Lok Sabha Question No. 4792 (UNSTARRED), answered on 2018-03-23
Subject: Setting up of Medical Device Testing Laboratories
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BIDYUT BARAN MAHATO, NARANBHAI KACHHADIA, GAJANAN CHANDRAKANT KIRTIKAR, KUNWAR HARIBANSH SINGH, T. RADHAKRISHNAN, VIJAY KUMAR S.R., SUNIL BALIRAM GAIKWAD

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

## LOK SABHA UNSTARRED QUESTIO N NO. 4792 TO BE ANSWERED ON 23 rd MARCH, 2018

## SETTING UP OF MEDICA L DEVICE TESTING LABORATORIES

## 4792. SHRI BIDYUT BARAN MAHATO:

SHRI NARANBHAI KACHHADIYA:

SHRI GAJANAN KIRTIKAR:

KUNWAR HARIBANSH SINGH:

SHRI T. RADHAKRISHNAN:

SHRI S.R. VIJAYAKUMAR:

DR. SUNIL BALIRAM GAIKWAD:

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

- (a) whether the Government has takennote of the fact that medical equipments especially pre - owned  medical  electronic equipment  is  entering  the  country via imports  without  any safeguards and if so, the details thereof;
- (b) whether the Government proposes to bring imaging and endoscopic equipment under the purview of the Drugs and Cosmetics Act, 1940;
- (c) if so, the details thereof along with the aims and objectives thereto;
- (d) the time by which it is likely to be brought under the purview of the said Act; and
- (e) the measures being taken by the Government to set up medical device testing laboratories and make them available at affordable cost 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 ca of medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules ma e thereunder. However, Medical equipment are not notified as Medical device under sect 3(b)(iv) of Drugs and Cosmetics Act, 1940.
- (b) to (d) : In the 78 th meeting of Drugs Technical Advisory Board (DTAB) held on 12 th February, 2018, the board has agreed to include ultrasound equipments and similar imaging equipments under the purview of section 3 (b) (iv) of the Drugs And Cosmetics Act, 194 medical devices, with a aim to regulate its import, manufacturing, distrib ution and sale.

(e): As per the Medical Device Rules, 2017, the Central Government may designate any laboratory having facility for carrying out test and evaluation of medical devices a medical  devices  testing  laboratory.    In  this  regard,  CDSCO has  requested  National Accreditation Board for Testing & Calibration Laboratories (NABL) accredited laborato on  01.03.2018  which  are  having  capacity  and  capability  for  testing  and  evaluation  o Medical Device including In Vitro Diagnostic, may get regist red with CDSCO and inform details of their activities.

It may be mentioned that since Financial Year - 16, 2015 funds have been approved/disbursed under the erstwhile Assistance to States for infrastructure Develo of Exports Scheme and th e current Trade Infrastructure for Export Scheme for setting up testing labs for medical equipment/common scientific facilities etc.