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Centre Extends GMP Compliance Deadline for Small and Medium Pharma Firms to December 2025
This extension applies to firms with an annual turnover of ?250 crore or less, offering them more time to adapt to the new regulatory standards.
- By Newsdesk
- Mysuru
- Jun 19, 2025
In a significant relief for India’s small and medium pharmaceutical enterprises (SMEs), the Union government has extended the deadline for implementing the revised Schedule M — the updated Good Manufacturing Practices (GMP) guidelines — until December 2025. This extension applies to firms with an annual turnover of ₹250 crore or less, offering them more time to adapt to the new regulatory standards.
The announcement was made by Khalid Ahmed Khan, Deputy Drug Controller and President of the Indian Pharmaceutical Association (IPA), Karnataka state branch, during the inauguration of a national conference on pharmaceutical quality assurance. The event, held at JSS College of Pharmacy, Mysuru, was organised by the PHD Chamber of Commerce and Industry’s health committee in collaboration with the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, JSS Academy of Higher Education and Research (JSS AHER), and the IPA’s Mysuru branch.
Khan explained that the revised Schedule M, which aligns with World Health Organization (WHO) and other international standards, places a strong emphasis on total quality management and the development of robust pharmaceutical systems. "While SMEs have been given until the end of 2025 due to the financial challenges of implementation, companies with turnovers above ₹250 crore and all newly established manufacturing units are expected to comply immediately," he said.
He also underscored the need for a quality-first culture across all levels of the pharmaceutical industry. “Leadership is important, but even those not in formal leadership roles can influence the quality mindset. Without a strong commitment to quality, neither the industry nor its professionals can thrive,” Khan added.
Dr. H. Basavana Gowdappa, Vice Chancellor of JSS AHER, praised the government’s efforts, particularly the introduction of the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), and urged stakeholders to view GMP not just as a regulatory requirement, but as a core responsibility.
Former Karnataka Drug Controller Amaresh Tumbagi detailed the upgraded inspection mechanisms introduced under the revised Schedule M and reflected on the evolution of India’s pharmaceutical regulatory landscape. Dr. Pramod Kumar TM, Principal of JSS College of Pharmacy, also provided insights into the current compliance environment.
The event was attended by several industry and government representatives, including Jatin Nagpal, Joint Secretary of PHDCCI; Dharmendra Kumar Yadav, Under Secretary at the Department of Pharmaceuticals; Yashwant Shinde, Manager at SIDBI; and Dr. Savitha RS, Secretary of IPA’s Mysuru branch.
The extension is expected to give MSME drug manufacturers critical breathing space to align with global quality standards while ensuring continuity and credibility in India’s vast pharmaceutical sector.