Paracetamol, 52 other drugs fail quality test

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged 53 medicines, including paracetamol and other commonly used drugs, for failing to meet quality standards. A total of 48 medicines were placed under a “Not of Standard Quality (NSQ)” alert, with another five deemed potentially spurious by the companies.

Widely used medications

• The drugs that failed quality tests include widely used medications such as paracetamol tablets (500 mg), anti-diabetic drug Glimepiride, hypertension treatment Telma H (Telmisartan 40 mg), calcium supplements Shelcal C and D3, and Metronidazole tablets used for skin infections. Other notable drugs include Fexofenadine Hydrochloride (used for allergies), Clavam 625 (recommended for oral infections), and Pan D (for acidity and indigestion).

The drugs that failed quality tests include widely used medications such as paracetamol tablets (500 mg), anti-diabetic drug Glimepiride, hypertension treatment Telma H (Telmisartan 40 mg), calcium supplements Shelcal C and D3, and Metronidazole tablets used for skin infections. Other notable drugs include Fexofenadine Hydrochloride (used for allergies), Clavam 625 (recommended for oral infections), and Pan D (for acidity and indigestion).

Several top-selling drugs produced by reputable pharmaceutical companies, such as Hindustan Antibiotics Limited, Alkem Laboratories, Life Max Cancer Laboratories, and Karnataka Antibiotics and Pharmaceuticals Ltd., were part of the list.

The CDSCO’s second list included five additional drugs that companies claim are spurious, including Sun Pharma’s Pulmosil (for pulmonary arterial hypertension), Pantocid (for acid reflux), and Ursocol 300, as well as Glenmark’s hypertension drug Telma H and Macleods Pharma’s Defcort 6 (for joint and muscle problems). These companies have denied responsibility for the flagged drugs, stating that they had not manufactured the affected batches.

In a response, Sun Pharma and other companies noted that “the impugned batch of the product has not been manufactured by them and that it is a spurious drug”. Investigations are ongoing to confirm the claims.

This development follows the CDSCO’s August ban on over 156 fixed-dose drug combinations due to potential risks to human health.