Govt to Extend Schedule M Compliance Deadline for Drug Manufacturers to Dec

The government is expected to grant an extension until December this year for the drug manufacturers to comply with the updated Schedule M. They stated that the drug regulations will be revised to allow for an extension of time. Once the last announcement is released—anticipated this week—the manufacturers will be required to submit an application to ten drug regulatory agencies outlining their approach to comply within the set timeline. 

According to sources, the health ministry requested the legal affairs department's opinion on its final draft notification regarding extending the deadline for small pharmaceutical companies to improve their facilities in order to meet the updated Schedule M.

Schedule M of the Drugs and Cosmetics Act specifies quality criteria for medicinal products. The updated Scheduled M standards were announced in January of the previous year. Units generating an annual turnover exceeding Rs 250 crore were required to comply starting July 1, 2023, whereas MSMEs had their implementation date set for January 1 of this year. Nevertheless, the MSMEs requested additional time to implement the required adjustments in their production methods. The ministry subsequently released a draft notice suggesting an extension of the deadline for the MSMEs.