The Central Drugs Standard Control Organisation (CDSCO) has given a waiver of local trials for crucial new directing antiviral drugs treating Hepatitis-C. The generic version of sofosbuvir and ledipasvir co-formulation and for daclatasvir drugs is expected to hit the Indian markets soon.
Prominent patient groups, including International Treatment Preparedness Coalition – South Asia, the Delhi Network of Positive People, thalassemic patients’ groups and Medecins Sans Frontieres ( MSF) or Doctors Without Borders are reported to be appealing to the health ministry and the Drug Controller General of India (DCGI) on the matter. The same matter has invited petitions from patient groups and access-to-medicine activists from Indonesia, Thailand, Malaysia, Nepal and Vietnam too. “The requirement for a local clinical trial in India will delay the introduction of the new HCV drug daclatasvir in the country, and also in other high-burden countries in the region,” stated the appeals.
These drugs are likely to be launched at a fraction of the branded version, providing a major relief to the 12 million (as confirmed by WHO) Hepatitis C patients. Under present circumstances, patients are also required to buy imported drugs at a huge cost to treat the disease which can be life threatening.
As of now, there are few generics available in the market to treat Hep-c for interferon-free treatment. Pegylated interferon is an old, expensive, injectable chemotherapy drug with serious side effects used to treat Hep C in combination with sofosbuvir and ribavirin. The interferon-free treatment, which costs over $90,000 in the US and over 50,000 euros in the EU will be available to Indian patients for about Rs 55,000 or about $1,000 or even less thanks to competition between generic manufacturers, as reported by TOI.
The combination of Sofosbuvir and daclatasvir has a 90 per cent cure rate. This combo cures the disease in a short-time, with no other generic version drug reported to cure in a similar manner.
Indian generics are already being used by patients in many countries spread across Australia, many European countries, the US, and Canada. Increase in generic drugs for Hep-C is only expected to revolutionise Hep C treatment in the region and all across the world as they did in the case of HIV/AIDS.