Kim Dancheck Bioproduct Reference Standard Scientist

Eli Lily Co.15. 07.11.2017 Parveen Jain Senior Manager Regulatory Affairs

Eli Lily Co.16. 07.11.2017 Erin Wang Consultant - Quality - Compendial Affairs

Eli Lily Co. USA17. 07.11.2017 Matthew Borer Senior Research Advisor,

Reference Standards, Eli Lily & Co.18. 03.02.2018 Manvi Porwal Scientific officer

Paul Ehrlich Institut, Germany



S. No. Date of Visit Name Designation

19. 13.01.2018 Dr. Manohar Agnani Joint Secretary PolicyNational Health MissionMinistry of Health & Family Welfare Govt. of India

20. 15.03.2018 Prof. Afework K Gzaw State MinisterMinistry of Science & TechnologyFederal Democratic Republic of Ethiopia

21. 19.03.2018 Dr. Mohd Shafi Koka State Nodal Officer, NHM, J & K

11. Major Achievements 11.1 The NABL Accreditation scope was

enhanced w.r.t the No. of Products (i.e. previously 91 products and for the current scope of accreditation there are 120 products)

11.2 The NABL Accreditation scope was enhanced w.r.t Biological and Chemical tests (i.e. previously 226 tests and for the current scope of accreditation there were 285 tests)

11.3 National Institute of Biologicals had

initiated the process of acquiring OHSAS 18001:2007 Certification in July 2017. NIB had undergone the certification audit Stage I & stage II as per United Kingdom Accreditation Service (UKAS) Certification Body OHSAS 18001:2007 requirements on 10.11.2017 and 04.02.2018 respectively. The actions for compliance to the observations observed during the audit were taken up and the reports for compliance were duly submitted to the certification assessment body (M/s Bureau Veritas Pvt. Ltd.).



1. Name of Head Rashmi Shrivastava, Scientist Gr III (since

26-05-17)

Dr. Reba Chhabra, Scientist Grade-I DD (QC) i/c (till 25-05-17)

2. Man Power in the Division: I. Name of Scientific Staff:

Dr. Swati Shalini, Junior Scientist (Since 07.07.2017)

Mr. Anirban Mukherjee, Junior Scientist (Till 06.07.2017)


Mr. Mohit Sharma, Laboratory Assistant

III. No.(s) of Contractual Staff : Eight

3. Aim and Scope: SRRDU has been functional as an independent

unit since 2008. The unit is nodal point for all the samples that are received in the institute for evaluation and release of report. Samples of various Biotherapeutics, Diagnostics, and Vaccines are received from the National Drug Regulatory authorities as well as several government medical organizations like Medical Service Corporation Limited,

SAMPLE RECEIPT AND REPORT DISPATCH UNIT

from various states like Jammu & Kashmir, Haryana, Rajasthan, Orissa etc. International samples from Bangladesh have also been received for quality evaluation by Vaccine Laboratory

4. Workflow of the Unit The complete workflow of department

has been well documented as per ISO 17025:2005 in approved SOPs for different categories of biologicals and is an ongoing process for continuous improvement in the efficiency of the system. All samples that are submitted are critically checked with respect to the essential official documents, proper storage temperature as per label claim, required quantities, testing fee. These checks are always as per the published and revised guidelines and the same is available on Institute’s website.

5. Sample receipt records: The total no. of biologicals tested at NIB

has increased by 12.4% to 209 (as shown in fig 1) and their testing fee has been revised according to recent GST norms. A new software was developed with the help of IT department for invoice generation against submitted testing fees.

160170180190200210

FY 2015-16 FY 2016-17 FY 2017-18

177185

209

Figure 1. Types of biologicals tested at NIB for last three financial years



0

500

1000

1500

2000

2500 2003

14 26 95 28

Fig 2: Total number of samples received at NIB during FY 2017-18 and their distribution in various categories

0200400600800

1000904

214

Therapeutics

0200400600800

1000819

229

Diagnostics

0500

100015002000

1723

443

Total samples

Figure 3: The number of Imported and Indigenous samples received in Therapeutics and Diagnostics laboratories

In FY 2017-18, total of 2,166 samples have been received under various categories (Fig. 2). Amongst them 2003, from regulatory

body, 95 from Government Medical Supplies, 14 survey samples, 26 legal samples and 28 as service samples were received.

The total no. of samples received in FY 2017-18 were increased from FY 2016-17 by 8% and the no. of samples received at BRL and IDKL has increased remarkably. The

maximum no. of samples were received in BPL lab followed by RPL lab and IDKL lab as shown in Figure 4.



6. Samples Evaluated and report released: Total 1966 reports were released in financial

year 2017-18. Thirteen (13) Not of Standard Quality (NSQ) and two (02) spurious (BRL) samples were reported out of which 10 belonged to Diagnostics labs (BRL, IDKL and BKL) and 03 belonged to Therapeutics lab (BP lab, TMA lab). The reporting of NSQ samples is important for release of only quality products in Indian market.

Reports released 1966

SQ-1951

NSQ-13

Spurious-2

7. Sample Storage and Record Keeping Retained samples are stored in designated

cold rooms of the Unit or at room temperature at different location depending upon the

label claims of sample. There are two walk-in cold rooms of 2-8°C and one -20°C. Samples are stored as per the location assigned and displayed on the main door of cold room. All the necessary details are entered in the retained sample register. Samples from the retained lot are issued as per the lab request for different purposes like Audits repeat testing, training etc. All the necessary records are maintained in the register. Complete unit is under CCTV surveillance for necessary security and the samples and records are kept under lock and key. The temperature of cold rooms is monitored both manually and digitally.

8. Customer Feedback. Annually the feedback for previous year

0

100

200

300

400

500

600

IDKL MDL BRL BKL BPL RPL EHL TMA VVL BVL

397

12

91

210

576

505

42 30

96

38

461

24

355

208

529496

25 1545

3

Sample received (FY 16-17) Sample received (FY 17-18)

Fig 4: The Trend in number of sample received at different laboratories in two consecutive Financial Years.



performance is sought by SRRDU, in the defined format prepared by Quality Management Unit, from all the stakeholders

in the beginning of new financial year. The chart below is depicted as the analysis of the response received.

87.50%82.50%

88.57%

70.00%

90.00%95.00% 92.50%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

Informationregarding

Laboratoryservices

Response toquery over

telephone, e-mail, fax

Attention andservice duringvisit to office

Participationin Committees

forPublication ofMonographs

On-timecompletion of

workincluding

delivery oferror - freetest reports

Reliability oftest results

Receptivenessto complaints& suggestions

Cust

umer

Sat

isfac

tion

Inde

x (%

)

Customer Feedback Parameters

Customer Feedback Analysis - Period 2016 - 2017*

*Received by SRRDU and Analysed by Quality Management Unit, NIB

9. Participation in Trainings/ workshop/ conferences Name of Scientist/

Attended By Name of Program Duration Organizer & Place of

TrainingDr. Swati Shalini

Sh. Mohit Sharma

e-Office training (FTS) 13-09.2017 NIB, NOIDA

Dr. Swati Shalini Internal training ISO 17025 26.08.2017 & 09.09.2017

NIB, NOIDA

9.1 A talk on ISO 17025:2005 clause 4.8 which is Customer Complaints was given by Ms Rashmi Shrivastava during

the Internal Training Organised by QMU, NOIDA on 26.08.2017 at NIB.



TRAINING UNIT

1. Name of Head: Dr. Reba Chhabra, Scientist Grade-I & i/c

DD(QC)

2. Manpower in the Lab/ Division:I. Name of Scientific staff:

Dr. Richa Barnawal, Scientist Grade-III, In-charge (up to 11th July 2018)

Sh. N.Nanda Gopal, Scientist Grade-III, In-charge (from 12th July 2018)

Sh. Jaipal Meena, Scientist Grade-III

Dr. Manjula Kiran Junior Scientist

Sh. Sanjeev Kumar, Junior Scientist (up to November 2017)

Dr Anoop Kumar, Junior Scientist

II. Number of Contractual Staff: 01

3. Aim & Scope: The training unit of National Institute

of Biologicals (NIB) comprises of the scientific staff of the institute who, along with their scientific duties are given additional responsibilities to function for synchronizing and implementing the training related activities of the institute. The training unit functions with the objective which is in line with NIB mandate 3.1.3 as laid down in Memorandum of Association. Besides regulatory officials, manufacturers, academicians, government analysts, blood bank officials, NIB also imparts trainings to graduate and post graduate students for building up the ‘National Talent Pool of skilled and trained manpower’ for indigenous manufacturing units for domestic

consumption as well as export of biologicals which is expected to increase significantly year over year. The training will help to bridge the gap of trained manpower for Quality Control of Biologicals in Government and Private sector as there is an acute shortage of skilled and hands-on trained manpower in the field of Biologicals.

4. Training Activities Undertaken 4.1 Training to Blood Bank officials

with Blood Cell, National Health Mission (NHM)

Blood Services are a crucial component of curative healthcare amenities. Adequate and safe supply of blood and blood components is essential to enable care of critical patients in the hospitals. The mission of the Blood Cell, NHM is to develop a coordinated long term action plan for the development and integration of diverse activities in the area of blood banking with a careful consideration of priorities and optimal use of resources and funds to ensure effective blood services in the country.

NIB in collaboration with Blood Cell, National Health Mission (NHM), has conducted a series of Seven training programmes on “Six Days Residential Training of Blood Bank Officials” with total 222 participants for Govt. Blood Bank Officials at NIB, NOIDA for technical support in Strengthening Blood Services in India at IDKL, BRL and Hemovigilance Cell in the following areas:

i. EQAS for Transfusion Transmitted Diseases and Blood Group Serology

ii. Training for Use of Cell counters and Its



Quality Assurance

iii. Haemovigilance training (BBO/ Clinicians/ Donors)

iv. Analysis of gaps in Blood Bank Management

v. Total Quality Management Systems

vi. The objective of the training is to improve the standards of Blood Banks and the Blood services in our country.

This initiative will facilitate in building up a “National Talent Pool of skilled and trained

manpower” to improve better quality, safety and efficacy of blood and blood products, well-equipped blood centres with adequate infrastructure, meeting the requirements of current good laboratory practices (cGLP) and Strengthen Total Quality Management System.

The training programmes helps Blood banks of our country in improving their standards and thereby providing excellent and high quality services for safeguarding Public Health in our country.

Table 1: Training to Blood Bank officials who are participated from nine states viz., Gujarat, Rajasthan, Andhra Pradesh, Kerala, Himachal

Pradesh, Jammu & Kashmir, Punjab, Haryana & Karnataka (S.No.1) and further Arunachal Pradesh, Bihar, Uttar Pradesh, Mizoram & Manipur.

S. No

Title of the Training Training attended by

Period of Training Total no. of Participants

1. Training of Trainers for Strengthening of blood services and e- Rakt Kosh for 9 states

Doctors and Laboratory Technicians

17th - 22nd Jul 2017

35 222

2. Training of Trainers for Strengthening of blood services and e- Rakt Kosh for the states of Mizoram & Manipur

Doctors & Laboratory Technicians

24th – 29th Jul 2017

39



S. No

Title of the Training Training attended by

Period of Training Total no. of Participants

3. Training of Trainers for Strengthening of blood services and e- Rakt Kosh for the state of Uttar Pradesh

Doctors 18th – 23rd Sep 2017(Batch 1)

28

9th – 14th Oct 2017 (Batch 2)

29

4. Training of Trainers for Strengthening of blood services for the states of Arunachal Pradesh


08th - 13th Jan 2018 28

5. Training of Trainers for Strengthening of blood services for the states of Bihar


05th - to 10th Mar 2018

38

6. Training of Trainers for Strengthening of blood services for the states of Uttar Pradesh

Laboratory Technicians

19th - 24th Mar 2018 25

4.2 Training of Graduate & Post Graduate Students from various Universities at NIB under “National Skill Development & Hands-on-Training on Quality Control of Biologicals” programme.

NIB in line with National Skill Development programme under “Pradhan Mantri Kaushal Vikas Yojana (PMKVY)” provides training on “National Skill development and Hands-on Training in Quality Control of Biologicals” for M.Sc. Biotechnology, Biochemistry and Microbiology students of University of Jammu & Himachal Pradesh.

The objective of this training Programme is to develop and enhance analytical skills and technical knowledge of M. Sc.

Biotechnology, Microbiology & Biochemistry students through Hands-on Training in Quality Control of Biologicals including Biotherapeutics, Diagnostics and Vaccines in NABL accredited and CDL notified laboratories. The training covers techniques used in quality evaluation like HPLC, Electrophoresis, ELISA, Bacterial Endotoxin testing, Transfusion Transmitted Infection testing, Blood Serology, Cell culture aseptic handling, sub culturing and maintenance, cell line based potency assays, animal handling, use of laboratory animals etc in QC testing of Biologicals performed in various labs of NIB and to create awareness about Global scenario of biological testing.

Table 2: Trainings under National Skill Development and Hands on Training in Quality Control of Biologicals

S. No Title of Training Training attended by

Date Total no. of Trainees

1 National Skill Development and Hands on Training in Quality control of Biologicals for M.Sc. Students from Universities of Jammu & Himachal Pradesh

M.Sc. Biotechnology, Microbiology & Biochemistry

3rd – 23rd

Jan 2018

43



4.3 Training of Graduate/ Post Graduate Students from various Indian Universities.

The institute provides 4 to 8 weeks training programme and 3 to 6 months dissertation/project work in Quality Control of Biologicals in various NIB laboratories to Graduate/ Post

Graduate Students of various Universities and Institutes. The training on various analytical platform makes them proficient, help in their future research endeavours and enable them to get good job opportunities.

Table 3: List of summer training/ dissertations conducted at NIB, NOIDA

S. No

Title of Training Training attended by Date Total no. of Trainees

1 Summer Training/ Dissertation B.Sc., B.Tech, M.Sc. Life Sciences, Biotechnology Biochemistry Microbiology & M. Tech

Apr 2017 to

Mar 2018

88



S. No

Title of Training Training attended by Date Total no. of Trainees

2 Orientation to Advanced Post Graduate Diploma students of Clinical Research and Pharmacovigilance from Apollo Hospitals Educational and Research Foundation (AHERF)

Advanced Post Graduate Diploma students of Clinical Research and Pharmacovigilance

17th Nov 2017 23

Total 111

4.4 Training to Manufacturers/ stakeholders

The Trainings were provided to the personnel from manufacturing facilities in the areas of quality testing of biologicals viz., biotherapeutics, diagnostics & vaccines (Table 4). In these training programme, hands-on training was given at respective Laboratories of National Institute of Biologicals on Product Specific Quality Control testing

and on Laboratory Quality Management System (LQMS). NIB in collaboration with Clinical Development Services Agency, DBT conducted National Workshops at NIB in the area of Diagnostics comprising of 46 participants with the objectives to make the participants aware about the basics of Laboratory Quality Management System (LQMS) so that they can enhance their quality deliverables while working in the area of diagnostics.

Table 4: Imparted training to manufacturers

S.

No

Title of Training Training attended by Duration Total no. of Trainees

1 National workshop on Total Quality Management System in Diagnostics

Manufacturers, QC/ QA officials, Regulators, Pharmacopeial bodies

5th - 7th Sep 2017

46

2 Training of manufacturers in Therapeutic Monoclonal antibody Laboratory and RPL

Manufacturers 21st Nov to 10th Dec 2017

04

3 WHO Hands-On Training Course- Determination of the Polyribosyl-ribitol-phosphate (PRP) content of the Haemophilus influenzae type b (Hib) capsular polysaccharide in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed Amperometric Detection (HPAEC-PAD)

Manufacturers 23th – 27th Oct 2017

05

Total 55



Table 5: 1st General Meeting WHO-National Control Laboratory Network for Biologicals (WHO-NIB)

S.

No

Title of Training Training Attend by Duration No of

Participants1. 1st General Meeting WHO- National

Control Laboratory Network for Biologicals (WHO- NNB)

National Control Laboratories from 21 countries

31st Oct –

2nd Nov 2017

39

4.6 International Trainees

NIB provided training to Bhutan officials to improve the quality of testing in the areas of Transfusion Transmitted Diseases and Blood Group Serology:

S. No Title of Training Training Attend by

Duration No of Participants

1. Hands on Training TTI testing and Blood grouping serology

Bhutan officials 12th -16th June 2017 02

5. Trainings imparted and Workshops conducted by laboratories

5.1 Immuno Diagnostic Kit Lab

Imparted two days Hands on training on Quality Control Evaluation to one Application Specialist of M/s Bio-Rad Laboratories (India) Pvt. Ltd., Haryana at Immunodiagnostic Kit Laboratory, NIB on 14th-15th March 2018

5.2 Molecular Diagnostic Lab:

Dissertation/ Summer Training of Graduate/Post Graduate students Projects

Ms. Nishi Tiwari- B.Sc. Biotechnology “Molecular Techniques to evaluate the Quality of Molecular Diagnostic kits” from Chandigarh University, Gharuan, Punjab.

Ms. Ranjana Patel- M.Sc. Microbiology-“Evaluation of Human Papilloma Virus (HPV) infection in Cervical scraps samples” from Awadhesh Pratap Singh University, Rewa (M.P).

5.3 Blood Reagent Lab

a. Dissertation/ Summer project for College students:

1. Four (04) students pursuing B. Tech/ B.Sc. (Biotechnology) from Dr. A.P.J. Abdul Kalam Technical University (APJAKTU) Lucknow, Maharshi Dayanand University Rohtak, (June 13-July 31, 2017) Chandigarh University Chandigarh (June 01-July 15, 2017), Jaypee Institute of Information Technology NOIDA (10 June 10- 17 July 2017) were trained on Grouping, Sub

4.5 Global Meeting Organised

The 1st General Meeting of WHO-National Control Laboratory Network for Biologicals was held at National Institute of Biologicals (NIB) during 31st October -2nd November,

2017 in which 39 personnel from 21 countries across the globe participated in the meeting.

This meeting at NIB primarily focus on the networking of National Control Laboratories for testing Vaccine for WHO supply.



Grouping and Phenotyping of Blood Samples for Quality Control Testing of Blood Grouping Reagents. (1 June-31 July 2017)

2. One (01) student pursuing M.Sc. (Biotechnology) from Shekhawati University Sikar (Rajasthan) was trained for six months on Grouping, Sub Grouping and Phenotyping of Blood Samples for Quality Control Testing of Blood Grouping Reagents. 3 July- 29 December 2017)

3. One (01) student pursuing B.Sc. (Biotechnology) from Chandigarh University Mohali Punjab, was trained for Three weeks on Grouping, Sub Grouping and Phenotyping of Blood Samples for Quality Control Testing of Blood Grouping Reagents. (11-29 December 2017)

4. One (01) student pursuing B. Tech. (Biotechnology) from Amity University

NOIDA was trained for 06 weeks on Grouping, Sub Grouping and Phenotyping of Blood Samples for Quality Control Testing of Blood Grouping Reagents. (15 Feb- 27 Mar, 2018)

5. One (01) student pursuing M.Sc. (Microbiology) from Jiwaji University Gwalior MP, was trained for four months on Grouping, Sub Grouping and Phenotyping of Blood Samples for Quality Control Testing of Blood Grouping Reagents. (1 Feb- 31 May 2018)

b. Training to Officials of Royal Centre for Disease Control, Bhutan

Officials of Royal Centre for Disease Control, Bhutan were imparted training on “TTI Testing and Blood Serology” from 12.06.17- 16.06.17 at National Institute of Biologicals, NOIDA.

5.4 Biochemical Kit Lab

Summer Training:

S. No.

Title Date Participants

No. Details

1. Aspects of Laboratory Quality Management System in a Quality Control Testing Laboratory

May 22, to

June 21, 2017

01 B. Tech Biotechnology student, SASTRA University, Tamil Nadu

2. Implementation of Laboratory Quality Management System in Biochemical Kit Laboratory and Quality Assurance of Blood Glucose Test Strips

June 05, to

June 30, 2017

01 B.Sc. Biotechnology Student, Chandigarh University, Punjab



5.5 Bacterial Vaccine Lab Training/ Workshop/Conference organized:

S.

No

Title of Training Date Participants

1 Total PRP Estimation in Haemophilus influenza Type B (HIB) TT conjugate vaccine

24.05.2017 to 09.06.2017

Graduate student of AMITY University

2 Total PRP Estimation in Haemophilus influenza Type B (HIB) TT conjugate vaccine

25.05.2017 to 27.06.2017

Graduate student of AMITY University

3 Determination of Polyribosyl-ribitol-phosphate (PRP) content of the Haemophilus influenza type b (Hib) capsular polysaccharide in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed Amperometric detection (HPAEC-PAD)

23.10.2017 to 27.10.2017

Six participants from three Indian vaccine Manufacturers i.e. Shantha Biotechnics, Bharat Biotech and Zydus Cadila

4 Quality Evaluation of Bacillus Calmette Guerin (BCG) Vaccine By ZN Staining Method

02.06.2017 to 03.07.2017

Graduate Student of Chandigarh University

5 Quality Evaluation of Bacillus Calmette Guerin (BCG) Vaccine By ZN Staining Method

13.06.2017 to 14.07.2017

Graduate Students of IMS Engineering College

5.6 Viral Vaccine Labi. Dissertation work of Student:

• Name of the student: Ms. Tanya Barik from Jiwaji University Gwalior.

• Name of the Project: Standardization and Validation of Measles and Rubella (MR) Vaccine (In-Vitro Microtitration Assay).

• Duration of training: 01.02.17 to 31.05.17 (Four months)

ii. Scientist (s) from Panacea Biotech Ltd:

• Name of the Scientist: Mrs. Anju, Mrs. Aarti and Mr. Anurag

• Name of programme: Hands on training “Identification and potency

testing of Live Attenuated Measles Vaccine and Rubella vaccine” given by Viral Vaccine Staff to the scientists from Panacea Biotec, Ltd.

• Duration and place of training: 12-01-18, 16-01-18 and 19-01-18 (Three Days),

5.7 Blood Products Lab

1. The senior scientists of the laboratory imparted internal training on ISO/IEC 17025: 2005 standard to junior laboratory staff held on 26th August & 9th September, 2017, at NIB, NOIDA.

2. The laboratory has imparted summer trainings and post graduate student dissertation projects for nine students in the reporting year 2017 – 2018. Details summarized in table below:



S. No. Title & details1. Development of Enzyme linked immunosorbent assay kit for determination of tetanus

Immunoglobulin. Ms. Manisha Mishra, Awadhesh Pratap Singh University, Rewa, Madhya Pradesh (06 months – from Feb. 2017 to May 2017).

2. Quality evaluation of newer generation recombinant factor VIII & factor IX Products. Ms. Suhasini Sharma, Meerut Institute of Engineering & technology, Baghpat Crossing, Meerut (06 months - from Jan. 2017 to May 2017).

3. Quality control testing of Plasma Derived Products. Ms. Shivani K, JSS College of Pharmacy, Ooty, Tamil Nadu (01 month - from June 2017 to July 2017).

4. Quality control testing of Human Albumin. Ms. Tarandeep Singh, Chandigarh University, Chandigarh (01 month - June 2017).

5. Quality Control Testing of Human Normal Immunoglobulin for Intravenous use. Ms. Arushi Saxena, Japee Institute of information Technology, NOIDA, Uttar Pradesh (02 months - from June 2017 to July 2017).

6. Quality control testing of Human Albumin. Ms. Aakanksha Makol, Jamia Hamdard University, New Delhi (01 month – July 2017).

7. Quality control of testing of plasma derived Products. Ms. Tanya Salotra, Chandigarh University, Chandigarh (01 month – Dec. 2017).

8. Quality control of testing of plasma derived Products “Human albumin’. Ms. Pooja Puniya, Chandigarh University, Chandigarh (01 month – Dec. 2017).

9. A Comparative Study on Different Methods of Bacterial Endotoxin Test as an Alternative to the Rabbit Pyrogen Test for Safety Testing in Different Plasma Derived Products. Ms. Priyanka Sharma, Shekhawati College, Sikar, Rajasthan, (06 month - from July 2017 to Dec. 2017).

