The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar, recently highlighted the government's concerted efforts to uphold the quality and safety standards of medicines across the country. Through the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare, several regulatory measures have been implemented to regulate the manufacturing, sale, and distribution of drugs.
Under the amended Drugs and Cosmetics Act 2008, stringent penalties have been introduced for the manufacture of spurious and adulterated drugs. To bolster oversight, manufacturing establishments now undergo mandatory joint inspections by drug inspectors from both the central government and state government before the grant of manufacturing licences.
Applicants seeking manufacturing licences are required to furnish evidence of the stability and safety of excipients to the State Licencing Authority, ensuring a thorough evaluation process. Additionally, bioequivalence studies for oral dosage forms of specific drugs have become mandatory to ensure efficacy.
The government has also taken steps to increase manpower within CDSCO, with the number of sanctioned posts rising significantly from 111 in 2008 to 931. Special courts dedicated to trying offences under the Drugs and Cosmetics Act have been established by states and UTs, facilitating the speedy disposal of cases.
In a bid to promote uniformity in administration, CDSCO coordinates with state drug control organisations and provides expert advice through Drugs Consultative Committee meetings. Furthermore, the revised Good Manufacturing Practices (GMP) under the Drugs Rules of 1945 aims to enhance quality standards in pharmaceutical production.
To assess regulatory compliance, CDSCO, along with State drug controllers, conducts risk-based inspections of manufacturing premises, resulting in over 250 regulatory actions. These measures underscore the government's commitment to ensuring the quality, safety, and efficacy of drugs, medical devices, and cosmetics nationwide.
Dr Bharati Pravin Pawar emphasised these initiatives in a written reply to the Lok Sabha, reflecting the government's proactive stance in safeguarding public health.