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State Drug Control Dept cancels 71 sales licences, suspends another 95 during February
Nandita Vijay, Bangalore | Thursday, March 25, 2010, 08:00 Hrs  [IST]

Karnataka drugs control department has issued show cause notices to 226 sales outlets and five manufacturing plants for violation of Drugs & Cosmetics Act. Around 95 licenses have been suspended and 71 sales licenses cancelled. One manufacturing unit was issued stop production order.

The state drugs control department inspectorate team carried out surprise checks of 1641 sales premises, 28 blood banks and 10 manufacturing plants during February 1 and February 28, said Dr BR Jagashetty, Karnataka Drugs controller.

The department also issued in February 28 fresh licenses to sales units. During the month, six prosecution cases were filed in the Court. In the same period, two cases were disposed off and both parties were convicted. Totally, nine complaints received from the public and were investigated. These inspections are at frequent to keep poor quality drugs at bay, he added.

The state's drug testing lab received a total of 219 samples for analysis of which 17 were declared not-of-standard quality and investigations are being carried out. These included Cofaid drug cough syrup manufactured by Coral Laboratories in Deharadun, Uttaranchal, Flexeze Premium tablets by Beloorbayir biotech in Tumkur and Enteric Coated Aspirin by Copper Pharma in New Delhi. These drugs were found to be sub-standard by the drug test lab at Mumbai too, said Dr Jagashetty.

The retail and wholesale pharmacists, hospitals and nursing homes have been advised to refrain from selling and prescribing these drugs.

Early this month, the Karnataka Drug Test Lab had found an antipyretic medicine 'Bulide-P nimesulide paracetamol tablets manufactured by Biocare Remedies in Gandhinagar, Gujarat to be not-of-standard quality. Other drugs included diclofenac sodium by DJ Biotech in Himachal Pradesh, Combisun (ibuprofen, paracetamol and magnesium oxide) tablets by Sunlife Sciences and Omeprazole (domperidone) tablets by Restech Pharma in Uttaranchal.

Of the companies from Bangalore which were issued orders for production of substandard drugs were Embiotic Laboratories for Alprazolam and EmCalm (Alprazolam) apart from OnTop Pharmaceuticals for Systaflam Gel which is a muscle relaxant.

According to pharma industry sources, drugs are declared not-of-standard quality when it resembles another popular drug brand. In addition, the drug could also contain less content of the active pharmaceutical ingredient (API), fail the disintegration or dissolution test, have presence of fungus in liquid preparation and contain adulterants which are injurious to health.

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