MSME drugmakers under DCGI lens over compliance with revised Schedule M norms: Report

Micro, small and medium-sized pharmaceutical companies may face regulatory action for non-compliance with norms under the revised Schedule M, with the Central Drugs Standard Control Organisation (CDSCO) directing states to plan inspections at drug manufacturing units, Business Standard has reported.

The move marks the end of the one-year grace period granted to MSME pharma units, those with an annual turnover of up to Rs 250 crore, for complying with the revised Schedule M norms.

Rajeev Raghuvanshi, Drug Controller General of India (DCGI), has directed state authorities to begin planning inspections to enforce the new pharmaceutical manufacturing standards, a report by Moneycontrol said.

The directive ends the current extension, which runs until December 31, 2025, for thousands of small and medium-sized pharmaceutical firms to comply with the revised norms. Raghuvanshi warned that strict action will be taken against units that fail to meet the updated quality requirements.

“You are requested to initiate planning for carrying out relevant inspections of manufacturing units who have applied for extension of revised Schedule M and effective date for revised Schedule M implementation for them is January 1, 2026, to verify their compliance with the requirements,” Raghuvanshi said in his letter to state and union territory regulators.

The DCGI also asked state regulators to submit monthly reports detailing inspections, observations, and actions taken.