EU seizes another generic package

In yet another instance of attacks on Indian generics in the European Union, a consignment of 1.74 million tablets of anti-platelet drug clopidogrel from Mumbai-based Macleods Pharma to Venezuela is learnt to have been seized at the Paris airport in October on grounds of patent violation.

Clopidogrel is used for inhibiting blood clots and is marketed as Plavix by US-based Bristol-Myers Squibb and French major Sanofi Aventis. It was the second-largest selling drug in 2008, with global sales of about $8.63 billion as per IMS Health estimates.

Officials from Macleods Pharma could not be reached for a comment. This is the latest in a series of seizures of India made generics in the EU. In May this year, a consignment of 3.04 million tablets of generic amoxicillin (for bacterial infections) worth €28,000, from Hyderabad-based Dr Reddy’s Labs, was seized at Frankfurt airport in Germany. The consignment was meant for the Republic of Vanuatu, a small country in the South Pacific Ocean.

Between October 2008 and early 2009, about 16 consignments of legitimate Indian generics worth crores of rupees, bound for markets in Columbia, Peru, Brazil and Nigeria, etc, were seized by the customs at the Amsterdam airport on charges of infringing the patent held by innovator companies in the Netherlands. The seized drugs, which included those for treating AIDS, alzheimer’s, blood pressure, etc, were from drugmakers such as Cipla, Aurobindo Pharma and Ind-Swift Laboratories.

The seizures have dented India’s generic exports tally — drug exports from the country between April, 2008 and January, 2009 totalled Rs 31,608 crore, according to the commerce ministry —- and also denied patients in the South American and African countries access to cheaper medicines.

“In spite of repeated assurances the EU has given, the practice has not stopped, and they continue to harass Indian generics which are destined to developing countries in South America and elsewhere,” D G Shah, secretary general of Indian Pharmaceutical Alliance said.

A New Delhi-based patent expert said the seizures, rather than the drugs seized, were illegal. “The said drugs neither enjoy patent protection in India nor in the countries where they were to be imported. They are patented products in the EU markets, but are not meant for the EU population. Hence, it’s not right to detain them in the EU. They were just getting exported from India to the other developing countries via the EU,” the expert said.

“Generics are not substandard or illegal. Often, the customs actions are instigated by complaints from EU companies alleging that the medicines may be counterfeit and violate their intellectual property. It’s a dismay that some members of the EU are linking safe and efficacious but low-cost generics with counterfeit medicines, which is an intellectual property issue,” the expert said.

An official of a domestic pharma company, whose consignments have been seized in recent past, pointed out that many developing countries do not have the capacity to manufacture medicines and hence rely on generics, which are 40-80% cheaper than innovators products, from countries like India. “As such, trade in legitimate medicines between countries is fundamental to ensuring access to medicines for millions,” the official said.

A member of the international humanitarian organisation Medecins Sans Frontieres (MSF) said barriers to legitimate trade of generics will seriously impair the efforts of humanitarian organisations in providing medicines to the least developed parts of the world. MSF works in over 70 countries and sources 80% of its requirement of AIDS drugs and 25% of its malaria and TB drugs, as also antibiotics, from India.
On its part, the government has assured the industry that it would take up the matter with the World Trade Organisation. Industry experts, though, aren’t ready to bet on when or how effective the talks with the world body would be, just yet.