Lack of financial aid, expertise mar MSME prospects to meet revised Sch M deadline

INDUSTRY experts have raised alarm that lack of financial assistance and guidance on technical expertise have marred pharma MSMEs’ prospects to comply with revised Schedule M guidelines of December 31, 2025.

- Shardul Nautiyal

This extended deadline for pharma MSMEs to comply with the revised Schedule M was granted by the Union Health Ministry, with the condition that they are eligible for the specified extension if they submit an upgrade plan to the Central Drugs Standard Control Organisation (CDSCO) by May 11, 2025.

“Pharma MSMEs, today, face challenges to comply with revised Schedule M guidelines due to limited resources. Many require financial assistance and technical support to upgrade their operations. Collaborative initiatives by regulators, industry bodies, and the government are crucial to bridge these gaps,” an expert pointed out.

It has been recommended that pharma MSME sector requires urgent interventions such as financial assistance in the form of collateral free loan with an interest rate of 3%. Interventions also include guidance on technical expertise such as Quality Management System (QMS), Risk Assessment and Data Integrity, among others.

According to an industry expert, “Pharma MSMEs are also required to equip themselves on air handling units (AHUs) in the drug production facility, and IP Reference Standards (IPRS) to check contamination in pharma products.”