Lok Sabha Question No. 1031 (UNSTARRED), answered on 2019-02-08
Subject: 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 UNSTARRED QUESTION NO. 1031 TO BE ANSWERED ON 08 TH FEBRUARY, 2019

## MEDICAL IMPLANTS

## 1031. DR. KAMBHAMPATI HARIBABU:

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

- (a) whether the Government has made it mandatory for hospitals, which are dealing in medical implants, to report cases to Medical Device Adverse Event (MDAE), maintained by the Indian PharmacopoeiaCommission (IPC) and if so, the details thereof;
- (b) the details of action taken on MDAE reports during the last four years; and
- (c) whether the Government has provisions in place to compensate the affected patients and if so, the details thereof along with the patients compensated during the last four years, State - wise?

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

- (a):  Realizing  the  need  for  having  a  system  to  monitor  the  safety  of  medical  devic mo nitoring and reporting of adverse events/side effects, Ministry of Health and Family Welfare has approved the commencement of "Materiovigilance Programme of India (MvPI)" with Indian Pharmacopoeia  Commission  (IPC),  Ghaziabad  as  the  National  Coordinating  Ce ntre  having dedicated functional Medical Device Adverse Event Monitoring Centres (MDMCs) all over th country. All the Adverse Drugs Reaction Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI) have also been entrusted to report adv erse events due to the use of medical devices. However, IPC collects such reports on voluntary basis.

Further,  there  is  provision,  under  the  Medical  Devices  Rules,  2017,  stipulating subsequent to approval of a medical device, the applicant is required to submit Periodi Update Reports (PSURs) to Central Drugs Standard Control Organisation (CDSCO).

- (b): Medical device alerts are issued on the website of CDSCO wherein 11 alerts have b issued in public interest till date.
- (c): Import, sale and manufacture of notified medical devices are regulated as drugs the  provisions  of  the Drugs  and  Cosmetics  Act,  1940  and  Medical  Devices  Rules,  2017. However, there is no specific provision in the said Act and Rules for compensation to a after a device has been found faulty.

However as per Section 27 of the said Act, a ny drug deemed to be  adulterated under section 17A or spurious under section 17B, when used by any person for, or in the diag treatment, mitigation, or prevention of any disease or disorder is likely to cause his likely to cause such har m on his body as would amount to grievous hurt within the meaning of section  320  of  the  Indian  Penal  Code,  solely  on  account  of  such  drug  being  adulterat spurious  or  not  being  of  standard  quality,  as  the  case  may  be,  shall  be  punishabl imprisonment for a term which shall not be less than ten years but which may extend to a t life and with fine which shall not be less than ten lakh rupees or three times value of confiscated, whichever is more, provided that the fine imposed on and released from the person convicted shall be paid, by way of compensation, to the affected party.