The Ministry of Health on Wednesday said it has extended the timeline to small and medium manufacturers having turnover of Rs 250 crore or less for compliance with revised schedule ‘M’ notification up to December 31.
Notably, on December 28, 2023, the Centre had notified revised schedule M requirements where “good manufacturing practices” was upgraded to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”.
The category of manufacturers was divided into two: the first category was of large manufacturers having turnover more than Rs 250 crore. A timeline of six months was given to such manufacturers for compliance, as per the Health Ministry statement.
For small and medium manufacturers having turnover less than or equal to Rs 250 crore, a timeline of 12 months was given for compliance. The revised schedule M requirements have been implemented for large manufacturers w.e.f. from June 28, 2024, it said.
The Health Ministry informed that small and medium manufacturers had advocated for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources.
“The same has been considered and the small and medium manufacturers have been given a time of three months from February 11, 2025 to submit their plan for upgradation in Form A to the Central License Approving Authority. For such manufacturers who submit these details, the timeline of implementation would be extended till December 31,” it said.
Stating that the revised schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India, the Health Ministry said, “The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.”