Drug manufacturers seeking an extension for implementing the revised Schedule M standards must conduct a gap analysis and submit a detailed application to the drug regulatory authority, outlining their compliance strategy, according to a new notification issued on Tuesday.
Small and medium-sized enterprises (SMEs) with an annual turnover of less than ₹250 crore can apply for an extension by submitting an upgradation plan within the next three months, the Drug Regulatory Authority announced. “These companies will be required to comply with the revised Schedule M norms according to the plans they submit,” a senior official confirmed.
Under the notification, the director, proprietor, or partner of a company must provide a gap analysis report along with an undertaking to initiate the upgradation process within three months of filing the application. Companies must also justify the requested timeline for full compliance.
Small manufacturers now have until December 31, 2025, to meet the revised Schedule M requirements, with applications to be filed online with the Central Licence Approving Authority. Further, the drug rules will soon be amended to allow an additional one-year extension if necessary.
The revised Schedule M, which enforces stricter quality control measures in pharmaceutical manufacturing, was first notified in January 2024. Companies with annual turnovers above ₹250 crore were required to comply by July 1, 2024, while MSMEs faced a deadline of January 1, 2025. However, several MSMEs requested more time to align their facilities with the new standards.
In response, the Ministry issued a draft notification proposing to extend the compliance deadline for smaller manufacturers and invited public feedback by January 11. “The feedback was consolidated, and the final draft was submitted to the Department of Legal Affairs for review,” a source said.
Pharma industry groups have been advocating for a two-year extension, citing the significant time required for infrastructure upgrades, workforce expansion, and staff training. The Federation of Pharma Entrepreneurs (FOPE) also appealed to the drug regulator, emphasizing the challenges MSMEs face in meeting the revised Schedule M within the earlier timelines.
