The Central Drugs Standard Control Organisation (CDSCO) has flagged safety concerns after declaring over 50 commonly used drugs, including paracetamol, Pan D, and calcium supplements, as “not of standard quality” in its latest monthly report.
“Not of Standard Quality (NSQ Alert)”
In its August 2024 report, the Central Drugs Standard Control Organisation (CDSCO) classified paracetamol, vitamin D and calcium supplements, hypertension drugs, and certain anti-diabetes medications under the “Not of Standard Quality (NSQ Alert)” category. These alerts were issued based on random monthly sampling conducted by state drug officers.
Vitamin C and Paracetamol Tablets
The list of medicines that failed the quality check includes Vitamin C and D3 tablets, Shelcal, Vitamin B complex, Vitamin C softgels, antacid Pan-D, paracetamol tablets (IP 500 mg), the anti-diabetic drug Glimepiride, and the hypertension medication Telmisartan.
These products were produced by various manufacturers, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences, among others.
Metronidazole
Metronidazole, a widely used treatment for stomach infections manufactured by Hindustan Antibiotics Limited (HAL), also failed quality testing. Additionally, Shelcal, a popular calcium and vitamin D3 supplement, has been listed in the NSQ Alert category.
Spurious: Clavam 625 and Pan D
A drug-testing laboratory in Kolkata has classified antibiotics such as Clavam 625 and Pan D as spurious. Additionally, Cepodem XP 50 Dry Suspension, a medication commonly used for treating infections in children, was also tested at the same lab and flagged by the CDSCO for failing quality standards.
The central drug regulator has released two lists: one containing 48 drugs that failed quality tests and another featuring 5 drugs in the NSQ Alert category, along with responses from their respective manufacturers.
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation,” the response from Pulmosil’s drug-make reads.
In August this year, the CDSCO banned over 156 fixed-dose drug combinations across the country for “likely risk to humans.”
