Small and medium-sized pharmaceutical manufacturers in India have received a reprieve in implementing the revised Schedule M of the Drugs Rules, 1945 (Good Manufacturing Practices) guidelines. The Ministry of Health & Family Welfare has conditionally extended the deadline to December 31, 2025, for companies with a turnover of ₹250 crores or less.
Revised Guidelines and Original Timeline
The government notified revised Schedule M requirements on December 28, 2023, upgrading good manufacturing practices and adding requirements for plan and equipment. Manufacturers were divided into two categories: large (turnover over ₹250 crores) and small/medium (turnover ₹250 crores or less). Large manufacturers had six months to comply, while small and medium manufacturers were given 12 months. Large manufacturers met the initial deadline of June 28, 2024.
Reasons for Extension:
Small and medium manufacturers cited challenges in infrastructure upgrades, personnel training, and securing necessary financial resources as reasons for needing more time.
Conditions for Extended Deadline
The Ministry has granted the extension with a condition: small and medium manufacturers must submit their upgradation plan (Form A) to the Central License Approving Authority within three months from February 11, 2025. Those who meet this requirement will have until December 31, 2025, to fully implement the revised Schedule M.
Positive Impact on Quality and Competitiveness
The revised Schedule M is expected to significantly improve the quality and safety of pharmaceutical products in India. The new regulations aim to strengthen the position of domestic pharma companies and boost their global competitiveness. The extended deadline gives smaller manufacturers the necessary time to meet these higher standards.
