52 Other Drugs Including Paracetamol Fail Quality Test

In its latest monthly drug alert list, the Central Drugs Standards Control Organisation (CDSCO) declared 53 drugs, including paracetamol, as “Not of Standard Quality” (NSQ). This list includes a range of widely used medicines like vitamin supplements, anti-diabetic pills, and high blood pressure medications that failed quality tests.

The NSQ alert is a result of random monthly sampling conducted by state drug officers. The recent list highlighted issues in popular medicines such as vitamin C and D3 tablets like Shelcal, vitamin B complex softgels, antacid Pan-D, Paracetamol tablets IP 500 mg, anti-diabetic drug Glimepiride, and high blood pressure medicine Telmisartan, among others. These medications are manufactured by major companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd.

One of the notable drugs that failed the quality test is Metronidazole, a widely used antibiotic for treating stomach infections, produced by PSU Hindustan Antibiotic Limited (HAL). Similarly, Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare in Uttarakhand, also failed the quality check.

Additionally, a drug testing laboratory in Kolkata labeled antibiotics like Clavam 625 and Pan D, produced by Alkem Health Science, as spurious.
The same lab also identified Cepodem XP 50 Dry Suspension, manufactured by Hetero in Hyderabad and prescribed for severe bacterial infections in children, as substandard.

Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd have also been flagged for quality concerns.
The drug regulator provided two lists – one containing 48 widely used drugs that failed quality tests and another with responses from pharmaceutical companies denying responsibility, calling the drugs spurious.

“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 investigation,” one of the responses stated.

Earlier in August, the CDSCO had banned over 156 fixed-dose drug combinations in the Indian market that posed potential risks to human health. These medicines included common fever drugs, painkillers, and allergy medications.