167 Drug Samples Fail Quality Standards In December: CDSCO

The Central Drugs Standard Control Organisation (CDSCO) on Wednesday announced that 167 drug samples tested by Central and state drug regulatory authorities were found to be ‘Not of Standard Quality’ (NSQ) in December, as part of its monthly drug alert.

According to the alert, Central Drugs Laboratories identified 74 drug samples as NSQ, while State Drugs Testing Laboratories flagged 93 samples for failing to meet prescribed quality standards.

The CDSCO released these findings as part of routine regulatory surveillance and publishes the list of NSQ and spurious drugs on its portal every month.

The regulator clarified that it categorises drug samples as NSQ when they fail to meet one or more specified quality parameters during testing.

Importantly, such failures are batch-specific and relate only to the particular samples tested by government laboratories.

The regulator stressed that the identification of a drug batch as NSQ does not automatically raise concerns about other batches or similar products available in the market.

In addition to NSQ findings, the December alert also flagged seven drug samples as spurious.

These included four samples from the North Zone in Ghaziabad, and one sample each from FDA Ahmedabad, Bihar, and Maharashtra.

The CDSCO said unauthorised manufacturers produced these medicines using brand names owned by other companies.

The regulator has launched an investigation and will take action under the Drugs and Cosmetics Act and Rules.

The CDSCO said it regularly identifies NSQ and spurious drugs in coordination with state regulators, demonstrating an active and responsive regulatory framework to protect public health and promptly remove substandard medicines from the market.

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