CDSCO Flags Over 160 Drug Samples as Not of Standard Quality in December 2025

India’s drug regulatory authorities have reported multiple instances of medicines failing to meet prescribed quality benchmarks during routine testing in December 2025. 

The findings, released through official regulatory surveillance updates, include both substandard and spurious drug samples. 

Authorities have stated that action is underway to address these cases and ensure continued monitoring of medicines available in the market.

Drug Samples Found Not of Standard Quality

Central Drugs Laboratories identified 74 drug samples, while State Drugs Testing Laboratories flagged 93 samples as Not of Standard Quality (NSQ) during December 2025. 

A sample is classified as NSQ when it fails to meet one or more specified quality parameters during laboratory testing.

Regulators clarified that such failures are limited to the specific batches tested and do not necessarily indicate quality concerns across other products available in the market.

Spurious Drugs Under Investigation

In addition to NSQ findings, authorities detected 7 spurious drug samples during the month. These included samples from North Zone Ghaziabad, FDA Ahmedabad, Bihar and Maharashtra.

The products were reportedly manufactured by unauthorised entities using brand names owned by other companies.

Officials confirmed that these cases are under investigation and that necessary action will be taken in accordance with applicable laws and regulations.

Ongoing Regulatory Surveillance

The Central Drugs Standard Control Organisation (CDSCO) publishes monthly lists of NSQ and spurious drugs as part of routine regulatory oversight. The surveillance programme is conducted in coordination with state regulators to identify and remove non-compliant medicines from the market.

Officials stated that this process is intended to maintain consistent monitoring of drug quality and strengthen regulatory responsiveness.

Comparison with the Previous Month

In November 2025, Central and State laboratories together identified 205 NSQ drug samples, while two spurious drug samples were reported from the North Zone, Ghaziabad. These findings were also linked to unauthorised manufacturers using registered brand names.

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Conclusion

The latest regulatory report highlights continued oversight of pharmaceutical quality standards across the country. Regular testing, disclosure of findings and ongoing investigations remain central to efforts aimed at ensuring medicines in circulation meet prescribed safety and quality requirements.

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