Lok Sabha Question No. 1056 (UNSTARRED), answered on 2019-02-08
Subject: Cases of Faulty Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: MANSHANKAR NINAMA, RAMESH POKHRIYAL NISHANK

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

## LOK SABHA UNSTARRED QUESTION NO. 1056 TO BE ANSWERED ON 08 TH FEBRUARY, 2019

## CASE OF FAULTY IMPLA NTS

## 1056. SHRI MANSHANKAR NINAMA: DR. RAMESH POKHRIYAL 'NISHANK':

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

- (a) whether the Government has come across cases of faulty implants being upplied to Government hospitals by a multinational company and if so, the details thereof;
- (b) whet her it is a fact that 02 out of every 10 implants done at All India Institute of Medical Sciences, New Delhi have gone wrong and patients have to come for revision surgery and if so, the details thereof and the reasons therefor;
- (c) whether the Government has takenote of the fact that the Securities and Exchange Commission (SEC), the top financial regulator in the United States has slapped a huge fine/penalty on a leading manufacturer of orthopaedic implant devices for violating its corruption norms in I ndia, China and Kuwait and if so, the details thereof;
- (d) whether the Government has initiated any investigation into the matter and if so, the details thereof and if not, the reasons therefor; and
- (e) the measures being taken by the Government to regulate the medical devices market which has so far remained unregulated and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): The issue of adverse effects of the product requiring higher rate of revision surg patients implanted with the Articular Surface Replacement (ASR) hip implant imported by DePuy  Medical  Private  Limited  (Now  Johnson  &  Johnson)  was  reported  t o  Central  Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare.

The Government had constituted a committee to examine the issues relating to fau ASR Hip Implants.  The committee, after detailed examination of the iss ue, submitted its report to the Government, which accepted the recommendations with some modifications. Based on th accepted recommendations, the Government constituted a Central Expert Committee under th Chairmanship  of  Dr.  R.K.  Arya,  Director,  Sports  I njury  Centre  inter -alia  to  determine  the quantum of compensation.

The Ministry of Health & Family Welfare has also requested all the States/UTs to State  Level  Committees  to  examine  the  affected  patients  within  their  jurisdiction  so process is less arduous for the patients.

A  formula  for  determining  compensation  for  the  affected  patients  has  also  b formulated and placed in public domain. The affected patients can approach either the Central Expert Committee or State Level Committee as per their convenience.

M/s Johnson & Johnson Pvt. Ltd. has been asked to comply with the recommendations o the Committee and to pay the compensation as per the formula approved by the Government the interest of the patients. However, M/sJohnson & Johnson Pvt. Ltd. has challenged the expert committee report on payment of compensation before the Hon'ble High Court of Delhi.

(b): No.

(c) & (d): No complaint has been received by Government in this regard.

(e): Medical devi ces are regulated as drugs notified under section 3 (b) (iv) of the Dru Cosmetics Act 1940 from time to time. Such medical devices are regulated under the said and Medical Devices Rules, 2017 made thereunder. At present, 23 Medical Devices are regu lated under the provisions of said Act.

Further  vide  Gazette  notification  S.O.  5980(E),  dated  03.12.2018,  in  pursuance  of -clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 194 Central Government, after consultation with the Drugs Technical Advisory Board, have specified the following 04 more devices intended for use in human beings as drugs with effect from day of January, 2020:

- (i) Nebulizer;
- (ii) Blood Pressure Monitoring Devices;
- (iii) Digit al Thermometer; and
- (iv) Glucometer