5.8 Recombinant Products Lab

i. Trainings Organized

S. No

Training Programme Period of Training No. of participants

Trainees Organization

1.Fundamental Techniques in cell culture

24th May to 07th Jul 2017 02

Amity University, NOIDA

Jaypee Institute of Information Technology

2. Quality control of Recombinant Products

31st May 2017 to 01st

Jun 2017 05

VIT, Vellore

25th May to 26th Jun 2017 01

Institute of Biotechnology, Chandigarh University

3. The Laboratory has participated and contributed in Orientation to 23 Advanced Post Graduate Diploma students of Clinical Research and

Pharmacovigilance from Apollo Hospitals Educational and Research Foundation (AHERF) on 17th November 2017, at NIB, NOIDA.



S. No

Training Programme Period of Training No. of participants

Trainees Organization

3. High performance liquid chromatography : Basics and Instrumentation

02nd Jun to 03rd Jul 2017 01


4. Introduction to recombinant Products and Liquid Chromatography

09th Jun to 31st Jul 2017 01

Jaypee Institute of Information Technology

5. Basic Introduction to Liquid Chromatography

13th Jun to 17th Jul 2017 01


6. Quality Control of Recombinant Products

7th Dec to 29th Dec 2017 03

Chandigarh University

7. 26thDec to 16th Jan 2018 01

Jamia Hamdard University, New Delhi

8. Quality Control of Recombinant Products

5th, 8th,9th Jan 2018 43

University of Jammu and Himachal Pradesh

9. Comparative analysis of Insulin analogues and mixture of Insulin Analogue with respect to purity parameters

Jan- Jun 201701

Dr. B. R. Ambedkar University, Agra

10. Quality Control of Recombinant Product-Insulin

Mar 2018 01


11. Study the stability of Reference Standard of Insulin Analogue-Glulisine

Feb–Mar 2018

01 Amity University, NOIDA

Total 61

ii. Workshop Organized:

• Two Days Workshop on “Best Global Practices to Become the Next Practices”, 6th and 7th

November. 2017, Organized by: NIB and Global Team Lilly USA. The primary objective of the workshop was capacity building at NIB by learning the latest strategies

adopted by various Pharmacopoeias to handle newer and more complex molecules, discussion on Method comparability, Pharmacopoeial Standard for Biotherapeutic Products – Industry Perspective, Quality Culture, Global Quality Culture, Compendial harmonization etc.



5.9 Enzymes and Hormones Lab

During 2017-2018, the laboratory provided hands-on-training to graduate and post graduate student of various universities of India on quality control evaluation of enzyme

& hormone. The laboratory also provided extensive training to two students of Iraq nationality studying in Acharya Nagarjuna University, Andhra Pradesh. The details of the training are summarized in table below.

S.

No.

Name of the Programme No. of

Participants/ Group

Duration of Training

1 Summer Training / Dissertation of Graduate and Post Graduate Students

Linta Sara Abraham

Jan to Jun 2017

Manisha Sharma July to Dec. 20172 Hands On Training Program on Quality Control Testing

of Biologicals for B. Tech Biotechnology students of VIT, Vellore Pharmacy Student)

05 Students 29th May- 9th Jun 2017

3 Summer training for Post Graduate & Graduate Students of Biotech & Microbiology from different Institute/University

05 Students Apr 2017 to Mar 2018

Training for International Students4 M.Sc. Microbiology Students of Acharya Nagarjuna

University, Andhra Pradesh (Student of Iraq Nationality) on Quality Control testing of Biologicals

02 Students

17th Jul – 18th

Aug. 17



S. No. Name of the Trainee

Duration of the Training

Degree Course

University Area of Training

1. Ms. Apurwa Kestwal

04.01.2017 to 04.07.2017

M.Sc. Microbiology

HNB Garhwal University Bioassay/ Bioactivity of mAbs

2. Ms. Megha Bansal 23.05.2017 to 23.07.2017

B.Sc. Biotechnology

Jaypee Institute of Information & Technology (JIIT), NOIDA.

Analytical

Characterization of mAbs

3. Ms. Monika Devi 25.05.2017 to 26.06.2017

B.Sc. Biotechnology

Chandigarh University Analytical


4. Mr. Shivam Rai 01.06.2017 to 31.07.2017

B.Sc. Biotechnology

Chhattrapati Shahu Ji Maharaj University (CSJMU)

Analytical


5. Mr. Neeraj Singh 05.06.2017 to 05.09.2017

M.Sc. Biotechnology

Chhattrapati Shahu Ji Maharaj University (CSJMU)

Bioassay/ Bioactivity of mAbs

6. Ms. Kiran Choudhary

01.07.2017 to 29.12.2017

M.Sc. Biotechnology

Shekhawati College, Sikar, Rajasthan

Analytical


5.10 Therapeutic Monoclonal Antibody Lab

Trainings Organized:

(i) Four-day training-workshop was organized by Therapeutic Monoclonal Antibody Laboratory in collaboration with M/s SCIEX, on 3rd to 6th July 2017 for TMA Laboratory staff, in order to have better understanding of the applications and hands-on training on different techniques of Capillary Electrophoresis viz, Capillary Zone electrophoresis, CE-SDS, Capillary Isoelectric Focusing Analysis etc at NIB, NOIDA.

(ii) Two day workshop on Global Quality Culture, Compendial Harmonization,

and Monoclonal Antibody Control Strategies was organized in collaboration with RPL-I Laboratory at NIB on 6th & 7th Nov. 2017, where M/s Eli Lilly’s global team from USA gave an insight into the technical knowhow of development and regulatory aspects of existing and upcoming Biosimilars. The primary objective of the workshop was capacity building at NIB by learning the latest strategies adopted by various Pharmacopoeias to handle newer and more complex molecules.

Trainings Imparted:

(i) B.Sc. /M.Sc. Biotechnology / Pharmacy students, N=12 completed dissertation/ summer training for the fulfillment of the degree course.



S. No. Name of the Trainee

Duration of the Training

Degree Course

University Area of Training

7. Ms. Vasudha 01.12.2017 to 29.12.2017

M. Pharmacy JSS College of Pharmacy, Ooty


8. Ms. Jyothsna 01.12.2017 to 29.12.2017

M. Pharmacy JSS College of Pharmacy, Ooty

Analytical


9. Mr. Madhav Gaba 07.12.2017 to 29.12.2017

B.Sc. Biotechnology



10. Mr. Anshul Bansal 15.01.2018 to 15.05.2018

M.Sc. Biotechnology



11. Mr.Rayaz Ahmad Bhat

22.01.2018 to 21.02.2018

M. Pharmacy NIPER, Guwahati Analytical


12. Ms. Abhishree Aggarwal

15.02.2018 to 09.04.2018

B.Sc. Medical Biotechnology



5.11 Allergen Testing Lab

Imparted training to four post graduate

students from Feb 2017- June 2017 on various aspects of Quality Control of Allergens.

S. No. Title Date ParticipantsNo. Details

1. Hands on exposure to Quality Control of Cockroach Allergens

Feb 10 to

Jul 10, 2017

01 M.Sc Biotechnology student,

Awadhesh Pratap Singh University, Rewa, Madhya Pradesh

2. Hands on exposure to Quality Control of Moth Allergens

May 24 to

Jul 24, 2017

02 B.Tech (biotech) + M. Tech (integrated) students,

Gautam Budh University, Greater NOIDA, Uttar Pradesh

3. Hands on exposure to Quality Control of Moth Allergens

May 25 to

Jun 25, 2017

01 B.Sc Biotechnology student,

Chandigarh University, Gharuan, Chandigarh, Punjab

4 Quality system ISO17025 26.08.2017 - NIB Staff and Bench Biologist



5.12 Animal Facility

Training/ Workshop/Conference organized

S. No.

Details of Trainings ProvidedNumber of

Participants

1.Summer training was given to a student from SRM University, Chennai on the topic “Assuring Safety of human coagulation factor VIII and human rabies immunoglobulin by in vivo regulatory tests from 6th June-30th June 2017.

1

2.Summer training was given to a student from SASTRA University, Thanjavur on the topic “Evaluation of the safety of human albumin by using Rabbit Pyrogen Test and Abnormal Toxicity Test from 1st June-30th June 2017.

1

3. Summer training was given to a student from IMS Engineering College, Ghaziabad, UP on the topic “Assuring safety of human coagulation factor IX by using in vivo regulatory tests” from 13th June-17th July 2017.

1

4.Summer training was given to a student from IMS Engineering College, Ghaziabad, UP on the topic “Assuring safety of cell culture rabies vaccine (CCRV) and human coagulation factor IX by using in vivo regulatory tests” from 13th June-17th July 2017.

1

5.Summer training was given to a student from IMS Engineering College, Ghaziabad, UP on the topic “Assuring safety of Human Hepatitis B Immunoglobulin in vivo regulatory tests” from 10th June-11th August 2017.

1

6.

Training was given to the students from Acharya Nagarjuna University, Andhara Pradesh on the topic “Potency Assay of Menotropin (HMG) FSH & LH Activity, General Biology, humane handling of and restraining of and injection procedures in laboratory animals and Minimization of pain and distress in laboratory animals from 7th -11th August 2017

2

7.

Two weeks training was provided to a Technician A from Defence Institute of Physiology and Allied Sciences (DIPAS), DRDO, Delhi on “Care, Breeding and Management of Laboratory Animals with Hands on Training on Restraining & Injection Procedures” from 19th February to 1st March 2018 at Animal Facility.

1

8.Summer training was given to a student from Jamia Hamdard University, Delhi on the topic “In Vivo Quality Control Testing of Biologicals” from 26th December 2017-12th January 2018.

1

Total Number of Trainees in 2017-2018 09



1. Name of Head: Dr. Reba Chhabra, Grade- I

2. Manpower in the Lab/ Division:I. Name of Scientific staff:

Dr Akanksha Bisht, Scientist Grade III: Officer In-charge HvPI.

II. Number of Contractual Staff: Three

3. Aim and Scope:Implementation and coordination of activities of Haemovigilance Programme of India (HvPI) is of the Mandate’s of NIB as per its bye-laws 3.4.1 as approved in the 24th Governing Body meeting of NIB held under chairmanship of Secretary (Health & F.W.)/ Chairman, Governing Body of NIB on 12th Dec, 2014.

4. Activities Undertaken150 Blood Banks are enrolled under this programme. National Institute of Biologicals has a web based reporting system for adverse transfusion reactions and donor reactions via indigenously developed software(s) Haemo-Vigil and Donor-Vigil. Till date 5478 Adverse Reaction Reports have been reported via Haemovigilance Software(s) out of which 2481 reports pertain to adverse blood transfusion reactions and 2997 reports are attributed to reactions during blood donation. Further, NIB has submitted the Haemovigilance Data, Analysis Report for the period from 24th January, 2013 to 30th April, 2016 to the Ministry on 27/05/2017. This report apart from findings consists of recommendations for improving blood transfusion practices.

HAEMOVIGILANCE DIVISION

NIB under Haemovigilance Programme of India (HvPI) has organized 10 CMEs/ Workshops across the country & trained about 1312 participants which includes Blood bank officials, clinicians, nurses & blood bank technical staff besides bringing out biannual release of HvPI newsletter to disseminate information about HvPI to health care professionals & other stakeholders.

Two PG students Mr. Rayaz Ahmad Bhat & Mr. Vishal Tiwari of M.Pharm Pharmacy Practice from National Institute of Pharmaceutical Education & Research (NIPER), Guwahati had performed 8 months research work as a part of their dissertation w.e.f. 4th July, 2017 in field of Haemovigilance Programme of India at HvPI Division of NIB on the following topics:

1. Pilot study to understand and compare challenges being faced in reporting of transfusion reactions by the Government, Private and Stand-alone/ Charitable blood banks enrolled under Haemovigilance Programme of India (HvPI).

2. Pilot study to understand and compare challenges being faced in reporting of reaction associated with blood donation by the government, private, stand-alone/ charitable blood banks enrolled under National Blood Donor Vigilance Programme.

Haemovigilance Programme of India (HvPI) is a member of International Haemovigilance Network (IHN) and Officer In-charge of HvPI is one of the Board Members of the IHN.



