The Prime Minister’s Office (PMO) has directed the Ministry of Micro, Small & Medium Enterprises to take urgent action after pharma MSMEs sounded an alarm over regulatory pressures affecting quality control compliance. MSME representatives warned that stringent regulatory requirements, especially those related to Good Manufacturing Practices (GMP), could disrupt production and lead to shortages of essential medicines such as antibiotics, anti-diabetics and oncology drugs.

The Federation of Pharma Entrepreneurs (FOPE) highlighted that out of around 6,000 MSME pharma units, only about 1,700 have submitted plans for GMP upgrades mandated by the authorities. The rest risk shutdowns, licence cancellations or stop production notices, FOPE stated. These smaller firms, particularly those in tier-2 and tier-3 cities, say the costs of environmental upgrades, clean-room installations, equipment qualification, and utilities overhaul are overwhelming.

The FOPE has also warned of potential job losses affecting over half a million skilled and semi-skilled workers. Added to this are delays and complexity in obtaining no objection certificates (NOCs) for exports, which threaten export orders. In their representation, the MSMEs urged the government to extend the deadline for compliance under the Revised Schedule-M of the Drugs and Cosmetics Act by two years to give them breathing space.

The PMO’s intervention underscores the seriousness of the supply chain risks raised by the MSMEs. With smaller manufacturers accounting for over 40 per cent of domestic generic medicine supply, failure of these units could jeopardise access to affordable medicines for millions of patients.