Over 50 Drugs, Including Paracetamol, anti-diabetic; Shelcal Fail Quality Tests

THN Desk

In a recent development, India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has reported that over 50 drugs, including widely used calcium and vitamin D3 supplements, anti-diabetic medications, and treatments for high blood pressure, have failed to meet quality standards.

In its latest monthly alert, CDSCO identified 53 drugs as “Not of Standard Quality (NSQ),” based on random sampling by state drug officers.

Among the drugs flagged were popular supplements like Shelcal, which contains vitamin C and D3, and other essentials like vitamin B complex softgels and Pan-D, an antacid. In addition, everyday medications such as Paracetamol tablets (IP 500 mg), the anti-diabetic drug Glimepiride, and high blood pressure medication Telmisartan were also found to be substandard.

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

Metronidazole, a widely used drug for treating stomach infections, was one of the prominent drugs that failed quality tests. It is manufactured by the public sector unit Hindustan Antibiotics Limited (HAL). Similarly, the vitamin D3 supplement Shelcal, which is distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare in Uttarakhand, also did not pass quality checks.

Furthermore, a Kolkata-based testing laboratory identified several antibiotics, such as Alkem Health Science’s Clavam 625 and Pan-D, as spurious. Another significant finding was that Cepodem XP 50 Dry Suspension, a drug prescribed for children with severe bacterial infections and manufactured by Hyderabad-based Hetero Drugs, was also deemed substandard. Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd were among other drugs flagged for not meeting required quality standards.

The CDSCO issued two lists, one consisting of 48 drugs and another with an additional five, along with responses from the companies involved. Many manufacturers, however, denied responsibility for the failed batches, claiming that the flagged drugs were “spurious” and not produced by them. In their responses, the companies stated, “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.”

This quality alert follows an earlier move by the CDSCO in August, where over 156 fixed-dose drug combinations were banned due to their potential risk to human health. These banned medications included commonly used fever reducers, painkillers, and allergy medicines. The recent findings raise significant concerns about drug safety and quality in the Indian pharmaceutical market.