The seizure of another consignment of Indian generic drugs, in transit, has pushed India to drag the issue to the TRIPS Council, a high-level body of the World Trade Organization (WTO) dealing with intellectual property issues.
Last month, French customs authorities seized 740,000 tablets of heart attack prevention medicine Clopidogrel that were shipped by Mumbai-based Macleods Pharma to Venezuela on complaints of alleged patent violation.
Sanofi Aventis, the European drug maker that enjoys the patent rights over the drug, complained that the consignment violated its patent rights.
India informed the TRIPS council meeting in Geneva last week that widespread and repeated seizures would have an adverse impact on legitimate trade of generic medicines, universal access to medicines in the Third World countries and national public health budgets.
This was the 18th instance of seizure, and second during the year, when generic drugs meant for developing countries were confiscated during transit within the European Union, though the manufacture of the drug in India and sale in the destination country were legal.
According to the Permanent Mission of India to WTO in Geneva, the seizure happened in spite of India’s persistent efforts to convince the European Commission on the need to review its rule that allows confiscation of such consignments even if they are not meant to be used in the country.
The government is also planning to take up the matter with WTO’s dispute settlement forum soon, said a senior government official.
The same drug was seized on similar grounds in October last year in Amsterdam and was released seven months later. The regulation in question — EC Regulation 1383 — allow protection of patents and other intellectual property rights (IPRs) and extends to goods in transit. Industry sources said the situation was likely to remain grim unless there was a change in the EU regulation.
Further, the transit issue has also been mixed up with sub-standard and spurious medicines, which, the domestic industry feels, needs a separate treatment as compared to allegations over IPR violations.
The Indian Pharmaceutical Alliance (IPA), the select club of leading domestic drug firms, has identified seizure in transit and IPR enforcement and protection as serious challenges being faced by the industry in the international arena. IPA had even asked for financial assistance from the government to fight the enormous challenges faced by the domestic industry at a global level.
“We have not sought any protection from the central government to save the industry. The intention is to seek appropriate funding mechanism for litigations involving issues such as seizures (happened in Paris)....”, IPA secretary general D G Shah said.
IPA members — Cadila Healthcare, Cadila Pharmaceuticals, Dr Reddy’s, Glenmark, Intas, Lupin, Sun, Micro Labs, Torrent, Unichem, USV and Wockhardt — account for a third of India’s drug exports and a third of the domestic market.
