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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.
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.
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