Dr. H.G. Koshia, Commissioner of Gujarat FDCA, has announced that Indian Pharma MSMEs are adopting the Revised Schedule M guidelines with greater enthusiasm. They are preparing to develop a comprehensive Pharmaceutical Quality System (PQS), integrate Quality Risk Management (QRM), conduct regular Product Quality Reviews (PQR), and implement computerized storage solutions for drug products to ensure production meets global quality standards.
Speaking as the Chief Guest at a recent workshop titled ‘Vendor Validation and Audit in Line with Revised Schedule M Guidelines’ in Ahmedabad, Dr. Koshia emphasized that India’s pharmaceutical Micro, Small, and Medium Enterprises (MSMEs) are poised to adopt the latest regulatory updates. The event was co-organized by the Central Drugs Standard Control Organization (CDSCO), FDCA Gujarat, and the Indian Drug Manufacturers Association (IDMA).
The workshop saw the participation of several notable figures, including Dr. Viranchi Shah, President of IDMA, Shrenik Shah, President of the IDMA Gujarat Chapter, and India’s Deputy Drug Controllers, Ravikant Sharma and Naresh Sharma.
This gathering served as a stage for discussing important revisions to Schedule M, which constitutes India’s Good Manufacturing Practices (GMP) guidelines. Industry and regulatory experts led sessions providing guidance on achieving compliance with the updated standards, as well as insights from CDSCO and FDCA Gujarat to help align with the regulatory framework.
The updates in the Revised Schedule M call for extensive validation activities like equipment qualification to ensure adherence to GMP standards. These changes are designed to enhance the quality of the supply chain and reinforce India’s standing as a dominant force in the global pharmaceutical sector.
Dr. Koshia acknowledged the importance of these collaborative efforts and stated, “This workshop reflects the unified dedication of CDSCO, FDCA Gujarat, and IDMA to advance compliance and excellence within India’s pharmaceutical industry. With robust participation from industry professionals, this event marked a crucial stride toward harmonizing India’s pharmaceutical operations with global expectations.”