CDSCO declares 62 drug samples as substandard

October 23, 2023
News
1 mins read

Source: Financial Express

The regulatory body has also flagged samples from companies like Concept Pharmaceuticals Ltd., Medipol Pharmaceutical India, Hindustan Antibiotics Ltd., Mednext Biotech Limited., Karnataka, Antibiotics and Pharmaceuticals Limited and Accent Pharmaceuticals & Diagnostics.

Central Drugs Standard Control Organisation (CDSCO) has raised an alert against 62 drug samples including typhoid fever vaccine from Bharat Biotech and Mankind Pharma’s Rabeprazole Gastro Resistant Tablets.

Rabeprazole Gastro Resistant Tablets is prescribed for treating acid-related diseases of the stomach and intestine such as acid reflux, peptic ulcer disease, and some other stomach conditions associated with excessive acid production.

According to the drug alert of September 2023 issued last week, out of 1188 tested samples, 1126 were declared as of standard quality. Moreover, none of the drug samples were declared as spurious.

It is noteworthy that samples of common drugs like Paracetamol Infusion IP manufactured by Tara Biosciences Pvt. Ltd, Iron and Folic Acid tablets by Deep Pharma, Calcium Citrate, Vitamin D3, Folic Acid, Mecobalamin & Pyridoxine Tablets (Metcanip) by Bonn Schtering Biosciences, and Levocarnitine Injection manufactured by Lenus Lifecare Pvt. Ltd., were flagged by the drug regulator.

Moreover, Pyrazinamide, a first-line medicine used to treat tuberculosis manufactured by Jackson Laboratories was also of substandard quality as CDSCO cites dissolution factor as the reason of sample failure.

The regulator has also flagged samples from companies like Concept Pharmaceuticals Ltd., Medipol Pharmaceutical India, Hindustan Antibiotics Ltd., Mednext Biotech Limited., Karnataka, Antibiotics and Pharmaceuticals Limited and Accent Pharmaceuticals & Diagnostics.

Last month the apex drug controller had raised an alert against at least five batches of syrups, for cough and allergic rhinitis, from two Indian manufacturers that have been found to contain higher than permissible levels of diethylene glycol and ethylene glycol.

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