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Karnataka DC finds 36 drugs substandard during inspection drive last fortnight

Our Bureau, Bengaluru
Friday, January 12, 2018, 08:00 Hrs  [IST]

Karnataka drugs control department has seized 36 not of standard quality drugs in early December. These drugs were picked up at random by the department’s enforcement team.
In its first round of inspection, the formulations tested at the Drug Test Lab in Bengaluru indicated 20 drugs to be of not-of-standard quality. These drugs included Thyroxine sodium tablets manufactured by Terrace Pharmaceuticals in Sansarpur in Himachal Pradesh. Lequit- M tablets containing levocetirizine HCI & monteluksat sodium tablets manufactured by Magnum Biotech, Aciv-800 manufactured by Zee Labs in Himachal Pradesh, Ambroxol hydrochloride, terbutaline sulphate and guaiphenesin expectorant manufactured by Med Manor Organics in Haridwar in Uttarkhand. Sodium Valproate tablets manufactured by Trugen Pharmaceuticals in Haridwar. Roller bandage manufactured in Tamil Nadu, Alpant-40 which contains pantoprazole manufactured by Sea Pharmaceuticals in Sirmour, Himachal Pradesh. Oflorich –OZ containing oflocacin and orindazole manufactured by Greef Formulations in Himachal Pradesh. Numbcaine which contains bupivacaine hydrochloride in dextrose injection was manufactured by Samrath Life Sciences in Baddi, Himachal Pradesh. Melozest containing meloxicam injection was manufactured by Poly Care Labs in GIDC Area in Kansari, Gujarat. Paracetamol oral suspension manufactured by Chennai Oscar Pharmaceuticals in Himachal Pradesh. Folic acid, pyridoxine hydrochloride tablets were manufactured by Pulse Pharmaceuticals in Uttarkhand.
During its second round of inspections, the state drugs enforcement team found 16 products to be substandard. These drugs found to fail the disintegration test, have higher moisture content among others. The drugs included amoxicillin and clavulanate potassium tablets which is a combination medicine used to treat varied bacterial infections was manufactured by Balaji Pharmtech in Baddi, Himachal Pradesh. Rabeprazole sodium with domperidone sustained release capsules manufactured by Knox Life Sciences in Baddi. Pyridase containing nimesulide, paracetamol and serratiopeptidase bolus was manufactured by Pure and Cure Healthcare at Haridwar in Uttarkhand.

“The department carries out the inspections and it is mandated to ensure quality drugs are sold at the pharmacy outlets”, said Bhagoji T Khanapure, Karnataka drugs controller.

In order to stall the circulation of these not-of-standard quality drugs in the market, the drug control department has signalled the hospitals and the chemists to avoid prescribing and stocking these drugs. Further it has also informed the public to ensure they do not purchase these drugs, he added.

According to industry observers, majority of the drugs are manufactured at the former excise free zones in the northern parts of the country. In these areas, there is poor monitoring of quality manufacturing practices.

“At times drugs fail quality tests because of poor quality of the active pharmaceutical ingredients. There are also instances of poor refrigerated transportation system which hamper the potency of the drugs,” they added.


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