volume no. 6: issue 1: january-june 2018 national

NATIONAL INSTITUTE OF BIOLOGICALSVolume No. 6: Issue 1: January-June 2018

NEWSLETTERMinistry of Health and Family Welfare

Government of India

Visit of Delegation from

Ethiopia

04 05 10 11 12Participation in Global Bio Conference

Korea

NIB Scientist selected as a specialist by

AAALAC

NIB Designated as CMDTL for IVD by Government of

India

OHSAS 18001: 2007 certification

Delegation from Ethiopia lead by Hon’ble H.E. Professor Afeworki Kassu Gizaw, Minister of State, Ministry of Science & Technology, Ethiopia

NATIONAL INSTITUTE OF BIOLOGICALS Volume No. 6: Issue 1: January-June 2018

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NIB is now globally spreading its wings with a lot of collaborative activities with many eminent scientists and experts of their field. It’s my immense pleasure to share about the visit of delegation from Ethiopia lead by Hon’ble H. E. Professor Afeworki Kassu Gizaw, Minister of State, Ministry of Science & Technology, which had an objective to explore areas of cooperation between the Government of India through NIB and Government of Ethiopia under the bilateral mode as well as under India - Africa Forum Summit.

Dr. Detlef Bartel, Head of Batch Control & Allergen Analytics, Paul Ehrlich Institute (PEI), Germany visited NIB for a Meeting on quality control testing of allergens conducted for the first time in India. Dr. Manvi Porwal, Scientist from PEI, Germany, visited NIB to explore various possibilities for initiating collaborations in the field of quality control of vaccines and plasma derived products.

NIB also disseminates its expertise globally at various international forums. Dr. J.P. Prasad, Scientist Grade-I participated in MFDS Global Bio Conference 2018, Seoul, organized by Ministry of Food and Drug Safety (MFDS), Korea.

I am delighted to announce that NIB vaccine testing laboratory has also started giving testing services to the neighbouring countries. Few officials from vaccine industry, Bangladesh, have visited NIB for future prospects of their product testing.

With a great pride I would like to mention that NIB has been designated as a Central Medical Device Testing Laboratory (CMDTL) for in-vitro diagnostics for HIV, HBsAg, HCV, Blood Grouping Sera, Glucose Test Strip and Fully Automated Analyser based Glucose Reagent by Government of India.

The Institute has successfully acquired the OHSAS 18001:2007 certification in addition to its existing ISO 17025:2005 accreditation status.

As a part of training mandate, NIB has been continuously contributing by imparting trainings in Quality Control testing of Biologicals. During this period, the institute conducted National Skill Development & Hands on Training for 43 Post Graduate Students of Jammu University, Himachal Pradesh University and 33 Post Graduate Students of National Institute of Pharmaceutical Education &Research (NIPER), Kolkata.

National Health Mission (NHM) under the Ministry of Health & Family Welfare in collaboration with NIB conducted residential training programs on “Training of trainers for Strengthening of Blood Services” for 181 Medical Officers and Technical personnel from Blood Banks from five states viz. Arunachal Pradesh, Bihar, Uttar Pradesh, Chhattisgarh and Meghalaya.

Dr. Surinder SinghDirector, NIB

Director’s Message


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This newsletter aims to disseminate information on the scientific activities under-taken by the institute to assure the quality, safety and potency of Biologicals and Biotherapeutics for promoting and protecting public health.

EDITORIAL TEAM

Ms. Y. MadhuEditor

Dr. Manjula KiranAssociate Editor

Mr. Md. Daud AliAssociate Editor

Ms. Vandana TandasiAssociate Editor

CONTENTS DIRECTOR’S MESSAGE

INTERNATIONAl VISITORS

PARTICIPATION OF NIB IN GlOBAl BIOCONFERENCE 2018, KOREA

TRAININGS

08 MEETINGS / CONFERENCES

11 CENTRAl MEDICAl DEVICE TESTING lABORATORy (CMDTl)

13 INTERNATIONAl WOMEN’S DAy & INTERNATIONAl yOGA DAy

14 VISITORS’ FEEDBACK

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04

05

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Please feel free to share your valuable thoughts & feedback for the betterment of the edition.Kindly contact Dr. Manjula Kiran, Associate Editor, e.mail:[email protected]

We look forward to hear from you!!!


