Government Extends Deadline for Small Manufacturers to Meet Revised Schedule M Norms Until 2025

In a significant move, the Union Health Ministry has granted a conditional extension for small and medium drug manufacturers to comply with the revised Schedule M norms, now set to be implemented by December 31, 2025. This decision comes after extensive feedback from industry stakeholders, particularly from associations like the Confederation of Indian Pharmaceutical Industry (CIPI), which sought a more extended timeline due to operational challenges.

Manufacturers with an annual turnover of ₹250 crores or less must submit their upgradation plans within three months from February 11, 2025. The health ministry emphasized that this extension is crucial for enhancing the quality and safety of pharmaceutical products in India.

The revised Schedule M, which focuses on Good Manufacturing Practices (GMP), was initially announced in December 2023, with compliance deadlines set for the end of 2024. However, the government recognized the need for additional time to allow smaller manufacturers to improve their infrastructure and training resources.

According to official data, around 10,500 manufacturing units operate in India, with approximately 8,500 categorized as MSMEs. Before this extension, it was estimated that nearly 5,000 manufacturers might have exited the market due to non-compliance.

The government maintains that the revised Schedule M requirements are a positive step towards ensuring the global competitiveness of Indian pharmaceutical companies while strengthening their domestic operations. This extension is seen as an opportunity for small manufacturers to align with international standards and enhance their production capabilities.