Paracetamol, Pan D, 51 other drugs fail quality tests by Indian drug regulator

India’s drug regulator has declared more than 50 drugs as "Not of Standard Quality (NSQ)” following a detailed quality test. Among others, calcium and vitamin D3 supplements, anti-diabetes pills and high blood pressure medicines have been labelled NSQ by the Central Drugs Standards Control Organisation (CDSCO). Additionally, the regulator has raised concerns over the quality of paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd.

CDSCO’s state drug officers conduct random quality checks on a monthly basis, based on which NSQ alerts are generated.

The drug regulator found that Vitamin C and D3 tablets Shelcal, vitamin B complex and vitamin C softgels, antiacid Pan-D, paracetamol tablets IP 500 mg, anti-diabetic drug Glimepiride, and high blood pressure drug Telmisartan are among 53 top-selling drugs that have failed in quality tests.

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Firms like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd are responsible for manufacturing of these medicines.

Metronidazole, another widely-consumed drug made by PSU Hindustan Antibiotic Limited (HAL), also features on the list.

Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Uttarakhand-based Pure & Cure Healthcare, also came under the regulator’s radar for poor quality.

In its alert, CDSCO shared two lists, with one bearing the names of drugs failing in quality tests and the other carrying responses from their manufacturers.

In the second column, the manufacturer of a drug claimed, citing the label number, that it didn’t not produce the flagged batches, suggesting that these may be spurious drugs.

However, the final determination is subject to ongoing investigations.

Companies such as Sun Pharma and Glenmark have also provided similar replies, asserting they had not manufactured the implicated medicines.

Earlier in August, the drug regulatory body had banned 156 fixed-dose drug combinations deemed "likely to involve risk to humans."

(With inputs from agencies)