Under the Drug and Cosmetics Act 1940, Drugs Inspector randomly draws drug samples from the supply chain for quality checks. Also, list of drugs of various companies, which are declared Not of Standard Quality/ Spurious/ Misbranded/ Adulterated by the Central Drugs Testing Laboratories are regularly uploaded on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of Drug Alert (www.cdsco.gov.in).

An online portal, SUGAM labs is in place since September 2023 for integrating the drug testing labs of the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specification and tracing the testing status in the laboratories.

Manufacturers are required to comply with the conditions of Licence granted under the said Act and Rules to manufacture any drugs for sale and distribution in the country. In case of drug samples declared as Not of Standard Quality by the Drugs Testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the Not of standard quality Drugs in the market. One of the conditions for licensing is regarding withdrawal/recall/take back of drugs which is reproduced below:

“the licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the drug has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch.”

The Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel stated this in a written reply in the Rajya Sabha today.

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HFW/ Status of Drug Quality Testing under CDSCO/01 April 2025/2