Health ministry unlikely to extend Schedule M GMP deadline for MSME pharma

The health ministry is unlikely to extend the revised Schedule M GMP deadline for MSME drugmakers beyond December 31, 2025, as it consults states ahead of risk-based inspections

With thousands of small drug manufacturers struggling to meet quality norms, the Union Health and Family Welfare Ministry is unlikely to give an extension to the deadline for complying with the revised good manufacturing practices (GMP) under Schedule M, according to people aware of the matter.

 

“The health ministry, along with the Central Drugs Standard Control Organisation (CDSCO) is having consultation meetings with state governments and licensing authorities on a daily basis to discuss implementation of Schedule M,” sources in the ministry said.  

 

Another official confirmed that the ministry had a consultative meeting with high drug manufacturing states on Monday. Queries mailed to the health ministry did not elicit a response until press time.

   

Under the revised Schedule M norms, first notified in 2022, pharma units are required to adopt tighter quality controls, including pharmaceutical quality systems (PQS), quality risk management (QRM), product quality review (PQR), equipment validation and a robust product recall mechanism.

 

“The ministry will not compromise on drug safety,” an official quoted above said, adding that while the government has handheld those willing to upgrade facilities through waivers and incentives, many small manufacturers are adamant on not upgrading.  

 

Low rates of compliance among an estimated 8,500 MSME pharma units could risk closure once risk based inspections start in January 2026.

 

Initially scheduled for December 2024, micro and small pharma firms with annual turnover of ₹250 crore or less were granted a one-year extension to comply with the revised norms until December 31, 2025.

 

However, this extension was conditional on conducting a gap analysis and filing an application with the drug regulator, outlining a compliance strategy by May 2025.

 

While around 2,000 MSME units already hold WHO-GMP certification, only about 1,700, or 26 per cent of India’s estimated 6,500 MSME pharmaceutical manufacturers that were required to come up to speed with revised GMP norms have submitted upgradation plans.

 

MSME industry bodies, however, argue that many smaller players have struggled due to capital constraints.

 

“All forms of upgradation require capital infusion of at least ₹2 crore, including additional land, retrofitting facilities and staff training,” said an executive with an MSME drug manufacturing firm.  

 

Many units operate from single facilities in small premises, such as apartments, making it difficult for them to make the upgrades within the deadline, he added.