INFORMATION TECHNOLOGY DIVISION

1. Name of Head: Dr. Reba Chhabra, Grade- I (till 26.05.2017)

Ms Rashmi Shrivastava, Grade III (Since 26.05.2017)

2. Manpower in the Lab/ Division:I. Name of Scientific staff: Sh P. S. Chandranand, Junior Scientist

Sh Deepak Mahajan, Computer Officer

II Number of Contractual Staff: Three

3. Activities Undertaken: IT Division has initiated the following

activities:

1. With the increase in National and International meetings, Conferences, Workshops, Trainings and Academic activities, the visit and stay of international Dignitaries and participants in the institute as well has been increased substantially .To cater the expected need of internet connectivity while their stay at Guest House / Hostel, IT Division has proposed to upgrade the BSNL Leased Line connectivity from 34 mbps to 100 mbps. Beside this, IT Division has also proposed to shift the other 34 mbps backup leased Line from NIC, CGO Complex, New Delhi to NIC, Shastri Park, Delhi for smooth functioning of network facility within the Institute. The IT Division has also facilitated the Wi-Fi facility during WHO Training Programme in the Guest House and Hostel Blocks.

2. Security Audit– The Division has

floated the limited tender enquiry for Security Audit of Sample Tracking System, Inventory Module, Haemo-vigil and Donor-vigil web based applications. The security audit was conducted as per Govt. of India guidelines from CERT-IN empanelled auditors and submitted its compliance audit report and certificate to National Informatics Centre (NIC). The Cyber Security Division of NIC has also conducted the compliance audit and notified that the web based applications of the Institute have undergone a third-party audit for web application security vulnerabilities and has been declared safe for hosting.

The IT Division has floated a limited tender enquiry for Drug Survey– AKS Software for third-party security audit through CERT-IN empanelled auditors as per Govt. of India guidelines and submitted its compliance audit report and certificate to National Informatics Centre (NIC). The compliance audit report for the same is pending with NIC.

3. The Division receives the quarterly information from various Laboratories/ Divisions/ Sections for updating the website of the Institute. The information is compiled in html pages in both English & Hindi language and reviewed by the Web Committee Members. Same is been updated with the approval of the competent authority.

4. The Division has also updated the Intranet LAN Portal of the Institute. The information such as SOPs, Monographs, AMC records, Committees etc. received



from Quality Management Unit has been updated time to time as per requirement.

5. The Division is in the process of attaining Guidelines for Indian Government Websites (GIGW) compliance status. In this regard Certification through STQC as per the directives of Ministry of Health & Family Welfare, Govt. of India is going on. In this matter, three cycles of STQC audit on current website of the Institute have been conducted. All the anomalies raised during the audit have been closed by IT Division and final certification in this regard is awaited.

6. The Division has submitted the proposal for migration of Institute’s website along with all the web based applications on to NIC National Cloud as per directions of Ministry of Health & Family Welfare, Govt. of India.

7. The Division has received tender enquires, corrigendum, tender extension date for uplinking on NIB website and Central Public Procurement Portal for wide publicity etc.

8. The Division has compiled the information received from various Laboratories / Divisions/ Sections for Annual Requirement of NIB for hosting on Startup Portal and MOHFW website. The work of annual requirement was initiated on 08.08.2017 and completed on 22.12.2017.

9. The Division participated in Physical Verification of Fixed Assets of the Institute. The report of the same has been submitted in due time for necessary action.

10. The Division has looked after the activities of Photography and Publications Display Unit (PPDU). The unit members has provided the necessary support with respect to photography work for LED display, preparation of video film for valedictory session during the training programme, meetings, and workshops etc. The unit has also keep the archiving related activities to keep the photography-data safe and secure.

11. The Division looks after the IT related arrangements in Conference Room and Meeting Room for various training programs and meetings held in the Institute. Beside this, IT Division has also provided the technical support for arrangements of Telecon and webinars etc. held during the year.

12. The IT Division has drafted number of tender enquiries such as Comprehensive Annual Maintenance Contract for Digital Multi-functional Photocopiers and Photocopy Machines, Supply of Toner Cartridges & Drum Units on Rate Contact basis, Provision of Data Storage Unit for Bacterial Vaccine Laboratory and SRRD Unit, Maintenance of Desktop Computers, Servers, Router, Printers, Scanners, UPS, Local Area Network and Network devices, Disposal of eWaste, Interactive Digital Podium. All the above mentioned services had been awarded to L-1 bidders with the approval of the competent authority.

13. The IT Division has drafted the specification for procurement of 32” and 40” LED TV for installation in Guest House and Hostel. In this regard, a limited tender enquiry has been floated by the Procurement Division.



B. IT enabled services undertaken are given below:

1. Sample Tracking Invoice Generation Software: The IT Division has developed in-house software for

Invoice Generation against testing fees received for quality control evaluation of all indigenously produced and imported biologicals products submitted by the manufacturers.

2. Other Invoice Generation Software: The IT Division has developed in-house software for generation of Other Invoice against payment received other than testing fees of samples such Sale of Laboratory Animals to CPCSEA Registered Institutes and Reference

Standard– Biotech Products, Sale of old newspapers & magazines and eWaste etc. Presently, the Invoice Generation Software’s are being used by the Sample Receipt and Report Dispatch Unit and Finance & Account Division of the Institute.

3. The IT Division has developed Allergen database software named as “Common Allergens of India”. The development of software work was

initiated on 22.09.2017 and completed on 08.02.2018. Presently, the Allergen Database Software is being used by the Allergen Testing Laboratory of the Institute.



5. E-mail Alert Software: The IT Division has developed an in house E-mail Alert Software for Engineering and Procurement related services. The objective of the E-mail Alert software

is to give reminder to the dealing hand in advance before expiry of any services and to submit the proposal for renewal of the same. The development of software work was initiated on 03.07.2017 and completed on 30.08.2017.

4. E-Office Training: The IT Division has imparted the training to all the Officers and Staff members to implement the File Tracking System (FTS) in the Institute.

The division-wise training was initiated in August 2017 and completed in December, 2017.



6. The IT Division is in process to develop a new dynamic website and mobile application for the Institute. The same

shall be hosted after Security Audit and on allocation of NIC Cloud Resources.



ENGINEERING DIVISION

Electro-Mechanical Engineering Works Undertaken:

The NIB campus specifically Laboratory & Animal House Building is complemented by various engineering services/ facilities/ installation to facilitate the day to day scientific activities. The detailed information about the various engineering works/ services/ facilities and installation undertaken during the Financial Year 2017-18 is as under:

1. Up-gradation of Sterility Lab at ground floor of Laboratory Building.

2. Renovation of Guest House in NIB Campus NOIDA.

3. Conference Hall, Audio-visual Systems in Laboratory Building.

4. Administration of various electro-mechanical engineering services/ facilities installation of day to day operation and maintenance & repairing, which are provided/ installed in the various buildings/ areas of NIB Campus.

5. Repair works of 8mVA, 33/11kV Transformer No. 2 of electrical power system.

6. Installation of Wireless Data Logging system in All Cold rooms, Incubator installed in Lab & Animal House Building to M/s. HLL, NOIDA.

7. Co-ordination with CPWD for undertaking STP/ETP plant.

Apart from the above the Institute has finalized the services contracts for annual operation and maintenance contract, and AMCs/ CMCs of the following Engineering

Services/ facilities and fixed scientific equipment during the financial year 2017-18:

i) Operation and NC Maintenance contract for External & Internal services (Electrical).

ii) Operation and comprehensive maintenance contract for fire-fighting system, water supply system, water softening plant system, neutralization system including centralized water softening plant of the Institute.

iii) Operation and maintenance contract for CCTV Surveillance system and Access Control system installed in various building/ locations/ areas of the Institute.

iv) Operation and maintenance contract for HVAC plant System including Window/ Split Cassette and package type AC units installed in various buildings of the Institute.

v) Operation & maintenance of 3x2.8T/Hr at 10.5kg/Sqcm Steam Generating Boiler including Economizers and allied accessories etc.

vi) Operation and maintenance of 20 Nos. Walk-in-cold Rooms, Constant Humidity Chambers and Environment Rooms, installed in the Laboratory & Animal House Building.

vii) Operation and maintenance contract for Sterilizers, Glass Washers, Glassware Dryers, Tunnel Washers and Case & Rack Washers installed in the Animal House facility of the Institute.



viii) Operation and maintenance contract for centralized R. O. Plant system installed in the Laboratory & Animal House.

ix) Repair and maintenance of the following engineering installation/ facilities/ fixed scientific equipment under AMC/ CMC contract with OEM or their authorized service agency in India, which are installed in various buildings/ areas of the Institute namely are: Elevators/ Lifts, Centralized UPS system, Electrical appliances, LED Signage, Telecommunication/ EPABX system/ PRI lines services, Bio-Safety Cabinets & Laminar Air Flow Stations, Under Counter Freezers, Chemical Fume Hoods, Refrigerators and Bio-waste Disposal including follow up with external agencies/ departments like BSNL, PVVNL, U.P. Pollution Control Board and NPC & PESO (formerly Department of Explosives, Government of India) respectively for environmental & safety consent orders.

x) Operation and maintenance of Steam Sterilizers, Washers and other equipment of Steris, USA make installed in laboratory and animal house.

xi) Assign the work for Installation of new dedicated walk in cold room for SRRDU (-20° C & 2-8° C) to M/s. HLL, NOIDA.

xii) Assign the work for rectification of underground firefighting piping network to CPWD.

Major Civil works undertaken during the year:

1. Renovation of all 22(twenty two) Suites & Rooms of Guest House.

2. Expansion and renovation works in the Cafeteria.

3. Construction of Crown Jet Fountain between Guest House and Hostel.

4. Up-gradation of Sterility Laboratory as per WHO norms.

5. Setting up of Centralized Equipment Lab for Immuno Diagnostic Kit Lab.

6. Providing interlocking paver blocks, repairs of stone foot paths, concrete road etc.,

7. Award of fresh annual contract for maintenance of Lawns & Gardens in NIB campus.

8. Provided controls, checks, systems and documentation as per ISO requirements for QHSE Audit/ Certification.

9. Complete support for repairs & maintenance of all Buildings (Area of Buildings more than 35,000 Sqm.), services and Institute campus.

10. Provided complete support for various Trainings and Workshops of CDSCO, NHM, Skill Development and own meetings etc. held in the Institute.

11. Painting of Erected Chimneys & Allied Structure of 03 Nos. DG Sets Chimneys, 01 No. Boiler Chimney and 01 No. Incinerator Chimney with Heat Resistant paint at NIB, NOIDA.



Head of the Administration: Dr. Reba Chhabra I/c. Deputy Director (Admin)During the year 2017-18, the following appointments have been made by the Institute:-

S. No. Name of Employee Designation

1. Shri W. Z. Quazi Procurement Officer

2. Ms. Poonam Laboratory Technician

3. Shri Sukhen Majhi Laboratory Technician

4. Shri Mohd Imran Laboratory Technician

5. Shri Reetesh Kumar Prajapati Laboratory Technician

6. Shri Mohit Lal Laboratory Technician

Meetings of the General / Governing BodyA. The 11th Meeting of the General Body was held on 08.01.2018

Composition of the General Body: Secretary (Health & Family Welfare) Chairman Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi. Secretary Member Department of Biotechnology, New Delhi

Secretary, DHR & DG, ICMR Member Ansari Nagar, New Delhi – 110029

Additional Secretary (Health) Member Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi – 110011. Additional Secretary & F.A. Member Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi – 110011.

Director General of Health Services, Member Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi – 110011.

REPORT OF THE ADMINISTRATIVE WORK



Drugs Controller General (India), Member Directorate General of Health Services, F.D.A. Bhawan, Kotla Road New Delhi - 110002.

Joint Secretary Member Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi – 110011.

Secretary Member Health & Family Welfare, H. Block Secretariat, Govt. of Andhra Pradesh, Hyderabad, Andhra Pradesh

Secretary Member Health & Family Welfare Department, Government of West Bengal, Writers Building, Kolkata.

Chairman Member Serum Institue of India Ltd., 212/2 Hadapsar, Pune - 411 028

Director Member Pasteur Institute of India, Coonoor – 643 103 (The Neelgiris)

The Chairman-cum-Managing Director Member National Dairy Development Board, Anand, Gujrat.

