Pharmaceutical Industry in Post TRIPS period:Changing Perspectives. A case study of north west region of India

      Аннотация: After India became a founder member of WTO and accepted the TRIPS agreement, It was apprehended that introduction of pharmaceutical product patents would have a negative impact on the Indian pharmaceutical industry by hampering its growth as the industry would no longer be able to manufacture by reverse engineering or export drugs whose product patents are in effect. However, the stronger patent regime proved a blessing in disguise for the Indian pharmaceutical industry. Contrary to expectations, the Indian pharmaceutical industry has shown a remarkable growth in Exports & R&D. The industry is also leading in DMF filings & ANDA filings with USFDA, a field which was not attended hitherto by the Pharmaceutical firms. The present study discusses the implications of product patents for the Indian pharmaceutical industry both at industry level and at firm level. Different databases have been used for industry level analysis as well as for the analysis of large scale firms, whereas primary data has been used to analyse the small scale firms. The Indian pharmaceutical firms’ responses provide important insights which have implications for firms from other developing countries.

Ключевые слова: Patents, WTO, TRIPS, Intellectual Property Rights, GMP, Pharmaceutical Industry of India, DPCO, Schedule M, DMF Filings with USFDA, ANDA Filings, ANDA approvals