Lok Sabha Question No. 4185 (UNSTARRED), answered on 2019-12-13
Subject: Death from Faulty Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Ramya  Haridas, Margani Bharat, Shrikant Eknath Shinde

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

LOK SABHA UNSTARRED QUESTI ON NO. 4185 TO BE ANSWERED ON 13 TH DECEMBER, 2019

## DEATH FROM FAULTY IM PLANTS

## 4185. MS. RAMYA HARIDAS:

SHRI MARGANI BHARAT:

DR. SHRIKANT EKNATH SHINDE:

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

- (a) whether the Government is aware of rising number of adverse events including deaths faulty  implants  of  medical  devices  which  include  breast  and  kne e implants,  pelvic  meshes, coronary stents and pacemakers, if so, the details thereof;

- (b) whether the attention of the Government has also been drawn to a corrupt nexus bet hospitals,  doctors,  global  pharma  majors  and  manufacturers  of  medical  device s  resulting  in unregulated sale and implants of medical devices in the country and if so, the details the

- (c)  whether  the  Government  proposes  to  bring  in  a  legislation  to  put  in  place  a  reg framework on implants of medical devices to check its rampant abuse;

- (d) whether it is true that the Government has set up a Committee to look into the side e medical devices and if so, the details thereof;

- (e) the manner in which the Government imposes penalties on manufacturers of medical device without incorporating it in the Drugs and Cosmetics Act; and

- (f) the steps taken to amend the Drugs and Cosmetics Act for this purpose?

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

(SHRI ASHWINI KUMAR CHOUBEY)

- (a): The Government has not received such reports.

Contd…….

(b)  &  (c):To  have  comprehensive  regulatory  provisions  for  import,  manufacture,  sale  a distribution of medical devices based on risk based criteria, the Government of India has notified the Medical Device Rules 2017 which have become effective from 01.01.2018 . For import or manufacture  of  any  medical  device,  the  applicant  is  required  to  submit  details  of specification, non - clinical as well as clinical data of safety and performance of the devic case of new Medical Devices, the safety, quality and perfo rmance data are evaluated by CDSCO in consultation with the Subject Expert Committee in the relevant therapeutic areas. Un said rules, there are provisions that subsequent to approval of a medical device, the ap required to closely monitor the device for its clinical safety. The applicant is required to s Periodic Safety Update Reports (PSURs) to CDSCO.

The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) announced by the Department of Pharmaceuticals in December, 2014 which is in operation since 01.01.2015 for voluntary  adoption  by  pharma  industry  provides  that  the  manufacturers  should  not  use unethical practices for luring doctors to boost sales of their products.

Further, Clause 6.8 (Code of Conduct for doctors in their relationship with pharmaceutical and allied health sector industry) of the Indian Medical Council (Professional Conduct, E and Ethics) Regulations, 2002 prohibits doctors from taking gifts, travel facilities, ho mo netary  grants  from  pharmaceutical  and  allied  health  sector  industry.  The  said  regu empowers  the  Medical  Council  of  India  and  respective  State  Medical  Councils  to  awa punishment to a doctor against any act in violation of code of Ethics.

(d): No.

(e) & (f):Notified medical devices are regulated under Drugs & Cosmetics Act, 1940 and Medical Device Rules, 2017 thereunder. The Act provides for penalties in case of violatio provisions.

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