Lok Sabha Question No. 2558 (UNSTARRED), answered on 2020-03-06
Subject: Notification of Medical Devices as Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: T. R. Paarivendhar, A. Ganeshamurthi, Asaduddin Owaisi, Imtiaz Jaleel Syed, Pratima Bhoumik, Devusinh Jesingbhai Chauhan

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

LOK SABHA UNSTARRED QUESTION NO. 2558 TH

TO BE ANSWERED ON 06 MARCH, 2020

## NOTIFICATION OF MEDI CAL DEVICES AS DRUGS

## 2558. DR. T.R. PAARIVENDHAR:

SHRI A. GANESHAMURTHI:

SHRI ASADUDDIN OWAISI:

SHRI SYED IMTIAZ JALEEL:

MS. PRATIMA BHOUMIK:

SHRI DEVUSINH JESINGHBHAI CHAUHAN:

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

- (a) whether there are no guidelines for medical devices like stents, pacemaker and ortho thereby  affecting  their  quality  standards  and  leading  to  unregulated  prices,  if  so,  t thereof;
- (b) whether the Government has notified the medical devices as drugs bringing a wide ran products under the Drugs and Cosmetics Act, 1940, if so, the details thereof;
- (c)  whether  approval  from  the  Drug  Controller  is  required  to  manufacture,  import  a nd  sell medical devices and the said notification is likely to ensure safety and efficacy for re prices under Drugs Price Control Orders (DPCOs), if so, the details thereof along with t framed for any violations;
- (d) whether the stakeho lders have raised concerns over proposed rules, if so, the details th and
- (e) the number of Government run embalming centres in the country, State/UT - wise  and  the manner in which the cost of embalming is regulated?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE

(DR. HARSH VARDHAN)

- (a): 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 devices.

As per Medical Device s Rules 2017, the notified medical device shall conform to the standards  laid  down  by  Bureau  of  Indian  Standards  (BIS)  or  as  may  be  notified  by  Cen Government  from  time  to  time.  If  such  standards  are  not  available  then  Internat nal Organisation  for  Standardisation  (ISO),  International  Electro  Technical  Commission  (IEC any other pharmacopeial standards will be applicable. If none of those are available, device shall conform to the validated manufacturer's standard.

Further, National Pharmaceuticals Pricing Authority under the Department o Pharmaceuticals has fixed ceiling prices for Coronary Stents and orthopaedic Knee Implan the year 2017.

(b): In order to bring the non - notified Medical Devices under r egulation, Government of India has,vide S.O. 648 (E) dated 11.02.2020, which will be effective from 01.04.2020, notifi medical  devices  intended  to  be  used  for  diagnosis,  prevention,  monitoring,  treatme alleviation of any disease or disorder, et c, as drugs under sub -clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.

The  Central  Government  has  also  amended  Medical  Devices  Rules,  2017  vide  G.S.R 102(E)  dated  11.02.2020,  effective  from  01.04.2020,  specifying  that registration  of  all  such medical devices will be in a phased manner.

(c): As per the Medical Device Rules, 2017, import of all classes of Medical Devices as as manufacture of Class C & D Medical Devices are regulated by CDSCO, while manufacture of Class A & B Medical devices are regulated by the concerned State Licensing Authorities ( appointed by the State Governments. Sale and distribution of the medical devices are regulate by t he State Licensing Authorities.

Pricing  of  notified  medical  devices  is  regulated  by  National  Pharmaceuticals  Pr Authority under the Department of Pharmaceuticals.

(d): The  above  notifications  were  finalized  with  the  previous  publication  of draft  and consideration of suggestions/comments of the stakeholders.

(e): The  data  regarding  the  embalming  centres  available  in  hospitals  run  by  St Governments/UT Administrations is not maintained centrally. As per information obtained f Central Go vernment Hospitals, the Department of Anatomy in Lady Hardinge Medical College is the recognized Government run embalming centre in Delhi. The cost of embalming at centre is regulated through the Ministry of Health & Family Welfare.

Further, em balming centres are also available in All India Institute of Medical Science New Delhi; Post Graduate Institute of Medical Education & Research, Chandigarh; and Jawaharlal Institute of Postgraduate Medical Education and Research, Puduchery.

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