53 medicines, including paracetamol, Pan D fail central drug regulator's quality test

Guwahati, Sept 26: The Central Drugs Standards Control Organisation (CDSCO) has labelled 53 medicines, most of which are of everyday use, as "not of standard quality," raising questions about their use and safety.

The central drug regulator classified paracetamol, Pan D, calcium and vitamin D supplements, blood pressure drugs, and some anti-diabetes tablets as "Not of Standard Quality" (NSQ) in its August 2024 report.

According to the CDSCO, a number of well-known companies, including Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd., were involved in the production of the drugs that were highlighted.

Reportedly, the antibiotics Clavam 625 and Pan D from Alkem Health Science have been declared bogus by a drug-testing facility in Kolkata.

The same lab found that the Cepodem XP 50 Dry Suspension from Hyderabad-based Hetero, which is recommended for kids with serious bacterial infections, was not up to par. Karnataka Antibiotics & Pharmaceuticals Ltd.'s paracetamol tablets have also raised questions about quality.

Two lists of medications were released by the central drug regulator that were not up to par. The first list includes 48 well-known medications, while the second list adds 5 more medications and includes a response section from the pharmaceutical companies that failed the tests.

However, the companies responded by denying responsibility for the drugs, claiming the drugs taken as sample by the CDSCO are not manufactured by them.

Earlier in August, the Centre had banned at least 156 Fixed Dose Combination (FDC) medicines due to safety concerns. The list included commonly used drugs such as antibiotics for fever and colds, painkillers, multivitamins, and more.

The Union Health Ministry issued a gazette notification prohibiting the manufacture, sale, and distribution of these FDCs under Section 26A of the Drugs and Cosmetics Act, 1940.

The list also includes Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine, and Camylofin Dihydrochloride 25 mg and Paracetamol 300 mg.