Ministry in talks with states to give some drug cos more time for good manufacturing practices compliance

New Delhi: The union health ministry is in hectic discussions with states to weigh options for giving an extension to implement the revised Schedule M regulations, which deal with good manufacturing practices for pharmaceutical products.

Several officials working with state drug regulatory authorities told ET that a six-month extension may be given to pharma units to comply with the rules. Such an extension, though, would not apply across the board, and may be given on a case-to-case basis.

Deadline extension


"The health minister has been holding extensive discussions with states on the issue. We are hopeful that the ministry may give a six-month extension to pharma units which have already submitted (production) upgrade plans," said an official on the condition of anonymity. Schedule M of the Drugs and Cosmetics Act prescribes good manufacturing practices such as a prompt product recall system for products known or suspected to be defective.

The revised Schedule M-which outlines tighter quality regulations for manufacturing-was notified in December 2023. While units with an annual turnover of more than ₹250 crore had to comply effective July 1, 2024, the implementation date for MSMEs was January 1, 2025. After MSMEs sought more time to make the necessary changes in their manufacturing processes, the ministry extended the deadline for them to December 31, 2025.

Industry sources said a hard deadline would lead to a shortage of supplies of commonly used medicines, may cause thousands of job losses and impact the medicine security of low- and middle-income countries that depend on imports from India.

'A lenient approach'

More than 20 pharma associations had asked the government to extend the timeline. "Many such units are not ready yet and hence an extension has been requested from the government," added another person.

As reported by ET earlier, more than 60% of the 8,500 registered small and medium pharma units in India may be forced to shut down if the deadline is not extended. India is estimated to have about 12,000 drug manufacturing units. According to industry representatives, the units that risk being shut down account for about ₹75,000 crore of the country's ₹2.5 lakh crore domestic drug market.

"Considering all these factors, the health ministry may take a lenient approach," said the second person.