Paracetamol, 52 other drugs fail quality tests in India
What's the story
India's drug regulator, the Central Drugs Standards Control Organization (CDSCO), has issued a "Not of Standard Quality (NSQ) Alert" for over 50 drugs. The alert was issued after random monthly sampling conducted by state drug officers. The list includes popular medications such as Paracetamol tablets IP 500mg, anti-diabetic drug Glimepiride, vitamin C softgels, antiacid Pan-D, Vitamin C and D3 tablets Shelcal, and high blood pressure medicine Telmisartan, among others.
Quality concerns
Top-selling drugs fail quality check
These drugs are produced by several pharmaceutical companies including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd. Metronidazole, a drug commonly used to treat stomach infections manufactured by HAL, was also found substandard. A drug-testing laboratory in Kolkata identified Alkem Health Science's antibiotic Clavam 625 and Pan D as spurious. The same laboratory also found Hetero's Cepodem XP 50 Dry Suspension, a medication prescribed for children with severe bacterial infections, to be substandard.
Lab findings
Kolkata lab identifies substandard drugs
Additionally, Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd were flagged for quality concerns. The CDSCO released two lists related to the drugs that failed quality tests. One list contains 48 popular drugs, while the second features responses from the pharmaceutical companies whose products failed these tests. However, they have denied taking responsibility for the substandard drugs. They stated that "the impugned batch of the product has not been manufacturer by them and that it is a spurious drug."
Past measures
CDSCO's previous actions to ensure drug safety
In August, the CDSCO banned over 156 fixed-dose drug combinations in the Indian market due to potential risks to humans. These included popular fever drugs, painkillers, and allergy tablets. According to the notification issued by the health ministry, the government banned Aceclofenac 50mg + Paracetamol 125mg tablet, Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg.