New Delhi [India], February 13 : The Ministry of Health & Family Welfare has conditionally extended the due date for implementation of revised Schedule M (Good Manufacturing Practices provision) in respect of small and medium manufacturers having turnover of Rs. 250 crores or less, up to December 31, as stated in press release.
According to the press release, the Government of India had notified revised Schedule M requirements wherein "good manufacturing practices" was upgraded to "good manufacturing practices and requirements of plan and equipment for pharmaceutical products" on December 28, 2023.
The category of manufacturers was divided into two; the first category was of large manufacturers having a turnover of more than 250 crores. A timeline of 6 months was given to such manufacturers for compliance. For small and medium manufacturers having turnover less than or equal to 250 crores, a timeline of 12 months was given for compliance.
The revised Schedule M requirements have been implemented for large manufacturers from June 28, 2024.
Small and medium-sized manufacturers had advocated for a longer schedule to build infrastructure, train staff, and arrange funding. In light of this, small and medium-sized firms have been granted three months starting on February 11 to submit their Form A upgrade plan to the Central License Approving Authority. The implementation timeline will be extended until December 31 for producers who provide these details.
The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India. The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.