Drug regulator for strict compliance with new Schedule M

NEW DELHI: India’s drug regulator has sought strict compliance with revised Schedule M. It has asked state drug regulators to carry out inspections of pharma manufacturing units which have applied for extension of Schedule M to verify their compliance with the requirements, in a bid to ensure quality of pharma products by mandating Good Manufacturing Practices (GMP).

“In case any manufacturing unit is found non-complying to the requirements of revised Schedule M during inspections, strict action shall be initiated against as per the provisions of Drugs and Cosmetics Act and rules,” the regulator said in a notice dated November 7.

The state drug regulators have been asked to submit monthly reports to the Central Drugs Standard Control Organisation on the inspections and observations made and the action taken pursuant to such inspections. "This may be treated as top priority and compliance is required to be ensured strictly," the regulator 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 Rs 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.