Biologicals

Last Updated on May 5, 2026

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

1. Licensing Process

• Guidance on Establishment of Pharmaceutical Unit, Application Process for Drug Manufacturing License and Post License Changes

2. Registration Process

• Guidance Document for Submission of Application on Form 5 F (CTD) for Registration of Biological Products for Human Use
• Guidance Document For Submission Of Application for Registration of rDNA therapeutic Proteins

3. Post Approval Variation of Drugs

• Guidance Document For Post Registration Variation of Pharmaceutical and Biological Products

4. Reliance Mechanism

• Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices

5. Lot Release of Biologicals

• GUIDELINE FOR LOT RELEASE OF BIOLOGICAL DRUGS

6. Appeals Against Regulatory Decisions

• Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)