Gilead gave voluntary licenses to Indian pharma companies to make genetic version of Sofosbuvir

Gilead on 16 September 2014 gave voluntary licenses to Indian pharma companies to make generic version of hepatitis C drug Sofosbuvir.

Created On: Sep 17, 2014 14:30 ISTModified On: Sep 17, 2014 15:28 IST

Gilead on 16 September 2014 gave voluntary licenses to Indian pharma companies to make generic version of hepatitis C drug Sofosbuvir. US based pharma major Gilead is the patent holder of Sofosbuvir drug.

Besides, Gilead also decided to provide the wonder drug Sofosbuvir in India at 1.1 lakh rupees compared to 50.4 lakh rupees for 24-week course in the US.

As per the deal, seven Indian companies will be allowed to sell the cheap drug in 91 developing countries. But these Indian companies will not be allowed to sell sofosbuvir in Brazil, Russia, China, Thailand and many other middle-income countries.

The seven Indian pharma companies who have been given the voluntary license ar: Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.

These companies have the right to develop and market generic versions of sofosbuvir and a related drug, ledipasvir, in 91 developing countries.

Granting of voluntary licenses will foster competition between these companies which in turn will bring down the price of the generic version of sofosbuvir and thus this will help bring about better access to patients globally.


Although the deal would be beneficial to India as it is estimated to have approximately 18.2 million people living with Hepatitis C virus (HCV). However, China, with the largest HCV burden of 29.8 million infected, and Brazil and Ukraine with 2.6 million and 1.9 million HCV burden 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 are covered are typically poorer countries where the burden is not as high. These countries would not have borne the burden of patent system as they have been exempt from patent obligations.

About Hepatitis C

• Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness.

• The hepatitis C virus is a bloodborne virus and the most common modes of infection are through unsafe injection practices; inadequate sterilization of medical equipment in some health-care settings; and unscreened blood and blood products.

• 130–150 million people globally have chronic hepatitis C infection.

• A significant number of those who are chronically infected will develop liver cirrhosis or liver cancer.

• 350 000 to 500 000 people die each year from hepatitis C-related liver diseases.

• Antiviral medicines can cure hepatitis C infection, but access to diagnosis and treatment is low.

• Antiviral treatment is successful in 50–90% of persons treated, depending on the treatment used, and has also been shown to reduce the development of liver cancer and cirrhosis.

• There is currently no vaccine for hepatitis C, however research in this area is ongoing.

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