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INTERNATIONAL VISITORS

Delegation of Ethiopia lead by Hon’ble H. E. Professor Afeworki Kassu Gizaw, Minister of State, Ministry of Science & Technology, Ethiopia visited the Institute on 15th March 2018, with an objective to explore areas of cooperation between the Government of India through NIB and Government of Ethiopia under the bilateral mode as well as under India-Africa Forum Summit.

Dr. Detlef Bartel, Head of Batch Control & Allergen Analytics, Paul Ehrlich Institute (PEI), Germany, visited NIB, NOIDA on 1st Feb., 2018 for an Interactive Core Committee meeting to discuss modalities on batch evaluation of allergens.

Dr. Manvi Porwal, Scientist, PEI, Germany, visited NIB, NOIDA on 3rd February, 2018 to explore the possibilities of collaboration in the areas of testing of vaccines and plasma derived products.

Abbott India Global team comprising of Ms. Corlis Murroay, Senior Vice President, Q.A., Regulatory & Engineering Services, Ms. Joann O’Connell, Divisional Vice President, Global Strate-gic Regulatory affairs and Ms. Sumati Randeo, Director, Global Strategic Regulatory affairs & Advocacy visited NIB, NOIDA on 6th March 2018.


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Md. Zakir Hossain, Sr. Manager Regulatory Affairs and Mr. Rabin Kumar Paul, Director (Manufacturing) from Popular Pharmaceuticals ltd. and Md. Shamsul Haque Sikder, Managing Director (CEO) from Ancient Chemicals ltd., Dhaka, Bangladesh visited NIB on 28th May 2018 to discuss on testing of their products.

Participation of NIB scientist in MFDS Global Bio Conference 2018, KoreaDr. J. P. Prasad, Scientist Grade-I & Head, Blood Product laboratory attended and delivered lecture on “Current Consideration for Immunoglobulin in NIB, India” from June 26th to 29th, 2018, in Seoul, Korea, organized by Ministry of Food and Drug Safety (MFDS), Korea.

Participation of NIB scientist in MFDS Global Bio Conference 2018, Korea


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TRAININGS ♦ One day EQAS Workshop was organized for distribution of HIV Proficiency test panel to SRls of Uttar Pradesh & Uttaranchal on 20th Feb, 2018.

♦ Two weeks training was given to a technical staff of 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 Feb-1st Mar, 2018 at Animal Facility.

♦ The Institute organized the National Skill Development & Hands on Training on Quality Control of Biologicals in the areas of Bio-therapeutics, Diagnostics, Bacterial & Viral Vaccines, Blood Products, Blood Group Serology, Animal Facility and laboratory Quality Management System. Under this program, 43 Post Graduate Students (23 Biotechnology, 05 Microbiology and 15 Biochemistry) of Jammu University and Himachal Pradesh University and 33 Post Graduate Students of National Institute of Pharmaceutical Education & Research (NIPER), Kolkata were trained at NIB from 03rd - 23rd Jan, 2018 and 23rd Apr-04th May, 2018 respectively.

National Skill Development & Hands on Training on Quality Control of Biologicals to post graduate students of Jammu University and Himachal Pradesh University


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♦ National Health Mission, in collaboration with National Institute of Biologicals conducted six residential training programs on “Training of trainers for Strengthening of Blood Services” for a total of 181 Medical Officers and Technical personnel from Blood Banks of 5 states i.e. Arunachal Pradesh, Bihar (2 batches), Uttar Pradesh, Chhattisgarh & Meghalaya during the period January to June 2018.

Blood Bank Officials from Arunachal Pradesh (8th – 13th Jan.2018) Blood Bank Officials from Bihar (5th – 10th March 2018)

Blood Bank Officials from Uttar Pradesh (19th – 24th March 2018) Blood Bank Officials from Chhattisgarh (16th – 21st April 2018)

Blood Bank Officials from Bihar (2nd April– 7th April 2018) Blood Bank Officials from Meghalaya (28th May– 2nd June 2018)


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MEETINGS/CONFERENCESSixth Technical Expert Committee Meeting of DS-IVDl under the Chairmanship of Prof. S. P. Thyagarajan, Prof. Emeritus & Dean Research, Sh. Ramachandra University, Chennai, Tamil Nadu and Former Vice Chancellor, University of Madras, was held on 04th April, 2018.

