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India approves sale of generic Hepatitis C drugs
By Kesavan Unnikrishnan Nov 29 2015
India has approved the sale of generic versions of hepatitis C drugs. The move will bring down the standard course of sofosbuvir and ledipasvir (generic versions of Sovaldi and Harvoni) to $1000 compared to $90,000 in United states and Europe [from Jules: the price in the US has been reduced by 50% to about $45-50,000 and in Europe similar reductions if not more are in place).
The Central Drugs Standard Control Organization (CDSCO) , the national regulatory body for Indian pharmaceuticals and medical devices, equivalent to FDA in the United States, granted a waiver of local trials for generic versions of drugs used in treating Hepatitis C. The sofosbuvir- ledipasvir combo is seen as a very potent cure for Hepatitis C with about 90% cure rate as compared to old interferon treatment which had serious side effects. The drugs are expected to hit the market in weeks costing a fraction of the branded versions.
The generic drugs will help in treating millions of Hepatitis C patients in developing countries, especially in Africa and South Asia. Globally, more than 130 million people are infected with the hepatitis C virus, and 350,000 to 500,000 people die from the infections each year, according to the World Health Organization.
The move is also expected to increase the flow of patients from the U.S. and Europe to India where insurers and governments have limited the use of these drugs to the sickest patients to control costs. A standard 12 weeks course of branded medicines costs over $90,000 (from jules: its $50,000 in US) in the US and over 50,000 in the EU.
Leena Menghaney, Head of Medecins Sans Frontieres (MSF) International's South Asia Access Campaign said:
"We welcome the availability of a pan-genotypic directly acting anti-viral (DAA) combination in India, which is a big step towards interferon free treatment for chronic HCV patients, many of whom urgently need treatment as they have advanced liver disease."

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