Health Minister Dinesh Gundu Rao
Credit: DH Photo
Bengaluru: The Indian Pharmaceutical Association (IPA) Karnataka branch, in association with the Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA), held a one-day workshop for pharma companies and students on Managing Regulatory Changes in Solid Oral Dosage Forms on Saturday.
The Health and Family Welfare Minister, Dinesh Gundu Rao, spoke about the critical issues directly impacting public health and the credibility of the pharmaceutical sector. “The Government has notified the revised Schedule M to modernise India’s Good Manufacturing Practices (GMP) in alignment with global standards such as WHO-GMP and international quality expectations,” said Rao.
Schedule M of the Drugs and Cosmetics Act, 1945, sets the national standards for Good Manufacturing Practices (GMP) for pharmaceuticals in India.
The revised Schedule M published in 2023 includes robust quality systems, efficiency and traceability in manufacturing, better training and competency among personnel, improved documentation and digital compliance, and stronger environmental and contamination controls.
The minister urged pharmaceutical proprietors to view these changes not as burdens but as investments in the credibility and sustainability of their businesses.
Speaking about another persistent challenge, Rao said that the presence of Not of Standard Quality (NSQ) drugs across the country is not acceptable. “I want to make it clear that there will be no tolerance against NSQ. Recent surveillance data and regulatory actions have shown avoidable instances of NSQ products related to poor adherence to quality standards, inadequate testing, lapses in documentation, and non-compliance with GMP.”
Speaking to DH, Dr Umesh S, Additional Drug Controller, said, “Following the revised Schedule M is a must, and trained faculty and employees and regulation of NSQs are mandatory.”