Paracetamol, Pan-D, Shelcal Among 53 Drugs To Fail Quality Test: CDSCO

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, high blood pressure drug Telmisartan, and many more are among the 53 top-selling drugs that failed the quality check by the drug regulator, India Today reported.

These medicines are manufactured by Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, Pure & Cure Healthcare and more.

Metronidazole, a widely used drug for treating stomach infections, produced by PSU Hindustan Antibiotic Limited (HAL), is among those that failed quality tests. Similarly, Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Uttarakhand-based Pure & Cure Healthcare, also did not pass the test. Additionally, a Kolkata drug-testing lab has deemed Alkem Health Science’s antibiotics Clavam 625 and Pan D as spurious. The same lab identified Hyderabad-based Hetero’s Cepodem XP 50 Dry Suspension, prescribed for children with severe bacterial infections, as substandard.

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

The drug regulator shared two lists of drugs that failed quality tests. While one contains 48 popular drugs, the second list features an additional 5 drugs along with a reply section from the pharmaceutical companies who failed these tests.

However, the responses indicate that the companies denied taking responsibility for the drugs, saying that they are “spurious,” the report added. “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to the outcome of an investigation,” the column for the drug makers’ reply read.

Notably, in August, the CDSCO banned over 156 fixed-dose drug combinations in the Indian market that are “likely to involve risk to humans”. These medicines included popular fever drugs, painkillers and allergy tablets.