Small & Medium Pharma Manufacturers to get period till 31.12.2025 for Implementation of Revised Schedule M
The Ministry of Health and Family Welfare vide notification GSR 127 (E) dated 11.02.2025 has amended Drugs (Amendment) Rules, 2023, vide which the requirements of GMP were revised by substituting Schedule M. The implementation for large scale manufacturers (with turnover more than Rs250 crores) is already effective. The implementation date for Small and Medium Scale manufacturers (with turnover equal to or less than Rs250 crores) which was 05.01.2025 is now extended to 31.12.2025.
However, such extension is subject to filing an application for such purpose to Central Licence Approving Authority i.e. Drugs Controller General India, New Delhi in prescribed Form A. The applicant is required to submit a detailed plan of upgradation for compliance with the provisions of revised Schedule M with the timeline for its implementation. The timeline for compliance shall not go beyond 31.12.2025.
Manufacturers now need to act promptly to conduct gap analysis with respect to plant, equipment, HVAC system, utilities, documentation, technical staff, etc. It may be noted that Government of India has provided online facility for filing applications through Online National Drugs Licensing System (ONDLS).