Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief (Pepfar).
Out of the 100 approvals by the US drug regulator Food and Drug Administration (FDA) so far, close to 95 per cent are for Indian companies.
Aurobindo leads the list with 34 approvals, followed by Cipla and US-based Mylan Laboratories' Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme.
The Pepfar programme, started in 2003, aimed at the prevention, treatment, and care of people infected with HIV/AIDS worldwide.
On October 6, the FDA approved the 100th anti-retroviral drug under the Pepfar programme.
"It is a service to the society and we are happy to be the leader in supplying anti-retrovirals, at one-third of the prices of original drugs under the programme," said K Nityananda Reddy, managing director of Hyderabad-based Aurobindo.
The service to society makes business sense, too, for the drug companies. Pepfar is the largest commitment ever by any nation for an international health initiative dedicated to a single disease and is focused on 15 of the hardest-hit countries in Africa, Asia, and the Caribbean.
These countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia. In May 2007, then US President George W Bush reauthorised the programme by increasing procurement of generic drugs and offered another $30 billion, in addition to the initial $15 billion commitment made in 2003.
“On average, we have earned $20 million to $25 million (Rs 92 crore to Rs 115 crore) annually in the last few years from Pepfar supplies. I anticipate a slight plus or minus revenue to this figure in the coming years from this programme,” said Amar Lulla, joint managing director of Mumbai-based Cipla, another major supplier.
As on September 30, 2008, the most recent figure available, Pepfar supported life-saving antiretroviral treatment for more than 2.1 million living with HIV/AIDS. In 2008, it provided nearly $1.6 billion in support of treatment programmes, including antiretroviral drugs and services.
“There is no separate data on the spend for drug procurement under the programme. Companies involved in the programme do not reveal their revenues separately. Supplies are staggered and procurement takes months or quarters later from the date the orders are placed,” said Ranjit Kapadia, vice president, institutional research with HDFC Securities.
"It is estimated that FDA’s actions are allowing Pepfar to spend $150 million (Rs 690 crore) more each year on patient access to care,” US FDA Commissioner Margaret A. Hamburg said in a statement.
The approval process for drugs is rapid. Even patent-protected drugs are procured for supply with a tentative approval in the countries covered under the programme.
The goal of the programme is to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, Pepfar will support training for at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.
