India’s drug regulator, the Central Drugs Standards Control Organization (CDSCO), has flagged 53 medicines that failed to meet quality standards.
These include popular drugs like calcium and vitamin D3 supplements, anti-diabetes pills, paracetamol, and medicines for high blood pressure.
Among the failed medicines are well-known products like Pan-D, Paracetamol IP 500 mg, Glimepiride for diabetes, and Telmisartan for blood pressure.
CDSCO has issued a “Not of Standard Quality” (NSQ) alert for these drugs based on its latest monthly drug alert list.
How the Quality Test is Conducted
The NSQ alerts are generated through random monthly sampling carried out by state drug officers.
This method ensures that a wide range of products, including some top-selling medicines, are tested for quality.
Among the 53 drugs that failed are Shelcal (Vitamin C and D3), Vitamin B complex softgels, and Pan-D, an antacid widely used in the market.
Manufacturers Under Investigation
The substandard medicines are manufactured by well-known companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics and Pharmaceuticals Ltd., and Pure and Cure Healthcare.
Among the failed drugs is Metronidazole, used to treat stomach infections, produced by the state-run Hindustan Antibiotics Limited.
Shelcal, distributed by Torrent Pharmaceuticals and produced by Pure and Cure Healthcare, also did not meet quality standards.
A drug-testing lab in Kolkata reported that antibiotics like Clavam 625 and Pan-D from Alkem Health Science were counterfeit.
Similarly, Hetero’s Cepodem XP 50 dry suspension, meant for children with bacterial infections, was found to be substandard.
Karnataka Antibiotics’ paracetamol tablets have also been flagged for quality concerns.
Pharmaceutical Companies’ Response
In response to the NSQ alert, pharmaceutical companies have denied responsibility, stating that the drugs in question are counterfeit.
According to their statements, the suspect batches were not manufactured by the companies as per the label claim.
Investigations are currently underway to verify these claims.
