BOMBAY, India – A major Indian pharmaceutical company said Friday it plans to bring a generic version of the anti-influenza drug Tamiflu (search) into the market early next year, filling any potential shortages in event of a bird flu epidemic.
The drug is already in short supply following fears of a possible epidemic. But the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, has refused to license generic versions of the drug despite pressure from several countries and United Nations Secretary General Kofi Annan.
Dr. Yusuf K. Hamied, chairman of Cipla Ltd., said that his company has already developed the generic version, oseltamivir, which would be much cheaper than Tamiflu — the only available drug that is effective in treatment of people infected with bird flu.
"We have been able to synthesize it. Once the lab work is done things don't take too long," Hamied said in a telephone interview. "We are in the process of scaling up and commercialization. That should be completed next month."
Hamied did not disclose how his company would price the generic brand, but said the company will make it available at "a humanitarian price."
"I have always said there should be access to medicine at affordable prices," he said.
A strip of 10 Tamiflu tablets cost about $60, a lot of money for people in Asia where millions earn less than a dollar a day. Patients are advised to take a tablet daily for at least a week and the dosage could extend up to six weeks for people living in epidemic infested areas.
The H5N1 strain of avian flu (search) has been sweeping through poultry populations in Asia since 2003, infecting humans and killing at least 65 people, mostly poultry workers. The virus does not pass from person to person easily, but experts fear the virus could mutate.
The 1918 influenza pandemic killed more than 40 million people. Subsequent pandemics in 1957 and 1968 had lower death rates, but caused extreme disruption.
World Health Organization spokesman Dick Thompson declined to comment specifically on Cipla's plans, but said WHO supported the line taken by Annan at a visit to the Geneva-based agency two weeks ago.
"We will take the measures to make sure poor and rich have access to the medications and the vaccines required," Annan said at the time.
Scientists in Taiwan have recently said they, too, can produce generic Tamiflu, if patent issues are resolved.
Generic manufacturers cannot legally sell the patented drug in the West and in many countries in Asia, including India, which recently tightened its patent laws. But the laws in many of these countries allow governments to invalidate patents during emergencies and permit sale of generics.
Hamied didn't say how and where he plans to sell his product, but insisted he won't "break the law."
"Anyone who wants the drug can purchase it from us," he said. "May be people in America and Europe would want to buy it from us, but they are governed by their own patents."
Roche declined a direct comment on Cipla's announcement.
"We fully intend to remain the sole manufacturer of Tamiflu, together with our partners," said Daniel Piller, a Roche spokesman, in Geneva.
The company had previously said it is increasing Tamiflu's production. The company also insists that making the drug is a very complex process and if any other company was given a license to make generic copy, it would take at least two to three years for the firm to ramp up production.
But Hamied said that was not the case with his company, which has copied dozens of Western drugs, including Pfizer's Lipitor and Viagra, as well as AIDS drugs, approved by the World Health Organization, that are used by hundreds of thousands of HIV-infected people worldwide.
"We have learned a lot in the past 30 years of flexible patent laws in India," he said.
Until January this year, India's patent laws allowed Indian pharmaceutical firms to make cheap versions of expensive Western drugs using a technique different than that of the patented product. But under the new law, Roche could possibly go to an Indian court, challenging any attempt by Cipla — India's third largest drug manufacturer — to market generic copies of Tamiflu.