Overview of Revised GMP Norms for MSME Pharmaceutical Manufacturers
Approximately 1,700, or 26%, of India's estimated 6,500 MSME pharmaceutical manufacturers are likely to meet the revised Good Manufacturing Practices (GMP) norms by December 31. This is a requirement under the updated Schedule M norms of the Drugs and Cosmetics Act, first notified in 2022.
Compliance and Risk of Shutdowns
- India has around 10,500 pharmaceutical manufacturing units, with nearly 8,500 under the MSME category.
- About 2,000 MSME units already hold WHO-GMP certification, implying around 3,700 units are expected to comply with the revised norms.
- Non-compliant units risk shutdown once inspections begin, although closures are unlikely to affect domestic drug supply significantly.
Geographical Variations in Compliance
- States like Gujarat and Maharashtra lead in compliance, with Gujarat achieving a 98.8% submission rate for gap analysis.
- Himachal Pradesh lags, with only 116 of over 650 units initiating the upgradation process.
Challenges and Extension for MSMEs
- Micro and small pharma firms with turnover less than ₹250 crore were granted a compliance extension until December 31, 2025, contingent on gap analysis and application submission by May 2025.
- Cost of compliance upgrades ranges from ₹50 lakh to ₹2.5 crore, posing capital challenges for smaller players.
- Only 180 units applied under the government's financial incentive scheme for upgrades.
Industry Impact and Future Outlook
- MSME units contribute about 7% to the Indian Pharma Market.
- Potential job losses from non-compliance could be offset by the growth of GMP-certified contract manufacturing facilities.
- Analysts suggest the government is unlikely to grant further extensions due to past incidents of non-compliance impacting public safety.
Key Statistics
- December 31, 2025: Revised Schedule M norms compliance deadline.
- 1,700 of 6,500 non-GMP MSME units have submitted upgrade plans.
- 98.8% compliance in Gujarat for MSME units filing gap analysis.
- Estimated cost of compliance upgrades: ₹50 lakh-₹2.5 crore.
