The Central Drugs Standards Control Organisation (CDSCO) has identified more than 50 widely used drugs from various manufacturers as "substandard" in its monthly report for August 2024.
The list of "not of standard quality" (NSQ) drugs includes popular medicines like antacid Pan D, calcium supplement Shelcal, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan, among others.
CDSCO's list is based on random sampling conducted by state drug officers on a monthly basis.
The list has raised concerns since most of the drugs flagged by CDSCO are manufactured by leading pharmaceutical companies and are widely used.
Products of notable firms such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd were included in the list.
Some of the companies have said that the flagged batches are "spurious" and not manufactured by them, according to News18.
Drugs that failed quality tests
Metronidazole, a common treatment for stomach infections, produced by the public sector undertaking Hindustan Antibiotic Ltd (HAL), has been identified as failing quality tests.
Similarly, Shelcal, sold by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare in Uttarakhand, did not meet the required standards.
Torrent Pharmaceuticals, in its exchange filing, clarified that a batch of Shelcal 500 drug that recently failed the CDSCO test has not been manufactured by the company, and is in fact non-genuine and 'spurious.'
Alkem Health Science’s antibiotic drug Clavam 625 and Pan-D have been found spurious by a drug-testing laboratory in Kolkata. Cepodem XP 50 Dry Suspension, commonly prescribed to children for various infections, failed to meet the required quality standards during laboratory testing.
A batch of Telma H (Telmisartan 40mg and Hydrochlorothiazide 12.5mg tablets IP) manufactured by Glenmark Pharmaceuticals was found to be non-standard. The drug is used to treat high blood pressure. Glenmark claimed the particular batch was not made by it.
In August, the CDSCO took decisive action by prohibiting more than 156 fixed-dose combination drugs from the Indian market. These included popular fever medications, painkillers, and allergy tablets. Since 2014, the regulator has reportedly banned 499 FDCs.
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