Drug Alert: 51 Drug Samples Fail To Qualify CDSCO Test, 3 Declared Spurious

September 8, 2023

New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 51 medicine batches for failing to qualify for a random drug sample test for the month of July, while three drug samples have been declared spurious.

The list of Drugs declared as Not of Standard Quality includes Stadmed's Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension), Hindustan Antibiotics' Ornidazole and Ofloxacin Tablets IP, Alves Healthcare's Rabeprazole Gastro-Resistant Tablets IP 20 mg, Zee Laboratories' Amoxycillin and Potassium Clavulanate Tablets I.P. 625 mg, Zenith Drugs' Cyproheptadine Hydrochloride Syrup IP (Hungree Syrup), and others.

Apart from the above, popular medicines such as Rosuvastatin Tablets IP (Rosuvas 10 Tablets) manufactured by Sun Pharma Laboratories, drug combination Tamsulosin Hydrochloride, and Dutasteride Tablets (Urimax D) manufactured by Cipla are also on the list of drugs declared as Not of Standard Quality.

Responding to the news, Sun Pharma spokesperson informed the Medical Dialogue Team, "We have investigated the matter and found that Rosuvas 10 (Rosuvastatin Tablets I.P. 10 mg) having batch number SID3056A are spurious. This batch is not manufactured by Sun Pharma. We have requested CDSCO, Delhi to take action on this and also made an appeal for removal of these products from the Drug Alert list."

Furthermore, the alert pointed out that Pantoprazole GastroResistant and Domperidone Prolonged Release Capsules IP (PAN-D), Pantoprazole Gastro-resistant Tablets IP (PAN 40), and Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625) are declared as spurious as the actual manufacturer, Alkem Health Science, has informed that the impugned batches of the product have 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 alert added regarding the spurious drug samples.

Also Read:48 Drug Samples Including Alkem's PAN 40, Cadila's ACILOC 150 Fail To Qualify CDSCO Test, 1 Declared spurious

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1306 samples. Out of these, 1252 samples were found to be of standard quality, while 51 of them were declared as not of standard quality (NSQ), and 3 drugs were declared Spurious.

A few of the reasons why the drug samples tested failed were the failure of the assay, the failure of the dissolution test, the failure of disintegration, and the failure of the identification test, and others.

The samples collected were tested in six laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.

Medical Dialogues