The Central Drugs Standard Control Organisation (CDSCO) has flagged 54 commonly used medicines as they failed the latest drug safety alert issued by the drug regulator in July.
According to the drug regulator’s July alert list, 51 samples have been declared as “Not of Standard Quality.” Meanwhile, three samples were flagged as spurious.
According to the notification issued on August 18, 1306 samples were tested and 1252 samples were declared as “of Standard Quality.”
Folic Acid Tablets, Paracin Plus Suspension, Norfloxacin Tablets, Amoxycillin & Potassium Clavulanate Tablets, Albendazole Tablets and Telmisartan Tablets are some of the drugs that were flagged by the regulator.
Moreover, Cipla’s Tamsulosin Hydrochloride & Dutasteride Tablets, Sun Pharma’s Rosuvastatin Tablets, and Alkem Laboratories’ Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP (PAN-D) were also flagged in the list, as seen by Financial Express.com.
In another notification, dated August 22, CDSCO has shared a revised list of June’s alert list which flagged Alkem Laboratories’ Pantoprazole Gastro-Resistant Tablets IP (PAN*40).
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to the outcome of the investigation,” the regulator stated in the remarks.
According to CDSCO, the assay of Pantoprazole is the reason for failure.
