If ever the Indian government needed a reason on why it should be careful in picking its battles, it can be found in the GVK Biosciences controversy in Europe and its entanglement with personal details around a whistle-blower.

In a normal situation, the Indian pharmaceutical industry would have been more than happy to have the Indian government batting for it, especially when it is targeted unfairly in certain foreign markets. For example in 2008, when inexpensive generic drug exports from India were seized in Amsterdam, even though the consignment was merely on its way to different markets (Latin America and Brazil), transiting through Europe.

 

But the GVK Biosciences case was different in that clinical trial data generated by one company was being called into question by the European authorities and this in turn had affected the EU marketing approvals of 700 generic drugs belonging to different drug companies, including those not from India.

 

Not surprising then, that industry-watchers informally wondered why the Indian government was taking up a company’s case (GVK) so strongly with the EU authorities. The Government was not seen taking up the issue when Ranbaxy was in the regulatory dock in the US, nor is it batting for other individual Indian drugmakers facing regulatory scrutiny in other markets.

 

Similarly, when Novartis lost its patent case on its blood cancer drug Glivec in India, contrary to expectations, the Swiss government did not step in to overtly bat for the company or take India to the Dispute Settlement Body of the World Trade Organisation (WTO).

 

There always is back-room activity and lobbying between countries and Governments to promote their industry, but companies are required to fight their own battles and Governments rarely step in overtly to do their bidding.

 

Export seizures

 

In 2008, Indian drug exporters clearly faced a problem. Of the 17 incidents of export seizures that year in the Netherlands on the grounds of patent-infringement, 16 were Indian medicine exports and one from China. This information from the Dutch government was given to the Health Action International (a Dutch network that worked on access to medicines) under the Freedom of Information Act.

 

The villain here was an EU regulation of 2003 and industry had then said that seizing exports transhipped through a region to another market was tantamount to a non-tariff barrier. The Indian Government even hauled authorities in the Netherlands to the WTO’s Dispute Settlement Body. And a truce was eventually called with the EU assuring safe passage for transiting drug exports.

 

Contrast this with details from a recent report in The Hindu, where an alleged “love-affair” of a former GVK Biosciences official ended in the company’s clinical trial controversy in the EU.

 

GVK Biosciences now faces an even steeper challenge in clearing the allegations against its data. But the Indian government too needs to introspect on the incident and do a lot more homework before it steps out in support of what may seem a legitimate industry grievance. Else, industry and Government could end up singed by the incident.

 

jyothi.datta@thehindu.co.in

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