12-18 million Indians affected with Hepatitis C in India finally have hope. US-based Gilead's revoluntionary drug Sofosbuvir will finally be available in India at a fraction of its original cost, thanks to licensing agreements with seven generic companies.
49-year old Faridabad-based school teacher Minu Madan was diagnosed with complete renal failure two years ago. Coping with frequent Dialysis, life took a turn for the worse when she also contracted liver disease Hepatitis C. Minu failed to respond to all available treatments. She was told her only hope was Gilead's new drug Sofosbuvir. But at Rs 1.8 crore for six months, the treatment was simply beyond her means.
Madan says: "Mere liye to yehi ek aakhri hope tha. Humne US mein jab pata kiya tha to ye dawa Rs 90 lakh ki pad rahi thi. Hum wo afford nahi kar sakte the. Par ab ye hume Rs 16,600 per month par mil rahi hai."
Hep C treatment has been a challenge because of efficacy of earlier drugs. However, Sofosbuvir, approved by the USFDA in 2013 has had a success rate as high as 80 percent. For patients like Minu, the launch of generic Sofosbuvir in India by seven firms under a voluntary license agreement has been nothing short of a blessing. Launch of generic versions means costs have come down to a much more reasonable Rs 1.2 lakh in India.
Some companies are even offering combination packages that include supporting drug Ribavirin and diagnostic kits for bundled prices.
Aid groups, however, sound cautious. They say the benefits of this wonder drug will be limited to a fraction of patients owing to a restrictive licence deal. They claim the process of collecting patients' identification and residence proofs by innovator company Gilead Sciences and its licensees will compromise on patient confidentiality and block access to those who lag behind on paper work.
Gilead, however, in a statement to CNBC-TV18 said: "The concerns raised reference a system in Egypt, presuming it will be replicated in all countries. This is not correct. Our generic partners are currently working on what they think would be a suitable, workable system for the countries they serve - including India. This is to ensure that the medicines reach their intended recipients and are not diverted out of the country of intended sale."
Medical experts feel the anti-diversion clause imposed by the innovator company won't be a major impediment.
Akash Shukla, liver specialist, KEM Hospital says: "I will still say it is a revolutionary drug. I don't think the anti-diversion clause will create problems. We need these treatments desperately. My only concern will remain on the patient confidentiality."
While Gilead has managed a voluntary licence deal with multiple partners, its own patent application on Sofosbuvir has been rejected in India. Although Gilead is challenging the order, the market is open for more generic launches in the interim, giving hope to millions of Hep C patients in the country.
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