Managing Director Member Haffkine Bio-Pharmaceutical Corpn. Ltd., Acharya Donde Marg, Parel, Mumbai.

Director, Member Secretary NIB, NOIDA



B. The 27th Meeting of the Governing Body was held on 08.01.2018 Composition of the Governing Body:

Secretary (Health & Family Welfare) Chairperson Ministry of Health & Family Welfare Nirman Bhavan, New Delhi-110011

Secretary (DBT), Govt. of India Member Block No.2, C.G.O. Complex Lodhi Road, New Delhi – 110003.

Secretary, DHR & DG, ICMR Member Ansari Nagar, New Delhi – 110029

Director General of Health Services Member Directorate General of Health Services, Nirman Bhavan, New Delhi- 110011.

Additional Secretary (Health) Member Ministry of Health & Family Welfare Nirman Bhavan, New Delhi – 110011.

Additional Secretary & F.A. Member Ministry of Health & Family Welfare Nirman Bhawan, New Delhi – 110011 Drugs Controller General of India Member Directorate General of Health Services, Nirman Bhavan, New Delhi- 110011. Joint Secretary Member Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi - 110011.




C. Meetings of Standing Finance Committees.

i. The 26th Meeting of the Standing Finance Committee was held on 05.04.2017

ii. The 27th Meeting of the Standing Finance Committee was held on 14.06.2017

iii. The 28th Meeting of the Standing Finance Committee was held on 28.09.2017

Composition of the Standing Finance Committee:

Additional Secretary Chairman Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi

Addl. DG, ICMR or his nominee Member Indian Council of Medical Research, Ansari Nagar, New Delhi - 110029.

Joint Secretary Member Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi - 110011

Drugs Controller General (I) or his nominee Member (Not below the rank of Asstt. Drugs Controller (I)) FDA Bhawan, New Delhi - 110002

Director (IFD) Member Minstry of Health & Family Welfare, Nirman Bhawan, New Delhi - 110011.




Particulars Amount ( Rs. in Crore)Budget Estimate (BE) 39.42Revised Estimate(RE)/Final Estimate 41.32Expenditure incurred during the year 37.27

BUDGET & FINANCEDuring the year 2017-18, the approved Budget Estimate (BE) allocation was Rs. 39.42 Crore and the Revised Estimate (RE) was also Rs. 41.32 Crore. The Institute generated a revenue of Rs. 13.30 Crore (Including Service Tax) from various

sources, i.e., Fee for testing of various biological products, and Fee for Training Programmes, Rents received from Hostel & Guest Houses and interest on the Saving Bank Account etc.

Details of the expenditure incurred on various Heads may be viewed from the Audited Annual

Accounts of the Institute given in the Report.



Aims and Scope The aim of the Rajbhash unit is to educate, train the employees of Institute to use Hindi language in day-to-day official works as per the rules of Rajbhasha. This unit also provides a platform to employees of the Institute to involve themselves and participate in various activities during celebration of the ‘Hindi Pakhwara’ and other activities organized by Nagar Rajbhasha Bhasha Karyanvyan Samiti, NOIDA.

The constitution of the Rajbhasha Committee of the Institute is as under:-

Dr. Surinder Singh Chairperson

Dr. Reba Chhabra Vice Chairperson

Shri S.K. Sharma Member

Shri. R.P Joshi Member

Shri. Sushil Kumar Dixit Member

Shri J.P. Pant Member-Secretary

The Committee has organized various programmes to promote the use of Hindi language in day-to-day official work.

Miscellaneous academic activitiesShri Sushil Kumar Dixit, Junior Hindi Translator, participated in “Essential Introductory Training for Translation” organised by Central Bureau of Translation, Ministry of Home Affairs, Govt of India, from 03 April 2017 to 17 May 2017 and passed the said training with “Very Good” (More than 60% marks) at CTB New Delhi.

RAJBHASHA (HINDI):

Participation in Meetings / Workshops1. Shri Sushil Kumar Dixit, Junior Hindi

Translator and Shri R. C. Dalai, Jr. Accountant attended a three- days workshop “Akhil Bhartiya Rajbhasha Prashikshan Shivir aur Sammelan” organized by Bhartiya Bhasha evam Sanskriti Kendra, New Delhi, from 12 October, 2017 to 14th October, 2017 at Goa.

2. Shri Sushil Kumar Dixit, Junior Hindi Translator, attended 35th Meeting organized by “Nagar Rajbhasha Karyanvayan Samiti” NOIDA on 15.02.2018 at Indian Oil Corporation Ltd, Sector 1 NOIDA.

Hindi PakhwaraHindi cell, National Institute of Biological organised Hindi Pakhwara from 01/09/2017 to 15/09/2017 by the guidelines issued by Rajbhasha Vibhag, Ministry of Home Affairs, Govt of India in this program talks were delivered by various officials of the Institute. Various type of competition were also organised in this pakhwara programme for the officials of the Institute.



PERSONNEL

A. (Scientific & Technical)

S. No Name Designation

1. Dr. Suridner Singh Director

2. Dr. Reba Chhabra Scientist Grade-I

3. Dr. Achla Prasad Scientist Grade-I & Deputy Director i/c

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

5. Dr. Shikha Yadav Scientist Grade-II (Sr. Vet.[Path.])

6. Sh. Neeraj Malik Scientist Grade-II

7. Dr. Charu Mehra Kamal Scientist Grade-II

8. Mrs.Ajanta Sircar Scientist Grade-III

9. Mrs Sudha V Gopinath Scientist Grade-III

10. Mrs Kanchan Ahuja Scientist Grade-III

11. Dr. R. K.Sharma Scientist Grade-III

12. Ms. Gurminder Bindra Scientist Grade-III

13. Ms. Shalini Tewari Scientist Grade-III

14. Ms. Rashmi Srivastava Scientist Grade-III

15. Ms. Richa Baranwal Scientist Grade-III

16. Dr. Suresh Kumar Scientist Grade-III (Jr. Vet.)

17. Mrs. Madhu Y Scientist Grade-III

18. Dr. Meena Kumari Scientist Grade-III

19. Dr. Akanksha Bisht Scientist Grade-III

20. Sh. Tara Chand Scientist Grade-III

21. Dr. Manoj Kumar Scientist Grade-III

22. Sh. Pankaj Kumar Sharma Scientist Grade-III

23. Sh. N. Nanda Gopal Scientist Grade-III

24. Sh. Subhash Chand Scientist Grade-III

25. Sh. Jaipal Meena Scientist Grade-III

26. Sh. Ashwini Kumar Dubey Scientist Grade-III

27. Dr. Sanjay Mendiratta Junior Scientist

28. Sh. Harit Kasana Junior Scientist

29. Ms. Vandana Tandasi Junior Scientist

30. Dr. Manjula Kiran Junior Scientist




31. Dr. Birendra Kumar Junior Scientist

32. Dr. Varun Singh Junior Scientist

33. Sh. Rajeev Kumar Junior Scientist

34. Sh.P.S.Chandranand Junior Scientist

35. Md. Daud Ali Junior Scientist

36 Dr. Richi V. Mahajan Junior Scientist

37. Dr. Anoop Kumar Junior Scientist

38. Dr. Anirban Mukherjee Junior Scientist

39. Ms. Archana Sayal Junior Scientist

40. Sh. Ajay Kumar Ade Junior Scientist

41. Ms Apoorva Anand Junior Scientist

42. Ms Swati Shalini Junior Scientist

43. Sh. Paras Jain Junior Scientist

44. Sh. Kallol Saha Laboratory Technician

45. Ms. Girija L.V. Laboratory Technician

46. Sh. Subhash Kumar Laboratory Technician

47. Sh. Brij Bhushan Laboratory Technician

48. Sh. Brij Bahadur Laboratory Technician

49. Ms. Poonam Laboratory Technician

50. Sh. Sukhen Majhi Laboratory Technician

51. Sh. Mohammed Imran Laboratory Technician

52. Sh. Reetesh Kumar Prajapati Laboratory Technician

53. Sh. Mohit Lal Laboratory Technician

54. Sh. Mohit Sharma Laboratory Assistant

55. Sh Rajiv Kumar Shrivastava Laboratory Assistant

56. Sh. Prdeep Kumar Laboratory Assistant

57. Ms. Priya Bhatt Laboratory Assistant

58. Sh. Narender Kumar Laboratory Assistant

59. Sh. Parminder Kumar Junior Animal Care Taker

B. (Administration, Procurement & Accounts)


60. Sh. S. K. Sharma Budget & Finance Officer

61. Sh. J.P. Pant Section Officer




62. Sh. W. Z. Quazi Procurement Officer

63. Sh. P. K. Mohapatra Section Officer (Admn.)

64. Sh. Sushil Kumar Dixit Junior Hindi Translator

65. Sh. Vikash Kumar Senior Accountant

66. Sh. R. C. Dalai Junior Accountant

67. Sh. Deepak Mahajan Computer Officer

68. Sh. Pawan Kumar Sharma Data Entry Operator

69. Sh. Manmeet Singh Private Secretary

70. Sh. R. K. Arora Steno Grade-III

71. Sh. Pardeep Kumar UDC

72. Sh. Upender Nath Sharma Cashier

73. Sh. Dhirender Singh UDC

74. Sh. Sanjeev Stores Assistant

75. Sh. Partho Pratim Mondal Stores Clerk

76. Sh. Prem Chand Gupta Stores Clerk

77. Sh. Pardeep Kumar UDC

78. Ms. Savita Rai Receptionist

79. Sh. Gobind Singh Rawat Staff Car Driver Grade-II

80. Sh. Ravi Dutt Staff Car Driver Grade-II

81. Sh. Harinder Singh Chauhan Staff Car Driver Grade-II

82. Sh. Leela Kishan Staff Car Driver Grade-II

83. Sh. Bijender Singh Group ‘C’

84. Sh. Suraj Pal Group ‘C’

85. Sh. Subhas Chand Group ‘C’

86. Sh. Rakesh Group ‘C’

87. Sh. P.C.Diwan Group ‘C’

88. Ms. Shobha Group ‘C’

89. Ms. Rajinderi Devi Group ‘C’

C. Engineering

S.No NAME DESIGNATION

90. Sh. Mukesh Kumar Assistant Engineer (Electrical)

91. Sh. R.P.Joshi Assistant Engineer (Civil)

92 Sh. Subhash Chand Junior Engineer (Electrical)



S.No NAME DESIGNATION

93. Sh.Chandra Pal Junior Engineer (Mechanical)

94. Sh.Amarjeet Singh Junior Engineer (Mechanical)

95. Sh. Krishna Kumar Junior Engineer (Civil)

96. Sh. H.P.Vashisht Electrician



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:

Dr. Reba Chhabra, Scientist Gr-I - Appellate Authority

Sh. S.K. Sharma, BFO - Central Public Information Officer (CPIO)

During the year (2017-18), the Institute received the following applications to obtain various types of information under the RTI Act:-

OpeningBalance

No. ofApplicationsReceived as

transfer fromother PA u/s

6(3)

Revived(including

cases transferred

to otherPAs)

No of casestransferred

to otherPAs

u/s 6(3)

Decisionwhere

request/appeal

Rejected

Decisionwhere

request/appeal

Accepted

RegistrationFee

Collected(in Rs.) u/s

7(1)

Request 1 1 5 - - 5 10

First Appeals

- 1 - - - 1 -

AUDITORS REPORTNIB


financial statements

INDEPENDENT AUDITOR’S REPORT

Report on the Financial Statements

We have audited the attached financial statements of National Institute of Biologicals (herein after called “NIB”), which comprise the Balance Sheet as at 31st March, 2018, the Income & Expenditure Account and Receipt and Payment Account for the year ended, and a summary of the significant accounting policies and other explanatory information.

Management’s Responsibility for the Financial Statements

The Management is responsible for preparation of these financial statements that give a true and fair view of the financial position and financial performance of NIB in accordance with the accounting principles generally accepted in India. This responsibility includes design, implementation and maintenance of adequate internal controls 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 conducted our Audit in accordance with Standards of Auditing issued by ICAI. Those Standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and the disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers 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 effectiveness of the entity’s internal control. An audit also includes evaluating the appropriateness of the accounting policies used and the reasonableness of the accounting estimates made by the 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 on the financial statements.

