In partnership with the Association of Biotechnology Led Enterprises (ABLE) and PricewaterhouseCoopers'(PwC), the Department of Pharmaceuticals has prepared a strategic vision document on biopharma, aiming to make India a leader in the sector in the next 20 years through different initiatives.

The Vision 2020 Biopharma Strategy, released here recently, has detailed the measures for the industry and the government to work towards making India one of the five toppers in the sector and grab 10 per cent of the expected 319 billion dollar global market by 2020, from the current share of 1.4 per cent in the US$ 137 billion market at present. It has also set a target of churning out at least 10 biopharma products by 2020 in the domestic sector and two of them in the global arena.

However, the strategic document said the country would need to spend another one billion dollar in the next ten years to achieve the goal and called for joint efforts by the industry and the government. One of the key recommendation of the paper is simplification of the regulatory framework. Creation of independent inspection facility and modification of the regulations on process verification have also been included as recommendations.

"The approvals procedure is very cumbersome. In most countries, a single central body is responsible for reviewing data from animal studies and granting permission to start clinical trials. In India, by contrast, there multiple bodies like DCGI, Genetic Engineering Approval Council, Recombinant DNA Advisory Committee, Review Committee on Genetic Manipulation, Institutional Biosafety Committee and many more at State and district levels. The government should therefore review and rationalise the roles of these bodies and streamline and simplify the approval procedure," the paper said.

Other recommendations in research area included building of protein characterisation laboratories, GLP certified animal study facilities, creation of a national animal breeding facility, expansion of viral testing facilities, financial assistance for ensuring compliance with global standards, promotion of development of pre-clinical service providers, practical support for clinical trials and simplification of the procedures for importing and exporting biologicals.

Under the manufacturing and commercialisation heading, the paper wanted a single-window clearance for approvals and clearances. Introduction of flexible pollution controls, investment in better transport links and cold chain facilities, and fiscal incentives to those into ancillary products like heating and water systems are the other recommendations.

The vision document also called for improving human capital in the sector. Expansion of capabilities in toxicity studies, trilateral relationship between industry, academia and the government, expansion of the workforce development pipeline, introduction of exchange programmes and scholarships, public awareness about career opportunities in the sector, and more training to the existing employees are other suggestions.

Provision of seed funding for innovation, construction of biotechnology clusters, promotion of translational research, and provision of financial support to specific areas are the steps mooted to boost the innovation. Another important area of care, as per the document, is the intellectual property rights. Besides, it also called for creation of a framework for intelligent regulation for the future.