Biological Drugs

Last Updated on January 21, 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:

  1. Submitting Form-5F (Common Technical Document) under SRO 713 for new drug product and generic drug products
  2. Priority consideration for drugs of public health emergency (Classes of drugs under priority review)
Registration Process

Registration procedure contains scientific review in order to ascertain quality, safety and efficacy of applied biological drug for registration.

This procedure is described in registration procedure for biological drugs.