New Delhi : The mega trade deal TPP, which includes the US and 11 other countries, is likely to have "serious implications" on the growth of domestic pharma industry, particularly the generic market, a study said.

According to the report 'Indian Pharmaceutical Industry: Challenges and Prospects', even as the domestic pharmaceutical industry has acquired a noteworthy position in the global markets, there are various challenges faced with regard to the changing regulatory environment and slowdown in trade.

The report was prepared by Exim Bank and has been presented to Commerce Secretary Rita Teaotia.

"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," it said.

The TPP is a trade agreement among 12 countries, including Australia, Brunei, Chile, Canada, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the US and Vietnam.

The agreement has been concluded but is not yet ratified for implementation by the participating countries. TTIP is under negotiations between the European Union and the US.

Further, the study noted that Pharmaceutical Inspection Cooperation 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 harmonised GMP framework of the PICS.

The study also pinpointed other hurdles such as shortage of skilled manpower, issues related to Intellectual Property Rights and credibility of clinical trial data in the growth of the pharma sector.

It also raised concerns 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 the 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.

It also pitched for 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, the 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.

"SME firms have low to nil participation in IPR activity, and they must be encouraged to undertake new drug discoveries," it added.

The study also emphasised that pharma 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 (FTAs) factoring its concerns for trade barriers.