Over 50 Drugs, Including Supplements, Fail Quality Tests by India’s Drug Regulator

The drug regulator provided two lists of failed drugs: one featuring 48 popular drugs and another with five additional drugs.

India's drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has flagged more than 50 widely used drugs, including supplements and medicines for diabetes and high blood pressure, as "Not of Standard Quality (NSQ)" in its latest monthly drug alert list.

The CDSCO identified 53 drugs as NSQ through its routine random sampling process conducted by state drug officers.

These drugs, which include popular medications such as calcium and vitamin D3 supplements, anti-diabetic pills, and high blood pressure medicines, failed to meet the required quality standards.

53 Drugs Fail Quality Tests

Among the drugs that failed quality checks are:

- Shelcal (Vitamin C and D3 tablets)

- Pan-D (an antacid)

- Glimepiride (an anti-diabetic drug)

- Telmisartan (a medication for high blood pressure)

- Paracetamol tablets IP 500 mg

These medicines are manufactured by well-known pharmaceutical companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals, Meg Lifesciences, Pure & Cure Healthcare, and others.

Substandard & Spurious Drugs

One of the drugs flagged in the alert is Metronidazole, a commonly used medication for stomach infections, produced by Hindustan Antibiotics (HAL).

Additionally, Shelcal, which is distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare, also failed the quality check.

Several antibiotics, including Clavam 625 and Pan D, produced by Alkem Health Science, were deemed spurious by a Kolkata-based drug testing lab.

The same lab found Cepodem XP 50 Dry Suspension, a drug prescribed for children with severe bacterial infections and produced by Hetero, to be substandard.

The quality tests also flagged Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals for not meeting the required standards.

Pharmas Deny Responsibility

The drug regulator provided two lists of failed drugs: one featuring 48 popular drugs and another with five additional drugs.

In the latter, pharmaceutical companies responded to the findings, denying responsibility for the substandard drugs and claiming they were spurious.

In a statement, some companies explained that the batch in question was not produced by them.

"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," read a reply from one of the companies, indicating ongoing investigations.

This latest alert follows the CDSCO’s decision in August to ban over 156 fixed-dose drug combinations in the Indian market, citing potential risks to human health. These included popular fever drugs, painkillers, and allergy tablets.

The CDSCO's ongoing quality checks and stringent measures aim to ensure the safety and efficacy of medicines available in the Indian market.

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