A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries

Background 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 i...

Full description

Bibliographic Details
Main Authors: Brenda Waning, Ellen Diedrichsen, Suerie Moon
Format: Article
Language:English
Published: Wiley 2010-01-01
Series:Journal of the International AIDS Society
Online Access:https://doi.org/10.1186/1758-2652-13-35
_version_ 1828004498654625792
author Brenda Waning
Ellen Diedrichsen
Suerie Moon
author_facet Brenda Waning
Ellen Diedrichsen
Suerie Moon
author_sort Brenda Waning
collection DOAJ
description Background 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 countries. Methods 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. Results 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. Conclusions 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 medicines.
first_indexed 2024-04-10T07:15:45Z
format Article
id doaj.art-fe034140bde048fb9283b25aa50d0f10
institution Directory Open Access Journal
issn 1758-2652
language English
last_indexed 2024-04-10T07:15:45Z
publishDate 2010-01-01
publisher Wiley
record_format Article
series Journal of the International AIDS Society
spelling doaj.art-fe034140bde048fb9283b25aa50d0f102023-02-25T12:30:34ZengWileyJournal of the International AIDS Society1758-26522010-01-01131353510.1186/1758-2652-13-35A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countriesBrenda Waning0Ellen Diedrichsen1Suerie Moon2Boston University School of Medicine, Department of Family Medicine, Boston, MA, USABoston University School of Medicine, Department of Family Medicine, Boston, MA, USASustainability Science Program, Center for International Development, Harvard Kennedy School of Government, Cambridge, MA, USABackground 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 countries. Methods 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. Results 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. Conclusions 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 medicines.https://doi.org/10.1186/1758-2652-13-35
spellingShingle Brenda Waning
Ellen Diedrichsen
Suerie Moon
A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
Journal of the International AIDS Society
title A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
title_full A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
title_fullStr A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
title_full_unstemmed A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
title_short A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries
title_sort lifeline to treatment the role of indian generic manufacturers in supplying antiretroviral medicines to developing countries
url https://doi.org/10.1186/1758-2652-13-35
work_keys_str_mv AT brendawaning alifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries
AT ellendiedrichsen alifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries
AT sueriemoon alifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries
AT brendawaning lifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries
AT ellendiedrichsen lifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries
AT sueriemoon lifelinetotreatmenttheroleofindiangenericmanufacturersinsupplyingantiretroviralmedicinestodevelopingcountries