Question : Categorisation of Medical Devices

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether the Department of Pharmaceuticals has asked medical device associations, healthcare industry bodies and relevant regulatory agencies to help in categorizing the medical devices and if so, the aims and objectives thereof;

(b) whether the Government proposes to fix the trade margins of distributor and retailer on medical devices and if so, the details in this regard;

(c) the time by which the medical devices are likely to be categorised; and

(d) the further steps taken/being taken by the Government to bring down the prices of medical devices?

MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a): Yes, Madam. The purpose is to segmentize the medical devices so as to have different trade margins for various categories of medical devices for different segments considering the vast diversity and the logistics required in delivering them to the patients.

(b) & (c): Industry has proposed that the total trade margins for medical devices could be capped to make quality medical devices affordable. Discussions on the issue with industry resulted in the need for categorization. However, there has been no consensus on the issue.

(d): To bring down the manufacturing cost for indigenous medical device industry, the Government has proposed a sub-scheme for “Assistance to Medical Device Industry for Common Facility Centres” under the umbrella scheme for Development of Pharmaceuticals Industry. However, no budget allocation has yet been made for the proposed scheme.

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