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Revised Schedule M extension for MSMEs serves as strategic roadmap towards quality benchmarks: Dr Khalid Khan
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Nandita Vijayasimha, Bengaluru
February 18 , 2025
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Revised Schedule M extension for MSMEs (micro small and medium enterprises) serves as a strategic roadmap to be able to comply with quality benchmarks and strengthen competitiveness in the domestic and international markets, said Dr M Khalid Khan, president, Indian Pharmaceutical Association (IPA), Karnataka State Branch.
By granting additional time for compliance, it allows MSMEs to upgrade infrastructure, adopt Good Manufacturing Practices (GMP), and align with global requirements. The transition of companies with a turnover of less than Rs. 250 crore to the revised Schedule M by December 31, 2025, is a positive step. However, considering the financial implications of this shift, it is imperative that the government provides adequate incentives, training modules, and resources to support the industry nationwide, he added.
Given the critical role of pharma MSMEs, financial support is essential to upgrade facilities and training workforce to successfully implement the revised guidelines. MSMEs should actively explore national and state-level strategies to raise funds and seek government support for subsidies and reduced interest rates on borrowings. These measures would alleviate financial burdens and accelerate compliance, with the revised Schedule M, Dr Khan told Pharmabiz.
As India cements its position as a global leader in pharmaceuticals, initiatives like ‘Make in India’ and ‘Viksit Bharat’ provide the necessary momentum. A significant step in this direction came with the implementation of the revised Schedule M on December, 28, 2023. These updated provisions align with international guidelines and have been welcomed by all stakeholders as a much-needed advancement, he noted.
India's pharmaceutical sector is heavily influenced by MSMEs which contribute significantly to both exports and the domestic market. To facilitate a smooth transition to the revised Schedule M, the government has provided a 12-month grace period for companies with a turnover of less than Rs. 250 crore. This thoughtful approach ensures that MSMEs receive the necessary time and support to implement the new regulations effectively, stated Dr Khan.
To this end, under the leadership of Dr. Premnath Shenoy, former president IPA Karnataka State Branch, a series of workshops were held providing invaluable insights on the revised Schedule M, covering crucial topics such as Total Quality Management (TQM), Quality by Design (QbD), Corrective and Preventive Actions (CAPA), among others.
Experienced industry professionals too chipped in their expertise to make the MSMEs ready to encounter the revised Schedule M requirements. We will continue this momentum of imparting in-depth training through workshops and conclaves planned for the future.
Furthermore, MSMEs need to take cognisance of Total Quality Management and ensure that management teams fully comprehend the new guidelines. In fact, prompt and well informed decision-making will be the key to its seamless implementation.
The revised Schedule M will elevate India's stand as a globally recognized, regulatory-compliant nation, strengthening its participation in the Pharmaceutical Inspection Cooperation Scheme (PICS), showcasing its commitment to stringent quality and safety standards on an international platform, said Dr Khan.
It is also crucial to provide adequate training to regulators, equipping them with a thorough understanding of the revised guidelines. By doing so, regulators can serve as facilitators, guiding the industry toward efficient, adequate, and affordable compliance with the new regulations. With the collective efforts of industry professionals, regulators, and academia, we can ensure that India continues to lead the global pharmaceutical industry, driven by quality, innovation, and sustainability, said Dr Khan.
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