Monday, November 3, 2008

Biotechnology Regulations in India: Progress-so-far

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. Under the topic of regulatory mechanisms, the National Biotechnology Strategy recommended “a competent single National Biotechnology Regulatory Authority be established with separate divisions for agriculture products/transgenic crops, pharmaceuticals/drugs and industrial products; and transgenic food/feed and transgenic animal/aqua culture. The authority is to be governed by an independent administrative structure with common chairman. The inter-ministerial group will evolve suitable proposals for consideration of the government.”

The National Biotechnology Development Strategy was approved by the Government of India in November, 2007 after a two year consultation period with multiple stakeholders including concerned ministries, universities, research institutes, private sector, civil society, consumer groups, non-government and voluntary organizations and international bodies. As regards the regulation of biotechnology, the Strategy states that the NBRA will be established as an “independent, autonomous and professionally led body to provide a single window mechanism for biosafety clearance of genetically modified products and processes”. DBT has been given the responsibility to set up the NBRA and until such time as the NBRA is fully functional, biotechnology regulation will continue under the existing regulatory framework.

The NBRA will be an independent, autonomous, statutory agency established by the Government of India to safeguard the health and safety of the people of India and to protect the environment by identifying risks posed by, or as a result of, modern biotechnology, and managing those risks through regulating the safe development and deployment of biotechnology products and processes. GM foods are regulated by the Food Safety and Standards Authority under the Food Safety and Standards Act, 2006 (FSSA, 2006). Product safety, efficacy, clinical trials and market authorization of recombinant drugs are regulated by the Drug Controller General of India (DCGI) under the authority of the Drugs and Cosmetics Rules 1945 (Rules, 1945) of the Drugs and Cosmetic Act 1940. The NBRA would be responsible for the GM food safety assessment and any subsequent authorization of the GM food as safe, all other rules and regulations that pertain to food (e.g., conventional safety provisions related to adulterants, extraneous matter and unhygienic/unsanitary processing or manufacturing of food) would still apply to the GM food as regulated by the FSSA and any other authority in India. The NBRA will also be responsible for regulating genetically modified organisms with applications in human and veterinary health and a sub-set of products derived from these. This will include the regulation of recombinant biologics such as DNA vaccines, recombinant gene therapy products, recombinant and transgenic plasma derived products like clotting factors, and veterinary biologics but will exclude all other therapeutic proteins derived from recombinant organisms, which will continue to be regulated by the DCGI.

In order to establish and empower the NBRA, DBT is considering promulgating new legislation, “National Biotechnology Regulatory Act (NBR Act)”. Elements of biotechnology regulation are currently spread over multiple acts and some of these would be amended to establish and operate the NBRA. Drafting new legislation would provide an opportunity to consolidate and enhance the efficiency and effectiveness of biotechnology regulation, increase collaboration with state governments in this area, promote public confidence in the regulatory system, and facilitate international trade.

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