Over 2,500 drugs found to be substandard, 379 spurious: Ministry of Health to Rajya Sabha

The government has issued notices to and taken action against Maiden Pharma and Marion Biotech, the minister pointed out.

On central drug regulation, Pawar noted that the Drugs and Cosmetics Act, 1940, amended under the Drugs and Cosmetics (Amendment ) Act, 2008, imposes stricter penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognisable and non-bailable.

Additionally, special courts have been set up in states and Union Territories to expedite the trial of offences under the Drugs and Cosmetics Act. The CDSCO has also significantly increased the number of sanctioned posts in the last decade.

To ensure drug efficacy, the Drugs and Cosmetics Rules, 1945, have been amended to require applicants to submit the results of bioequivalence studies along with applications for manufacturing licenses of oral dosage forms of certain drugs.

The manufacturing establishment must undergo a joint inspection by drug inspectors from the Center and state before the grant of a manufacturing license.

Furthermore, amendments to the Drugs and Cosmetics Rules, 1945, make it mandatory for applicants to submit evidence of stability and safety of excipients to the State Licensing Authority (SLA) before obtaining a manufacturing license.

Pawar mentioned that the CDSCO plays a pivotal role in coordinating the activities of State Drug Control Organizations and providing expert advice through the Drugs Consultative Committee (DCC) meetings, aiming to ensure uniformity in the administration of the Drugs and Cosmetics Act.

SLAs appointed by respective state governments exercise regulatory control over drug manufacturing, sale, and distribution through licensing and inspection systems.

Manufacturers are required to comply with the conditions specified in their licenses under the Act and Rules to sell and distribute drugs in the country. Cases concerning the quality or safety of drugs are handled by the SLA, which can take necessary actions, including prosecution in the appropriate court of law.