Health Ministry Mulls Extension for Pharma Firms to Comply with Revised Schedule M GMP Norms
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New Delhi: The Union Health Ministry is holding discussions with state governments and drug regulatory authorities to consider granting additional time to certain pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) norms prescribed under Schedule M of the Drugs and Cosmetics Rules.
according to a recent media report in The Economic Times, the move comes amid concerns that a section of the domestic pharmaceutical industry, particularly small and medium-sized manufacturers, is facing challenges in meeting the stricter quality standards within the existing deadlines.
The revised Schedule M norms mandate higher benchmarks for pharmaceutical manufacturing, covering aspects such as quality management systems, upgraded infrastructure, documentation, risk management, and quality control processes. These changes were introduced to align India’s drug manufacturing ecosystem with global quality standards and improve patient safety. The implementation timelines were notified in a phased manner based on the size and scale of manufacturing units.
Officials familiar with the deliberations stated that the ministry is exploring the option of providing conditional extensions to companies that have shown genuine intent and progress towards compliance. Any additional time, if granted, is likely to be linked to strict monitoring and time-bound action plans, ensuring that quality standards are not compromised while allowing manufacturers to complete necessary upgrades.
Industry representatives have raised concerns that rigid enforcement of the revised GMP deadlines could lead to the closure of a large number of small and mid-sized drug units, which may disrupt the supply of essential medicines and impact employment in the pharmaceutical sector. They have urged the government to adopt a more pragmatic approach by offering extensions to firms that are actively upgrading facilities but require more time due to financial and operational constraints.
At the same time, government officials have maintained that public health and drug quality will remain non-negotiable. Any relaxation in timelines would not amount to dilution of standards, but rather a calibrated approach to ensure compliance without triggering unintended disruptions in drug availability, reports The Economic Times.
