Posted By :  Admin1

PTI

Published On Aug 8, 2023 at 06:30 PM IST

New Delhi: The Central Drugs Standard Control Organisation (CDSCO), along with state licensing authorities, has conducted risk-based inspections of 162 pharmaceutical firms, resulting in show cause notices issued in 143 cases, according to Union Health Minister Mansukh Mandaviya. Out of these, stop production orders were issued in 40 cases, while 66 cases saw cancellation or suspension of product/section licenses. Additionally, warning letters were sent in 21 cases, and in one instance, an FIR was lodged, leading to three arrests under the Drugs Rules, 1945.

A notification by the Directorate General of Foreign Trade mandated cough syrup manufacturers to obtain a certificate of analysis from a government-approved laboratory before exporting their products. Over 900 cough syrup samples have been analyzed and issued a Certificate of Analysis (CoA) as of now.

The manufacturing, sale, and distribution of drugs in India fall under the purview of the Drugs and Cosmetics Act, 1940, and Rules, 1945. Regulatory control involves licensing and inspection by State Licensing Authorities (SLAs) appointed by respective state governments. Manufacturers must adhere to license conditions for drug production, and when quality or safety issues arise, SLAs take appropriate action, including legal prosecution.