Quality Scare: Paracetamol from Hetero and Telmisartan from Alkem Fail CDSCO Tests

In its August 2024 report, the Central Drugs Standard Control Organization (CDSCO) flagged various medications, including paracetamol, vitamin D and calcium supplements, blood pressure drugs, and some anti-diabetes medications, as “Not of Standard Quality” (NSQ). These alerts arise from routine monthly sampling by state drug authorities.

Among the drugs that failed the quality assessment are vitamin C and D3 tablets, Shelcal, vitamin B complex supplements, vitamin C softgels, the antacid Pan-D, paracetamol (IP 500 mg), the anti-diabetic drug Glimepiride, and the blood pressure medication Telmisartan.

These medicines were produced by multiple companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences, among others.

Additionally, Metronidazole, a common antibiotic for stomach infections made by HAL, failed quality control checks. The widely used calcium and vitamin D3 supplement Shelcal also appeared on the NSQ alert list.

A drug-testing laboratory in Kolkata identified Clavam 625 and Pan D as spurious, while Cepodem XP 50 Dry Suspension, a common pediatric infection treatment, failed quality tests according to CDSCO.

CDSCO published two lists: one containing 48 drugs that failed quality standards and another listing 5 drugs under NSG Alert status, along with manufacturer responses.

For example, Pulmosil’s manufacturer stated that the flagged batch was not produced by them and is believed to be counterfeit, pending investigation.

In a related development, CDSCO banned over 156 fixed-dose drug combinations nationwide in August 2024 due to potential risks to human health.