Key Points
New Delhi: Three of the key government departments involved in free trade agreement (FTA) negotiations with European countries appear to be not on the same page on provisions under discussion that directly relate to pharmaceutical products, ThePrint has learnt...
Last month, at least two meetings as part of the negotiations with the EFTA were held where representatives of the Department of Industry and Internal Trade Promotion (DPIIT) under the Union Ministry of Commerce and Trade, the Ministry of Health and Family Welfare, and the Department of Pharmaceuticals (DoP) were present.. Representatives of the Organisation of Pharmaceutical Producers of India (OPPI), which represents multinational drugmakers, and the Indian Pharmaceutical Alliance (IPA), a network of research-based Indian pharma companies, were also invited for the meetings...
A second official present in the meetings told ThePrint that the reservations expressed by some government departments on the proposed clauses are on the grounds that they will hamper patients access to life-saving drugs, and also hurt the local pharmaceutical industry...
Explaining its implications, a health ministry official said the Central Drugs Standard Control Organisation (CDSCO) at present does not recognise the Patents Act, and approves bridging studies and market authorisation even for drugs under patent to non-innovative companies based on the scientific evidence.. Once the regulatory data protection system is introduced in India, this could change, the official added...
OPPI expressed its support for creation of an innovative ecosystem in the country and sought to clarify that RDP is not just for MNC pharma companies but it will particularly help in spurring innovation in AYUSH, phyto-products that are not permitted patent protection under the Patents Act, 1970, as investments in development of products that do not otherwise qualify for patents, can also benefit from market exclusivity for a certain period, said OPPI director general Anil Matai...
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