Lok Sabha Question No. 11 (STARRED), answered on 2019-06-21
Subject: Cases of Faulty Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Janardan Singh Sigriwal

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

## LOK SABHA STARRED QUESTION NO. 11 TO BE ANSWERED ON THE 21 ST JUNE , 2019 CASES OF FAULTY IMPL ANTS

## *11. SHRI JANARDAN SINGH SIGRIWAL:

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

(a)  whether  the  Government  has  come  across  cases  of  faulty  implants  be supplied to Government hospitals by a multinational company and if so, the d thereof;

(b) whether a large number of implants done at major Government Hospitals h gone wrong and patients have to undergo revision surgery and if so, the d thereof and the reasons therefor;

(c) whether the Government is aware that the Security and Exc hange Commission (SEC) of United States has slapped a huge penalty on a leading manufact urer of orthopedic implant devic s for violating norms in India, China and Kuwait and i so, the reaction of the Government thereto;

(d) whether the Government has initiated any investigation in this regard an the details thereof and if not, the reasons therefor; and

(e) the measures being taken by the Government to regulate the medical dev market in the country?

## ANSWER T HE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a) to ( e):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 11* FOR 21 ST JUNE , 2019

- (a)      The  issue  of  adverse  effects  of  the  products  requiring  higher  rate  of  revision surgeries in patients implanted with Articular Surface Replacement (ASR) hip implant imported  by  M/s  DePuy  Medical  Private  Limited  (Now  Johnson  &  Johnson)  was reported to Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare.

The Government had constituted a committee to examine the issues relating to faculty  ASR  Hip  Implants.    The  Committee,  after  detailed  examination  of  the  issue, submitted  its  report  to  the  Government,  which  accepted  the  recommendations  with some  modifications.    Based  on  the  accepted  recommendations,  the  Government constituted  a  Central  Expert  Committee  under  the  Chairmanship  of  Dr.  R.  K.  Arya, Director, Sports Injury Centre, Safdarjung Hospital, New Delhi, inter-alia to determine the quantum of compensation.

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

A formula for determining compensation for the affected patients has also been 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 of the Committee and to pay the compensation as per the formula approved by the Government in the interest of the patients. However, M/s Johnson & Johnson  Pvt. Ltd has challenged the expert committee  report  on payment  of compensation before the Hon'ble High Court of Delhi.

- (b) As per the records provided by M/s Johnson and Johnson, out of 4700 patients implanted with ASR hip implants, 292 patients have undergone revision surgery due to ASR hip implant.
- (c) & (d)    No complaint has been received by Government in this regard.
- (e) The manufacture, sale and distribution of Medical Devices is regulated under Drugs and Cosmetics Act and Medical Device Rules, 2017. These rules were published by Government of India on 31 st January, 2017 and became effective from 1 st January 2018.

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