Last Updated on September 28, 2023

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Biological products.

1. Drug Manufacturing License

Guidance on Establishment of Pharmaceutical Unit, Application Process for Drug Manufacturing License and Post License Changes
English ( 591 KB – PDF)

2. Registration Process

Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use
English ( 568 KB – PDF)

Guidance Document For Submission Of Application for Registration of rDNA therapeutic Proteins
English ( 228 KB – PDF)

3. Post Approval Variation of Drugs

Guidance Document For Post Registration Variation of Pharmaceutical and Biological Products
English ( 735 KB – PDF)

4. Reliance Mechanism

Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)

5. Lot Release of Biologicals

English ( 831 KB – PDF)

6. Appeals Against Regulatory Decisions

Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)