The European Union has banned around 700 generic medicines for alleged manipulation in the clinical trials conducted by India's pharmaceutical research company GVK Biosciences. The 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 period between 2004 and 2014 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 commission's decision was taken last week 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 are based on clinical trial data allegedly manipulated by the Hyderabad- based company.
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.
Pharmaceutical companies have the right 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 inspection revealed that "data manipulation of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, appeared to have taken place over a period of at least five years," London-based EMA said in a statement.
"Their systematic nature, the extended period of time during which they took place and the number of staff involved all these 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 all the allegations made by the European drug regulators and offered to conduct fresh studies of the medicines involved at its own cost.
By Premji
