New Delhi | December 19,2025 | SKY LINK TIMES
CDSCO Flags 205 Substandard Drugs:
India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged 205 drug samples as Not of Standard Quality (NSQ) in its monthly drug safety alert for November 2025, raising fresh concerns over medicine quality and regulatory compliance across the country.
The alert, issued on Friday, is part of routine regulatory surveillance conducted jointly by central and state drug testing authorities to ensure patient safety and maintain drug quality standards.
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Break-up of NSQ Drugs Identified
According to the CDSCO notification:
1.64 drug samples were declared NSQ by Central Drugs Laboratories
2.141 drug samples were identified as NSQ by State Drugs Testing Laboratories
The regulator clarified that the classification of a drug as NSQ is based on failure in one or more specified quality parameters, such as potency, dissolution, or composition.
Health officials emphasised that the failure is batch-specific and does not imply quality issues with other batches or brands of the same medicine currently available in the market.
Two Spurious Drugs Found in North Zone
In addition to substandard medicines, the CDSCO revealed that two drug samples from the North Zone, Ghaziabad, were identified as spurious.
> “These drugs were manufactured by unauthorised manufacturers using a brand name owned by another company,” officials stated.
The matter is currently under investigation, and authorities have assured that strict action will be taken under the Drugs and Cosmetics Act and Rules.
Monthly Disclosure to Enhance Transparency
As part of its transparency initiative, the CDSCO publishes a monthly list of NSQ and spurious drugs on its official portal. This practice enables state regulators, healthcare professionals, and the public to stay informed and take necessary precautions.
The regulator reiterated that such actions are taken regularly in collaboration with state drug controllers to ensure that unsafe or substandard medicines are swiftly identified and removed from the supply chain.
Also Read:https://skylinktimes.in/india-sends-73-tonnes-of-life-saving-medicines/
October Data Shows Similar Trend
The November figures follow a similar trend observed in October 2025, when the CDSCO had declared 211 drug samples as NSQ. Of these:
63 samples were flagged by Central Drugs Laboratories
143 samples were identified by State Drugs Testing Laboratories
This consistency highlights the ongoing challenges in quality compliance within India’s vast pharmaceutical supply network, despite stringent regulatory mechanisms.
Why This Matters
Drug quality failures can compromise treatment outcomes and patient safety. Regulatory surveillance and timely disclosure play a critical role in strengthening trust in India’s healthcare system and ensuring medicines meet approved safety standards.
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