Earlier the government had invited public comments on the draft, citing that the notification will be finalised after considering the public comments received till January 11.
According to a senior government official, as of January 8, no comments had been received.
However, FOPE, which represents the pharmaceutical MSME sector, has now written to the government to extend the deadline till December 31, 2026 instead of the December 31 deadline suggested in the draft.
“Such time is required for existing manufacturers to carry out extensive upgradation as required including arranging finance/additional collateral security, training, implementation etc,” FOPE said in its letter dated January 10.
Schedule M outlines quality standards for pharmaceutical products. The revised norms were notified by the health ministry in January last year.According to the new draft, the “small and medium manufacturers with turnover of or less than ₹250 crore may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority within a period of three months from the date of publication of this notification along with the plan of upgradation. For such manufacturers, the timeline for implementation shall be extended till December 31, 2025,” it said.