Emphasis of Matters

We draw attention to Note No. 2,3, & 13 of these financial statements which indicates that NIB is procuring certain Fixed Assets through its procurement consultant M/s. HLL Lifecare Ltd. and reconciliation with HLL Lifecare Ltd. is pending for a long time, hence, the Overstatement/Understatements of Capital Assets cannot be quantified. Our opinion is not Qualified in respect of this matter.

Report on Other Legal and Regulatory Requirements

1. Attention is invited to :

• Note No. 1 Physical verification of Fixed Asset.

• Note No. 4 regarding sale of certain Fixed Assets.

• Note No. 7 regarding long outstanding creditors.

• Note No. 8 regarding non confirmation of balances from third party.

• Note No. 9 regarding non consideration of Pension Fund A/c in the books of NIB.

• Note No. 10 regarding inclusion of Income & Expenditure on account of Haemovigilance Project.

• Note No. 14 regarding maintenance of separate accounts for various projects not included in NIB books.

• Note No. 15 regarding Internal Control System.

• Note No. 17 regarding utilization of Grants

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 purposes of our Audit;

(b) In our opinion, the proper books of account have been kept by the NIB so far as it appears from our examination of those books;

(c) In our opinion, the Balance Sheet, Income & Expenditure account dealt with by this report



complies with the accounting standards issued by the ICAI; and

(d) In our opinion, the Balance Sheet, Income & Expenditure account dealt with by this report are in agreement with the books of account maintained by NIB.

Opinion

Subject to the Emphasis of Matters Para and other observations/ comments in Para I of “Report on Other Legal and Regulatory Requirements” above, in our opinion and to the best of our information and according to the explanations given to us, the aforesaid financial statements give a true and fair view.

1) In the case of Balance Sheet of the state of affairs of the NIB as at 31st March, 2018; and

2) In the case of Income and Expenditure account, of the Income & expenditure for the year ended on that date.

AAJV AND ASSOCIATES

Chartered Accountants

Reg. No. 07739N

ANIL KUMAR AGGARWAL

Place of Signature: NOIDA Partner

Date: 30/08/2018 M. No. 098261


National Institute of Biologicals N

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financial statements N

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INST

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M

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INC

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(

FRN

NO

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.



NATIONAL INSTITUTE OF BIOLOGICALS Ministry of Health and Family Welfare

SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2018

Amount In ` Amount In `

SCHEDULE 1 -CORPUS/CAPITAL FUND For Current Year ended on 31.03.2018 For Previous Year ended on 31.03.2017

Balance as at the beginning of the year 20807,90,336.76 2,08,35,68,787.76

Add: Grant Utilised for Security Deposits - -

Add: Increase in Stock of Fuel for Boillers & D.G Set 18,11,193.00 -27,78,451.00

Less: Interest on Security Deposit- Electricity - -

Less: Prior Period Adjustments - HLL Consultancy - -

Less: Cost of Assets Written Off -

Add: Grant utilised for Security Deposits - Electricity - - - -

Add: Receipts from sale of Assets - 2,08,26,01,529.76 - 2,08,07,90,336.76

Add: Capital Assets Fund

Balance at the beginning of the year 19,76,66,625.00 11,27,17,780.00

Addition during the year 3,38,61,318.83 8,49,48,845.00

Less: Adjustment on account of Sale of Capital Assets -32,43,096.00 -

Less: Adjustment for amount of fixed asset excess charged in P.Y -6,79,763.00 22,76,05,084.83 - 19,76,66,625.00

Add: Grant utilised for advances of previous years 1,11,36,918.00 65,29,206.00

Add: Grant Utilised for Advances during the Current Year against goods & services 65,471.00

1,95,39,616.00

Add: Grant utilised for Prepaid Expenses Increase/Decrease during the year - Electricity 8,53,752.00

-34,37,990.00

BALANCE AS AT THE YEAR END 2,32,22,62,755.59 2,30,10,87,793.76

SCHEDULE 2 -CURRENT LIABILITIES AND PROVISIONS For Current Year ended on 31.03.2018 For Previous Year ended on 31.03.2017

A. CURRENT LIABILITIES

1. Sundry Creditors

a) HSCC 1,54,57,028.00 1,54,57,028.00

b) Goods 1,32,20,935.83 2,86,77,963.83 1,07,94,325.00 2,62,51,353.00

2. Advances Received

-Advance Received for Sale of Refrence standards & SERB Project 2,600.00 4,14,400.00

Fund received for SERB Project 5,44,797.00 8,76,000.00

Fund Received From DST- Nanomission 3,00,000.00 -

-Receipts payable to MOH & FW, GOI 99,97,711.00 4,65,37,358.00

-Earnest Money Deposit 14,99,100.00 1,23,44,208.00 26,74,400.00 5,05,02,158.00

3. Statutory Liabilities

-TDS (Professional) 1,05,685.00 1,68,408.00

-TDS (Contractors) 2,30,345.00 3,45,298.00

-WCT - 1,18,212.00

-CST - 17,400.00

-Swachh Bharat Cess Pyable - -10,032.00

-UPTT - 3,36,030.00 750.00 6,40,036.00

4. Other Current Liabilities

-Security deposit/Retention Money 32,54,233.00 32,96,549.80

-Salary Payable 76,89,186.00 59,36,112.00

-Expenses Payable 23,81,281.54 16,52,879.00

-Testing Fees Refundable 5,85,461.00 -

-Claim Payable 1,40,468.00 78,917.00

-Audit Fee Payable 66,000.00 -

-Employer Contribution to NPS (Payable) 2,63,800.00 1,72,877.00

-Payable to Staff - 3,79,057.00

1,43,80,429.54 1,15,16,391.80

B. PROVISIONS

1. For Gratuity 40,16,252.00 54,27,154.00

2. Accumulated Leave Encashment 43,14,400.00 83,30,652.00 45,82,956.00 1,00,10,110.00

TOTAL 6,40,69,283.37 9,89,20,048.80


financial statements N

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SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2018

SCHEDULE 4 -CURRENT ASSETS , LOANS & ADVANCES For Current Year ended on 31.03.2018 For Previous Year ended on 31.03.2017

A. CURRENT ASSETS 1. Cash balances in hand 20,022.68 18,712.88

2. Balance with Banks : - Saving Accounts 6,85,94,127.26 9,92,98,718.47 3. Stamps in hand 7,118.00 6,86,21,267.94 8,425.00 9,93,25,856.35 TOTAL (A) 6,86,21,267.94 9,93,25,856.35 B. LOANS, ADVANCES AND OTHER CURRENT ASSETS 1. Loans (a) Staff Advances - Computer Advance 90,250.00 12,900.00 - Scooter Advance - 16,000.00

- House Building Advance 1,30,230.00 2,74,230.00

- Tour Advance - - - LTC Advance - 7,660.00 - Festival Advance - 29,700.00

- Motor Car Advance 78,000.00 1,14,000.00 - Departmental Advances - 2,98,480.00 - 4,54,490.00 (b) Other Entities engaged in activities of NIB - Advance to CDSCO- Drug Survey - 10,00,000.00 - Advance to CPWD 10,00,000.00 10,00,000.00 - Advance to DAVP 3,582.00 3,582.00 - Advance to DGS&D (Computer) - 2,01,392.00 - Advance to HSCC (ETP) 5,69,091.00 5,69,091.00 - Advance to HSCC (Other work) 6,48,934.91 6,48,934.91 - Advance to IOCL 65,471.00 26,951.00 - Advance to National Physical Laboratory - 42,665.00 - Advance to NICSI - 1,01,933.00 - Advance to NIN NCLAS - 22,87,078.91 1,162.00 35,95,710.91 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 1,73,40,107.00 2,84,59,918.00

-Advance to HLL Life Care Ltd for Consultancy - - b) Deposits -Bank Deposit for sales tax registration 25,000.00 25,000.00 -Security Deposit with Balmer Lorrie 3,00,000.00 3,00,000.00 -Security Deposit with PVVNL 79,57,678.00 79,57,678.00 -Security Deposit with Padam Petroleum 25,000.00 25,000.00 -Security Deposit with NOIDA 9,30,750.00 9,30,750.00

-Security Deposit with Telephone 10,000.00 10,000.00

-Security Deposit with PNG(IGL) 1,92,000.00 1,92,000.00 -Security Deposit with Gas (BPCL) 3,550.00 3,550.00 -CENVAT Recoverable - 2,67,84,085.00 9,81,448.00 3,88,85,344.00

3. Claim Receivable Claim Receivable - Drug Survey 9,85,087.00 -

Claim Receivable - Haemovigilance 60,640.00 -

Claim Receivable - Others 4,41,900.00 21,98,029.00 4. Receivable from IPC - Haemovigilance - -

5. Sundry Debtors 35,45,968.00 - 6. Pre-paid Expenses 11,44,724.00 2,90,972.00

7. Stock-Fuel for Boillers & D.G Set 62,91,806.00 44,80,613.00 8. Interest Accrued on FDRs - - 9. TDS Receivable (2016-17) 39,453.00 39,453.00

10. TDS Receivable (2017 - 18) 2,64,735.00 - 11. GST Recoverable 35,73,099.00 -

12. CENVAT Recoverable 62,451.00 -

13. Grant Receivable/Payable to MOHFW, GOI -49,61,493.35 44,62,839.87

TOTAL (B) 4,08,18,013.56 5,44,07,451.78 TOTAL (A+B) 10,94,39,281.50 15,37,33,308.13




SCHEDULES FORMING PART OF INCOME & EXPENDITURE FOR THE YEAR ENDED AS AT 31st MARCH 2018

SCHEDULE 5 - RECEIPTS FROM TESTING & SALES For Current Year ended on 31.03.2018 For Previous Year ended on 31.03.2017

1. Receipts from Testing

-Sample testing receipts 12,49,13,203.00 12,49,13,203.00 12,99,56,756.00 12,99,56,756.00

2. Receipts from Sales

-Sale of Refrence Standards 15,60,000.00 8,80,000.00

15,60,000.00 8,80,000.00

TOTAL 12,64,73,203.00 13,08,36,756.00

SCHEDULE 6 - GRANTS/SUBSIDIES (Irrevocable Grants & Subsidies Received)

For Current Year ended on 31.03.2018 For Previous Year ended on 31.03.2017

Grant Received During the year 38,21,00,000.00 29,62,00,000.00

Grant unutilized b/f from the previous year -44,62,839.87 3,57,97,999.13

Total 37,76,37,160.13 33,19,97,999.13

Grant Adjusted towards Revenue Expenditure:

Current Year Expenditure 34,82,57,608.95 31,71,10,532.00

Less: Expenses Adjusted from Current Year Income 13,29,97,711.00 21,52,59,897.95 14,05,37,358.00 17,65,73,174.00

(taken to income & expenditure Account) 16,23,77,262.18 15,54,23,451.13

Less: Grant utilized for purchase of fixed Assets 2,27,41,507.83 71,23,967.00

Less: Grant utilized for advances against Fixed Assets/ Goods/Services/Deposits for C.Y 65,471.00 1,95,39,616.00

Less: Current Year income transferred to MOH & FW 12,30,00,000.00 9,40,00,000.00

Less: Current Year Income Payable to MOH & FW 99,97,711.00 4,65,35,984.00

Less: Increase in Stock of Fuel for Boillers & D.G Set 18,11,193.00 -27,78,451.00

Add: Adjustment for amount of fixed asset excess charged in P.Y 6,79,763.00

Add: Previous Year’s Advance adjusted towards Goods & Services 1,86,958.00 10,96,835.00

Less: Prepaid Expenditure during the year - Electricity 8,53,752.00 -34,37,990.00

Add: Advance of Previous Year Refunded/Received During the Year 1,87,145.00 -

Less: Security Deposits - Electricity - -

Grant Payable/(Receivable) to Govt. of India (Refer schedule-4) 49,61,493.35 -44,62,839.87

