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Federal Institute for Drugs and Medical Devices banned sale of 80 generic drugs

German drug regulator on 10 December 2014 banned the sale of 80 generic drugs with immediate effect on the grounds that their clinical trials were insufficient.

Dec 11, 2014 15:08 IST
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German drug regulator Federal Institute for Drugs and Medical Devices (BfArM) on 10 December 2014 banned the sale of 80 generic drugs with immediate effect on the grounds that their clinical trials were insufficient.

It also suspended the marketing authorisation given to the drugs concerned based on the data of clinical trials conducted by the India's pharmaceutical research company GVK Biosciences between 2008 and 2014.

As per the data, the generic versions of these drugs have the same effect on the human body as the original branded versions, which cannot be accepted as a basis for marketing approval.

The regulator itself investigated the marketing authorisation of 176 medicines by 28 pharmaceutical companies.

The ban comes after regulators in Germany, France and Belgium suspended marketing approval of 25 generic drugs in the first week of December 2014.

Highlights of the ban
• All the drug manufacturers, wholesale dealers, medical stores and other outlets were ordered not to sell or use these 80 drugs any longer.
• With the ban of 80 drugs, the medicines for treating high blood pressure, depression, migraine, epilepsy and Parkinson's disease will be affected.
• These medicines involved the products of 16 pharmaceutical companies including Stada and Dr Reddy's, Lupin, Micro Labs and Torrent. MNC companies facing the ban include Mylan and Abbott.
• The banned drugs include Escitalopram, Clopidogrel, Irbesartan, Levetiracetam and Valsartan, Cefpodoxim and Tacpan. Patients using these medicines were advised to consult their doctors.

 

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