Pharmaceutical Drugs

Last Updated on January 21, 2022

Division of Pharmaceutical Evaluations & Registration (PE&R) is responsible for evaluation, assessment, and registration of pharmaceutical drugs for human and veterinary use.  

PE&R Division performs following regulatory functions for locally manufactured and imported drug products:-

  1. Pre-marketing assessment / evaluation of drugs
  2. Registration of Pharmaceutical drugs
  3. Renewal of registered pharmaceutical drugs
  4. Post registration variation of pharmaceutical drugs

Laws: Drugs are registered according to provisions of following laws:

  • DRAP Act, 2012
  • 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 pharmaceutical 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 Procedure

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