CDSCO flags 330 substandard drug samples and one spurious drug in September regulatory alert

The Central Drugs Standard Control Organisation (CDSCO) has identified 330 drug samples as Not of Standard Quality (NSQ) and one spurious drug sample during its routine regulatory surveillance for September 2026. The findings were released in the authority's monthly report.

According to the report, Central Drugs Laboratories identified 42 drug samples as NSQ, while State Drugs Testing Laboratories identified an additional 288 samples. The regulatory body clarified that the failures are specific to the particular drug products and batches tested by the government laboratories, noting that these results do not apply to other drug products available in the market.

Additionally, one drug sample from the National Capital Territory of Delhi (NCT) was identified as spurious. The report states that this drug was manufactured by unauthorised manufacturers who used a brand name owned by another company. Authorities have stated that the matter is currently under investigation and appropriate action will be taken in accordance with the applicable Act and Rules.

The identification of drug samples as NSQ is based on their failure to meet specified quality parameters, which include strict quality, strength, purity, or identity specifications. CDSCO and state drug regulators declare drugs as NSQ based on laboratory testing conducted under the provisions of the Drugs and Cosmetics Act, 1940.

The regulatory authority emphasized that the identification of NSQ and spurious medicines is conducted regularly in collaboration with state regulators to ensure these products are identified and removed from the market. The list of NSQ and spurious drugs is displayed on the CDSCO portal every month as part of this routine regulatory activity.

In a similar surveillance report released earlier, the CDSCO identified 220 drug samples as NSQ during routine checks in August 2026. That total included 29 samples identified by Central Drugs Laboratories and 191 by State Drugs Testing Laboratories. The August report also noted one spurious drug sample from the NCT of Delhi, which was similarly manufactured by unauthorised entities using another company's brand name. Investigations and legal actions regarding those previous findings continue under the Drugs and Cosmetics Act and Rules.

"Regulatory oversight and quality compliance are critical pillars for any business operating in the healthcare and pharmaceutical sector. Routine surveillance by authorities like the CDSCO highlights the ongoing necessity for strict adherence to manufacturing standards, quality parameters, and IP protections. For enterprises in this space, maintaining robust internal quality controls is essential to mitigate compliance risks and ensure consumer safety." — Dr. Shishir Gupta, Founder & CEO, StartupLanes