Archive · 21 Sep 2025
MSME Ministry Addresses Drug Crisis Concerns
The Ministry of Small and Medium Enterprises (MSME) is looking into concerns about drugmakers in India.
Small and medium-sized drug companies are worried they might have to close because of new rules about how they make medicine.
A group of these companies wrote to the government saying that these rules are too expensive for them.
They fear that if they have to close down, there could be shortages of important medicines, like those for diabetes or cancer.
The group wants more time to meet the new requirements, or else many businesses might shut down and people could lose their jobs.
The government is now considering what to do.
The MSME Ministry is addressing concerns from small and medium drugmakers about GMP upgrades.
FOPE warns that thousands of MSME pharmaceutical units face shutdowns under the revised Schedule M mandate.
The PMO directed the MSME ministry to take action following a letter from FOPE.
FOPE's letter highlights concerns of essential drug shortages and job losses if units shut down.
FOPE is demanding an extension of the compliance deadline for the revised Schedule M.
- Who
- MSME Ministry, FOPE (Federation of Pharma Entrepreneurs), and the government
- What
- The MSME Ministry is addressing concerns raised by small and medium drugmakers regarding GMP upgrades and potential shutdowns.
- When
- The PMO directed the MSME ministry on August 21st, 2025. News18 published the story on September 21, 2025.
- Where
- India
- Why
- FOPE warned that many MSME pharmaceutical units face closure due to costly GMP upgrades.
- Main Actors
- MSME Ministry, FOPE, PMO, Department of Pharma, DCGI
- FOPE's Concern
- MSME pharma units face closure due to GMP upgrades
- GMP Deadline
- Revised Schedule M
- Units Affected
- Approximately 6,000 MSME pharmaceutical units
- FOPE Demand
- Extension of the compliance deadline
- Impact
- Potential shortages of essential drugs and job losses