Ahead of talks with EU, concerns remain on drug-export seizures

P. T. Jyothi Datta Mumbai | Updated on March 12, 2018 Published on February 01, 2012

Third-country transit consignments continue to come under EU scanner

The recent seizure of Ajanta Pharma's consignment of medicines by Dutch authorities, though the export was headed for Surinam, has raised fresh concerns with domestic drug-makers.

Despite the assurance from European Union authorities that Indian drug consignments would be allowed to transit – Ajanta Pharma's shipment was detained on alleged intellectual property violations, in late 2011.

The incident has raised a serious concern on the EU's intention, say pharma industry insiders, as negotiations on the Free Trade Agreement between India and the EU are scheduled for next week.

India's stance

Responding to industry apprehensions following the Ajanta incident, a Commerce Ministry official told Business Line, their concern was understandable. But Indian authorities have been reassured that the incident occurred due to negligence. While this should not hold up the FTA discussion, the official said, the Government can take further action, if need be – if such negligence is repeated.

In 2008, Indian exports accounted for 16 of the 17 seizures by Dutch authorities on the basis of the EU regulation 1383/2003. The Indian Government even hauled authorities in the Netherlands to the World Trade Organisation's Dispute Settlement Body. And a truce was eventually called with the EU assuring safe passage for transiting drug exports.

Detained shipment

It is against this backdrop that Ajanta's shipment of 34 cartons to its buyer in Paramaribo, Surinam, were detained. The consignment comprised Kamagra tablets and jelly (Sildenafil citrate) and Apcalis tablets (Tadalafil), transported through KLM Royal Dutch Airlines in early November.

The Dutch Customs detained the cargo till late November and allowed 29 cartons containing Kamagra to proceed to Surinam, retaining the remaining cartons of Apcalis Sx tablets under the suspicion that they were counterfeits, the company said.

Though the consignment was released after intervention by the Indian Government – healthcare advocacy groups point out that an assurance does not resolve the legal problem of drug seizures.

Patent and IP issues

European customs authorities have in the past detained shipments of legitimate generic drugs including antibiotics and AIDS medicines, which were in transit through the EU to patients in developing countries on the grounds that they infringe European intellectual property law (patents and trademark).

However, it turned out that the medicines were not in violation of IP laws (where they come from and are going), but were legitimately produced by mainly Indian generic companies and were being imported by Brazil, Peru, Colombia, Mexico, Nigeria and other developing countries at affordable prices, said the international humanitarian organisation Medecins Sans Frontieres.

They were also concerned if the FTA negotiations would put forward proposals on border measures – similar to its customs regulations – in the articles that cover intellectual property enforcement. This provision on border measures if accepted by India can ultimately affect the distribution and availability of affordable generic medicines across the developing world, it added.

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Published on February 01, 2012
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