Quality Compliance Plan from MSME Drugmakers
Context:
The Indian government has announced stricter regulations for micro, small, and medium pharmaceutical enterprises (MSMEs) to ensure compliance with the World Health Organisation’s Good Manufacturing Practices (WHO-GMP) for life-saving medicines.
Key Highlights
- Deadline for GMP Compliance: MSME drugmakers must submit detailed action plans within three months to upgrade their manufacturing facilities.
- Companies must comply with WHO-GMP standards by December 31, 2025, or risk shutting down operations.
- Extension for Smaller Firms: The government has extended the original deadline for small pharmaceutical companies (with a turnover of ₹250 crore or less) by one year.
Good Manufacturing Practices (GMP)
Established by the World Health Organisation (WHO), these are essential guidelines aimed at ensuring that pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. These practices are crucial for safeguarding public health by minimising risks associated with pharmaceutical manufacturing. More than 100 countries have integrated WHO-GMP provisions into their national regulations, reflecting a global commitment to maintaining high standards in pharmaceutical manufacturing.
Reason for Tightened Norms
- The decision follows reports of substandard quality in Indian-made drugs, which failed overseas quality tests due to alleged contamination.
- Out of 10,000 MSME drugmakers in India, only 2,000 currently comply with WHO-GMP standards.
- Action Plan Requirements: Firms must provide:
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- FY24 turnover data.
- Gap analysis of their plants, equipment, labs, utilities, and HVAC systems.
- A justification for the time needed for upgrades.
- Applications must be filed with the Central Licensing Authority.
- Schedule M Revision: In 2023, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, outlining GMP standards.
- Larger firms with a turnover above ₹250 crore were required to comply within six months, while smaller firms were given one year.
Schedule M of the Drugs and Cosmetics Rules, 1945, outlines the Good Manufacturing Practices (GMP) essential for the manufacture of pharmaceutical products in India. |
Industry Concerns
- Small drugmakers have requested more time to meet compliance requirements.
- Harish Jain Manawat, president of the Federation of Pharmaceutical Entrepreneurs, has urged the government to extend the deadline by two years, citing financial and logistical challenges in upgrading facilities.
This initiative underscores India’s commitment to improving drug quality and ensuring public safety while addressing the challenges faced by smaller pharmaceutical companies.
