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MSMEs ready to embrace revised Schedule M to ensure drug quality: Dr H G Koshia
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Shardul Nautiyal, Mumbai
December 03 , 2024
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“Indian Pharma MSMEs are now more proactive in implementing the Revised Schedule M guidelines. They are gearing up to establish a robust Pharmaceutical Quality System (PQS), integrate Quality Risk Management (QRM), conduct Product Quality Reviews (PQR), and adopt computerized storage systems for drug products. Their ultimate aim is to produce quality drugs that meet global standards,” stated Dr. H.G. Koshia, Commissioner of Gujarat FDCA.
Dr Koshia was speaking as the Chief Guest at a workshop on ‘Vendor Validation and Audit as per Revised Schedule M Guidelines’ hosted by the Central Drugs Standard Control Organization (CDSCO), in collaboration with the Food and Drug Control Administration (FDCA), Gujarat, and the Indian Drug Manufacturers Association (IDMA) in Ahmedabad recently.
Dr Koshia further emphasized the readiness of India’s pharmaceutical Micro, Small, and Medium Enterprises (MSMEs) to adopt the latest regulatory advancements.
The workshop featured prominent dignitaries, including Dr. Viranchi Shah, president of IDMA, Shrenik Shah, president of IDMA Gujarat Chapter and Deputy Drug Controllers of India, Ravikant Sharma and Naresh Sharma.
The event provided a platform to discuss critical updates to Schedule M—India’s Good Manufacturing Practices (GMP) guidelines. Key sessions were led by industry and regulatory experts, shedding light on Best practices for ensuring compliance with the revised standards and insights from CDSCO and FDCA Gujarat on aligning with the regulatory framework.
The Revised Schedule M mandates comprehensive validation processes, including the qualification of equipment, to ensure GMP compliance. These updates aim to bolster supply chain quality and strengthen India's position as a global pharmaceutical leader.
Dr Koshia highlighted the significance of such collaborative initiatives, stating, “This workshop underscores the shared commitment of CDSCO, FDCA Gujarat, and IDMA to fostering compliance and excellence in India’s pharmaceutical sector. With the strong participation of industry professionals, this workshop marked a significant step in aligning the operations of Indian pharmaceutical manufacturers with evolving global standards.”
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