Lok Sabha Question No. 3306 (UNSTARRED), answered on 2019-07-12
Subject: Violation of Medical Ethics
Ministry: HEALTH AND FAMILY WELFARE
Asked by: M. K. Raghavan

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

LOK SABHA UNSTARRED QUESTION NO. 3306 TO BE ANSWERED ON 12 TH JULY, 2019

## VIOLATION OF MEDICAL ETHICS

## 3306. SHRI M.K. RAGHAVAN:

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

- (a) whether the Government has conducted any study on the inducements to doctors and dubious deals  with  hospitals by  pharma  companies  in  the  country  and if  so,  the  details  and  findings thereof;
- (b) whether the Ind ian subsidiary and dealers of major MNCs have violated major ethics of the medical sector;
- (c) if so, the details of these alleged violations including dodgy records, rigging bids inflated invoices etc.;
- (d) whether the faulty orthopaedic implant devices are being used resulting in major physical deficiency to the implanted patients and if so, the measures taken to help and compensate such patients; and
- (e)  whether  the  Government  proposes to  come  out  with  a  regulator  to  control  the otherwise unregulated medical bazar and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI ASHWINI KUMAR CHOUBEY)

(a) to (c): The Department of Pharmaceuticals under the Ministry of Chemicals & Fertil zer , has prepared  a  Uniform  Code  of  Pharmaceuticals  Marketing  Practices  (UCPMP)  for  voluntary adoption by pharmaceutical companies with effect from 01.01.2015 as guidance to the indu for  promotion  and  marketing  of  drugs  and  medical  devices.    N o  instance  of  unsuccessful implementation of UCPMP by pharma Associations/companies has been brought to notice by Department of Pharmaceuticals.

Further, Clause 6.8 (Code of Conduct for doctors in their relationship with pharmace and allied health sector industry) of the Indian Medical Council (Professional Conduct, Etiq and Ethics) Regulations, 2002 prohibits doctors from taking gifts, travel facilities, hos cash  or  monetary  grants  from  pharmaceutical  and  allied  health  secto r  industry.  The  said regulation  empowers  the  Medical  Council  of  India  and  respective  State  Medical  Council award punishment to a doctor against any act in violation of code of Ethics for doctor complaints  are  referred  by  MCI  to  the  concerned  Stat e  Medical  Councils  where  the doctors/medical practitioners are registered. The MCI is an Appellate Authority.

(d):The  issue  of  adverse  effects  of  the  product  requiring  higher  rate  of  revision  surg patients implanted with the Articular Surface Repl acement (ASR) hip implant imported by M/s DePuy Medical Private Limited (Now M/s Johnson & Johnson) was reported to Central Drugs Standard Control Organisation (CDSCO) ,Ministry of Health and Family Welfare by the said firm.

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

A formula for dete rmining compensation for the affected patients has also been formulat and  placed  in  public  domain. The  affected  patients  can  approach  either  the  Central  Expert Committee  or  State  Level  Committees  constituted  by  the  State  Governments  as  per  th convenie nce.

M/s Johnson & Johnson Pvt. Ltd. has been asked to comply with the recommendations of t Committee and to pay the compensation as per the formula approved by the Government in t 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.

The High Court of Delhi has, on 30.05.2019, ordered that the petitioner pay the sum of ₹ 25 lakhs to each verified claimant, without pr ejudice to the rights of the claimants . Based on Court order, the list of verified claimants along with supporting documents has been provided Johnson and Johnson for complying with the court's order.

(e): Medical Devices are already regulated under Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 thereunder.