CDSCO flags batches of popular drugs failing quality tests; spurious drugs raise safety concerns

Select batches of popular and commonly used drugs, including the antacid Pan D, the anti-bacterial medicine Clavam 625, and the calcium supplement Shelcal, among basic medicines like paracetamol tablets made by specific manufacturers, have been flagged for failing quality tests in the latest monthly drug alert issued by the country’s drug regulatory agency.

In total, the Central Drugs Standard Control Organisation (CDSCO) in its monthly report for August identified 48 products and drug combinations, across 35 companies, in 48 locations that include Sikkim, Pune, Baddi, Haridwar and others, as “not of standard quality”. Consequently, the CDSCO has issued an alert.

Samples were tested by the Central laboratories, including those in Kolkata, Guwahati, Mumbai and Chandigarh.

Popular Brands

Multiple batches of a popular medicine, Telmisartan tablets — a common medication prescribed to treat high blood pressure — have failed quality tests, the report mentioned.

In fact, one batch of Metronidazole — an antibiotic used to treat stomach infections — manufactured by State-owned Hindustan Antibiotics Ltd has also been flagged as “not of standard quality”.

The CDSCO report has mentioned one batch of Shelcal, manufactured by the Uttarakhand-based Pure & Cure Healthcare, as having failed the tests.

Batches of Alkem Health Science’s Clavam 625 and Pan D have also been found to be spurious.

Hyderabad-based Hetero’s Cepodem XP 50 Dry Suspension — prescribed to children to treat severe bacterial infections of the throat, lungs, urinary tract or more — was found to be spurious.

Karnataka Antibiotics & Pharmaceuticals Ltd’s paracetamol tablets have also been flagged.

An Alkem spokesperson told businessline that the products “seem to be spurious” and that the company is engaging with authorities on the matter.

Hetero did not respond to emailed queries, while a response is awaited from the Department of Pharmaceuticals.

Another 11 drugs were declared as “not of standard quality” based on a report from the State laboratory located in Thiruvananthapuram.

Drug Makers’ response

The CDSCO has also posted a second list of their “alert,” which includes five drugs manufactured by the country’s top drug makers, including three drugs by Sun Pharmaceuticals, one by Glenmark and one by Macleods Pharma have been mentioned.

This is the first time CDSCO has posted two different lists — one containing products of big pharma companies and their replies and the other being a regular list.

Drugs manufactured by Sun Pharma include the acid reflux medication Pantocid, the erectile dysfunction medicine Pulmosil, and the gallstone dissolving drug Ursocol 300. Other medicines are Glenmark’s Telma H, a popular hypertension drug, and Macleods Pharma’s arthritis drug Defcort 6.

In their response, Sun Pharma, Glenmark and Macleods said, “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 the investigation.”