The Central Drugs Standard Control Organisation (CDSCO) has flagged 48 commonly used medicines as they failed the latest drug safety alert issued by the drug regulator in March.
In its monthly list, released on its website, the drug regulator has highlighted the medicines failing the quality parameters in the month of March out of the total 1,497 samples. According to the list, 1449 samples were declared as of Standard Quality.
These flagged medicines include anti-diabetic, antibiotics, calcium and cardiac drugs. The list also includes some of the popular drugs like epilepsy drug Gabapentin, hypertension drug Telmisartan, anti-diabetes drug combination Glimepiride and Metformin and HIV drug Ritonavir.
The alert list also includes iron and folic acid tablets, probiotics and several multivitamin pills. It also includes Vitamin C, Vitamin B12, Folic Acid and Niacinamide injections.
Moreover, the list also involves other common medicines like Amoxycillin, Calcium & Vitamin D3 Tablets, Telmisartan Tablets, and Albendazole Tablets.
Following this development, a spokesperson of Glenmark told Financial Express.com: “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 also maintained that they have taken necessary measures.
“As a responsible manufacturer, we have provided proactive information and leads to all concerned regulatory officials from time to time. Additionally, we have taken the necessary measures, which include engaging an external agency to investigate the presence of counterfeit drugs across the country,” the spokesperson added.
Meanwhile, Abott India Limited issued a public notice which stated that the company has issued a voluntary recall of one batch of Thyronorm Tablets (Thyroxine Sodium). According to the public notice, the recalled batch is AEJ0713; Mfg., Date: March 2023. The drug is used for the treatment of Hypothyrodism. According to the company, this batch has been invoiced only in Madhya Pradesh and Telangana.
“Patients who has recently purchased Thyronorm with batch no AEJ0713; Mfg., Date: March 2023; Expiry Date: Februrary 2025 are requested to return the bottle to the chemist they purchased it from…,” the company stated in the notice.
According to media reports, the company also maintained that it was working with distributors and partners to facilitate this recall.
“This batch has been invoiced only in MP and Telangana. This issue does not affect or extend to any other batch or dosage strength of Thyronorm or other Abbott products,“ the company added as quoted by media.
