Government extends Schedule M implementation deadline till year-end for small, medium pharma firms

The government on Wednesday extended the due date for implementation of revised Schedule M -- good manufacturing practices provision, for small and medium pharmaceutical firms with turnover of Rs 250 crore or less, till the end of this year.

The Ministry of Health & Family Welfare has given three months from February 11, 2025, to the small and medium pharmaceutical firms to submit their plan for upgradation to the central license approving authority in order to be eligible to qualify for Schedule M deadline extension, the ministry said in a release.

The ministry further said it has conditionally extended the due date for implementation of revised Schedule M, the good manufacturing practices provision, in respect of small and medium manufacturers having turnover of Rs 250 crore or less, up to December 31, 2025.

On December 28, 2023, the Centre notified revised 'Schedule M' requirements wherein "good manufacturing practices" was upgraded to "good manufacturing practices and requirements of plan and equipment for pharmaceutical products".

Under this, manufacturers were divided into two groups with the first category of large manufacturers having turnover more than Rs 250 crore. A timeline of six months was given to such manufacturers for compliance and the revised Schedule M requirements have been implemented for these manufacturers from June 28, 2024.

For small and medium manufacturers with turnover less than or equal to Rs 250 crore, a timeline of 12 months was given for compliance.

"Small and medium manufacturers had represented for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources," the ministry said.

It added, "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, 2025." 

The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India, the ministry said.

The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally, it added.