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FOPE urges govt to extend revised Schedule M implementation to December 31, 2026
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Nandita Vijayasimha, Bengaluru
January 14 , 2025
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The Federation of Pharmaceutical Entrepreneurs (FOPE), which has welcomed the extension of the revised Schedule M implementation to December 31, 2025, has now noted practical challenges faced by the micro small and medium enterprises (MSMEs) for the access to financial and human
resources.
Comprehending the impending financial and human resource challenges as significant obstacles for pharmaceutical companies in meeting the revised deadline for compliance with revised Schedule M, FOPE has urged the government to consider extending the compliance timeline to December 31, 2026.
Schedule M, a part of the Drugs and Cosmetics Rules, sets out guidelines for good manufacturing practices (GMP) and quality standards for pharmaceutical products in India. The recent revisions aim to align domestic standards with global norms, improving product quality and boosting export opportunities.
However, implementing these changes often requires substantial investments in infrastructure, equipment upgrades, training, and recruitment of skilled personnel.
Our concerns reflect the difficulty smaller and mid-sized pharmaceutical manufacturers face, as they often lack the financial capacity to undertake significant upgrades within the stipulated timeframe. The organization has
requested an extension to ensure that these companies can comply without jeopardizing their operations or market presence, said Jagdish Kumar, executive director in a communication to the Union government.
Kumar said that an extension is much desired because it will further facilitate manufacturers in implementing the requirements of revised Schedule M.
Noting that the draft notification provides for a timeline extended till December 31, 2025 Kumar said that, FOPE understood the situation and requested the government to provide time till December 31, 2026. The MSMEs will needed such an extension even as they are existing manufacturers to carry out the required upgradation of the facility. For all this the industry will also need the monetary resources and additional collateral security training and implementation etc.
Licenses in most cases are granted by the state drugs control authorities. Hence, application for grant of extension of compliance with revised Schedule M should be submitted to the concerned licensing authority, he said. Once the application is submitted, it means there is an intention to upgrade for compliance by the manufacturer. Hence the grant of extension should be automatic in the interest of ease of doing business. Few shortcomings even after extended period of time should be viewed leniently.
“We request you to overlook the few compliances which are tough to meet with the existing infrastructure and there shall be provision to consider on the ground reality at time of inspections without compromising with the quality parametres but need to understand the regulators. Such provisions should be inserted for the existing manufacturers. These flexible approaches are accepted globally”, stated Kumar in his communication note to the government.
According to industry observers, the government's response to FOPE's request will be crucial in determining the industry's preparedness to meet revised GMP standards and its ability to compete in global markets.
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