MSME Pharmaceutical Companies Receive One-Year Extension to Meet Revised Schedule M Good Manufacturing Practice Standards

The Indian government has granted small and medium-sized pharmaceutical companies, specifically those with annual revenues under ₹250 crore, an additional year to comply with the updated Schedule M standards, which outline quality benchmarks and good manufacturing practices. The Union Health Ministry has now set December 31, 2025, as the new deadline for approximately 8,500 MSME pharmaceutical units to implement these revised standards.

Initially, in December 2023, the government revised the Good Manufacturing Practices (GMP) under Schedule 'M' of the Drugs and Cosmetics Act to align with global standards, particularly those of the World Health Organization (WHO). Larger pharmaceutical companies, with annual turnovers exceeding ₹250 crore, were given six months to comply, while MSME units were allotted twelve months. However, MSME firms requested a two-year extension, citing challenges in financing equipment upgrades and training personnel. In response, the Health Ministry has extended the deadline by one year, subject to certain conditions.

To avail themselves of this extension, small pharma companies must submit an online application to the Central Licensing Approval Authority, including an upgrade plan, within three months from the notification's publication date. Following this period, audits will be conducted to ensure that the committed upgrades are being implemented. Non-compliance may result in further action by the authorities.