Global pharmaceutical firms are pressuring the United States to act against India to stop more local companies producing up to a dozen new varieties of cheap generic drugs still on-patent, sources with direct knowledge of the matter said.
An Indian government committee is reviewing patented drugs of foreign firms to see if so-called compulsory licences, which in effect break exclusivity rights, can be issued for some of them to bring down costs, two senior government officials said.
The drugs that are part of the review process are used for treating cancer, diabetes, hepatitis and HIV, said the sources, declining to give details. No timeline has been given for completion of the review process.
Emerging markets, from South Africa to China and India, are battling to bring down healthcare costs and boost access to drugs to treat diseases such as cancer, HIV/AIDS and hepatitis.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing drugs market in India.
But they have been frustrated by a series of decisions on patents and pricing, as part of New Delhi's push to increase access to life-saving treatments where only 15 percent of 1.2 billion people are covered by health insurance.
India is currently on the US government's Priority Watch List - countries whose practices on protecting intellectual property Washington believes should be monitored closely.
The U.S. industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) believes Washington should take a tougher line by downgrading it to a Priority Foreign Country, a classification for the worst offenders, which may trigger possible actions, sources said.
"The multinational companies are exploring all options - from paring their investments in the country to forcing the U.S. to take some actions," said a source in New Delhi, who is directly involved in the situation.
"Companies feel something should be done at the earliest to check the violations of their intellectual property in the country. They want government-to-government pressure to change things," he said.
All the sources declined to be named due to sensitivity of the matter. A PhRMA representative declined to comment.
If India gets relegated by the United States to Priority Foreign Country level, it will join Ukraine as the second country in that segment. Countries in the Priority Watch List include China, Indonesia, Pakistan, Russia, Thailand and Argentina.
"PhRMA makes submissions to the U.S. government every year on trade issues but this year they really want to