The Central Drugs Standard Control Organization (CDSCO) , the national regulatory body for Indian pharmaceuticals and medical devices, equivalent to FDA in the U.S., 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 a 90 percent 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-week course of branded medicines costs over $90,000 in the US and over €50,000 in the EU.
Leena Menghaney, Head of Médecins Sans Frontières (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.