EU to hear Indian officials over ban on drugs tested by GVK Bio: report

30 Dec 2015


The European Union (EU) has agreed to meet Indian officials and address concerns over the ban on 700 drugs tested by GVK Biosciences earlier this year so as to reach an understanding on future trade relations.

The EU had imposed an import ban on 700 generic drugs tested by the company in July and this had almost scuttled bilateral trade talks between India and the EU.

The January meet will examine India's stand that there was no data manipulation by GVK in the whole drug testing process.

''The meeting with officials from the EU's health and food safety department will take place in January. The EU had sent us an agenda and background paper for the meeting and we have already sent our comments on it, pointing out where we do not agree. This will be discussed in detail at the meeting,'' the Hindu BusilessLine quoted official sources as saying.

Officials, however, are not sure whether such a meeting will help revoke the EU ban, but hope it will help improve the future scenario for Indian generic drug makers.

The EU had, in July, banned 700 generic equivalents of off-patent drugs tested by GVK on charges of manipulation of data of clinical trials for bio-equivalence testing made by French standards agency Agence Nationale de sécurité du Médicament et des (ANSM) (See: EU bans 700 generic drugs over alleged manipulation of trials by GVK).

India retaliated by calling off the restart of bilateral free trade talks with the EU as an immediate reaction. However, India relaxed its stand since and decided to hold an initial stock-taking meeting with the EU on the free trade agreement, formally known as the Broad-based Trade & Investment Agreement (BTIA), in January (India defers FTA talks with EU over GVK ban).

''There is no formal connection between the re-launch of the India-EU BTIA and the meeting on GVK, but these are happening simultaneously. The EU has realised that if it wants healthy trade relations with us, it has to heed to our concerns,'' the official said.

The ANSM had alleged that the electrocardiogram (ECG) data of volunteers examined between 2008 and 2014 by GVK was manipulated, and, hence, the tests were not reliable.

The European Union intervened and in August ordered withdrawal of all drugs tested by GVK during the period from EU markets, although there was no evidence or complaints regarding the quality or efficacy of the medicines.

Interestingly, even the US Food and Drug Administration, which insists on high standards, had found no problem with the processes followed by GVK and has not taken any action against the drugs in its markets, the official pointed out.

''We are very clear in our assessment that there was nothing wrong with the ECGs and we have enough proof to back that. Some of our arguments and related documents have already been submitted to the EU. We hope to convince them when we meet,'' the official said.

A six-member government panel consisting experts from various departments, including drug regulators and cardiologists, set up in October, to look into allegations made by ANSM, also found no irregularities in GVK's testing procedure.

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