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Karnataka drugs control dept seizes 12 sub-standard drugs during surprise inspection drive
Nandita Vijay, Bangalore | Tuesday, March 1, 2011, 08:00 Hrs  [IST]

The Karnataka drugs control department has seized 12 not of standard quality drugs from the pharmacy outlets in the state. The inspections were carried out by the enforcement team between February 11-15, 2011.

The drugs that were seized in the inspection include chloroquine phosphate injection manufactured by Weismanna Healthcare Pvt. Ltd. in Pernamitta in Andhra Pradesh, Raberon DSR which is a raberprazole sodium and domperidone sustained release capsule of Valence Helath Care in Kangra district of Himachal Pradesh, dexamethasone sodium phosphate injection by Amkay Laboratories in Meerut, Monorab which is raberprazole sodium tablets by DM Pharma  in Solan in Himachal Pradesh, uramine chlorpheniramine maleate injection by Unison Pharmaceuticals in Baddi, Himachal Pradesh, Maxal tablets  which are calcium carbonate magnesium hydroxide, zinc and vitamin D3 tablets manufactured by Stride Organics Pvt. Ltd in Uttarakhand, Anclofanic P tablets manufactured by Anchor Pharma in Daman, Codylex Linctus manufactured by Anglo French Drugs & Industries, Unideine which is a povidone iodine solution manufactured by Biogenetic Drugs Pvt. Ltd at Solan in Himachal  Pradesh, hydrogen peroxide topical solution manufactured by Kaytee Labs in Ujjain in Madhya Pradesh, NISIG Plus which are paracetamol and nimesulide tablets manufactured by Shivalik Remedies in Roorkee and Alcef O-200 which are Cefixime tablets manufactured by  Vapi Care Pharma Pvt. Ltd. in Solan district of Himachal Pradesh.

The drugs were tested at Drug Test Lab in Bangalore and found to be not of standard quality.  We have issued the orders to chemist, hospitals and doctors not  to stock and prescribe these drugs respectively, stated Dr BR Jagashetty, Karantaka drugs controller.

The state drugs department which has been engaged in carrying out such surprise checks frequently has helped it to seize the drugs which are of not of standard quality. Prescribing such drugs will have no effect on the disease condition, he added.

The drugs  are found to be  not-of-standard quality when it bears a resemblance to another popular drug and has less content of the active pharmaceutical ingredient. There are also instances where the drug is manufactured without license. It could be grossly substandard if the drug content  is below 70 per cent for thermo liable products and below 5 per cent of the permitted limits for the thermo stable products, stated pharmacology experts.

Tablets and capsules are declared as substandard if it fails the disintegration and dissolution tests. Other causes of declaring drugs as substandard or not-of-standard quality is when the product is found to have the  presence of fungus in liquid preparations and the adulterants found injurious to health.

For the  small and large  volume parenterals, the products are declared substandard if it disqualifies in the  sterility, pyrogen/endotocin test and for its toxicity levels.   In the case of vaccines if  they fail in terms of potency, sterility, toxicity or moisture contents, they are declared as substandard.

Comments

B G Prabhakumar Mar 4, 2011 6:09 AM
Dear Nanditha,
This just to clarify that when a drug bears a resemblance to another popular drug it falls under the category Spurious Drug, which is a separate category for the purpose penal action. Likewise when a drug is infested with fungus it would be more appropriate to deem it under the category Adulterated Drug, which again is a separate category for the purpose penal action.

Your preivious report on the same subject contained similar statements. Hence this clarification.

Thanks and regards,

Prabhakumar B G .

report in penulatimate para

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