The proposed formation of National Biotechnology Regulatory Authority (NBRA) is set to take away some powers of from the Drug Controller General of India (DCGI) on recombinant vaccines and Food Safety and Standards Authority. NBRA formation will also lead to disbanding of the Genetic Engineering Approval Committee (GEAC).
"The NBRA will 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. These will continue to be regulated by the DCGI,'' according to the draft Bill prepared by the Department of Biotechnology to set up the NBRA.
The National Biotechnology Regulatory Act, aimed at setting up the NBRA, seeks to amend the Drugs and Cosmetics Rules (8th Amendment) 1988 to exclude recombinant pharmaceuticals from the jurisdiction of the DCGI. Besides it seeks to amend a host of existing legislations to take away some powers from the FSSA and leaving many existing organisations redundant.
"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,'' the Bill says.
The NBRA would be led by an eminent biotechnologist in the full-time position of chairperson and he will hold the rank of Secretary. He will be supported by two advisory bodies. The Inter-Ministerial Advisory Board (IMAB) will promote inter-ministerial and departmental coordination and cooperation as regards the implementation of India's national biotechnology regulatory system. The second body, the National Biotechnology Advisory Council (NBAC), will address overarching policy-related issues that may affect the regulation of biotechnology.
The agency will have three regulatory branches. One will be for agriculture, forest and fisheries, second will be for human and animal health while the third will be for industrial and environmental application and each of the branches would be headed by a chief regulatory officer.
The human and animal health branch will regulate genetically modified organisms with applications in human and veterinary health. This will include the regulation (i.e., clinical trials, pre-commercial safety assessment, product approval, post-release monitoring) of recombinant biologics (e.g., DNA vaccines, recombinant gene therapy products, and recombinant and transgenic plasma derived products like clotting factors) and veterinary biologics.
"The DCGI will regulate all other therapeutic proteins derived from recombinant organisms. Where there are combination products comprised of a biological product component with a device and/or drug component they will be assigned to an authority for review and regulation in accordance with the products' primary mode of action. When a product's primary mode of action is attributable to a type of biological product assigned to NBRA, the product will be assigned to NBRA. Similarly, when a product's primary mode of action is attributable to a type of recombinant product assigned to DCGI, the product will be assigned to DCGI,'' the Bill explained.