New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has on its website, flagged 48 medicine batches failing the quality parameters in March out of the total 1,497 samples tested, reflecting a failure rate of over three per cent.
The list includes medicines, medical devices or cosmetics which are either not of standard quality or spurious, adulterated or misbranded. However, the flagged products were declared not of standard quality or Not of Standard Quality (NSQ). Top-selling medicines such as epilepsy drug Gabapentin, hypertension drug Telmisartan, anti-diabetes drug combination Glimepiride and Metformin and HIV drug Ritonavir are part of the drug alert. It also includes the popular hypertension drug Telma, which includes Telmisartan and Amlodipine. Other commonly used medicines flagged include iron and folic acid tablets, probiotics and several multivitamin pills. It also includes Vitamin C, Vitamin B12, Folic Acid and Niacinamide injections.
According to a News18 report, these drugs are manufactured by private as well as public drug makers, including PSU Karnataka Antibiotics & Pharmaceuticals, Uttarakhand-based Synokem Pharmaceuticals, Haryana-based Nestor Pharmaceuticals, Uttar Pradesh-based JBJM Parenterals, Solan-based Ronam Healthcare and Mumbai based Glenmark Pharmaceuticals.
Industry experts said that once the drug features in the list — along with the batch number, manufacturing date and expiry date — the company recalls the entire batch. “After the recall, the entire batch has to be destroyed,” an industry veteran was quoted as saying.
NSQ drugs can adversely impact the quality of treatment and cause harm to patients, besides contributing to the emergence of drug resistance and the spread of the disease. The Ministry of Health and Family Welfare is already conducting massive nationwide audits and raids at several drug manufacturing units to fix the gaps in good manufacturing practices, the report added.
“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 the removal of the product from the drug alert list. 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,” said a Glenmark spokesperson
