Response to President Clinton's and India's Initiative

[Guest guest]

India’s initiative to provide low-cost pediatric formulations to 62 countries

welcomed

Non-resident Indians and international advocacy groups urge India to reject

proposal to adopt the Data Exclusivity provisions to its Drugs and Cosmetics Act

in order to maintain its leadership in providing low-cost medicines worldwide

Washington DC, World AIDS Day: December 1, 2006 — The Stop HIV/AIDS in India

Initiative (SHAII) is joined by the Students Global AIDS Campaign (SGAC),

American Medical Students Association (AMSA), Global AIDS Alliance (GAA), and

Global Action for Children (GAC) in welcoming India’s initiative to provide

low-cost pediatric formulations to 62 countries and to expand its own treatment

outreach to children living with HIV/AIDS. SHAII and her partners have been

campaigning for the provision of pediatric formulations through government

programs, as opposed to providing children with fractions of the adult

medication, which often results in over or under dosage.

“Although it is a great initiative, with less than 100 physicians trained to

treat India’s more than 250,000 children living with HIV/AIDS, adopting a narrow

and target-based approach to increase treatment access from 1048 to 10,000

children in four months without a strong policy framework and guidelines may

prove to be counterproductive,” said Dr. Vineeta Gupta, Director of SHAII.

“India must immediately develop and implement national guidelines based on a

holistic approach, not only for the treatment, but also for the protection,

support, and care of orphans and vulnerable children affected by HIV/AIDS in

order to make this initiative really effective,” added Dr. Gupta. Dr. Gupta

served as a maternal and childcare physician in India’s public healthcare system

for over a decade and has witnessed the pitfalls and failures of target-based

healthcare programs.

The initiative to provide low-cost pediatric formulations reinforces India’s

leadership in providing global access to AIDS medication. This leadership is

under grave threat, as India is considering Data Exclusivity amendments to the

Indian Drugs and Cosmetics Act (DCA). If adopted, these amendments will severely

impede the future production of low-cost generic medications.

Under the current Trade-Related Aspects of Intellectual Property Rights (TRIPS)

agreement of World Trade Organization (WTO), India is not obligated to impose

data exclusivity regulations. The WHO has additionally affirmed this view, yet

there is strong pressure from the United States and multinational pharmaceutical

companies to enact these provisions. " The pressure from the US is responsible

for the Indian government's move to introduce data exclusivity. This needs to be

exposed by the global civil society, " said Gopa Kumar of the Center for Trade

and Development, India. Of the 1.6 million people

living with HIV/AIDS receiving ARVs worldwide, more than 50% rely on Indian

generic medicines.

Vineeta Gupta. MD, JD, LL.M

Director, Stop HIV/AIDS in India Initiative

Phone 202-789-0432 Ext 207

www.shaii.org

Email: guptahr@...