Paracetamol, Pan-D Among 53 Top-Selling Drugs Fail Quality Test By Indian Regulator

The Central Drugs Standards Control Organisation (CDSCO), in its recent monthly drug alert list, declared more than 50 drugs, including calcium and vitamin D3 supplements, high blood pressure medicines, and anti-diabetes pills as “Not of Standard Quality (NSQ) Alert”. These medicines and supplements have failed quality tests by India’s drug regulator.

NSQ alerts are generated after the state drug officers conduct random monthly sampling. Among the 53 top-selling drugs that have failed quality check include Paracetamol tablets IP 500 mg, antiacid Pan-D, vitamin B complex and vitamin C softgels, Vitamin C and D3 tablets Shelcal, anti-diabetic drug Glimepiride, and high blood pressure drug Telmisartan, among others.

The medicines that have failed to pass the quality check are manufactured by Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Hetero Drugs, Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, Meg Lifesciences, and more.

Metronidazole, a drug used widely for treating stomach infections, produced by PSU Hindustan Antibiotic Limited (HAL), also feautures in the failed quality check list. Additionally, Shelcal, manufactured by Uttarakhand-based Pure & Cure Healthcare and distributed by Torrent Pharmaceuticals, did not pass the quality test.

Notably, Alkem Health Science’s antibiotics Clavam 625 and Pan D have been deemed as spurious by a Kolkata drug-testing lab. The same lab has also identified Hyderabad-based Hetero’s Cepodem XP 50 Dry Suspension as substandard. This medicines is prescribed for children with severe bacterial infections.

Karnataka Antibiotics & Pharmaceuticals Ltd’s Paracetamol tablets have also been flagged for quality concerns.

The drug regulator shared two lists of drugs that failed to pass the quality tests. The first list contained 48 popular drugs and the second list featured an additional five drugs with a reply section from the pharmaceutical companies that failed these quality checks.

However, the responses in the reply section suggested that the companies denied to take responsibility for the failed drugs and rubbished claims that they are “spurious”.

“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 column for the drug makers’ reply read.

Last month, the CDSCO had banned more than 156 fixed-dose drug combinations in the Indian market as they were “likely to involve risk to humans”. These drugs also included popular painkillers, fever drugs, and allergy tablets.