48 Drug Samples Including Alkem PAN 40 Cadila ACILOC 150 Fail To Qualify CDSCO Test, 1 Declared Spurious

22 July 2023

In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of June, while one drug sample has been declared spurious.

The list of Drugs declared as Not of Standard Quality includes Rosuvastatin and Vitamin D3 Tablets manufactured by Synokem Pharmaceuticals (Batch No.22S1GTA576), Prednisolone Tablets manufactured by Unicure India (Batch No.PDT1009), Paracetamol Tablets I.P. 650 mg manufactured by Hindustan Antibiotics(Batch No.0019), Acenomac 1 (Nicoumalone Tablets IP) manufactured by Macleods Pharmaceuticals(Batch No.FNU02202A), Aciclovir Tablets IP 400 mg manufactured by Nestor pharmaceuticals(Batch No.YCTZ-01), Cetirizine tablets manufactured by Hindustan Antibiotics (Batch No.0051) and others.Apart from the above, popular medicines such as PAN 40 (Pantoprazole Gastro-Resistant Tablets I.P.) manufactured by Alkem health science (Batch No.22441073), and ACILOC 150 (Ranitidine tablets I.P. 150mg) manufactured by Cadila Pharmaceuticals (Batch No.LD21512) are also on the list of drugs declared as Not of Standard Quality.Furthermore, FLAGORIN, Heparin Inj. I.P. 1000 IU/ml manufactured by Divine Laboratories has been declared as Spurious.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1273 samples. Out of these, 1225 samples were found to be of standard quality, while 48 of them were declared as not of standard quality (NSQ), and 1 drug was 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

Medical Dialogues