The bill to bring in a comprehensive National Biotechnology Regulatory Act and to establish the National Biotechnology Regulatory Authority of India was finally presented in the Parliament last week after three years of consultations and debates. The objective of the Bill, drafted by the Department of Biotechnology, is to regulate research, import, transport, use of organism and products made from modern biotechnology through this Authority. The Bill seeks to make the NBRA as an autonomous and statutory agency to safeguard the health and safety of the people and to regulate the safe development and deployment of biotechnology products and processes in the country. The Authority will have overriding powers on matters related to the development and deployment of biotechnology products and processes in the country. NBRA will streamline the process of regulatory approval for biotech products through a single window agency. As biotech products are more complex than the chemical drug molecules, more specialized information needs to be considered during the approval process to decide whether they are safe, efficacious and suitable for human use.
Considering the need to ensure high level of safety and efficacy of biotechnological products, the government has been following a rigorous quality control system and enforcement mechanisms so far. Currently, safety assessment and commercialization of biotech products is regulated by two key committees under the Environment (Protection) Act of 1986 and the Rules 1989 namely Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology and Genetic Engineering Approval Committee in the Ministry of Environment & Forests. And the recombinant pharma products are regulated under EPA as well as Drugs & Cosmetics Act 1940 and Rules 1945. Biotech industry has been experiencing long delays in getting approvals on account of the multiplicity of these technical agencies of the government in getting clearances. With the establishment of NBRA, the regulatory approval pathway for biotech products should be well defined. For the biotech industry of the country such an exclusive regulatory pathway is extremely necessary for product development as it can remove uncertainty in terms of timelines to market and in obtaining final product approval. Biotech is a high technology sector which can deliver advanced drugs, high quality food products and efficient agriculture technology with lower costs. Now the officials of the DBT and other departments have the responsibility to facilitate the formation of NBRA once the Bill is passed in the Parliament. Bureaucratic delays should not hold up or delay its establishment as is the case with well intended initiatives.