With the country witnessing a boom in the sector, the Department of Biotechnology is in the process of setting up an independent National Biotechnology Regulatory Authority (NBRA) to ease the present multi-level clearance system and help the players in getting the clearance done without long delays.
The DBT, entrusted by the Government to function as the administrative department in establishing the NBRA, is holding consultations with various stakeholders and the relevant procedures are being followed for obtaining proper approvals. However, it is not yet clear when the authority will be in place, sources in the DBT said.
The authority is expected to bring relief to the players in the booming sector, hit by long time-consuming regulatory approvals. Multiple regulatory system, in the absence of a single framework and policy, has been a bane for the biotech sector which is growing at 40 per cent, and it also proved a deterring factor for new players.
"The NBRA will be an effort to streamline and simplify the approval process. Biotechnology will be a major growth sector for us as Indian competitive advantage is increasingly evident. An appropriate policy and regulatory framework can be beneficial to the biotech industry as well as to the Indian society that directly benefits from the biotechnology," said a DBT official.
Citing the reasons like ensuring of high level of safety and efficacy of biotechnological products, there is a rigorous quality control system and enforcement mechanisms in place. Currently, safety assessment and commercialisation of biotech products is regulated by various committees under the Environment (Protection) Act 1986 and the Rules 1989 viz Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology (DBT), Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment & Forests (MoEF). Also, the recombinant pharma products are regulated under EPA as well as Drugs and Cosmetics Act 1940 and Rules 1945.
Industry players on the other hand were experiencing long delays in getting approvals and the sector on the overall was in turn was suffering, due to the technicalities and clearance mechanism by the Government.
It may be recalled that the MoEF and Ministry of Agriculture (MoA) constituted two expert Committees under Dr R A Mashelkar for recombinant pharma products and Prof M S Swaminathan for agriculture biotechnology products. Both the panels recommended a single authority. As a follow-up of the recommendations, MoA submitted a Cabinet Note for establishing NBRA. Subsequent deliberations on the note by the Committee of Secretaries (COS), the Prime Minister's office has directed DBT to function as the administrative department for setting up of NBRA.