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APDCA orders recalling of coronary stents, cancels license of 22 medical stores

Our Bureau, HyderabadThursday, May 24, 2007, 08:00 Hrs  [IST]

The Andhra Pradesh Drug Control Administration (APDCA) has found that Costar paclitaxel cluting coronary stent systems, which have been rejected in the USA, have found their way into Hyderabad. During a surprise inspection on Interventional Technologies Private Limited at Ameerpet area in Hyderabad, the inspectors of APDCA found that the company had stocked 27 such stents in its premises. These stents, manufactured by Conor Medsystems Inc of Ireland, were found to be not on par with the company's internal standards in respect of clinical trials in the USA. The dealer, on being told about these defective stents, recalled 97 such stents from the market. They were estimated to be worth of Rs 96 lakh. The APDCA, in a press statement here cautioned the doctors against using these stents. It also asked the distributors to recall all stents manufactured by Conor from the market immediately. The inspectors also conducted surprise raids on 32 medical stores in the city and found 22 of them violating Rule 65(2) and Rule 65 (4)(3) of the Drugs and Cosmetics Rules, 1945. These stores were selling prescribed drugs without the presence of registered pharmacist and also without issuing sales bills. The city has as many as 3000 medical outlets and some of them are reportedly dispensing medicines without having registered pharmacists. The APCDA has long been demanding that the government to take action against the drug stores selling prescribed drugs without having the registered pharmacists. The state is already facing a serious shortage of pharmacists for several months.

 
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