New Delhi: A pharma group has sought extension for those production units that have already submitted upgradation plans and can demonstrate execution progress, even as the drug regulatory authority seems reluctant to extend the December 31 deadline for implementing the revised schedule aimed at strengthening good manufacturing practices.
The Indian Drug Manufacturers’ Association (IDMA) has written to the health secretary requesting for extension for existing applicants where work is in progress.
“Several manufacturers who applied and commenced upgradation in good faith have made measurable progress, but may not be able to complete all activities within the presently available period due to genuine implementation constraints such as execution sequencing of civil/HVAC works, procurement lead times, validation schedules, and availability of qualified technical resources,” it said.
The association has urged that these pharma markers should be enabled through a case by case facilitative mechanism based on review of the project plan and actual progress achieved.
They also said that several MSME manufacturers, despite intent to comply, remained hesitant to apply for extension due to the absence of clarity on certain provisions of the revised Schedule M.
They have therefore urged further conditional opportunity up to December 2026 to comply with the revised Schedule M. “So that MSMEs who did not apply earlier, particularly due to interpretative uncertainty may come forward with structured plans and join the compliance pathway with confidence,” the letter dated December 23 said.
Schedule M of the Drugs and Cosmetics Rules, 1945, prescribes the good manufacturing practices (GMP) for pharmaceutical products such as a prompt product recall system for products known or suspected to be defective.
The revised Schedule M-which outlines tighter quality norms for manufacturing-was notified in January 2022. While units with annual turnover of more than ₹250 crore had to comply from July 1, 2023, the implementation date for MSMEs was January 1 this year. However, MSMEs sought more time to make the necessary changes in their manufacturing processes. The ministry then issued a notification, giving small drug companies time until December 31 this year to adhere to the revised Schedule M.
Drug makers that wanted to extend the timeline for implementation of Schedule M were asked to carry out a gap analysis and file an application with the drug regulator, detailing their strategy to comply with the revised manufacturing standards.
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