Thursday, May 28, 2009

Karnataka drugs control dept issues over 3000 show cause notices, suspends 1,000 licenses

Bangalore: Karnataka drugs control department has issued a total of 3,768 show cause notices, suspended 1,398 licenses and cancelled 921 licenses of both manufacturers and the pharmacy outlets during the period ending March 31, 2008-09.
During the year a total of 88 prosecution cases were filed in the court. In addition, there were 69 cases disposed and 50 convictions carried out. Around 178 complaints received from the public are being investigated.
In the government drug testing lab, a total of 3,311 samples were analyzed of which 240 were declared not-of-standard quality and investigations are being carried out.
Drugs like diclofenac sodium tablets manufactured by Ankur Drugs and Pharma and MoxMac-500 capsules produced by Everest Formulations also at Salon district in Himachal Pradesh were found to be not-of-standard quality.
Saffron Biotech P Ltd which is located at the HSIDC in Haryana was engaged in the production of Ranitidine Hydrochloride and was found to be of not-of-standard quality and its sales were banned in Karnataka. Another company, Pharmadeep Remedies in Hyderabad which produces cetirizine dihydrochloride syrup was intimated that its product did not approve the required quality standards.
According to Dr BR Jagashetty, Karnataka Drugs Controller, the regular investigations have helped to seize the not-of-standard quality drugs. The presence of a full-fledged lab has now led to ensure constant monitoring of the drug quality. "We have warned the pharmacy outlets and the medical care centres in the state not to sell or use the drug if they had stocks," Dr Jagashetty said.
Among the offences brought to the notice of the Special Court for Economic Offences, Bangalore, the proprietor of Re-Life Clinic was convicted for stocking Schedule H drugs and fined Rs 6,000. Family Medicals in Bangalore was found to stock drugs without license and failing to disclose the source of the medicines. Panchvati Chemists and Druggists was found to sell expiry dated drugs and convicted for the offences under the Drugs & Cosmetics Act. A pharmacy outlet Sri Vinayaka Medical Hall was found to sell Scheduled drugs without the presence of a qualified pharmacist.
In addition, the Additional CJM Court at Mysore also convicted the proprietors of Olcare Laboratories at GIDC Estate at Wadhwan City for manufacture of not-of-standard quality drugs.
"The constant checks will only help to maintain the quality standards in the State. We have found that companies in Karnataka have been adhering to the required quality standards. But units located outside the state especially the excise free zones in the north have found to produce poor quality drugs. The need of the hour is surprise inspections which will help to clamp down the violators of the Drugs & Cosmetics Act," informed Dr Jagashetty.

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