Centre Consults States on Extending GMP Compliance Timeline for Pharma

The Union Health Ministry is in discussions with state governments on the possibility of granting additional time to certain pharmaceutical manufacturers to comply with revised Good Manufacturing Practices (GMP) norms under Schedule M of the Drugs and Cosmetics Act. The move reflects concerns that strict enforcement of deadlines could disrupt drug supply and affect smaller manufacturing units across the country.

The updated Schedule M guidelines, notified in December 2023, introduced tighter pharmaceutical manufacturing standards covering quality control, infrastructure, documentation, and risk management, aligning India’s regulatory framework more closely with global benchmarks. Under the revised norms, large drug companies with annual turnover above ?250 crore were required to comply by mid-2024. MSME pharma companies were initially given time until January 1, 2025, which was later extended to December 31, 2025, following sustained industry representations.

Despite this extension, officials acknowledge that many manufacturers are still upgrading facilities, validating processes, and mobilising capital to meet the new requirements. The Centre is therefore consulting state drug regulators on whether limited, conditional extensions can be granted to companies that show verified progress and submit time-bound compliance plans under GMP compliance rules.

Industry associations have cautioned that immediate enforcement could lead to shutdowns of several small and mid-sized units, affecting employment and the availability of essential medicines. Such disruptions could impact both the domestic market and India pharma exports, particularly to developing countries that rely heavily on Indian generics. Estimates indicate that a sizeable portion of smaller units remains short of full compliance with drug quality standards.

Government officials have reiterated that there will be no dilution of quality norms. Any GMP deadline extension, if approved, would be selective, closely monitored, and linked to measurable milestones. The objective, officials say, is to strengthen drug manufacturing compliance while preventing shortages and maintaining stability in the pharma industry regulations framework.

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A final decision is expected after consultations with state authorities, keeping public health priorities at the centre of the policy approach.