The participants of US-Indian industry dialogue at BIO (Biotechnology Industry Organization) urged the government of India to focus on efforts to provide clear regulatory guidelines for clinical trials with the input of biotechnology industry. In this regard, the US and Indian industries and other relevant stakeholders agree to jointly develop a white paper which outlines areas of concern as well as recommend measures to ease the difficulties faced by the industry to promote innovation.

After the IT sector revolution in India, the sector that has a tremendous growth potential is biotechnology. If tapped correctly it will give a great boost to the growth of Indian economy. Though the biotechnology industry had started on a triggering note a decade ago, it has faced a lot of problems eventually with regard to the delays in approvals for clinical trials. The main challenge is the regulatory norms which has become a time consuming affair.

Speaking at the Bio India international conference in Hyderabad, Kiran Mazumdar Shaw, CMD, Biocon, said, “We need to get our regulatory frameworks in order. The manner in which the clinical trials are conducted and the time taken for getting approvals for a new drug development has become a big stumbling block for investments in this sector.”

Comparing the delays in approvals in India with that of the US, she said, “In the US pharma companies get clearance within 30 days, while in India this process is more complex and takes any where between 3 months to one year.”

Further she said there is a lack of understanding in the manner in which clinical trials are conducted. There are certain ethical considerations which are not followed. There is a lot of subjectivity involved, instead of following the norms and rules the approval agencies in India are also giving importance to irrelevant issues raised by some NGOs and political parties which is causing a great harm to the future growth of the industry.

Mazumdar Shaw however, commended the government with regard to bringing out the draft guidelines for biosimilars. With regard to the government’s interest to freely allow FDI in pharmaceutical industry, the Biocon chief was not in favour of such a move as it would devalue the sector completely.

The other hurdle faced by the pharma industry is in funding. Venture capitalists still find this sector risky, and hence are refraining from investing in it. “The ecosystem for innovation is still in its nascent stage, and hence there is uncertainty as far as funding is concerned,” said Aaraon Schact, the executive director and COO, Global External R&D, Eli Lilly.

Earlier, Glenn Saldanha, CMD, Glenmark Pharmaceutical said that with increasing costs of drug discovery, research partnerships with multinational companies could be the way forward for Indian pharmaceutical companies. The costs of new drug development between 2005 and 2010 were about $2 billion, 50 per cent higher than what it was between 1999 and 2004.

He said that alliances with Indian companies are going to be crucial for global companies. “As India is a low cost destination in the world, big pharma companies are looking beyond innovation to branded generics,” he said.

Explaining about the huge growth India made during the past one year, BIO executive vice-president Alan Eisenberg said, “the bio-pharma industry in India had grown 25 per cent to $4 billion in 2010 and there was a huge potential.

The BIO is a trade association which represents over 1100 companies, universities and research institutions around the world. Bio’s members focus on developing products and technologies to address challenges in healthcare, agriculture and the environment.

The Association of Biotechnology Led Enterprises (ABLE) is the nodal biotech industry association of India with more than 200 organizations from all segments of biotech as its members. ABLE focuses on the growth of the Indian biotechnology sector by being a platform for all stakeholders to interact and by its advocacy efforts.