[Ip-health] New study demonstrates India's central role in ARV supply to developing countries

Suerie Moon suerie_moon at yahoo.com
Tue Sep 14 06:17:49 PDT 2010

Dear all,
The Journal of the International AIDS Society today published a new study demonstrating the central role Indian generic manufacturers play in supplying antiretroviral medicines to developing countries.  A better understanding of India's role is of particular importance given ongoing negotiations for bilateral or regional trade agreements that may introduce new IP obligations that could constrain or restrict generic supply.  Please find the abstract pasted below, and full article available open access at: 

Your comments are most welcome,
-Suerie Moon
A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countriesBrenda Waning, Ellen Diedrichsen and Suerie Moon Journal of the International AIDS Society 2010,

14 September 2010

Abstract (provisional)

Indian manufacturers of generic antiretroviral (ARV) medicines 
facilitated the rapid scale up of HIV/AIDS treatment in developing 
countries though provision of low-priced, quality-assured medicines. The
 legal framework in India that facilitated such production, however, is 
changing with implementation of the World Trade Organization Agreement 
on Trade-Related Aspects of Intellectual Property Rights, and 
intellectual property measures being discussed in regional and bilateral
 free trade agreement negotiations. Reliable quantitative estimates of 
the Indian role in generic global ARV supply are needed to understand 
potential impacts of such measures on HIV/AIDS treatment in developing 
We utilized transactional data containing 17,646 donor-funded 
purchases of ARV tablets made by 115 low- and middle-income countries 
from 2003 to 2008 to measure market share, purchase trends and prices of
 Indian-produced generic ARVs compared with those of non-Indian generic 
and brand ARVs. 
Indian generic manufacturers dominate the ARV market, accounting for 
more than 80% of annual purchase volumes. Among paediatric ARV and adult
 nucleoside and non-nucleoside reverse transcriptase inhibitor markets, 
Indian-produced generics accounted for 91% and 89% of 2008 global 
purchase volumes, respectively. From 2003 to 2008, the number of Indian 
generic manufactures supplying ARVs increased from four to 10 while the 
number of Indian-manufactured generic products increased from 14 to 53. 
Ninety-six of 100 countries purchased Indian generic ARVs in 2008, 
including high HIV-burden sub-Saharan African countries. Indian-produced
 generic ARVs used in first-line regimens were consistently and 
considerably less expensive than non-Indian generic and innovator ARVs. 
Key ARVs newly recommended by the World Health Organization are three to
 four times more expensive than older regimens. 
Indian generic producers supply the majority of ARVs in developing 
countries. Future scale up using newly recommended ARVs will likely be 
hampered until Indian generic producers can provide the dramatic price 
reductions and improved formulations observed in the past. Rather than 
agreeing to inappropriate intellectual property obligations through free
 trade agreements, India and its trade partners - plus international 
organizations, donors, civil society and pharmaceutical manufacturers - 
should ensure that there is sufficient policy space for Indian 
pharmaceutical manufacturers to continue their central role in supplying
 developing countries with low-priced, quality-assured generic 

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