(a) whether the Government has constituted any Committee headed by Dr. V.M. Katoch regarding the domestic manufacturing of Active Pharmaceutical Ingredients (APIs);
(b) if so, the details of the recommendations of the Committee; and
(c) the steps taken by the Government on the recommendations and the outcome of their implementation, if any?
MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)
(a): Yes, Madam.
(b): The Committee has submitted its recommendation which inter-alia mentions establishment of Mega Parks for APIs with common facilities such as common Effluent Treatment Plants (ETPs), Testing facilities, Captive Power Plants / assured power supply by state systems, Common Utilities/Services such as storage, testing laboratories, IPR management, designing, guest house/accommodation, etc., maintained by a separate Special Purpose Vehicles (SPV); a scheme for extending financial assistance to states to acquire land and also for setting up common facilities; revival of public sector units for starting the manufacturing of selected and very essential critical drugs (e.g. penicillins, paracetamol etc.); financial investment from the Government for development of clusters which may be in the form of a professionally managed dedicated equity fund for the promotion of manufacture of APIs and extending fiscal benefits to creation of the entire community cluster infrastructure and individual unit infrastructure; extension of fiscal and financial benefits to promote the bulk drugs sector; promoting stronger industry-academia interaction, synergising R&D promotion efforts by various govt. agencies; incentivising scientists, duty exemptions for capital goods imports.
(c): After examining the recommendations, Government at present is now looking into the financial viability of supporting the proposal for providing assistance for common minimum facilities for 03 Greenfield Bulk Drugs/ API Parks to the extent of Rs. 200 cr each. Besides this, the Department in association with Ministry of Environment, Forests & Climate Change and Ministry of Commerce & Industry are sorting out the issues relating to the difficulties being faced by the Bulk Drug Manufacturers relating to Environmental issues.
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