An Exim Bank study “Indian Pharmaceutical Industry: Challenges and Prospects” has noted that although the Indian pharmaceutical industry acquired a noteworthy position in the global pharma sector, there are various challenges faced with regard to the changing regulatory environment and slowdown in trade. The Study highlighted that the Trans Pacific Partnership Agreement (TPP) and the Transatlantic Trade and Investment Partnership (TTIP) Agreements are likely to have serious implications for the Indian pharmaceutical industry, and could materially affect the Indian generic industry.

Moreover, the Pharmaceutical Inspection Co-operation Scheme (PICS) regulatory environment is envisaged to be a vital challenge for the India pharma industry, particularly the MSME pharma segment, as they would have to invest significantly to upgrade their facilities to be at par with the harmonized GMP framework of the PICS.

The first copy of this report was presented to Rita A. Teaotia, commerce secretary, ministry of commerce & industry, government of India, at New Delhi on August 31, 2016.

The Study pinpoints other hurdles in the growth of the pharma sector which include shortage of skilled manpower, issues related to intellectual property rights in the pharma sphere and credibility of clinical trial data, over dependence on China for bulk drugs and APIs, and the need for intensifying research and development activities of the pharma companies.

To alleviate the growth constraints, the Study has recommended strategies to enhance the potential of this sector which include among others, addressing the issues related to good manufacturing practices, and data integrity by way of stronger compliance and better risk management capabilities, addressing unethical practices in clinical research, increasing production of essential drug intermediaries and APIs at competitive prices to attain self-sufficiency, and promoting research and development by way of providing incentives.

According to the Study, Indian pharmaceutical SMEs have bright prospects of growth which must be propelled by making available low cost finance and adequate training and skill development programmes. In this regard, the Study noted that the pharmaceutical SME firms have low to nil participation in IPR activity, and they must be encouraged to undertake new drug discoveries.

The Study also emphasized that Indian pharmaceutical industry’s concerns arising due to the execution of upcoming trade pacts, such as TPP and TIPP may be addressed through diplomatic channels, and additionally, India should pursue other Free Trade Agreements factoring its concerns for trade barriers.