Lok Sabha Question No. 1669 (UNSTARRED), answered on 2022-12-16
Subject: Central Drugs Standard Control Organisation
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Vijayakumar (alias) Vijay Vasanth, Margani Bharat

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.1669 TO BE ANSWERED ON 16 th  DECEMBER, 2022

## CENTRAL DRUGS STANDARD CONTROL ORGANISATION

## 1669: SHRI VIJAYAKUMAR (ALIAS) VIJAY VASANTH: SHRI MARGANI BHARAT:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  whether  it  is  a  fact  that  the  Central  Drug  Standard  Control  Organisation  (CDSCO)  is effectively regulating the medical devices industry in view of the concerns being expressed regarding standard and quality of the medical devices, if so, the details thereof;
- (b)  whether the Government is aware of the fact that they have only 20 CDSCO-approved medical device testing labs compared to the size of the country, if so, the details thereof;
- (c)  whether  it  is  a  fact  that  the  government  is  considering  to  set  up  a  new  regulator  for medical devices, if so, the details thereof;
- (d) whether the Government is aware of the fact that there is a new licensing method has been launched from October this year; and
- (e) whether the Government is aware that the CDSCO in its existing structure and expertise is mainly Pharma centric, if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a):  Central  Drugs  Standard  Control  Organisation  (CDSCO)  regulates  the  medical  devices under Medical Device Rules (MDR) 2017.  To ensure the quality of medical devices in the country,  compliance  of  the  provisions  of  the  MDR,  2017  is  required.  This  includes comprehensive provisions to regulate Clinical Investigation, Manufacture, Import, Sale and Distribution of the notified medical devices as per risk based classification.

For class A&B the manufacturing license is granted by the concerned State Licensing Authority after conformity assessment by registered notified body. The manufacturing license for  class  C&D  medical  devices,  is  granted  by  Central  Licensing  Authority  after  inspection carried out by the Medical Device Officers notified by the Government.

A manufacturer has to comply with the Bureau of Indian Standards (BIS). If these are not available then manufacturer has to comply International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) standards. If ISO/IEC standards are not available then manufacturer has to comply with pharmacopoeial/ manufacturer validated standards.

(b) to (e) : CDSCO has registered 28 NABL accredited laboratories for the testing of medical devices on behalf of the manufacturer. Six Central Medical Device Testing Laboratories are notified by Government of India for testing the legal samples.

Ministry of Health & Family Welfare has published a gazette notification S.O. 648 (E) dated  11.02.2020  and  G.S.R.  102(E)  dated  11.02.2020,  in  order  to  regulate  all  medical devices in phase wise manner, whereby Class A and B medical devices are under licensing regime from 01.10.2022 and class C and D medical devices will come under licensing regime from 01.10.2023.

CDSCO has a separate division for medical devices. There are 236 notified Medical Device Officers working in the zonal/ sub-zonal/ port offices and head office of CDSCO. 23 Drugs Inspector (Medical Devices) and 03 Assistant Drugs Controllers (Medical Devices) are working for medical devices regulation.

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