Last week, EU banned 700 generic medicines alleging manipulation of data in clinical trials of these drugs and formulations, which were conducted by GVK Biosciences.
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“We have estimated the value of the products banned by the European Union to be between $1-1.2 billion”. These medicines will be banned in 28 member countries of European Union.
European Union (EU) on July 26, 2015 has banned the marketing of around 700 generic drug medicines.
Appaji said the commerce ministry is expected to discuss the implications of this decision and the steps that need to be taken in meetings over the next two days.
With this ban, 700 generic medicines will lose their validity for use in the EU and now they will not be distributed or sold by pharmaceutical companies, drugs stores, wholesale dealers and other outlets.
Earlier, GVK BIO stated that the company respects the conclusions of the French authority, but believes it was a matter of interpretation and was hard to conclude that ECGs were manipulated and claims its clinical development unit was inspected over 25 times by various regulatory agencies including UK-MHRA, ANSM, USFDA, DCG of India, ANVISA (Brazil), WHO, MOH Turkey, with no reported critical findings.
On the impact on the GVK BIO business, while the move is bound to be a reputation hit for the company, the impact on the financials may not be much. The inspections showed systematic manipulation of clinical trial data. This medicine is now no longer recommended for suspension.
Such studies are intended to establish that generic drugs have the same effect on the human body as the original branded versions.
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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 previous year. GVK BIO is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. “We will continue to work with the Government of India and our customers to help resolve this”.
