DCGI asks State DCs to take action on SMEs not implementing Sch M

THE Central Drugs Standard Control Organisation (CDSCO) has asked the drug controllers (DCs) of the States and Union Territories (UT) to start immediate inspection and action on the units under Rs. 250 crore turnover, who have not applied for the extension of timeline for implementation of Revised Schedule M, without waiting for the deadline to be over.

- Gireesh Babu

For the units who have applied for the extension, the central drug regulator has directed the State regulators to start planning for carrying out relevant inspections to verify their compliance with requirements, as the effective date for Revised Schedule M implementation for them is January 1, 2026.

"However, immediate inspection and action shall be initiated right now for those units who have not applied for the extension, as the revised Schedule M is already applicable for such units," said Dr Rajeev Singh Raghuvanshi, DCGI.