The Centre has extended the deadline for the adoption of prescribed good manufacturing practices (GMP) by small and medium pharmaceutical manufacturers to December 31, 2025, stretching further the timeline for their provisions that have been mandatory since 2005.

The Union health ministry said on Wednesday it had conditionally extended the due date for implementation of the revised Schedule M (Good Manufacturing Practices provision) for small and medium manufacturers with turnovers of ₹250 crore or lower to December 31, 2025.

The Centre had notified the revised Schedule M requirements on December 28, 2023, setting a timeline of 12 months for small and medium manufacturers and six months for bigger manufacturers. The health ministry said large manufacturers had implemented the requirements by June 28, 2024.

Small and medium manufacturers had sought extension of the timeline to "enable improvements in infrastructure, training of personnel and arranging financial resources", the health ministry said in a note explaining the decision to extend the timeline.

The revised Schedule M requirements are intended to help ensure the quality and safety of pharmaceutical products manufactured in India, the ministry said. The regulations would enable pharma companies to "strengthen their domestic position" and "become more competitive globally", it said.

The Centre had said in July 2023 that Schedule M would become “compulsory” for small and medium manufacturers, surprising sections of pharma industry executives who said it was their understanding that the rules had been mandatory since 2005.

The Centre's 2023 directive to manufacturers appeared to reflect that the government was aware that some members of manufacturers had yet to adopt Schedule M and that regulatory authorities had yet to enforce it, pharma industry executives had said at the time.

The move in 2023 to get the industry to adopt the revised Schedule M came amid concerns about the quality of pharmaceutical products from India amplified by alerts about contaminated India-made cough syrups from the Gambia and Uzbekistan during 2022.

The health ministry, replying on February 4 to a question in the Rajya Sabha by MP Sushmita Dev, had said draft rules published on January 4, 2025, extend the timeline for manufacturers with turnovers less than ₹250 crore to December 31, 2025.