HIV drug monopoly in India? Many doctors think so
Doctors and concerned organizations have called upon the price regulator and the Competition Commission of India to intervene and ward off the apparent monopoly of Dolutegravir- a new HIV drug that received the Indian drug controller’s approval just last month.
The drug which is sold by GlaxoSmithKline’s Viiv Healthcare unit is considered to be the best-in-class HIV drug. It brings down the virus levels faster and also has higher barrier to resistance than the previous line of drugs.
But the catch is that just one Indian drug maker- Emcure would be allowed to sell it in the Indian private market- a caveat that comes due to a licensing agreement with Viiv Healthcare. Such a scenario exists when Indian generic makers including Cipla and Aurobindo Pharma have licence to sell the drug in almost 50 other countries. These companies are allowed to sell the drug through public sector tenders or via NGOs in India.
Many think that this condition is both restrictive and anti-competitive.
“It is such an irony that Indian drug makers who are known to provide affordable medicines to the world will not be able to sell the drug in India, as ViiV has effectively blocked access to the drug through licence conditions that limit its supply to public sector entities and NGOs in India with prior permission from the company – and not through private sales. The CCI or the pricing regulator (the National Pharmaceutical Pricing Authority) should step in to make sure that this drug doesn’t become monopoly,” ,” said Leena Menghaney of Doctors Without Borders, an aid organization.
Concern about pricing
Another concern shared by many doctors is about the pricing of the drug.
According to Dr Mandar Kubal, director of Infectious Diseases & Pulmonory Care, Mumbai. “If priced premium, many patients would lose out on benefit of a good drug.” He added that if the license weren’t this restrictive the entry of more firms in the market would have pushed the price down, as was the case with the new class of Hepatitis-C drugs.
Dr. Sanjay Pujari, an HIV specialist has this to say: “If you position it as first line, then pricing is key, and I don’t understand this licensing pact so I expect eventually other drug companies too would get license.”
Around 2 million patients are under ARVs in India. Around 90 percent of the public requirement for ARVs is procured by NACO.
But the HIV patients claim that NACO lags in adding new therapy lines to its treatment guidelines,making the patients dependent on private markets.
The cost of treating with Raltegravir- considered the second best in treating HIV is about Rs 8,000 per month.
“Without access to Dolutegravir in the private sector, people living with HIV who have developed resistance to existing HIV medicines will not be able to get effective treatment they need to stay alive,” said Loon Gangte of the Delhi Network of Positive People.
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