Ranbaxy seeks US drugs approval

The drugs may be used in a US government-backed programme

Ranbaxy, one of India's leading drug companies, has submitted two generic Aids treatments for approval by the US Food and Drug Administration (FDA).

The firm hopes the so-called antiretrovirals, or ARVs, will be included in US Aids relief programmes should they get approval.

Ranbaxy has now filed a total of three antiretrovirals for FDA approval.

The US is the world's largest drug market, and President George W Bush has vowed to fight HIV.

Although they are not a cure, ARVs block the HIV virus's ability to replicate.

They can delay the onset of Aids by protecting the immune system from attack.

Emergency plan

Last year, President Bush announced the Emergency Plan for Aids Relief - PEPFAR - which aims to treat at least two million people with antiretroviral therapy, preventing new infections and caring for millions of persons infected with HIV.

Ranbaxy hopes that its new ARVs will be included in the programme, which focuses on nations in Africa and the Caribbean - home to nearly 50% of HIV infections in the world, according to the United States Agency for International Development (USAIDS).

"We are working speedily to provide all the data required by the FDA so our generic ARVs can be approved," Ranbaxy's chief executive Brian Tempest said in a statement.

The generic drugs will be manufactured at Ranbaxy's plant in the northern state of Himachal Pradesh that was recently inspected and approved by the FDA.

In its statement Ranbaxy said it was committed to providing affordable generic drugs to poor HIV/Aids infected patients throughout the world and will soon file its complete range of ARVs with the FDA.

Generic drugs are the same as brand-name products, but are dispensed under its generic chemical name.

They are cheaper, and can be sold on the market when the patent has expired on the branded version.

Drugs withdrawn

In 2004, Ranbaxy voluntarily withdrew all its antiretroviral drugs from a World Health Organisation (WHO) list.

A Ranbaxy spokesman told the BBC the company had done that as a matter of "abundant caution" after several discrepancies were found in studies carried out by the independent Contract Research Organisation (CRO).

The WHO had earlier sent a warning letter to Ranbaxy, as well as rivals Hetero and Cipla, saying that their generic drugs did not meet international standards of good clinical practice and good laboratory practice.

Ranbaxy's spokesman said the company is now carrying out its own studies on the ARVs and hopes to make a fresh submission to the WHO by the end of March this year.

One of India's largest pharmaceutical companies, Ranbaxy sells its products in over a hundred countries and has manufacturing operations in seven countries.