India’s biotechnology regulatory system has experienced a number of changes since the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (Rules, 1989) were first notified under the Environment (Protection) Act, 1986, including the elaboration of aseries of guidance documents published by the Department of Biotechnology (DBT) in 1990, 1998 and 1999. The extraordinary growth of the Indian biotechnology sector has significant implications for policy in the area of regulation, and two specific reports were commissioned by the Ministry of Agriculture and the Ministry of Environment and Forests to evaluate the regulatory framework for products of agricultural biotechnology and recombinant pharmaceuticals, respectively.

The 2004 Report of the Task Force on the Application of Agricultural Biotechnology chaired by Prof. M.S. Swaminathan recommended the establishment of an “autonomous, statutory and professionally-led National Biotechnology Regulatory Authority” (NBRA) that would have “two separate wings – one dealing with food and agricultural biotechnology, and the other with medical and pharmaceutical biotechnology.” The Report recommended that the “NBRA is essential for generating the necessary public, political, professional and commercial confidence in the science based regulatory mechanism in place in the country.”

The 2005 Report of the Task Force on Recombinant Pharma chaired by Dr. R.A. Mashelkar similarly supported the establishment of a National Biotechnology Regulatory Authority/Commission “providing a professionally managed single window mechanism for giving various clearances including biosafety issues.” A model for the NBRA was proposed that “would comprise of four wings namely: a) Agricultural products / Transgenic Crops; b) Pharmaceutical/ Drugs and Industrial Products; c) Transgenic Foods/Feed; and d) Transgenic Animals/ Aquaculture” and that “alternate models of how a National Biotechnology Regulatory Authority can be created also needs to be examined.” The Mashelkar Report additionally provided a series of recommendations to streamline the existing regulatory system for recombinant pharmaceuticals until the feasibility of establishing a NBRA could be evaluated.

In 2005, DBT published a draft National Biotechnology Development Strategy which elaborated a ten year vision for the future of biotechnology in India. Key policy recommendations and approaches to implement these were established through a process of multi-stakeholder consultations that focused on cross-cutting issues of relevance to allsub-sectors of the biotechnology community.