Revised Schedule M Puts Pressure on Small Drug Manufacturers

• Over 4,000 MSME pharma units may face closure due to non-compliance
• Only 1,700 out of 6,000 companies submitted GMP upgrade plans
• Risk of drug shortages and price hikes looms amid shutdown threats

As the deadline has now passed, a large number of India’s small and mid-sized pharmaceutical manufacturers may be forced to shut down, as they have failed to provide required upgrade plans under the new Schedule M regulations. According to the government, only approximately 1,700 of an estimated 6,000 micro, small, and medium enterprises (MSMEs) in the sector submitted proposals to provide upgrades to meet the new Good Manufacturing Practices (GMP) norms.

The revised Schedule M, in January 2024 come in force in January 2025, calls for compliance with WHO-GMP standards, the government seeks to raise quality across India's pharmaceutical industry. Smaller units cite financial pressure and technical capacity as key impediments to achieving these standards.  

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There may be severe repercussions, thousands of units may receive ‘stop production’ notices, and that could mean mass job losses, disruption in the availability of essential medicines (including oncology medicines), as well as knock-off price increases in the domestic market. The government has offered extensions to these deadlines until December 2025 for SMEs with turnover up to ?250 crore, but stakeholders suggest that financial assistance is also required to avoid mass shut downs and significant impacts on the essential medicines supply chain.