CDSCO Raises Safety Concerns Over 53 Drugs Including Paracetamol, Pan D

The Central Drugs Standards Control Organisation (CDSCO) has reported that more than 50 drugs, including paracetamol, Pan D, and calcium supplements, are classified as ‘not of standard quality’ (NSQ), prompting safety concerns about their use.

In its August 2024 report, the central drug regulator highlighted medications such as paracetamol, vitamin D and calcium supplements, high blood pressure drugs, and specific anti-diabetes medications in the NSQ Alert category. These alerts are based on random monthly sampling conducted by state drug officials.

Among the medicines that did not pass quality checks are vitamin C and D3 tablets, Shelcal, vitamin B complex, vitamin C softgels, Pan-D, paracetamol tablets (IP 500 mg), the anti-diabetic drug Glimepiride, and the high blood pressure medication Telmisartan.

These products were manufactured by several companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences. Notably, Metronidazole, a widely used treatment for stomach infections produced by HAL, also failed quality testing, alongside Shelcal, a popular calcium and vitamin D3 supplement.

Additionally, a Kolkata drug-testing laboratory identified antibiotics such as Clavam 625 and Pan D as spurious. Cepodem XP 50 Dry Suspension, a common medication for infections in children, was also flagged by the CDSCO for failing quality tests.

The CDSCO has issued two lists: one containing 48 drugs that did not meet quality standards and another with five drugs in the NSG Alert category, including the manufacturers' responses.

“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 investigation,” stated the response from Pulmosil's drug manufacturer.

Earlier in August, the CDSCO imposed a ban on over 156 fixed-dose drug combinations nationwide, citing a “likely risk to humans.”

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