SCHEDULE 7 - INTEREST EARNED For Current

Year ended on 31.03.2018

For Previous Year ended on 31.03.2017

1) On Saving accounts 38,94,725.00 80,02,020.00

2) On Loans To Employees/Staff 54,280.00 62,975.00

TOTAL 39,49,005.00 80,64,995.00

SCHEDULE 8 - OTHER INCOME For Current

Year ended on 31.03.2018


a) Usage receipts for Hostel, Guest House & Conference Hall 6,20,650.00 4,60,800.00

b) Sale of Tender Forms 38,584.00 27,478.00

c) Training Fees 3,20,000.00 1,24,000.00

d) Receipts from Sale of Assets 2,37,175.00 -

e) Misc Receipt 8,90,555.00 1,80,740.00

f) Interest Income - HSCC - 5,21,164.00

g) Sale of Lab Animal 3,97,215.00 2,92,606.00

h) License Fees 33,656.00 28,819.00

i) Interest on Haemovigilance A/c 37,668.00 -

TOTAL 25,75,503.00 16,35,607.00




SCHEDULES FORMING PART OF INCOME & EXPENDITURE FOR THE YEAR ENDED AS AT 31st MARCH 2018

SCHEDULE 9 - ESTABLISHMENT EXPENSES

For Current Year ended on 31.03.2018


a) Salary and Wages 8,86,72,724.00 7,52,28,800.00 b) Allowances and Bonus 2,67,458.00 4,75,614.00 c) Employer’s Contribution to NPS/ other Fund 27,15,978.00 21,64,229.00 d) Staff Welfare expenses - 17,03,175.00 e) Expenses on Employee’s Retirement and Terminal Benefit 2,06,79,658.00 1,06,32,472.00 f) Others -Medical Reimbursement 17,62,217.00 16,32,635.00 -LTC Expenses 19,53,246.00 7,62,507.00 -Liveries - - -Reimbursement of Tution Fees 14,34,094.00 8,34,900.00 -Honorarium 29,000.00 38,000.00 -Recruitment Expenses 88,753.00 1,47,168.00 TOTAL 11,76,03,128.00 9,36,19,500.00

SCHEDULE 10 - OTHER ADMINISTRATIVE EXPENSES



a) Consultants/Cont. Emp.Payment 2,96,23,163.00 2,89,28,756.00 b) Purchase of office consumables 5,69,880.00 8,21,403.00 c) Office Maintenance 1,18,95,166.00 1,50,67,716.00 d) Rent, Rates and Taxes 3,30,859.00 39,258.00 e) Vehicles Running and Maintenance 1,62,585.00 1,76,214.00 f) Postage, Telephone and Communication Charges 7,10,724.00 8,28,771.00 g) Printing & Stationary 27,79,849.00 29,18,670.00 h) Travelling and Conveyance Expenses 16,60,934.00 18,76,290.00 i) Expenses on Seminar/Workshops 2,86,367.00 4,65,235.00 j) Hospitality/Staff Welfare Expenses 12,66,879.00 - k) Auditor’s Remuneration 66,000.00 60,000.00 l) Professional Charges 12,06,231.00 24,43,568.00 m) Advertisement and Publicity 18,83,687.00 10,10,815.00 n) Other Expenses: - Miscellaneous Expenses 17,428.00 19,850.00 - Security Services expenses 1,64,58,978.00 1,19,43,141.00 - Honorarium (others) 5,44,000.00 3,02,000.00 - House Keeping Charges 66,47,070.00 64,09,612.00 - Hiring of Vehicles 40,07,411.00 39,72,939.00 - Hindi Promotion 77,395.00 1,07,145.00 - Bank Charges 237.65 - - Internet Access Charges 7,82,255.00 8,30,053.00 - Travelling (others) 5,30,028.00 10,46,943.00 - Newspapers & Periodicals 2,79,710.00 3,12,963.00 - Other Office Expenditure 7,75,485.00 41,513.00 - Pest Control Charges 2,00,115.00 2,07,304.00 - Consultancy Charges- HLL 5,27,820.00 2,88,558.00 o) Expenditure on Haemovigilance Programme 38,77,028.00 - TOTAL 8,71,67,284.65 8,01,18,717.00

SCHEDULE 11 - LAB SERVICES - OPERATION & MAINTENANCE EXP



a) Electricity and Water Charges 6,69,83,950.00 6,13,61,836.00 b) Repair & Maintenance - Lab Equipments 94,25,390.00 91,03,200.00 c) Operation & Maintenance - Electrical 40,84,181.00 35,94,334.00 d) Operation & Maintenance - DG Sets 20,19,312.00 55,35,322.00 e) Operation & Maintenance - HVAC Plant 76,34,469.00 84,23,281.00 f) Operation & Maintenance - Boiler 17,40,285.00 16,96,779.00 g) Operation & Maintenance - Water Supply system 51,93,049.00 25,94,965.00 h) Operation & Maintenance - Air Compressor 13,750.00 33,165.00 i) Operation & Maintenance - Cold Room 25,45,819.00 22,15,731.00 j) Operation & Maintenance - BMS 10,38,888.00 10,76,063.00 k) Operation & Maintenance - Lifts 6,17,969.00 6,63,811.00 l) O & M Acces Control System 10,84,210.00 9,53,825.00 m) Purchase of Lab Consumable 1,39,92,810.00 1,51,72,748.00 n) Purchase of Lab Chemicals 35,48,440.00 21,07,276.00 o) Purchase of Kits & Reagents 1,58,68,847.30 1,52,71,290.00 p) Purchase of Lab Animal 2,77,000.00 1,92,000.00 q) Lab Misc. Expenses 2,85,583.00 - r) Consumption of Fuel for Boillers & D.G Set Opening Balance of Fuel 44,80,613.00 Add: Purchases 88,59,480.00 Less: Closing stock 62,91,806.00 70,48,287.00 1,31,65,676.00 s) Bio-Waste Disposal Charges 84,957.00 2,11,013.00 TOTAL 14,34,87,196.30 14,33,72,315.00




DETAILS OF GRANT UTILISATION FOR THE FINANCIAL YEAR 2017-18

PARTICULARS GIA - SALARY GIA - GENERAL GIA - ASSETS TOTAL

RECEIPTS

Grant unutilized b/f from the Previous Year -1,36,62,500.00 -1,74,756.87 93,74,417.00 -44,62,839.87

Grant in Aid Received From Ministry 11,90,00,000.00 23,00,00,000.00 3,31,00,000.00 38,21,00,000.00

TOTAL RECEIPTS (A) 10,53,37,500.00 22,98,25,243.13 4,24,74,417.00 37,76,37,160.13

LESS:- EXPENDITURE INCURRED & PROVISION

Establishment Expenses 11,76,03,128.00 - - 11,76,03,128.00

Administrative Expenses - 8,71,67,284.65 - 8,71,67,284.65

Lab Services-Operation & Maintainance Exp - 14,34,87,196.30 - 14,34,87,196.30

Increase in Stock of Fuel for Boillers & D.G Set - 18,11,193.00 - 18,11,193.00

Payment made for Fixed Assets during the year:

Additions in Fixed Assets - - 3,38,61,318.83

3,38,61,318.83

Less: Advance of Previous year Utilized against Fixed Assets - - -1,11,19,811.00

-1,11,19,811.00

Less: Adjustment for amount of fixed asset excess charged in P.Y - - -6,79,763.00

-6,79,763.00

Advance against Fixed Assets, Goods & Services (Net) - 65,471.00 - 65,471.00

Less: Advance of Prev. Year Utilized/Refunded against Goods & Services - -3,74,103.00 - -3,74,103.00

Add: Grant Utilised for Prepaid Expenses Increase/Decrease - 8,53,752.00 - 8,53,752.00

TOTAL CURRENT YEAR EXPENDITURE / UTILISATION (B) 11,76,03,128.00 23,30,10,793.95 2,20,61,744.83 37,26,75,666.78

GRANT RECEIVABLE/PAYABLE TO GOI (A) - (B) -1,22,65,628.00 -31,85,550.82 2,04,12,672.17 49,61,493.35




RECEIPTS AND PAYMENTS ACCOUNT FOR THE YEAR ENDED 31ST MARCH 2018RECEIPTS Current Year Previous Year PAYMENTS Current Year Previous Year

1. Opening Balance 1. Expenses -Cash in Hand 18,713.00 28,418.00 -Establishment Expenses 9,60,74,356.00 7,52,39,640.00 -Bank Balance 9,92,98,718.47 10,39,20,365.47 -Administrative Expenses 87,28,123.65 52,24,575.00 -Stamps in Hand 8,425.00 5,042.00 -Lab Services- O&M Exp 10,30,60,025.76 9,05,70,221.00 -Expenditure on Haemovigilance Programme 39,00,000.00 - 2. Grants Received 2. Payments made against funds -From Government of India 38,21,00,000.00 29,62,00,000.00 -Advance to HLL Lifecare Limited (Net) - 1,94,70,000.00 -Advance to IOCL 88,98,000.00 1,26,50,000.00 3. Interest Received: -Advance to CPWD - - -On Bank deposits 38,94,725.00 80,02,020.00 -Advance to CDSCO - Drug Survey 10,00,000.00 10,00,000.00 -Interest Recovered from Scooter, HBA & Computer advance - - -Advance to DGS&D (Computer) - -

-Advance to Contractors & Suppliers (Net) 32,74,867.00 10,77,681.00 4. Other Income -Advance to A-Hartrodit Pvt. Ltd. - - -Receipts from Hostel/Guest houses 2,44,350.00 3,71,775.00 -Advance to PNB Custom - - -Sale of Tenders Forms 41,930.00 29,428.00 -Advance to Sunhare kal ki Pahle - - -Sample Testing Receipts & Sale of Ref. Standards 14,06,20,792.00 14,67,55,833.00 -Advance to NICSI 1,58,522.00 - -Funds Received from NHM - U.P. State 18,70,500.00 - -Advances Received 4,13,002.00 - -Fund Received from WHO 12,28,186.00 -Training fees 3,20,000.00 1,24,000.00

-Licence Fee - - 3. Expenditure on Fixed Assets & Capital Work-in-Progress

-Other Interest Income - - -Machinery & Equipment 6,31,369.00 26,94,761.00 -Miscellaneous Receipts 4,34,384.00 2,91,966.00 -Computers - - -Sale of Lab Animals 3,97,215.00 2,92,606.00 -Computers & Computer Software 3,26,588.00 4,26,844.00 -Furniture & fixture 6,05,187.00 3,22,320.00 -Office Equipments 7,27,770.00 18,87,712.00 -Vehicle - - 5. Other Receipts -Books 4,68,121.00 70,494.00 Recovery from Staff Advances -Tools - - -Computer Advance - -

-Scooter Advance - - 4. Payment of Internal Receipts/Unspent Balances

-House Building Advance - - -To the Government of India 12,30,00,000.00 9,40,00,000.00 -Tour Advance 79,824.00 2,81,155.00 -Previous Year Receipts Paid to Ministry 4,65,37,358.00 1,44,65,822.00 -Motor car Advance - -LTC Advance 74,102.00 7,466.00 5.Other payments -Festival Advance - - Advances disbursed during the year -Departmental Advance 22,488.00 46,053.00 -Scooter Advance - 30,000.00 -Advances to Contractors Utilized during the year during the year - - -Festival Advance - 45,000.00

-Advance Received for Reference Standards 14,40,800.00 4,14,400.00 -Computer Advance 1,00,000.00 - -Advance Received from NISCI 1,59,619.00 - -Tour Advance 2,97,000.00 7,27,500.00 -EMD received during the year 57,30,100.00 92,31,500.00 -LTC Advance 15,03,928.00 4,98,675.00 -Security Deposit/Retention Money Received during the year 5,57,316.00 2,64,923.00 -Departmental Advance 2,06,950.00 4,90,134.00

