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Paracetamol, Pan D among 53 medicines to fail drug regulator's quality test; raise safety concerns
Central body CDSCO declared Paracetamol, Pan D and 51 other drugs ‘not of standard quality’ in its monthly quality check report.
The Central Drugs Standards Control Organisation (CDSCO) declared more than 50 drugs, including paracetamol, Pan D, and calcium supplements, as ‘not of standard quality’ in its recent monthly report, raising safety concerns regarding their usage.
In its August 2024 report, the central drug regulator identified paracetamol, vitamin D and calcium supplements, high blood pressure medications, and certain anti-diabetes pills under the “Not of Standard Quality (NSQ Alert)” category. NSQ alerts are generated from random monthly sampling conducted by state drug officers.
Medicines that failed the quality check include vitamin C and D3 tablets, Shelcal, vitamin B complex, vitamin C softgels, anti-acid Pan-D, paracetamol tablets (IP 500 mg), the anti-diabetic drug Glimepiride, and the high blood pressure medication Telmisartan.
These products were manufactured by several companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences, among others.
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Metronidazole, a commonly used treatment for stomach infections produced by HAL, also failed quality testing. Similarly, Shelcal, a popular calcium and vitamin D3 supplement, has been flagged in the NSQ Alert category.
A Kolkata drug-testing lab deemed antibiotics like Clavam 625 and Pan D as spurious. Cepodem XP 50 Dry Suspension, a common infection medication used for children, was also tested in the same lab and flagged by CDSCO for failing the quality test.
The central drug regulator issued two lists - one with 48 drugs that failed the quality tests and another with 5 drugs in the NSG Alert category, along with the response from their manufacturers.
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation,” the response from Pulmosil's drug-make reads.
In August this year, the CDSCO banned over 156 fixed-dose drug combinations across the country for “likely risk to humans.”