♦ Dr. Reba Chhabra Scientist Gr. I & In-charge DD(QC)-Diagnostics and Dr. R. K. Sharma, Scientist Gr. III & Head, Immunodiagnostic & Molecular Diagnostic Kit laboratory attended a meeting to explore areas of collaboration with Andhra Pradesh Med Tech Zone (AMTZ), Visakhapatnam as a WHO Support cell for WHO-Prequalification program for In-Vitro Diagnostics, held at Visakhapatnam on 16th April, 2018.

♦ Dr. Reba Chhabra, Scientist Gr. I & In-charge Deputy Director (Quality Control) – Diagnostics attended Technical Specification Committee meeting at Nirman Bhawan, New Delhi on 19th June, 2018.

The Third Meeting of Technical Expert Committee of Molecular Diagnostic laboratory was held on 22nd June, 2018 under the Chairmanship of Prof. Raies A Qadri, Prof & Head, Department of Biotechnology, University of Kashmir, Srinagar, for strengthening of its activities.


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Vaccine laboratory of the Institute conducted 2nd Stakeholder’s meeting on 23rd May 2018, regarding inclusion of WHO protocol for Determination of Polyribosyl-ribitol-phosphate (PRP) content of Haemophilus influenza type b (Hib) in liquid vaccine presentations by High Performance Anion Exchange Chromatography Pulsed Amperometric detection (HPAEC-PAD) in Indian Pharmacopoeia.

Vaccine laboratory Meeting with Stakeholders


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Dr. Achla Prasad, Scientist Grade – I and Head Allergen Testing laboratory attended 51st National Conference of Indian College of Allergy, Asthma and Applied Immunology (51st ICAAICON 2018) as a

faculty and delivered a talk on ‘Quality Control of Indigenous Allergens: limitations and Possible Ways Forward’ held at lucknow from 16th to 18th March, 2018.

♦ Ms Shalini Tewari, Scientist Gr. III, Allergen laboratory attended the meeting on proposed Addendum / Modification in Allergen Monograph published in Indian Pharmacopeia- 2018 at Indian Pharmacopeia Commission (IPC) on 27th June 2018.

♦ DCG (I) had convened a meeting on 21stMarch, 2018 at CDSCO (HQ) for discussion on Quality Control of Final Bulk Allergen Products manufactured indigenously for assuring safety and efficacy of marketed allergen products. The Scientists from NIB, CDSCO officials, experts from Indian Pharmacopoeia Commission and four representatives from Indigenous manufacturers attended the meeting.

ANIMAL FACILITY

Animal facility of the institute supplied more than 1300 animals to various Research Institutes and Academia in Delhi and nearby areas during the period Jan-June 2018.

♦ Dr. Suresh Kumar, Scientist Grade III, Animal Facility was invited as an external expert in the CSIR Assessment Committee at CSIR-Central leather Research Institute, Adyar, Chennai-600020 (Tamil Nadu) on 8th February, 2018.

♦ Dr Shikha yadav, Scientist Gr.-II & Head, Animal Facility was invited as

i Resource person to deliver a talk on “Anaesthesia & Analgesia in laboratory Animals” at Centre of Medical Biotechnology, Maharshi Dayanand University (MDU), Rohtak, Haryana on 17th March, 2018

ii Speaker on “Implementing Refinement in Animal Experiments-Severity Assessment, Clinical Score Sheets and Humane End Points” at CSIR-IMTECH, Chandigarh on 29th March, 2018.

♦ Dr. Shikha yadav, Scientist Grade-II & Head, Animal Facility became an Adhoc Specialist (Site Visitor) of the Association for Assessment and Accreditation of laboratory Animal Care, International (AAAlAC).


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Central Medical Device Testing Laboratory (CMDTL)National Institute of Biologicals, NOIDA has been designated as a Central Medical Device Testing Labora-tory (CMDTL) by Government of India vide Gazette No. S.O. 2237 (E), dated 01st June, 2018 for in-vitro diagnostics for human immunodeficiency virus, Hepatitis B surface Antigen and Hepatitis C virus, Blood Grouping Sera, Glucose Test Strip, Fully Automated Analyser based Glucose Reagent.

2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

�

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

ORDER

New Delhi, the 1st June, 2018

S.O. 2237(E).— In pursuance of the powers conferred by sub-rule (2) of rule 19 of the Medical Devices Rules,

2017, the Central Government hereby designates the laboratories specified in column (2) of the Table below having

facilities for carrying out test and evaluation of medical devices, as Central Medical Device Testing Laboratory for the

purposes of —

(a) testing and evaluation;

(b) functioning as an appellate laboratory; and

(c) to carry out any other function as may be specifically assigned to it by the Central Government,

in relation to the medical devices specified in column (3) of the said Table.

