CDSCO Reports 159 Substandard Drug Samples in May, One Spurious in Assam

India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has flagged 159 drug samples as 'not of standard quality' (NSQ) during routine surveillance in May. Additionally, one sample was found to be spurious in Assam, according to the latest monthly alert issued by the agency.

Of the total NSQ samples, 46 were identified by central drug laboratories and 113 by state drug laboratories. A drug sample is labelled as NSQ when it fails to meet the prescribed quality parameters, such as purity, potency, or stability standards set by the Drugs and Cosmetics Act.

The CDSCO has clarified that the findings pertain only to the specific batches tested and do not indicate that other batches of the same products are substandard. The regulator emphasised that routine surveillance is part of ongoing efforts to ensure drug quality and safety in the country.

The spurious sample, detected in Assam, refers to a counterfeit drug that is deliberately mislabelled or contains incorrect ingredients. Such samples are treated as a serious violation under law. The CDSCO's alert serves as a notice to manufacturers and state authorities to take corrective actions, including recall or investigation, when necessary.

This monthly alert is a standard practice by the CDSCO to keep the public and stakeholders informed about the quality of drugs in the market. The agency continues to monitor and enforce compliance with quality standards across pharmaceutical manufacturing and distribution chains.