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Drug regulator CDSCO flags 205 drug samples as not of standard quality in November

Central and state drug testing laboratories identified substandard and spurious medicines during routine nationwide surveillance

Representational image
Representational image IANS

India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged 205 drug samples as Not of Standard Quality (NSQ) following nationwide testing carried out in November, according to its latest monthly drug alert.

Of the total samples that failed quality checks, 64 were identified by Central Drugs Laboratories, while 141 were flagged by State Drugs Testing Laboratories. The findings form part of routine regulatory surveillance undertaken jointly by central and state authorities to monitor the quality of medicines available in the market.

The CDSCO stated that the list of NSQ and spurious drugs is uploaded on its official portal every month as part of its transparency and compliance measures. Officials clarified that a drug sample is classified as NSQ when it fails to meet one or more prescribed quality parameters during laboratory testing.

Such failure is limited to the specific batch tested and does not automatically raise concerns about other batches or similar products available in the market.

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In addition to substandard drugs, regulators also identified two spurious drug samples in November from the North Zone laboratory in Ghaziabad. These were found to have been manufactured by unauthorised entities using brand names owned by other companies.

The matter is currently under investigation, and regulatory action will be initiated in accordance with the Drugs and Cosmetics Act and its associated rules.

Health officials emphasised that the ongoing identification and removal of NSQ and spurious medicines is a continuous exercise carried out in coordination with state drug regulators to safeguard public health and maintain the integrity of the pharmaceutical supply chain.

The November figures show a marginal decline compared to October, when a total of 211 drug samples were declared NSQ. At that time, Central Drugs Laboratories had identified 63 substandard samples, while State Drugs Testing Laboratories had flagged 148.

With IANS inputs

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