The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21, and will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).
The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences.
The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21, and will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).
Medicines affected by the sales ban will lose their validity for use in the EU from that date, and they should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drugs stores and other outlets, the agency based in Bonn said in a press statement on Thursday.
Pharmaceutical companies have the possibility to appeal against the suspension of marketing approvals, but it will have no immediate effect, and the ban will remain in force, the statement said.
The commission's decision taken last week is in response to a recommendation by the EU drug regulator European Medicines Agency (EMA) in January, that marketing authorisation of these drugs should be suspended as they were based on clinical trial data allegedly manipulated by the Hyderabad- based company.
EMA's Committee for Medicinal Products for Human Use (CHMP) had examined the marketing authorisation given to over 1,000 generic drugs from EU member nations on the basis of bio-equivalence studies conducted by GVK Bio during the 2004-2014 period, after an inspection of the company's facility in Hyderabad by the French Medicines Agency (ANSM) in May, last year showed "systematic manipulation of clinical trial data."
The inspection revealed "data manipulation of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years," London-based EMA said in a statement earlier.
"Their systematic nature, the extended period of time during which they took place and the number of member of staff involved, cast doubt on the integrity of the conduct of the trials at the site generally and on the reliability of data generated," the agency said.
GVK Bio had vehemently denied the allegations made by the European drug regulators and offered to conduct fresh studies of the medicines involved at its own cost.
Such studies are intended to establish that generic drugs have the same effect on the human body as the original branded versions.
EMA recommended to the national regulators in January to suspend the marketing authorisation of around 700 generic drugs examined by CHMP.
It also decided that for more than 300 medicines out of the 1,000, sufficient supporting data from other sources were available, and therefore they will remain on the market as the regulator is satisfied with the available data.
It had also asked the European Commission, the executive arm of the EU, to take a legally-binding decision, applicable to all member nations irrespective of whether they have taken interim measures to suspend marketing authorisation for medicines since the allegations against the Indian company were raised at the end of last year.
As the first European national regulator, BfArM had in December suspended the marketing authorisation for around 80 generic drugs on account of "substantial deficiencies" in clinical trials conducted by GVK Bio.
However, its decision could not be implemented in the case of 21 medicines due to legal challenges by their manufacturers and the suspension of marketing approvals was lifted in several other cases after their manufacturers submitted new clinical trials data.
BfArM said it will publish a new list of suspended medicines after the European Commission’s order takes effect.
It will also officially inform pharmaceutical companies about the suspension of marketing approvals for their drugs.
The German regulator said it has no information that the medicines subjected to clinical trials by GVK Bio posed any health risk for patients who continued to use them.
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