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Pharma units granted 12-month extension for Schedule M compliance
Industry News- Jan 07,25
The extension provides time for MSMEs to secure financing and implement the required changes.
The Union Health Ministry has granted a 12-month extension for pharmaceutical manufacturing units to comply with the revised standards of Schedule M under the Drugs and Cosmetics Act. The new deadline for compliance is December 31, 2025, following requests from industry stakeholders for more time to upgrade their facilities.
Schedule M, part of the 1945 Drugs and Cosmetics Act, defines the Good Manufacturing Practices (GMP) for pharmaceutical production in India, including requirements for premises, equipment, and manufacturing processes. The revision of Schedule M, announced in December 2023, aims to bring India's standards in line with global benchmarks, particularly those set by the World Health Organisation (WHO), to ensure the production of high-quality pharmaceutical products.
To facilitate a smooth transition, a six-month period was initially provided for large manufacturers (with annual turnover above Rs 2.5 billion) and a 12-month period for Micro, Small, and Medium Enterprises (MSMEs) (with annual turnover below Rs 2.5 billion). The original deadline for MSMEs to comply was set for January 1, 2025. However, following requests from industry associations, the Health Ministry has extended the compliance deadline by an additional three months for MSMEs, allowing them to submit plans for facility upgrades and register with the Central Drugs Standard Control Organisation (CDSCO). The revised deadline now stands at December 31, 2025, for all manufacturers.
The extension provides time for MSMEs to secure financing and implement the required changes. After three months, CDSCO will audit the facilities, and action will be taken if the planned upgrades are not executed.
The revised Schedule M aims to elevate India's pharmaceutical manufacturing standards to match global expectations, particularly to meet the WHO's GMP certification criteria. India is a key exporter of medicines to low- and middle-income countries, many of which require WHO-certified products.
The Department of Pharmaceuticals (DoP) has launched the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) to support MSMEs in upgrading their facilities. To date, CDSCO has inspected over 800 manufacturing units and 252 public testing labs, showing progress in implementing GMP standards across the sector.
(The Hindu)
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