Lok Sabha Question No. 812 (UNSTARRED), answered on 2018-12-14
Subject: Pricing of Medical Devices
Ministry: HEALTH AND FAMILY WELFARE
Asked by: PRITAM GOPINATH MUNDE, SHRIKANT EKNATH SHINDE, SHIVAJI ADHALRAO PATIL, Shrirang Appa Barne, ANANDRAO  ADSUL

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

## LOK SABHA UNSTARRED QUESTION NO. 812 TO BE ANSWERED ON 14 TH DECEMBER, 2018

## PRICING OF MEDICAL D EVICES

## 812. DR. PRITAM GOPINATH MUNDE:

DR. SHRIKANT EKNATH SHINDE:

SHRI ADHALRAO PATIL SHIVAJIRAO:

SHRI SHRIRANG APPA BARNE:

SHRI ANANDRAO ADSUL:

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

- (a) whether the importers' lobby is pitching for increase of 18 per cent in Maximum RetailPrice (MRP) for all medical devices simultaneously making a request to the Government to rationalise the trade margins, if so, the response of the Government thereon;
- (b) whether there is an urgent need for an integrated and calibrated development policy to put 'Make in India' initiative in medical devices sector in topon foreign made devices;
- (c) if so, the response of the Government thereon and the steps taken in this regard;
- (d)  whether  the  Government  has  taken note  of  the  reports  in  newspapers  about unaffordable hospital  bills  and  exorbitantly priced  medical  devices  used  in  treatment which  has  created distrust in healthcare industry; and
- (e) if so, the steps taken by the Governm nt to address the issue?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL )

- (a): The Department of Pharmaceuticals, which is mandated with the task of dealing wi pricing issues of medical devices, has informed that it has not received any such r pr sentation from the industry for increase of 18 percent in medical devices.
- (b) & (c): Realising the needs of medical devices sector, the Government has operationalized a sub - scheme,  namely,  Development  of  Common  Facility  Centre  for  Medical Devices (DCFC- MD). It aims to provide financial assistance to upcoming medical device par for  creation  of  Common  Facility  Centre  (CFC).  This  move  is  expected  to  bring  down  t manufacturing cost of indigenous medical devices, thus making them competitive and giving a fillip  to  'Make  in  India'.  Further ,  Department  of  Pharmaceuticals has  issued  guidelines  for implementation  of  Public  Procurement  (Preference  to  Make  in  India)  Order,  2017.  T Department has also clarified in the guidelines that USFDA/CE Certific ations, etc. shall not be mandatory for those medical devices for which Bureau of Indian Standards (BIS) standards This move is also expected to boost manufacturing of indigenous medical devices.

(d) & (e): Health  is  a  State  subject.  The  Government  of  India  has,  however,  enacted Clinical Establishments (Registration and Regulation) Act, 2010 for registration and reg of the Clinical Establishments with a view to prescribe the Minimum Standards of fa cilities and services provided by them. Under the Clinical Establishments (Central Government) Rules, notified under this Act, the clinical establishments (in the States/Union Territories whe Act  is  applicable)  are  inter - alia  required  to  fo llow  Standard  Treatment  Guidelines  as  may  be issued by Central/State Governments, display their rates at a conspicuous place and cha rates for each type of procedure and service within the range of rates determined from time in consultation with the State Governments. The National Council for Clinical Establishments has approved a standard list of medical procedures and a standard templa costing of medical procedures and the same has been shared with the States/UTs where the A appl icable  for  appropriate  action.  Further  action  lies  within  the  purview  of  the  S Governments as the implementation and enforcement of the said Act is within the remit o State/UT Governments.

Currently,  the  Act  is  applicable  in  11  States namely  Sikkim,  Mizoram,  Arunachal Pradesh,  Himachal  Pradesh,  Uttar  Pradesh,  Bihar,  Jharkhand,  Rajasthan,  Uttarakhand,  As and Haryana and all Union Territories except Delhi. Other States may adopt the Act under (1) of Article 252 of the Constitut ion.