NEW DELHI: In a move that comes as a huge relief to patients of chronic Hepatitis C, the apex committee of the Central Drugs Standard Control Organisation (CDSCO) has granted a waiver of local trials for crucial new direct-acting antiviral drugs treating the disease.
The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir is expected to bring the generic version of these drugs, which cost a fraction of the branded versions, into the Indian market within weeks. Some patients facing a threat to life currently import these drugs at a huge cost.
According to the World Health Organisation, about 12 million people are infected with Hepatitis C in India. India is now one of the few countries where generics are available 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.
Indian generics are expected to revolutionise Hep C treatment in the region and all across the world as they did in the case of HIV/AIDS. People from countries where treatment is being rationed by the governments, such as in Australia, many European countries, the US, and Canada, already come to India to get treated and this trend is only likely to continue.
Several 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 have been petitioning the health ministry and the Drug Controller General of India (DCGI) seeking a clinical trial waiver for these drugs. Over a dozen patient groups and access-to-medicine activists from Indonesia, Thailand, Malaysia, Nepal and Vietnam too had sent similar appeals. “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.
HCV Patients with advanced liver disease, thalassemics, those with HIV co-infection or those with kidney disease undergoing dialysis who have hepatitis C need daclatasvir in combination with sofosbuvir for effective treatment. They cannot tolerate interferon and/or ribavirin and treatment with sofosbuvir alone was not possible for them. Hence they were left with no treatment option when the manufacturer of daclatasvir, Bristol Myers Squibbs (BMS), was not willing to bring the drug to India or other developing countries.
Sofosbuvir was registered in India in January 2015 and daclatasvir was registered this month. The combo is seen as a very potent cure with about 90% cure rate and for no other disease has such a short-time cure become available, that too in a generic version.
According to the recommendations of a high level committee, waiver of clinical trials in India for approval of a new drug that has already been approved outside India can be considered only in cases of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy. This was hampering the waiver that millions of Hep C patients were petitioning for.
However, the technical committee, after examining the case of sofosbuvir, said that it was the only drug which could be safely used in several categories of Hepatitis C patients. In the case of daclatasvir, the committee said that the drug in combination with other medicinal products became imperative to expedite the treatment of all types (genotypes) of Hepatitis C and hence recommended the waiver.
“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,” said Leena Menghaney, head of MSF’s South Asia Access Campaign.