India's Pharma Crackdown: January 1 Deadline for Global Standards

In the directive dated November 7, Drug Controller General of India (DCGI) Rajeev Raghuvanshi has asked all state and union territory (UT) drug controllers to submit a monthly report on the observations made during the checking, and action taken after such inspections are carried

"In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated," the notice states.

CDSCO Schedule M norms are India's guidelines for pharmaceutical companies on good manufacturing practices, which were revised in 2023 to align with international standards.

Large pharmaceutical firms met a June 2024 deadline, while smaller manufacturers were given until December 2025 as part of an earlier extension. Industry groups had sought further extensions, warning that compliance costs could bankrupt small businesses.

The new directive brings to an end the one-year grace period that was extended to micro, small and medium pharma firms, or those with an annual turnover of less than or equal to Rs 250 crore, for compliance with the revised Schedule M.

"You are requested to initiate planning for carrying out relevant inspections of manufacturing units that have applied for extension of revised Schedule M, and the 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

The Central drug regulator has rejected industry pleas for more time after toxic cough syrup from a Chennai factory was linked to child deaths in Madhya Pradesh in September.

The government had directed drugmakers in late 2023 to upgrade plants to World Health Organisation-recommended norms, including measures to prevent cross-contamination and enabling testing of batches of medicines that are produced.

- IANS