Question : Import of Medical Devices and Implants

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 (MRP) 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 medical devices including cardiac 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 the Government to bring in a stringent pricing regime so as to bring cap on prices of stents implants other medical devices etc.?

ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE
(SHRI JAGAT PRAKASH NADDA)
(a): Globally, diseases of heart valve constitute a major cause of cardiovascular morbidity and mortality with rheumatic heart disease being the dominant Valvular Heart Disease (VHD) in 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 disease suffer from VHD.

(b): A position paper published by Federation of Indian Chambers of Commerce & Industry (FICCI) (2014-15) informs that Indian medical device industry is primarily import driven with imports contributing close to 75% of the market. Medical electronics and Hospital equipments and surgical instruments form more than 50% of sale with 87% being imported as per the document on “Recommendations of Task Force on the Medical Devices sector in India – 2015”.
As informed by Department of Pharmaceuticals, the Government of India had taken up the issue with leading manufacturer of stents to reduce the prices voluntarily. As an outcome 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 coronary stents manufactured by them.
(c): As informed by Drug Controller General of India, the Drugs & Cosmetics Act and Rules 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).