53 medicines including Paracetamol, calcium supplements declared substandard

The alerts are generated from random sampling conducted by state drug officers, aimed at ensuring the integrity and safety of pharmaceuticals in the market.

Edited By: Satyam Singh

Last Updated : 25 September 2024, 07:23 PM IST

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New Delhi: India's Central Drugs Standards Control Organisation (CDSCO) has reported that 53 drugs, including widely used medications like Paracetamol, vitamin D3 supplements, and anti-diabetes pills, have failed quality tests. This alarming development raises serious safety concerns for consumers and healthcare providers alike.

The CDSCO's latest monthly drug alert list categorized these medications as "Not of Standard Quality (NSQ) Alert." The alerts are generated from random sampling conducted by state drug officers, aimed at ensuring the integrity and safety of pharmaceuticals in the market.

Closer look at affected medications

Among the notable drugs failing the quality check are:

Calcium and Vitamin D3 supplements
Anti-diabetic medication: Glimepiride
High blood pressure medication: Telmisartan
Antacid: Pan-D
Paracetamol tablets IP 500 mg

These medications are manufactured by several companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare.

One particularly concerning case is that of Metronidazole, a common treatment for stomach infections, produced by HAL, which also failed the quality tests. Similarly, the popular calcium supplement Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare, did not meet quality standards.

Issues identified by testing labs

Further complicating matters, a Kolkata drug-testing lab has flagged Alkem Health Science's antibiotics Clavam 625 and Pan D as spurious. Additionally, Hetero's Cepodem XP 50 Dry Suspension, which is prescribed for children with severe bacterial infections, was also found to be substandard.

The Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were highlighted as having quality concerns, adding to the growing list of medications that have failed safety checks.

What have Pharmaceutical companies said?

In light of these quality failures, the CDSCO released two lists detailing the drugs that did not pass inspections. While the first list includes 48 popular drugs, the second list contains five additional medications, along with responses from the pharmaceutical companies implicated.

Notably, these companies have largely denied responsibility, asserting that the batches in question were "spurious." One such response indicated, "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 subject to the outcome of investigation."

Previous regulatory actions

This latest alert follows the CDSCO's decision in August to ban over 156 fixed-dose drug combinations in the Indian market that posed "likely risks to humans." These combinations included commonly used fever medications, pain relievers, and allergy tablets, further highlighting the critical need for stringent drug safety regulations.

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53 medicines including Paracetamol, calcium supplements declared substandard