Pharma MSMEs may get time to adopt new manufacturing rules

With thousands of small drug manufacturers struggling to meet tougher quality norms, the government is weighing a year's extension to the deadline for complying with the revised good manufacturing practices (GMPs), said two government officials aware of the development.

- Priyanka Sharma

The deliberations come ahead of the 1 January 2026 rollout of revised Schedule M standards that are aligned with World Health Organization norms.

The Union health and family welfare ministry will hold consultations with state governments on the issue starting Monday, one of the officials said.

Low compliance by the country’s 8,500 small and medium enterprises (MSMEs) manufacturing pharmaceuticals would raise the risk of plant closures and disruptions across India’s $50 billion pharmaceutical sector, a major global supplier of generic medicines.

The revised Schedule M GMP had been earlier extended from the previous 1 January 2025 cutoff. The proposed extension for MSMEs, which have revenue of ₹250 crore or less, comes in the backdrop of less than a third of them submitting their upgrade plans, with the remaining units risking immediate closure and penalties.

There are a total of 10,500 drug manufacturing units in India, of which 8,500 fall under the MSME category. These units produce 70% of India's generic drugs and they face upgrade costs of 10-15 crore per facility. Of these 8,500 MSMEs, 2,000 have already complied with the revised schedule for the new quality standards.

“Out of these 6,500 MSME drug firms, only 1,400 (21.53%) have submitted the necessary upgrade plans to the government,” said the first of the two government officials cited above, requesting anonymity.