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In a significant move aimed at bolstering India’s pharmaceutical industry, the Health Ministry has granted a 12-month extension for small and medium-sized pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) outlined under Schedule M of the Drugs and Cosmetics Act. This decision follows requests from MSMEs, highlighting the need for additional time to upgrade their manufacturing facilities in order to meet global standards.
India, a key global exporter of medicines to low- and middle-income countries, is increasingly under pressure to ensure its pharmaceutical manufacturers adhere to the World Health Organization’s (WHO) GMP certification. With approximately 2,000 MSME pharma units currently holding WHO GMP certification, the extended deadline aims to facilitate the remaining companies in upgrading their infrastructure and processes to align with international benchmarks for product quality and safety.
The Central Drugs Standard Control Organization (CDSCO) has been proactive in its efforts to increase awareness about the revised requirements. Recently, 36,855 participants took part in awareness sessions held across the country, reflecting the industry’s commitment to ensuring that local production facilities meet global compliance standards.
This extension is expected to provide MSMEs with the necessary time and resources to make the essential changes to their operations, ensuring that Indian pharma companies continue to play a pivotal role in the global healthcare supply chain. The Health Ministry emphasized that the alignment of GMP standards with international norms is crucial to maintain the high-quality standards of products produced by Indian manufacturers.
As the deadline extension unfolds, industry stakeholders are optimistic that this move will not only strengthen India’s position in the global pharmaceutical market but also contribute significantly to the country’s ongoing healthcare development initiatives.
