New Delhi: The drug companies in India will now have to meet the standard specified in the revised schedule M – as the new rules come into effect, starting today, January 1. Earlier, the pharmaceutical companies had sought an extension in the implementation of new standards. However, the government did entertain the request meaning now “the industry will have to comply with the provisions or face action” a senior government official to ET.
As per the new provision, government can now initiate audits and risk-based inspection to ensure that the standards are being maintained by drug companies.
The industry must now adhere to the newly implemented Schedule M norms, which outline manufacturing practices and standards for premises, plants, and equipment used in pharmaceutical production. These norms include provisions for annual product quality reviews, quality risk management, and a comprehensive pharmaceutical quality system.
Industry leaders previously met with the health minister to request an extension for implementing the revised Schedule M norms, citing challenges such as delays in procuring machinery and upgrading infrastructure. They urged the ministry to give them extra time to ensure the survival of micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector to adjust to the changes.
Schedule M of the Drugs and Cosmetics Rules, 1945, outlines Good Manufacturing Practices (GMP) for pharmaceutical products, including a system for the prompt recall of defective products. The revised Schedule M was notified by the health ministry in January 2024.
Laghu Udyog Bharati (LUB), an RSS affiliate, and the Federation of Pharma Entrepreneurs (FOPE), representing MSME pharma units, also appealed to Health Minister JP Nadda to defer the implementation of the new norms.
Rajesh Gupta, all-India head of pharma at LUB and president of the Himachal Drug Manufacturers Association, said, “We support the government and have initiated awareness seminars, but we need time until December 2026 for infrastructure upgrades.”
He noted that companies are grappling with issues related to loans, machinery procurement, and infrastructure improvements, all of which require time to resolve.
