Lack of clarity in norms on clinical trials dogs biotech firms

Tags: Companies
Most biotechnology companies seem to be a worried lot these days owing to the lack of clarity in clinical trials regulation and are seeking robust guidelines that could drop the procedural delays towards research development and commercialisation of drugs in India.

Voicing their opinion at the BIO India summit in Hyderabad, companies represented by Association of Contract Research Organisations and the Association of Biotechnology Led Enterprise along with Biotechnology Industry Organization (BIO) said they have made the initial representation to the Drugs Controller General of India, citing the need for significant efforts towards clear guidelines for clinical trials.

“Biotechnology and pharma is the next big thing in India after IT, in terms of offering economic growth opportunities. While the sector has been a great success story in terms of generics, next huge potential lies in drug discovery. However, concerns about the regulatory affairs and clinical trials which need to be looked upon deter the kind of growth that research and development would have otherwise experienced,” said Kiran Mazumdar Shaw, chairman and managing director of Biocon.

It is said that the typical time consumed for research in India is three to four times of that in US and Europe, often delayed by procedures and protocols. “Many companies today think it is not optimal to conduct trials in India because they eat up too much time by the end of the development stages. Also, the low cost advantage gets negated as the time exceeds more than warranted. Also, most trials have to face with a lot of subjectivity which is uncalled for,” she said.

The other challenge that global companies find is the lack of importance that Venture capitalist and risk capitalists see in investing here. “The stumbling block is not just the regulatory apparatus that supports innovations, but also the fact the ecosystem for innovation is not yet fully formed here as the venture capitalists and capital markets are not supportive too, It is absolutely important to remove this uncertainty,” said Aaraon Schact, executive director and chief operating officer, Global External R&D, Eli Lilly.

BIO is a trade association that represents over 1100 companies, universities and research institutes across the globe. Bio India is an annual conference that brings together companies from US, Europe and Asia with an attempt to explore potential partnerships and collaborations with Indian life science companies.

“Conducting clinical trials is most important for introducing affordable medicines as well as for fostering innovation in developing novel medicines for neglected, chronic and topical diseases in the country. The clinical data could further help tailor make therapiesfor Indian population,” said Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals, adding that the government should be more proactive for sorting out the regulatory concerns and provide for speedy trials.


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