Indian generics to be safe from seizure while passing through EU.

NEW DELHI: Pharmaceutical exporters can breathe easy as the European Union has finally agreed to India's demand to amend its Customs regulations to stop confiscation of drugs en route to African and Latin American countries. Till the amendment is brought about, the European Commission has promised that no further seizures would take place at any European port, a government official has said.

European Union Trade Commissioner Karel de Gucht assured India of these measures during his recent bilateral meeting with Commerce and Industry Minister Anand Sharma in Brussels.

"The EU trade commissioner categorically stated that EC (European Commission) regulation 1383 will be amended to take care of India's concerns related to seizures," the official said. EC regulation 1383 lays down Customs action against goods suspected of infringing certain intellectual property rights.

India's pharmaceutical industry exports cheap generics to many countries in Africa and Latin America. Generics are copies of drugs that no longer enjoy patent protection.

Some of the generics exported by India continue to enjoy patent protection in the European Union. The Customs authorities of some of these countries have therefore confiscated the consignment of such drugs on the way to other countries through European ports for violating their intellectual property rights.

The seizures took place following complaints by pharmaceutical giants holding patents to the medicines in Europe including Sanofi-Aventis SA , Novartis AG and Eli Lilly & Co. This had created uncertainty for India's Rs 40,000 crore generics export industry following at least 17 cases of seizures of consignments in the Netherlands, Germany and France over the last two years.

India protested strongly against the confiscations, which it termed illegal, as the generics were off patent in India and were not meant for sale in the EU. It also raised humanitarian concerns, arguing that countries in Africa and Latin America do not have the capability to manufacture these life-saving medicines and cannot afford the patented alternatives.

India even took the issue to the World Trade Organization (WTO), arguing that the seizures amounted to violation of the international intellectual property agreement, Trips, and asked the EU for consultations.

Most of the seized consignments were produced by reputed Indian companies such as Dr Reddy's and Aurobindo Pharma . "The EU had earlier offered to send notes to all Customs authorities advising them against seizures but India was insistent that it would not settle for anything less than an amendment in Customs rules," the official said. Despite the EU's assurance of amending its rules, India is not in a hurry to withdraw its complaint and consultation request filed with the WTO. "We prefer to wait and watch the EU deliver its promise before we withdraw the issue from the WTO," the official said.

Source : economictimes.indiatimes.com