Lok Sabha Question No. 74 (STARRED), answered on 2018-12-14
Subject: Faulty Medical Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: HARI BABU KAMBHAMPATI

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

## LOK SABHA STARRED QUESTION NO. 74 TO BE ANSWERED ON THE 14 TH DEEMBER ,2018 FAULTY MEDICAL IMPLA NTS

## *74. DR. KAMBHAMPATI HARIBABU:

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

- (a) whether the Government has taken cognizance of the increasing faulty med implants in the country and if so, the details thereof;
- (b) the steps being taken to hold the manufacturers and importers accountable faulty medical implants; and
- (c) the details of regulatory conditions in place to safeguard the concern patients?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a)to ( c) : A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 74* FOR 14 TH DECEMBER , 20 18

(a) & (b): The Central Government through the Central Drugs Standard Control Organisation (CDSCO), takes cognizance of faulty notified medical implants corrective action under the Drugs & Cosmetics Act, 1940 and Rules thereunder and when such reports are received. The Government has not received any su report that there is an increase in faulty medical implants in the country.

(c):   To have comprehensive regulatory provisions for import, manufacture, and distribution of medical devices based on risk based criteria, Governmen notified the Medical Devices R ules, 2017 which became effective from 01 January 2018.

For import or manufacture of any medical device, the applicant is requi submit details of design, specification, non - cli ical as well as clinical data of safet and performance of the devices.

I n case of new Medical Devices, the safety, efficacy and performance d are evaluated by CDSCO in consultation with the Subject Expert Committee in relevant  therapeutic  areas.  Under  the  said  rules,  there  are  provisio subsequent to approval of a medical device, the applicant is required to close monitor  the  device  for  its  clinical  safety.  The  applicant  is  required  t Periodic Safety Update Reports (PSURs) to CDSCO.

Further, Ministry of Health and Family Welfare has approved th commencem ent  of  "Materiovigilance  Programme  of  India  (MvPI)"  with  Indian Pharmacopoeia  Commission,  Ghaziabad  as  the  National  Coordinating  Centre having  dedicated  functional  Medical  Device  Adverse  Event  Monitoring  Centre (MDMCs)  all  over  the  country.  All  the  Advers e  Drugs  Reaction  Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI) have also been entrusted to report adverse events due to the use of medical devices.

Under the Medical Device Rules, there is also provision for recall of m devices. If a manufacturer or importer considers or has reason to believe medical device is likely to pose a risk to the health of patient manufacturer/importer is required to immediately initiate procedures to wit the medical device in q uestion from the market and patients.