Only one co can sell
drug in India, while other Indian cos can sell it in 50 countries
Doctors and aid
organisations have called upon the Competition Commission of India (CCI) and
the drug price regulator to step in to ward off the monopoly over a new HIV
drug, dolutegravir, which received the approval of the Indian drug controller
last month.
Dolutegravir -sold by
GlaxoSmithKline's Viiv Healthcare unit under the Trivicay brand -is considered
the best-in-class HIV drug as it reduces virus levels faster and has a high
barrier to resistance compared to the previous line of drugs.
However, only one
Indian drug maker, Emcure, will be allowed to sell the medicine in the Indian
private market, because of a licensing agreement with Viiv Healthcare under the
Medicine Patent Pool.
This is despite
Indian generic makers like Cipla, Aurobindo Pharma, Hetero and Strides Arcolab
having licence to sell this drug in nearly 50 other lowand middle-income
countries. However, these companies can sell the drug through public sector
tenders or through NGOs in India. Activists call this condition restrictive and
anti-competitive.
“It is such an irony
that Indian drug makers who are known to pro vide 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,“ said Leena Menghaney of Doctors Without
Borders, an aid organisation. “The Competition Commission or the pricing
regulator (the National Pharmaceutical Pricing Authority) should step in to
make sure that this drug doesn't become monopoly .“
GSK and Emcure did
not respond to emails asking them about price at which they will be selling
this drug in India.
Some doctors are
concerned about how the drug would be priced.
“If priced premium,
many patients would lose out on benefit of a good drug,“ said Dr Mandar Kubal,
director of Mumbai-based Infectious Diseases & Pulmonary Care Pvt Ltd. If
the licence was not restrictive, the presence of more companies in the market
would have driven the price lower, like it happened in the case of new class of
Hepatitis-C drugs, Kubal added.
“If you position it
as first line, then pricing is key, and I don't un derstand this licensing
agreement so I expect eventually other drug companies too would get licence,“
said Dr Sanjay Pujari, an HIV specialist.
In India, about 2
million patients are under anti-retrovirals (ARVs) and almost 90% of the public
requirement for ARVs is procured by the National AIDS Control Organisation
(NACO). However, HIV patients say NACO is far behind when it comes to adding
new therapy lines to its treatment guidelines, which makes patients to depend
on private markets. The antiHIV market in India is estimated to be `300 crore,
with an 11 % growth rate, according to research firm AWACS. The cost of
treatment for raltegravir, which is the second best in line treatment for HIV ,
is around `8,000 per month.
ET VIEW
Boost Supplies:
We need proactive
policy to ward off monopoly rent-seeking. What's required is stepped-up output
of the drug to better cope with demand.What's also needed is largescale
sourcing by government and other public agencies, so that supply gets a healthy
boost. In parallel, we need to update norms for pricing of patented imported
drugs.
Source: 27th December,2016
