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BIO India Hosts Biopharmaceutical Regulatory and Policy Roundtable

September 17, 2012
During last week’s BIO India International Conference, BIO, in partnership with the Association of Biotech-Led Enterprises (ABLE) and the Confederation of Indian Industries (CII) held a roundtable to discuss ways that U.S. and Indian industry can work together to facilitate the development of new biotechnology products and commercialization.

Participants in the roundtable represented U.S. and Indian industry, academia, and government and shared their views on critical issues important to the development of the Indian biotechnology sector, including intellectual property, R&D collaboration, and regulation of biotechnology products.

Key findings included:

R&D Collaboration

  • Success in biotechnology collaboration requires:

    • Shared risk

    • Shared incentives

    • Shared rewards

  • Importantly, in collaborations involving U.S. and Indian partners, there should be a balance of risks and rewards by both sides, recognizing that each provides key contributions to the partnership, and each wishes to minimize risks while maximizing rewards.

  • To enable R&D collaborations, it is necessary to have a legal framework for translating discoveries into products and creating incentives for those who are willing to take on the necessary risks.

Biosimilars Regulations

  • India’s Drugs Controller-General has recently issued new guidelines for biosimilars regulations.  These guidelines are generally accepted to be well-crafted and science-based, but need continued refinement over time.  Industry and other stakeholders should provide feedback to the Indian government in its application of these regulations.

  • Regulations should not be so onerous as to make innovative products or biosimilars unaffordable to Indian patients.

  • The first priority is to streamline and rationalize the necessary clearances in order to eliminate unnecessary processing delays.

Intellectual Property

  • Recent legal developments in India have raised key questions that will impact the biotechnology industry, particularly the development of new, innovative products for Indian consumers. These issues, including compulsory licensing, will be explored in future discussions.

  • Biotech product R&D and commercialization is a capital-intensive endeavor, which requires both incentives such as intellectual property rights to develop these needed products and a system for providing them to those who need them.

Through the BIO India International Conference, the BIO International Convention and ongoing advocacy efforts, BIO aims to help the industry flourish within India's borders and help patients and citizens benefit from the promise of biotech.

To learn more about BIO India and BIO’s advocacy efforts please visit