53 Indian Medicines Fail Quality Tests, Raising Safety Concerns

Wed Sep 25 2024
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NEW DELHI: India’s Central Drugs Standards Control Organisation (CDSCO) has reported that 53 widely used medicines, including paracetamol and various supplements, have been flagged as “Not of Standard Quality (NSQ) Alert” in its latest monthly drug alert list.

The alert, generated from random monthly sampling by state drug officers, has raised significant safety concerns about Indian drugs among healthcare professionals and consumers alike. The list includes popular medications such as calcium and vitamin D3 supplements, anti-diabetic drugs, and medications for high blood pressure.

Additional findings from a Kolkata drug-testing laboratory deemed Alkem Health Science’s antibiotics Clavam 625 and Pan D as spurious, while Hetero’s Cepodem XP 50 Dry Suspension, prescribed for severe bacterial infections in children, was identified as substandard.

The CDSCO has published two lists of drugs that failed quality checks, comprising a total of 48 top-selling medications and an additional five. In response to the alerts, several pharmaceutical companies have denied responsibility for the products, claiming they are “spurious.”

“The actual manufacturer has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” the responses from the drug makers stated.

This alarming news follows previous action by the CDSCO in August, when over 156 fixed-dose drug combinations were banned from the Indian market due to risks to human health. The banned medications included popular fever drugs, painkillers, and allergy tablets.

The repeated failures of quality standards in India’s pharmaceutical sector have drawn attention to the need for stringent regulatory oversight and quality assurance measures.

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