The Karnataka drugs control department has seized 33 not-of-standard quality drugs in a massive inspection drive conducted between February 15 and March 10, 2014.
The drugs are found to fail on in dissolution and disintegration tests when samples are assessed after being picked up randomly by drug inspectors from pharmacy outlets and the manufacturing sites.
The 33 drugs which failed the test and the companies engaged in the production of the same included Iron and folic acid tablets manufactured by Medicamen Biotech in Haridwar, Combivat injection which is a vitamin B complex injection manufactured by Martin & Brownsciences in Solan district in Himachal Pradesh, Acifact aceclofenac tablets of Oxford Pharma, Haridwar, Nasiwar cold tablets by Meridian Medicare, Solan, Flavored dispersible amoxicillin tridhydrate tablets by Minopharm Labs in Pernamitta in Andhra Pradesh, Jocare which is a calcium phosphate, magnesium and zinc tablets by DR Johns Lab in Haridwar, Orrator 500 mg of Cefuroxime Axetil tablets by Roseate Medicare in Solan, Loten which is a blood pressure tablet containing atenolol and amlodipine manufactured by Symet Labs in Hyderabad, Prazol-40 mg which is a Pantoprazole tablet manufactured by Globin Pharmaceuticals in Roorkee district in Uttarkhand, among others.
According Raghurama M Bhandary, Karnataka drugs controller, the inspections are conducted frequently to ensure that safe and quality drugs are sold across pharmacies.
When such not-of-quality standard drugs are in circulation, the state drugs control department also alerts hospitals and doctors across the state to refrain from stocking and prescribing such drugs.
Under the provisions of Drugs and Cosmetics (Amendment) Act 2008 and Rules, the medicines produced by licensed manufacturers and reported to have defects of serious nature to affect the quality of the drug come under the purview of not of standard quality drugs. These defects may broadly be if the active ingredient content is found to be below 70 per cent for thermo labile products and below 5 per cent of the permitted limits for thermo stable products.
In the case of tablets/capsules failing in dissolution test and active contents found less than 70 per cent for thermo labile products and below 5 per cent of the prescribed limits for thermo stable products also come under this category.
Liquid preparations showing presence of fungus, parental preparations failing in sterility, pyrogen/endotoxin test or undue toxicity and vaccines failing in potency, sterility, toxicity or moisture content are in the substandard category.
Further, if the drug is found to have the presence of any adulterant which renders the product injurious to health, then it is also under the not-of standard quality category.
The department has three drug test labs which undertake the assessments of the drugs. These labs are located in Bengaluru, Hubli and Bellary. While the Bengaluru facility is National Accreditation Board for Testing and Calibration Laboratories (NABL) certified, the other two DTLs are in the process of seeking NABL certification.