GMP deadline for pharma firms likely to be extended

WITH NEARLY 75% of pharmaceutical units yet to begin the upgrading work for their manufacturing facilities, the government might be forced to extend the deadline to implement revised Schedule M guidelines for smalland medium-sized pharma units beyond the year-end, sources close to the development told FE.

- MANU KAUSHIK

Even for the 1,700-odd units that had applied for extension with the Central Drugs Standard Control Organisation (CDSCO) this year, 20-30% of the upgradation work is still pending.

"Nearly 5,000 units have not even started the upgradation work due to practical issues and lack of clarity on specific provisions under the revised rules. The extension sought by the industry might be considered given the present circumstances," a source said.

In February, the CDSCO had granted extension to the pharma companies falling under ₹250-crore annual turnover to comply with the revised Schedule M (good manufacturing practices, or GMP) guidelines by December 2025.

MSMEs had advocated for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources.