In a decisive move to tighten quality assurance across the pharmaceutical sector, the Union Ministry of Health and Family Welfare has proposed key amendments to the Drugs Rules, 1945. The draft rules mandate that drug manufacturers formally designate and authorise qualified, experienced personnel specifically responsible for the batch release of medications.
While existing manufacturing licenses require technical staff details for production and testing, current regulations lacked an explicit provision naming the individual accountable for final batch clearance. Under the proposed framework, makers must maintain rigorous batch-release records and issue certificates in a newly prescribed standard format.
This critical checkpoint ensures that every medicine undergoes an exhaustive review of quality parameters and documentation before entering the distribution chain. By fixing clear individual responsibility and reinforcing Good Manufacturing Practices (GMP), the amendments aim to elevate product safety and regulatory oversight nationwide. The Ministry has invited public objections and suggestions on the draft proposals submitted to the Under Secretary for Drugs Regulation in New Delhi.
India Sets Sights on Equitable Climate Finance and Action Ahead of COP31
Sponsored
Nurturing Creativity – Keekli Charitable Trust, Shimla
