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09 FEB 2024
In a concerted effort to safeguard public health and uphold the integrity of the pharmaceutical industry, stringent regulatory measures have been implemented to ensure the quality of medicines across India. The Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare have spearheaded several initiatives to fortify the regulatory framework, bolstering oversight and accountability in drug manufacturing, sale, and distribution.
Key regulatory measures include amendments to the Drugs and Cosmetics Act, 1940, enacted through the Drugs & Cosmetics (Amendment) Act 2008, which imposes stringent penalties for the manufacture of spurious and adulterated drugs. Notably, certain offenses have been made cognizable and non-bailable, underscoring the gravity of violations.
To reinforce the inspection process, the Drugs and Cosmetics Rules, 1945, now mandate joint inspections of manufacturing establishments by Drugs Inspectors from both the Central Government and State Government before the grant of manufacturing licenses. Additionally, applicants are required to furnish evidence of stability and safety of excipients to the State Licensing Authority, ensuring compliance with quality standards prior to licensure.
Furthermore, amendments to the Drugs and Cosmetics Rules, 1945, stipulate the submission of bioequivalence study results along with applications for manufacturing licenses of oral dosage forms of certain drugs, enhancing efficacy assessment. The revision of Schedule M to the Drugs Rules 1945 emphasizes adherence to Good Manufacturing Practices and premises requirements for pharmaceutical products, further raising manufacturing standards.
In collaboration with State Drug Control Organizations, CDSCO facilitates risk-based inspections of drug manufacturing premises, with 275 inspections conducted to assess regulatory compliance. Actions such as issuance of show cause notices, stop production orders, and license suspensions or cancellations have been undertaken based on inspection findings, demonstrating a proactive approach to enforcement.
The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar, affirmed these regulatory efforts in a written reply in the Lok Sabha, emphasizing the government’s commitment to ensuring the quality, safety, and efficacy of drugs, medical devices, and cosmetics in the country. By continually refining and strengthening the regulatory framework, India aims to uphold the highest standards of pharmaceutical integrity, safeguarding public health and trust in the healthcare system.
