Union Ministry of Health Proposes Amendments to Schedule M to Align Grade A Microbial Monitoring Requirements with WHO Guidelines
PIB National (English) · Published 4 November 2026 · Last updated
The Health Ministry will amend Rule 68 of the Drugs Rules, 1945 to mandate qualified personnel for batch‑release under Schedule M, aligning India’s GMP with WHO standards.
Key points
- The Union Ministry of Health and Family Welfare has issued a draft notification proposing amendment of Rule 68 of the Drugs Rules, 1945.
- The amendment seeks to make it mandatory for drug manufacturers to appoint a qualified and experienced authorised person for batch‑release in compliance with Schedule M (GMP).
- Previously, only the Central Licensing Approving Authority (CLAA) or its designee could approve licences for batch‑release; the draft expands authorisation to any suitably qualified individual appointed by the manufacturer.
- The draft notification invites objections and suggestions from stakeholders for 30 days from its publication date.
- The Ministry states the change will strengthen accountability, ensure traceability of batch‑release decisions and add an oversight layer for product quality.
- The amendment is intended to help manufacturers enhance compliance with WHO‑aligned GMP and reinforce the regulatory framework for drug quality assurance.
- The proposal is part of a broader effort to align India’s microbial monitoring (Grade A) requirements with WHO guidelines under Schedule M.
- No financial outlay or specific implementation timeline was disclosed in the draft notification.
Background
- The Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940, prescribe GMP standards through Schedule M.
- WHO guidelines on microbial monitoring (Grade A) set international benchmarks for sterility testing and batch‑release in pharmaceutical manufacturing.
- Earlier, batch‑release authority rested solely with the CLAA, limiting flexibility for manufacturers to appoint internal quality experts.
- Recent FDA and WHO inspections have highlighted gaps in India’s batch‑release documentation and personnel qualifications.
- The Ministry’s move follows multiple stakeholder consultations and recommendations from the Pharmaceuticals and Medical Devices (PMD) Division to modernise GMP compliance.
UPSC relevance, Prelims facts and Mains angle for this issue are in the full SWAदेSH note.
Original report: PIB National (English)