Last Updated on November 5, 2026 12:02 am by INDIAN AWAAZ
AMN
The Union Ministry of Health and Family Welfare has notified proposed amendments to Schedule M of the Drugs Rules, 1945, issued on October 28, 2026, to harmonize India’s pharmaceutical manufacturing standards with international World Health Organization (WHO) Good Manufacturing Practices for sterile products.
Key Highlights of the Proposal
- Grade A Area Control: The updated norms focus on high-risk, sterile processing environments (Grade A clean areas) where exposed products, sterilised components, and primary containers are handled.
- Mandatory Investigation: Under the revised framework, detecting any microbial growth within a Grade A zone will automatically trigger a mandatory regulatory and internal investigation.
- Safety & Quality Standards: The regulatory update aims to eliminate contamination risks, enhance quality assurance, and safeguard sterile drug production nationwide.
- Public Consultation: The Ministry has thrown open the draft notification for review, inviting feedback, suggestions, and objections from industry stakeholders and the public.