A new study published on Tuesday has established that Indian generic manufacturers supplied more than 80% of donor-funded AIDS medicines to developing countries in the last seven years, confirming India's status as the pharmacy of the Third World.
The study -- A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries -- was done by UNITAID, an international facility for the purchase of drugs against HIV/AIDS, malaria and TB founded in 2006, Boston School of Medicine and the Center for International Development, Harvard Kennedy School of Government.
According to the study, in 2008, India-produced generics accounted for 91% of paediatric anti-retroviral (ARV) volume. AIDS treatment has experienced startling progress over recent years, with about four million people starting treatment between 2003 and 2008, largely due to India's ability to produce low-cost quality medicines, said a UNITAID statement.
At the same time, the study expressed concern that the legal framework in India that facilitated such production, was changing with implementation of the World Trade Organization ( WTO) agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS). UNITAID also expressed concern over intellectual property measures beyond TRIPS being negotiated in regional and bilateral free trade agreements (FTAs), such as the FTAs with the European Union and Japan, which could create IP obligations for India that could cause price rise and delay access to newer and better ARVs.
"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," revealed the study. For instance, the Indian generic version of the most commonly used first-line adult regimen (lamivudine/ nevirapine/ stavudine) dropped from $414 per person per year in 2003 to $74 in 2008.
"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," observed the study.
Rather than agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners -- plus international organisations, 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, concluded the study.
"The findings of this study raise grave concerns for us because UNITAID relies heavily on Indian generic manufacturers to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50 countries," said Jorge Bermudez, UNITAID Executive Secretary. "What we need today is a more flexible approach to scale up treatment and not the opposite."
The study -- A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries -- was done by UNITAID, an international facility for the purchase of drugs against HIV/AIDS, malaria and TB founded in 2006, Boston School of Medicine and the Center for International Development, Harvard Kennedy School of Government.
According to the study, in 2008, India-produced generics accounted for 91% of paediatric anti-retroviral (ARV) volume. AIDS treatment has experienced startling progress over recent years, with about four million people starting treatment between 2003 and 2008, largely due to India's ability to produce low-cost quality medicines, said a UNITAID statement.
At the same time, the study expressed concern that the legal framework in India that facilitated such production, was changing with implementation of the World Trade Organization ( WTO) agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS). UNITAID also expressed concern over intellectual property measures beyond TRIPS being negotiated in regional and bilateral free trade agreements (FTAs), such as the FTAs with the European Union and Japan, which could create IP obligations for India that could cause price rise and delay access to newer and better ARVs.
"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," revealed the study. For instance, the Indian generic version of the most commonly used first-line adult regimen (lamivudine/ nevirapine/ stavudine) dropped from $414 per person per year in 2003 to $74 in 2008.
"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," observed the study.
Rather than agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners -- plus international organisations, 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, concluded the study.
"The findings of this study raise grave concerns for us because UNITAID relies heavily on Indian generic manufacturers to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50 countries," said Jorge Bermudez, UNITAID Executive Secretary. "What we need today is a more flexible approach to scale up treatment and not the opposite."
Source:TOI