In a bid to ensure the safety and efficacy of medicines available in the market, the Drug and Cosmetics Act of 1940 mandates that Drugs Inspectors randomly collect samples from the supply chain for quality checks. The Central Drugs Standard Control Organization (CDSCO) regularly publishes a list of drugs that fail to meet quality standards—categorized as Not of Standard Quality (NSQ), Spurious, Misbranded, or Adulterated—on its official website under the “Drug Alert” section.

To further strengthen drug quality monitoring, the government launched the SUGAM Labs online portal in September 2023, integrating the drug testing laboratories of CDSCO. This digital platform automates the entire testing workflow for medical products, including drugs, vaccines, cosmetics, and medical devices, ensuring compliance with quality specifications and providing real-time tracking of testing statuses.

Pharmaceutical manufacturers are required to strictly adhere to licensing conditions under the Drug and Cosmetics Act and associated rules. If a drug sample is found to be of substandard quality by CDSCO laboratories, the concerned manufacturer is immediately directed to recall the affected batch and halt further distribution. As per licensing conditions, firms must comply with withdrawal and recall procedures upon notification from the Licensing or Controlling Authority. The directive explicitly states that any batch of drugs failing to meet prescribed strength, quality, or purity standards must be withdrawn from sale, and recalled wherever feasible.

With these stringent regulations and digital advancements, India is reinforcing its commitment to drug safety, public health, and regulatory transparency, ensuring that substandard medicines are swiftly identified and removed from circulation.