TABLE

Serial

Number

Name of Laboratory Category of medical device

(1) (2) (3)

1. The National Institute of Biologicals,

Noida

In-Vitro Diagnostics for human Immunodeficiency

virus, Hepatitis B Surface Antigen and Hepatitis C

Virus, Blood Grouping sera, Glucose Test Strip, Fully

Automated Analyser Based Glucose Reagent

2. The Central Drugs Testing laboratory,

Chennai

Condoms

3. The Central Drugs Laboratory, Kolkata Surgical Dressings, Surgical Cotton, Surgical Bandages,

Disinfectant

4. The Regional Drugs Testing Laboratory

(RDTL), Guwahati

Disposable Hypodermic Syringes, Disposable

Hypodermic Needle, Disposable Perfusion Sets,

I.V. Cannulae

5. The Central Drugs Testing Laboratory,

Mumbai

Intra Uterine Devices (IUD) and Falope Rings

2. The laboratories designated above are duly accredited by the National Accreditation Body for Certification

Laboratories.

3. This Order shall come into force on and from the date of its publication in the Official Gazette.

[F.No. X.11035/22/2018-DR]

SUDHIR KUMAR, Jt. Secy.

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.

Reassessment of NIB Laboratories for ISO/IEC 17025:2005 Accreditation To maintain the continued status of Accreditation as per International Standards of ISO/ IEC 17025: 2005 requirements, the National Institute of Biologicals laboratories reassessment was carried out by a team of external Assessors (lead Assessor and Technical Assessors) from NABl on 9th and 10th June, 2018. The purpose was for renewal of its unique and vast accredited scope in disciplines of Chemical and Biological tests which have been submitted for 120 products in seven categories consists of 160 chemical and 125 biological tests.


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OHSAS 18001:2007 Certification

The Institute has successfully acquired the OHSAS 18001:2007 certification (Certificate No. IND 18.8672U/HS) valid from 24th May, 2018 till 11th March, 2021.

OHSAS 18001:2007 is the international-ly recognized standard for Occupational Health and Safety Management Systems and it is stands for Occupational Health and Safety Assessment Specification.

This certification provides a framework to identify, control and decrease the risks associated with health and safety within the workplace.


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INTERNATIONAL WOMEN’S DAY CELEBRATION AT NIB: 08thMARCH 2018

INTERNATIONAL YOGA DAY: 21st JUNE 2018


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VISITORS’ FEEDBACK

Professor Afeworki Kassu Gizaw, State Minister Ministry of Science & Technology, Ethiopia.

Dr. Aparna Singh Shah, Regional Advisor, Blood Safety & laboratory Technology, SEARO, W.H.O.

Dr. Manohar Agnani, Joint Secretary Policy, National Health Mission, MOHFW, Govt. of India.

Dr. Ram Vishwakarma, Director, C.S.I.R. – I.I.I.M., Jammu

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NATIONAl INSTITUTE OF BIOlOGICAlS Volume No. 6: Issue 1: January-June 2018

SUPERANNUATION

Mr. R C Dalai, Junior Accountant, superannuated from NIB on 28th February, 2018 after rendering 20 years of service since 1998. NIB will always be indebted for his contributions.

NIB wishes him a happy and healthy life.

Mr. Sanjeev Sharma, Junior Scientist, voluntarily retired from NIB on 3rd Jan 2018 after rendering 22 years of service since 1995. His dedication to scientific work and commitment were exemplary and were inspiration to his fellow colleagues.

NIB team wishes him a bright future ahead.

VOLUNTARY RETIREMENT


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Newsletter Editorial Team acknowledges the contribution of all the staff members of NIB.

NATIONAL INSTITUTE OF BIOLOGICALSA-32, Sector-62, Near NH-24, NOIDA - 201309, Uttar PadeshNIB website: http://nib.gov.in, Email: [email protected]: 0120-2400072, 2400022, Fax: 0120-2403014

For any other information/Suggestions/Queries related to Newsletter kindly contact:Dr. Manjula Kiran, Associate Editor, Email: [email protected]

Inauguration of “Training of Trainers for Strengthening of Blood Services” for Blood Bank Officials from Bihar State

under NHM Program on 2nd April, 2018.

ACKNOWLEDGEMENT

volume no. 6: issue 1: january-june 2018 national

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