-Net Claims received during the year 53,05,548.00 39,27,514.00 -Motor Car Advance - - -Net Increase in payment of Statutory dues - - -Other Advance 71,338.00 1,92,873.00 -Creditors for Fixed Assets/Capital Goods - - -Security Deposit (Travelling) - - -TDS Receivable received - 1,47,637.00 -Security Deposit (Electricity) - - -Received from IPC - Haemovigilance - 20,00,000.00 -Security Deposit released during the year - 6,03,505.00 -Decrease in Debtors 1,93,537.00 - -Security Deposit (Gas-BPCL) - - -Claim Payable - - -Security Deposit (PNG-IGL) - - -Employee’s Contribution to NPS - - -EMD released during the year 89,57,803.80 87,34,700.00 -Adv Rec for Hospitality Expenses-IPC - 9,00,000.00 -Statutory Liabilities Paid 2,18,21,213.00 2,89,49,642.00 -Adv Rec From CDSCO 10,00,000.00 2,00,000.00 -Receivable from IPC - Haemovigilance - 20,00,000.00 -Fund Recd From Science & Engineering Board (SERB) - 8,76,000.00 -Net Service Tax paid during the year - 1,062.00 -Receipts from Spurious Drug Survey - - -Payment made for Expense Payable 1,16,205.00 57,172.00 -Adv for Sale of Waste LA/Oil 1,56,704.00 - -Payment to Suppliers of Goods & Services 13,64,88,458.00 11,35,61,912.00 -Funds Received from WHO 12,28,186.00 - -Net GST paid during the year 64,11,838.00 - -Funds Received from DST - Nanomission 3,00,000.00 - -Funds Received from NHM - U.P. State 18,70,500.00 - 6.Closing Balances -Cash in Hand 20,022.00 18,713.00 -Bank Balance 6,85,94,127.26 9,92,98,718.47 -Stamps in Hand 7,118.00 8,425.00 TOTAL 64,54,97,976.47 57,43,18,101.47 TOTAL 64,54,97,976.47 57,43,18,101.47

For AAJV & ASSOCIATES Chartered Accountants (FRN NO. 007739N)

FOR NATIONAL INSTITUTE OF BIOLOGICALS

CA Anil Kumar Aggarwal Partner (M.No. 098261)

S.K. Sharma Dr. Reba Chhabra (Budget & Finance Officer) (Scientist-I/DD(QC) i/c & HOO)

Place : Noida Dr. Surinder Singh Date : 30/08/2018 (Director)

As per our report of even date attached.



(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 (hereinafter referred to as NIB) adopts accrual system of accounting, however, the incomes i.e. receipts from Sale of Reference Standard, Sample Testing Charges, Training Fee received, and 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 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 ASSETSRATES OF DEPRECIATION CHARGED

Machinery & 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, the depreciation has been provided for the full year and in respect of sale/disposal of fixed assets, no depreciation has been provided for in the year of sale/disposal, but it has no financial implication due to this deviation from the prescribed provisions of the ICAI.

SCHEDULE 12



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 the ICAI.

e) During the year, the depreciation has been charged from the year of original purchase of assets, procured through procurement consultant M/s HLL Lifecare Ltd. irrespective of the year of capitalization in respect of additions in fixed assets.

3. Grant-in-Aid

a) The Grant-in-Aid received from the Ministry of Health & family Welfare (MOH&FW), 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.

b) The grants utilized for the purchase of fixed assets 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 Assets Fund.

d) A chart for receipt and utilization of Grant according to its grant head has been prepared and shown at Sr. No. 17 to Notes on Accounts to the financial statement. The inter head adjustments have been made in case of excess/deficit of grants received.

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.

b) From 2013-14 onwards, Consultancy charges paid for procurement of Fixed Assets is considered as revenue expenditure



c) The NIB has been maintaining Separate books of account for Haemovigilance Project and upto F.Y 2016-17 all the expenditure pertaining to this project was funded by Indian Pharmacopeia Commission (IPC) an Autonomous Institution of Ministry of Health and Family Welfare Government of India. However, all expenditure pertaining to this project during the F.Y 2017-18 has been included in the books of account of NIB and Interest Income & Expenditure pertaining to this project has been credited/debited to Income and Expenditure of the NIB by way of single entry as “Expenditure on Haemovigilance Programme” and income as “Interest on Haemovigilance A/c”, to this account, there is a change in accounting policy.

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 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 likelihood of outflow of resources is remote, no provision or disclosure is made.

(B) NOTES ON ACCOUNTS1. NIB has maintained Fixed Assets detail in soft format and keeping hard copy of the

same for records. The Physical Verification of Fixed Assets is under process at the balance sheet date. The Depreciation has been charged at old rates till the verification of all assets is being completed. Quantitative reconciliation of Fixed Assets items will be made only after completion of physical verification of fixed assets.

2. The depreciation of Rs. 5,94,62,834.99/- (Includes additional depreciation of Rs. 9,39,135/- in respect of fixed assets procured through M/s HLL Lifecare Ltd. in the different previous year and capitalized during the year) 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.

3. The assets procured through the Procurement Consultant HLL Lifecare Ltd. are being capitalized in the year in which adjustment vouchers are being received from HLL Lifecare



Ltd. irrespective of original date of purchase of assets, it is noticed due to this, in many cases, the capitalization of assets and adjustment of depreciation thereon have been delayed.

4. Certain Assets have been sold/exchanged under Buy-back during the year. Sale proceeds/equivalent amount of exchange/buy-back value of assets have been shown in other income same is ultimately shown as payable to MOH&FW, GOI. The Capital Assets Fund has been reduced by the original cost of assets sold/exchanged. Impact is shown below. No Profit/loss on sale of these assets has been booked.

Asset Sold/

Exchanged

(under Buy-back)

Gross Block

Accumulated Depreciation

W.D.V. as on 01.04.17

Sale Proceeds/

Exchange /Buy-back value*

Remarks*

Air Conditioner 417500 340527 76973 66000 Shown as Other Income in Income & Expenditure Account.

Vehicle 1186002 981531 204471 132719Computers 1639594 1557614 81980 38456

5. All liabilities are recognized to the extent information available.

6. NIB transfers all the receipts earned during the year from its various operations to the Ministry of Health & Family Welfare, GOI and already transferred an amount of Rs.12,30,00,000/-out of total receipts of Rs.13,29,97,711/-.The balance amount of Rs. 99,97,711/- is shown as “Receipts Payable” to MOH&FW under the head of “Current Liabilities”.

7. Sundry Creditors includes a sum of Rs. 1,54,57,028/-, which is payable to M/s HSCC (I) Ltd. on account of construction of Laboratory & Animal House and consultancy fee. This amount is payable from the last many years, due to some technical defects intimated to HSCC and which was not yet rectified. The Institute is also in process of reconciliation and final settlement of this with the HSCC.

8. Party’s balances are subject to confirmation.

9. During the Financial Year 2017-18, NIB has transferred Rs. 1,36,00,000/- to “NIB Pension Fund Account” and 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 reflected/shown in the books of NIB along with the interest thereon. The abstract of this account is given below:-



Account

Type

Opening Balance as on 01.04.2017

(Rs.)

Fund T/F from NIB A/c

(Rs.)

Interest Earned

(Rs.)

Fund Utilized for disbursement of Pension

(Rs.)

Balance as on 31.03.2018

(Rs.)

NIB-Pension A/C

6,34,213 1,36,00,000 58,821 1,36,49,471 6,43,563

Due to non-consideration of above mentioned figures income and assets are understated to the extent of Rs. 58821/- and Rs. 643563/- respectively.

10. During the Financial Year 2017-18, NIB has transferred Rs. 39,00,000/- to “NIB Haemovigilance Account”. This amount has been kept in a separate bank account and all expenses pertaining to this project has been incurred from this account only. The balance of that bank account as stood on 31.03.2018 is not reflected/shown in the books of NIB. Income and Expenses of this project has been included in the Income & Expenditure account of the NIB as mandated in the meeting of Governing body of the MOH&FW and instructions obtained from time to time.

11. Purchase of Diesel to the extent utilized during the year has been recognized as expenditure and the balance amount is shown as stock forming part of Current Assets.

12. NIB has not gathered any information from suppliers/service providers about their status under Micro, Small and Medium Enterprises (Development) Act, 2006 during the year. Therefore, the required information, regarding the dues outstanding to Micro, Small and Medium Enterprises as on 31.03.2018 and interest payable, if any, are not recognized and reported.

13. The advances to contractors & suppliers includes the following:

Sl. No.

Party’s Name Amount in Rs. Remarks

1. M/s HSCC (I) Ltd. 12,18,026/- Amount of Rs. 5,69,091/- was provided for Effluent Treatment Plant (ETP) & Rs. 6,48,935/- for other work is subject to confirmation. This amount is outstanding for last many years and under process for final settlement with HSCC.

2. M/s HLL Lifecare Limited

1,73,40,107/- Amount still lying under Advances to Contractors & Suppliers and the same is yet to be been utilized/capitalized.

3. CPWD 10,00,000/- The amount is lying as Advances as work yet to be completed/necessary documents not received till date.



14. Separate bank accounts are maintained for various projects/schemes on behalf of other entities by the Institute. Their balances in the Bank as on 31.03.2018 are given below. Interest income therefrom and balances therein belong to other entities and hence are not included in the books of accounts of NIB.

S. No. Account TypeInterest Earned

(Net)

Balance

as on 31.03.20181. NIB-Haemovigilance A/c 37,668 64,9762. NIB-UPSAC A/c 18,339 3921133. NIB-Training & Workshop 35,705 30,05,6424. NIB-HITES 36,070 3,13,788

15. In order to strengthen the internal audit system, an audit committee has been formed.

16. Previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary.

17. The summary of Grants Received and Utilized during the year is as under:

S. No.

Nature of Grant Opening Balance

Amount Received

Amount Utilized

Shortfall/

Excess Utilized

1. GIA-Assets 93,74,417 3,31,00,000 2,20,61,745 2,04,12,6722. GIA-Salary (1,36,62,500) 11,90,00,000 11,76,03,128 (1,22,65,628)3. GIA-General (1,74,757) 23,00,00,000 23,30,10,794 (31,85,551)

Total (44,62,840) 38,21,00,000 37,26,75,667 49,61,493

For AAJV AND ASSOCIATES FOR NATIONAL INSTITUTE OF BIOLOGICALSChartered Accountants (FR No. 07739N)

CA Anil Kumar Aggarwal Partner S.K. SHARMA Dr. Reba Chhabra(M. No. 098261) (Budget & Finance Officer) (Sc. Gr.-I/ DD (QC)/H.O.O)

Place: Noida Dr. Surinder SinghDate: 30/08/2018 (Director)

AUDITORS REPORTNIB-GPF



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 Provident Fund as at 31st March 2018 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 the Note no. 2 regarding non receipt of Interest on Bond of PSIDC for last so many years.

3. 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 acconts.

4. Subject to Para 2 of this report, in our opinion and to the best of our information and according to the explanations 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 2018; and

b) In the case of the Income & Expenditure Account Excess of Income over Expenditure for the year ended on the date.

For AAJV AND & ASSOCIATES

Chartered Accountants

(FRN 007739N)

(CA ANIL KUMAR AGGARWAL)

Partner

(M. No 098261)

PLACE: NOIDA

Date: 30/08/2018


financial statementsN

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.No.

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31.

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financial statementsSC

HED

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- 2

: E

xces

s of

Inc

ome/

Expe

ndit

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for

the

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s on

31.

03.2

018

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National Institute of BiologicalsN

ATI

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financial statementsSC

HED

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- 4

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to M

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0



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.

3. Fixed Assets:

There are no fixed assets.

4. Investments:

Investments are Non Trade Investments and 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 quantified and considered.

2. The interest on Investment in bonds of Punjab State Industrial development Corporation Ltd.(PSIDC), a Punjab State Govt. Undertaking, is not recovered for last so many years, however, the Company (PSIDC) has in its letter dated May 3, 2018 stated that the Punjab Govt. has made budgetary provisions for the same and the interest will be disbursed in due course.

3. TDS Recoverable of F.Y. 2017-18 from NIB is shown in the current assets.

4. The previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary to confirm to the current period presentation.

For AAJV & ASSOCIATES Chartered Accountants (FRN NO. 007739N)

FOR NATIONAL INSTITUTE OF BIOLOGICALS General Provident Fund

CA Anil Kumar Aggarwal Partner (M.No. 098261)

S.K. Sharma (Budget & Finance Officer)

Dr. Reba Chhabra(Scientist-I/DD(QC) i/c & HOO)

Place : NoidaDate : 30/08/2018

Dr. Surinder Singh(Director)



Notes

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