Lok Sabha Question No. 634 (UNSTARRED), answered on 2016-02-26
Subject: Import of Medical Devices and Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: HEENA VIJAYKUMAR GAVIT, R. VANAROJA, ARVIND GANPAT SAWANT, DHANANJAY BHIMRAO MAHADIK, KRUPAL BALAJI TUMANE, BHAVANA GAWALI (PATIL), VIJAYSINH MOHITE PATIL, SUPRIYA SADANAND SULE, YERRAM VENKATA SUBBAREDDY, V. SATHYABAMA, T. RADHAKRISHNAN

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

## LOK SABHA UNSTARRED QUESTION NO. 634 TO BE ANSWERED ON 26 TH FEBRUARY, 2016

## IMPORT OF MEDICAL DE VICES AND IMPLANTS

## 634. DR. HEENA VIJAYKUMAR GAVIT:

SHRIMATI VANAROJA R.:

SHRI ARVIND SAWANT:

SHRI DHANANJAY MAHADIK:

SHRI KRUPAL BALAJI TUMANE:

SHRIMATI BHAVANA PUNDALIKRAO GAWALI PATIL:

SHRI MOHITE PATIL VIJAYSINH SHANKARRAO:

SHRIMATI SUPRIYA SULE:

SHRI Y.V. SUBBA REDDY:

SHRIMATI V. SATHYA BAMA:

SHRI T. RADHAKRISHNAN:

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

- (a) whether over a third of patients suffer from heart valve disease among all heart diseases, if so, the details thereof;
- (b)  whether  India  imports  75  per  cent of  its medical  device  requirements particularly  in cardiovascular  surgery  and the  heart  patients  are  forced  to  pay  lakhs of  rupees  for  imported valves, if so, the details thereof and the reaction of the Government thereto;
- (c) whether the Maximum Retail Price (M RP) is written the medical devices/ equipment used for cardio/ orthopedic surgery, if so, the details thereof and if not, the reasons therefor;
- (d) whether any core committee of the Government has recommended that the prices of m edical devices including ca rdiac stents and implants be capped; and
- (e) if so, the details thereof along with the time by which the said recommendations would be implemented along  with  the  other  steps  taken/being  taken by he  Government  to  bring  in  a stringent pricing regime so as to bring cap on prices of stents implants other medical devices etc.?

## THE MINISTER OF HEALTH AND FAMILY WELFARE

## ANSWER (SHRI JAGAT PRAKASH NADDA)

- (a): Globally, diseases of heart valve constitute a major cause of cardiovascular morbidi mortality  with  rheumatic  heart  disease  being  the  dominant  Valvular  Heart  Disease  (VHD) developing countries including India.  Indian Council of Medical Research ( ICMR) has informed that as per experts, around 15 - 20%  of  total  patients attending the hospitals with heart disea suffer from VHD.

(b) : A position paper published by Federation of Indian Chambers of Commerce & Industry (FICCI) (2014 - 15) informs that Indi an medical device industry is primarily import driven with imports contributing close to 75% of the market.  Medical electronics and Hospital equip and  surgical  instruments  form  more  than  50%  of  sale  with  87%  being  imported  as  per document on 'Rec ommendations of Task Force on the Medical Devices sector in India - 2015'.

As informed by Department of Pharmaceuticals, the Government of India had taken u the issue with leading manufacturer of stents to reduce the prices voluntarily.  As an one  manufacturer  has  reduced  the  prices  of  coronary  stents  by  10%.    Further, a  few  other manufacturers  have  informed  that  there  has  been  substantive  reduction  in  prices  of  co stents manufactured by them.

(c): As informed by Drug Controller General of India, the Drugs & Cosmetics Act and Rule there under do not mandate that maximum retail price (MRP) should be indicated on the label.

(d) & (e): No such recommendation has been made by the Core Committee on National List of Essential Medicines (NLEM).