Lok Sabha Question No. 614 (UNSTARRED), answered on 2018-07-20
Subject: Medical Implantable  Devices
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUDHEER GUPTA, ASHOK SHANKARRAO CHAVAN, BIDYUT BARAN MAHATO, KUNWAR HARIBANSH SINGH, GAJANAN CHANDRAKANT KIRTIKAR, DHANANJAY BHIMRAO MAHADIK, VIJAY KUMAR S.R., VIJAYSINH MOHITE PATIL, P.R. SUNDARAM, HEENA VIJAYKUMAR GAVIT, RAJEEV SHANKARRAO SATAV, T. RADHAKRISHNAN, JAYAKUMAR JAYAVARDHAN, S. RAJENDRAN

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

LOK SABHA UNSTARRED QUESTION NO. 614 TO BE ANSWERED ON 20 th JULY, 2018

## MEDICAL IMPLANTABLE DEVICES

## 614. SHRI SUDHEER GUPTA:

SHRI ASHOK SHANKARRAO CHAVAN:

SHRI BIDYUT BARAN MAHATO:

KUNWAR HARIBANSH SINGH:

SHRI GAJANAN KIRTIKAR:

SHRI DHANANJAY MAHADIK:

SHRI S.R. VIJAYAKUMAR:

SHRI MOHITE PATIL VIJAYSINH SHANKARRAO:

SHRI P.R. SUNDARAM:

DR. HEENA VIJAYKUMAR GAVIT:

SHRI SATAV RAJEEV:

SHRI T. RADHAKRISHNAN:

DR. J. JAYAVARDHAN:

SHRI S. RAJENDRAN:

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

- (a) whether most of the medical implantable devices are not regulated by any law in the country and if so, the details thereof;
- (b) whether the Government proposes to regulate the sale, manufacture and import of medical implantable devices and if so the details thereof;
- (c) whether the Government has consulted various stakeholders in this regard, if so, the response thereto; and
- (d) the details of steps taken/being taken by the Government to ensure quality of implant/medical devices made available in the country?

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

(SHRI ASHWINI KUMAR CHOUBEY)

(a): The Central Drugs Standard Control Organisation (CDSCO) ,under the Ministry of Health and Family Welfare ,regulates the safety, efficacy and quality of 15 notified category of me devices under the provisions of Drugs and Cosmetics Act, 1940 and R ules ma e thereunder. Under  the  said  rules,  the  implantable  medical  devices  like  Cardiac  stent,  Drug  Eluting Orthopaedic Implant and Internal prosthetic replacements are regulated as medical devices section 3(b)(iv) of Drugs and Cosmetics Act, 1940.

(b) & (c): In the 79 th meeting of Drugs Technical Advisory Board (DTAB) held on 16 th May, 2018, the Board has agreed to include  all implantable medical  devices under the purv section 3 (b) (iv) of the Drugs And Cosmetics Act, 1940 as me dical devices, with an aim to regulate their import, manufacture, distribution and sale.

Further,  a  public  notice  dated  22.06.2018  has  been  published  for  inviting  comme /suggestions from stakeholders in this regard.

(d): Medical Devices Rules, 2017 have been implemented with effect from 01.01.2018 whi have detailed provisions for regulation of manufacture, import, sale and distribution of devices covered under the said Act to ensure their quality.  Further, as brought out above, the DTAB  has  agreed  to  include  all  implantable  medical  devices,  CT  scan  equipment,  MRI equipment,  Defibrillators,  Dialysis  Machine,  PET  equipment  and  X - Ray  Machine  under  the purview  of  section  3  (b)  (iv)  of  the  Drugs  And  Cosmetics  Act ,  1940  with  the  objective  of ensuring their quality.