India’s Department of Biotechnology recently drafted the National Biotechnology Regulatory Bill, with a corresponding regulatory authority. The NBRA will be an autonomous, independent body providing biosafety clearance of genetically modified products and processes.
The draft proposes NBRA being responsible for regulation of recombinant biologics, such as DNA vaccines, recombinant gene therapy products, and veterinary biologics. However, the Drug Controller General of India (DCGI) under the Centre of Drug Control Organization will continue to regulate therapeutic proteins from recombinant organisms. Combination products with both a genetically engineered biological and drug component will be regulated based on the products’ primary mode of action. Therefore, it may be regulated by the NBRA or the DCGI.
Currently, biotech-related products are regulated under the following regulations:
- Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells, 1989 issued under Environment (Protection) Act, 1986
- Drugs and Cosmetics Rules (8th Amendment), 1988
- Plant Quarantine (Regulation for Import into India) Order 203
- Seeds Bill, 2004
- Food Safety and Standards Act, 2006
The NBRA will be responsible for regulating the research, manufacture, importation and use of genetically engineered organisms and products. It will be responsible for setting up clinical trial regulations, fees for product registration, and also serve as the main point of contact for international activities relating to biotech regulations. In addition, it will notify the public of all applications for registration, clinical trials, and all regulatory decisions made.
In terms of structure, the Authority shall have at least three regulatory branches:
- Agriculture, Forest and Fisheries Branch
- Human and Animal Health Branch
- Industrial and Environmental Applications Branch
DNA vaccines intended to induce or increase an antigen specific immune response for immunization and vaccines for use in humans containing living genetically engineered organisms will be regulated by the Human and Animal Health Branch. This branch will also regulate recombinant blood and plasma derived products, and also recombinant gene therapy products such as nucleic acids and viruses.