Pharma units likely to face action for Schedule M violations: Experts

The one-year grace period for MSME drug manufacturers to comply with revised Schedule M norms has ended, with the CDSCO instructing state regulators to initiate inspections & action against violators

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 conduct inspections at drug manufacturing units, said industry experts.

 

The move indicated the end of the one-year grace period granted to Micro, Small, and Medium Enterprises (MSME) pharma units — those with an annual turnover of up to ₹250 crore — for complying with the revised Schedule M norms.

 

The revised Schedule M, which prescribes quality standards and good manufacturing practices (GMP) for drugmakers, was notified by the Union Health Ministry in December 2023 and became effective from January 1, 2025.

 

The compliance deadline for MSMEs was later extended to December 31, 2025, following representations from smaller firms citing financial constraints in meeting the upgraded GMP standards. The extension was conditional on companies applying to the central licensing authority with corrective and preventive action (CAPA) plans for facility upgradation.

 

India has about 10,500 pharmaceutical manufacturing units, of which nearly 8,500 fall under the MSME category. Around 2,000 of these currently hold WHO-GMP certification.

 

People familiar with the matter said only 1,600–1,700 MSME units have applied for the extension, raising concerns that a significant number may face closure due to non-compliance.

 

The CDSCO directive seeks immediate inspection and action against units that have not applied for the extension, as the revised Schedule M is already applicable to them.

 

“Most of the smaller units have not applied for the extension, claiming financial difficulties in upgrading within the stipulated timeframe,” an industry source said. The CDSCO has earlier maintained that there would be no relaxation in enforcing GMP norms.

 

“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,” Drug Controller General of India (DCGI) Rajeev Raghuvanshi said in a directive, dated November 7.

 

State and Union Territory drug controllers have also been asked to submit monthly reports to the CDSCO detailing inspections, observations and action taken.

 

The heightened scrutiny of smaller manufacturing units comes amid recent deaths linked to contaminated cough syrups. At least 24 children reportedly died of kidney failure in Madhya Pradesh’s Chhindwara district after consuming contaminated cough syrup. The product, Coldrif, manufactured by Tamil Nadu-based MSME firm Sresan Pharma, was found to contain 48% diethylene glycol (DEG), an industrial solvent.

 

Two other cough syrups — Respifresh TR and Relife — produced by Gujarat-based MSME firms were also found to contain DEG levels above permissible limits. Separately, a spurious sample of Besto-Cof (Dry Cough Formula) was detected in Chhattisgarh during CDSCO’s routine monthly quality check for September.