New Delhi: The Ministry of Health has announced an extension for small and medium pharma companies with a turnover of less than Rs 250 crore, granting them an additional 12 months to implement the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The new deadline for compliance is set for December 31, 2025. This decision follows requests from manufacturing units seeking more time to upgrade their facilities, as stated in the ministry’s announcement.
GMP standards aim to ensure product quality by controlling various factors such as materials, methods, machines, processes, personnel, and facility environments. With approximately 10,500 manufacturing units in India, 8,500 of which fall under the MSME category, the country remains a major exporter of medicines, particularly to low- and middle-income countries (LMICs) that require WHO GMP certification. Currently, around 2,000 MSME units hold the necessary certification.
Over the past 15-20 years, significant advancements have been made in pharmaceutical manufacturing and quality. The ministry noted that the evolving understanding of the field has emphasized the crucial link between manufacturing practices and product quality. To stay aligned with global standards, particularly those set by WHO, the government revised the GMP guidelines outlined in Schedule M of the Drugs and Cosmetics Act. This revised Schedule M, notified in December 2023, aims to ensure that India’s pharmaceutical products meet globally acceptable quality standards.
To facilitate a smooth transition to the new standards, the government has provided a six-month transition period for large manufacturers (with turnovers above Rs 250 crore) and a twelve-month extension for MSMEs. This notification was published on January 5, 2024. The Central Drugs Standard Control Organization (CDSCO), in partnership with state and union territories, has launched an intensive nationwide awareness campaign to educate stakeholders about the revised Schedule M. Over 15 awareness sessions have already been conducted, attracting 36,855 participants.
Under the revised schedule, large manufacturers were required to comply with the new standards by July 1, 2023, while MSMEs were initially given until January 1, 2025. However, due to feedback from industry associations representing the MSME sector, the deadline has been extended to December 31, 2025. The main challenges cited by MSMEs include securing financial resources for upgrades and allowing sufficient time for implementation.
To support MSMEs, the Department of Health and Family Welfare has issued a draft notification allowing these units an additional three months to register with CDSCO and submit their upgrade plans. Following this, a comprehensive audit will be conducted, and units that fail to meet their commitments will face appropriate action.
To date, CDSCO has inspected over 800 manufacturing units and 252 public testing labs. Feedback from these audits, along with input from stakeholders, indicates significant progress toward GMP compliance, with many MSMEs already initiating upgrades. This positive momentum is expected to contribute to the continued production of safe, effective, and high-quality pharmaceutical products in India.