No WTO agreement violated by issuing CL on Nexavar: Sharma
Sao Paulo: Commerce and Industry Minister Anand Sharma Thursday said India has not violated any provision of multi-lateral trade agreement by issuing compulsory licence (CL) for patented anti-cancer drug - Nexavar - to be produced and sold at a much cheaper cost in the country.
"We have not violated of any WTO agreement...This (invoking CL) is very much in conformity with the international agreement under the WTO," Sharma said here while addressing industry leaders of pharmaceutical sectors.
Sharma is leading a Ficci business delegation, mainly consisting of players from pharmaceuticals industry, to Brazil.
In March, Hyderabad-based Natco Pharma was allowed to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by patent-holder Bayer Corporation, under compulsory licensing (CL).
The German firm has already filed an appeal against the Indian Patents Office's order with the Intellectual Property Appellate Board.
As per the WTO agreement, a CL can be invoked by a government, allowing someone else to produce a patented product or process without the consent of the patent owner in public interest.
India's intellectual property rights regime is fully TRIPS-compliant, the minister said, adding that the developed nations have invoked CL more than developing economies.
"In case of India, this was the process of adjudication. It was not an executive invocation," he added.
He said around the same time when India had issued the CL for anti-cancer drug, the US government, through an executive order, placed an order with Indian company for anti-cancer drug.
Natco was allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment compared to a whopping Rs 2.80 lakh a month charged by Bayer for its patented Nexavar drug.
Seeking greater cooperation in pharmaceutical sector, the minister informed the industry leaders that India is the third largest medicines producer in the world and produces 20 percent of world's generic drugs.
According to sources, the minister took up several problems of Indian pharmaceutical sector during his meeting with Brazilian Minister of Development, Industry and Foreign Trade Fernando Pimentel.
"The minister raised the issue of requirement of multiple testing despite having approvals from agencies like USFDA, delayed registration of products in Brazil, delay in port clearances and fast tracking of issuing of import licenses," sources said.
On the occasion, industry leaders too raised their problems and concerns which they are facing here.
Mumbai-based J B Chemicals Senior Manager (International Marketing) Prakash Ramgiri said, "Though there are huge opportunities present in Brazil for Indian pharma businessmen, issues like delay in registration process needs to be sorted out immediately to increase cooperation in the sector."
Ramgiri was part of the Ficci business delegation.
Natco Pharma Director Madhusudhan V said a working group needs to be formed to resolve all the concerns of both Indian and Brazil.
Echoing similar views, Arun Kumar Khanna, Chief Operating Officer, Emcure, said Indian companies are also facing the problem of reference prices, which was asked by Brazilian authorities during the marketing process of a product.
Emcure has formed a joint venture with Brazilian firm Biolab for some cardio-vascular segment products. The company is also in the process of acquiring a local company. "We will acquire a firm here," Khanna said.
India's pharmaceutical exports stood at USD 13 billion in 2011-12.
Besides, both the ministers also discussed to further facilitate movement of professionals and increasing cooperation in small and medium enterprises units.
At present, the bilateral trade stood at USD 10 billion and is expected to touch USD 15 billion by 2015.