Source: Medical Dialogues
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine batches for failing to qualify for a random drug sample test for December– 2023.
These include Montelukast Sodium and Levocetirizine Dihydrochloride Tablets manufactured by Bonsai Pharma, Multi-Vitamin Tablets (VITAJACKS-S TABLETS) manufactured by Jackson Laboratories, Telmisartan and Amlodipine Tablets IP (Zensartan-AM Tablets) manufactured by Windlass Biotech Limited, Telmisartan Tablets IP 40 mg (Telmibeck-40 Tablets) manufactured by Biocore Pharmaceuticals, Pregabalin Capsules IP (Pragavir Capsules) manufactured by Mayoford Pharma.
Furthermore, the list of drug samples that declared ‘Not Of Standard Quality’ includes Cyproheptadine HCl and Tricholine Citrate Syrup (CYPOFINE-T Syrup) manufactured by SUNFINE HEALTHCARE, Sodium Valproate manufactured by ZEE LABORATORIES, Aceclofenac, Paracetamol and Serratiopeptidase Tablets (ACETOP- SP TABLETS) manufactured by Yug Enterprises, Cefpodoxime Proxetil Tablets IP (DOXTIL-200 TABLETS) manufactured by Morisus Healthcare, more.
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In addition to the above, popular drugs such as Diltizem Tablets IP 60mg manufactured by Skymap Pharmaceuticals and Pantoprazole Gastro-resistant Tablet which is marketed under brand name PAN-40, manufactured by Alkem Health Science are also on the list of samples declared as Not of Standard Quality.
This came after the analysis and tests conducted by the CDSCO Drugs Control Department on 1008 samples. Of these, 930 samples were found to be of standard quality while 78 were declared Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of uniformity of weight, failure of completeness of solution, clarity of solution and particulate matter, failure of pH, particulate Matter and description.
The samples collected were tested in four laboratories, RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, and RDTL- Guwahati.
