Paracetamol, Pan D, among 53 drugs fail drug regulator’s quality test; raises safety concerns

The Central Drugs Standard Control Organisation (CDSCO) declared over 50 drugs, including paracetamol, Pan D and calcium supplements, as ‘not of standard quality’ in its recent monthly report, raising safety concerns over their use.

In its August 2024 report, the central drug regulator placed paracetamol, vitamin D and calcium supplements, hypertension medicines and some anti-diabetes tablets in the “not of standard quality (NSQ alert)” category. NSQ alerts are generated from random monthly sampling done by state drug authorities.

The 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), anti-diabetic drug Glimepiride and hypertension drug Telmisartan.

These products were manufactured by several companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Ltd (HAL), Karnataka Antibiotics and Pharmaceuticals Ltd, Pure & Cure Healthcare and Meg Lifesciences.

Metronidazole, a commonly used treatment for stomach infections produced by HAL, also failed the quality test. Similarly, calcium and vitamin D3 supplement Shelcal has been marked in the NSQ alert category.

A drug-testing laboratory in Kolkata found antibiotics such as Clavam 625 and Pan D to be fake. Cepodem XP 50 Dry Suspension, a common infection drug used for children, was also tested in the same lab and was flagged by the CDSCO for failing the quality test.

The central drug regulator released two lists – one containing 48 drugs that failed the quality test and the other containing 5 drugs in the NSG alert category, along with the response of their manufacturers.

“The genuine manufacturer (as per label claim) has informed that the suspect batch of the product is not manufactured by them and is a counterfeit drug. The product is considered counterfeit, however, this is subject to the outcome of the investigation,” reads the response of the drugmaker of Pulmosil.

In August this year, the CDSCO banned over 156 fixed dose drug combinations across the country for “potential risk to humans”.