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Hepatitis C drug in India to cost Rs 49 lakh less than in US

Sofosbuvir, the wonder medicine for Hepatitis C that costs $84,000 or Rs 50.4 lakh for a 24-week treatment regimen in the US, will soon be available in India for about $1,800 or roughly Rs 1.1 lakh for the same regimen. The patent holder, pharma major Gilead, announced on Monday that it would be selling the drug at this price in India and also giving voluntary licences to seven Indian pharma companies to produce it.

The voluntary licencing deal promises to make the drug cheap in Indias as well as up to 91 countries where the Indian firms are allowed to sell it. But this has come at the cost of these Indian companies agreeing to abandon India's partners in its fight against Big Pharma for access to inexpensive medicines — Brazil, Russia, China, Thailand and many other middle-income countries. The Indian manufacturers will not be allowed to sell sofosbuvir in these countries.

Under the licensing agreement Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab have the right to develop and market generic versions of sofosbuvir and a related drug, ledipasvir, in 91 developing countries.

"We believe in the capabilities of our partner companies for high quality, low cost, high volume manufacturing. The competition between them will bring down the price of the generic version of sofosbuvir and thus this partnership will help bring about better access to patients globally. Gilead will have no control over their pricing. Our partner companies will set their own prices," said Greg H Alton, executive vice president of Gilead, at a press conference.

Gilead will be selling sofosbuvir at $300 per bottle (28 pills meant for one month of treatment at one pill per day), or about 1% of the US price. The Indian companies' representatives said they could not tell at what price they would make the drug available as they would have to finish one production cycle to be able to decide the price. India is estimated to have approximately 18.2 million people living with Hepatitis C virus.

Medecins Sans Frontieres (MSF) pointed out that the Gilead licence was leaving out the countries with the highest burden of people living with hepatitis C virus (HCV). China, with the largest HCV burden of 29.8 million infected, and Brazil and Ukraine with 2.6 million and 1.9 million respectively have been excluded as they are considered "commercial markets". Many other countries with large HCV burden like Thailand, Malaysia, Peru, Argentina, Ecuador and Colombia have also been left out of the agreement.

What's covered are typically poorer countries where the burden is not as high, MSF pointed out. These countries would not have borne the burden of patent system as they have been exempt from patent obligations. "Generic entrants might be particularly reluctant to serve all smaller volume, poorer countries because of the cost of registering their products and establishing distribution systems," pointed out Prof Brook K Baker, senior policy analyst in the School of Law in Northeastern University.

"We welcome the interest of generic companies to scale up production of new direct-acting antivirals and Gilead's decision to make the final agreement public; however, a highly restrictive voluntary license that blocks millions of people with Hepatitis C from affordable prices is not acceptable. MSF hopes that excluded governments will take all relevant measures available under global trade rules and national patent laws to secure low-cost generic versions of these medicines," said Rohit Malpani, Director of Policy and Analysis, MSF Access Campaign.

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