Proposed Amendments to Drugs Rules, 1945
Ministry of Health and Family Welfare · Governance · Posted 03 NOV 2026 6:43PM
What happened
The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to mandate drug manufacturers to formally authorise qualified personnel for drug batch release and maintain prescribed records for every batch. The move aims to strengthen accountability, ensure traceability, and reinforce quality assurance in pharmaceutical manufacturing.
Why it matters for UPSC
This development is important for the UPSC syllabus under government policies and interventions in health and governance, illustrating regulatory measures to ensure drug quality and accountability in pharmaceutical manufacturing.
Key objectives
- Mandate drug manufacturers to formally authorise a qualified and experienced person for batch release.
- Require maintenance of prescribed records and introduce a prescribed format for the Batch Release Certificate.
- Establish clear responsibility, ensure traceability of decisions, and strengthen compliance with Good Manufacturing Practices (GMP).