Lok Sabha Question No. 484 (UNSTARRED), answered on 2019-02-06
Subject: Evaluation of Laboratories
Ministry: SCIENCE AND TECHNOLOGY
Asked by: DHANANJAY BHIMRAO MAHADIK, HEENA VIJAYKUMAR GAVIT, JAYAKUMAR JAYAVARDHAN, VIJAYSINH MOHITE PATIL, RAJEEV SHANKARRAO SATAV, SUPRIYA SADANAND SULE

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE AND TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA

## UNSTARRED QUESTION  NO. 484 TO BE ANSWERED ON 06/02/2019

## EVALUATION OF LABORATORIES

## 484.   SHRI DHANANJAY MAHADIK :

DR. HEENA VIJAYKUMAR GAVIT :

DR. J. JAYAVARDHAN :

SHRI MOHITE PATIL VIJAYSINH SHANKARRAO :

SHRI SATAV RAJEEV :

SHRIMATI SUPRIYA SULE :

Will the Minister of SCIENCE AND TECHNOLOGY be pleased to state:

- (a) whether the Government has set any standards to evaluate the working of the laboratories that test vaccines in the country;
- (b) if so, the details thereof;
- (c) whether these laboratories are able to meet the international standards;
- (d) if so, the details thereof; and
- (e) the other steps being taken by the Government in this regard?

## ANSWER

## MINISTER OF SCIENCE & TECHNOLOGY  AND EARTH SCIENCES; ENVIRONMENT, FOREST AND CLIMATE CHANGE

(DR. HARSH VARDHAN)

- (a  to  e)  Yes  Madam,  National  Accreditation  Board  for  Testing  and  Calibration Laboratories  (NABL)  is  a  Constituent  Board  of  Quality  Council  of  India. NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body's accreditation which involves third-party assessment of the  technical  competence  of  testing including  medical  and  calibration laboratories, proficiency testing providers and reference material producers. Accreditation program is voluntary in nature.

NABL provides accreditation in all major fields of Science and Engineering such  as  Biological,  Chemical  covering  various  scopes  like  Drugs,  Food, Water, Pollution etc. The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025: 2005 'General Requirements for the Competence of Testing and Calibration  Laboratories.  NABL  accreditation  system  also  takes  note  of the  requirements  of  Mutual  Recognition  Arrangements  (MRAs)  of  which NABL is a member.

NABL accredits laboratory based on test and test methods , laboratories seeking  accreditation are  assessed  and  their  compliance to International Standard ISO/IEC 17025 :General Requirements for the Competence of Testing and Calibration Laboratories is ensured. The laboratories accredited by NABL for Vaccines are Central Research Institute, Kasauli; Enterovirus Research  Centre  (Indian  Council of  Medical  Research), Mumbai  and the National Institute of Biologicals, Noida.

The National Good Laboratory Practice Compliance Monitoring Authority (NGCMA)  has  also  been  set  up  under  the  administrative  control  of  the Department of Science and Technology (DST) to award GLP certification to test facilities conducting pre-clinical testing of chemicals (viz. Pharmaceuticals, Industrial Chemicals, Pesticides, Veterinary Drugs, Cosmetics,  Food  Additives,  Feed  additives,  etc.)  in  accordance  with Organization for Economic Cooperation and Development (OECD) Principles  of  GLP.  NGCMA  has  certified  47  test  facilities  in  the  country whose  data  is  mutually  accepted  by  36  OECD  member  countries  in accordance with Mutual Acceptance of Data (MAD) agreement.

******