The Indian government has reinforced its commitment to ensuring the quality and safety of drugs available in the market through stringent quality checks, a robust recall system, and enhanced online monitoring.
Random Drug Sample Checks:
Under the Drug and Cosmetics Act 1940, Drugs Inspectors conduct random quality checks by drawing samples from the drug supply chain. This proactive approach aims to identify and remove substandard or potentially harmful drugs from circulation.
“Drug Alert” System on CDSCO Website:
The Central Drugs Standard Control Organization (CDSCO) maintains a “Drug Alert” system on its website (www.cdsco.gov.in). This system regularly publishes lists of drugs from various companies that have been declared Not of Standard Quality (NSQ), spurious, misbranded, or adulterated by Central Drugs Testing Laboratories. This transparency allows healthcare professionals and consumers to stay informed about potentially problematic drugs.
SUGAM Labs Online Portal for Enhanced Monitoring:
Since September 2023, the CDSCO has implemented the SUGAM labs online portal. This platform integrates the drug testing labs of the CDSCO, automating the entire workflow for testing medical products, including drugs, vaccines, cosmetics, and medical devices. SUGAM labs facilitates real-time tracking of testing status, ensuring efficiency and accountability.
Manufacturer Compliance and Recall Obligations:
Drug manufacturers are required to adhere to the conditions of their licenses granted under the Drug and Cosmetics Act and Rules. In cases where drug samples are declared NSQ, manufacturers are mandated to immediately recall and halt further distribution of the affected drugs.
Mandatory Recall Clause:
A crucial licensing condition states that:
“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.”
