Forty-eight medicines including anti-diabetic, antibiotics, calcium and cardiac drugs, have failed quality tests, the top health regulator said in a drug safety alert issued in March, media reports said.
The Central Drugs Standard Control Organization (CDSCO) flagged 48 commonly used medicines such as epilepsy drug Gabapentin, hypertension drug Telmisartan, anti-diabetes drug combination Glimepiride and Metformin and HIV drug Ritonavir.
The alert list includes iron and folic acid tablets, probiotics and multivitamin pills, Vitamin C, Vitamin B12, Folic Acid and Niacinamide injections as well as Amoxicillin, Calcium and Vitamin D3 and Albendazole tablets.
The medicines failed quality parameters in March out of 1,497 samples analyzed. 1449 samples were declared as of standard quality.
The Financial Express quoted a spokesperson of Glenmark as saying: “We have investigated the matter and found that the TELMA AM Tablets (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) batch number 18220076 from the NSQ list of ‘March 2023 Month Drugs Alert’ are counterfeit medicines and have not been manufactured by Glenmark. We have requested the CDSCO to take action on this and also made an appeal for removal of the product from the drug alert list.”
The spokesperson said they have taken necessary measures, which include engaging an external agency to investigate the presence of counterfeit drugs across the country.
Drugs categorized as not-of-standard quality can adversely impact the quality of treatment and cause harm to patients, besides contributing to the emergence of drug resistance and spread of the disease.
Another report said Abott India had voluntarily recalled one batch of Thyronorm Tablets (Thyroxine Sodium) – AEJ0713; Mfg., Date: March 2023 – invoiced only in Madhya Pradesh and Telangana.