167 Drug Samples Identified as Not of Standard Quality in December 2025 Regulatory Alert

In December 2025, a total of 167 drug samples were flagged as not of standard quality by central and state laboratories. This identification is part of routine regulatory surveillance to ensure drug safety.

In December 2025, the Central Drugs Laboratories identified 74 drug samples as not meeting quality standards, according to a health ministry statement. Additionally, state drug testing labs found 93 samples to be of substandard quality. These findings are part of routine regulatory checks, with results published monthly on the CDSCO portal.

The identification process for drugs not meeting quality standards involves testing specific batches against set parameters. If a batch fails, it is marked as NSQ. However, this does not imply that all products in the market are affected, only those specific batches tested by government labs.

Spurious Drugs and Ongoing Investigations

In December 2025, four drug samples from North Zone Ghaziabad and one each from FDA Ahmedabad, Bihar, and Maharashtra were identified as spurious. These were produced by unauthorised manufacturers using brand names owned by other companies. The matter is currently under investigation, with legal actions to follow.

The collaboration between central and state regulators aims to identify and remove substandard and spurious drugs from the market regularly. This ongoing effort ensures public safety by maintaining the quality of available medications.

The health ministry's statement emphasised that identifying NSQ and spurious drugs is a continuous process. It is crucial for safeguarding consumers by ensuring that only quality-assured drugs are available in the market.

With inputs from PTI