Last Updated on December 2, 2022
Division of Biological Evaluation & Research is responsible for evaluation, assessment, and registration of biologicals for human and veterinary use.
Laws: Biological Drugs are registered in accordance with following laws:
- DRAP Act, 2012 (Schedule I)
- The Drugs Act, 1976
- The Drugs (Licensing, Registering & Advertising) Rules,1976
- The Drug (Specifications) Rules, 1978
- The Drugs (Labeling & Packing) Rules, 1986
You can register biological drugs (for human use) by:
- Submitting Form-5F (Common Technical Document) under SRO 713 for new drug product and generic drug products
- Priority consideration for drugs of public health emergency (Classes of drugs under priority review)
Registration of Biological for Human Use:-
Registration of Biological for Veterinary Use:-