India’s top drug maker, Ranbaxy Laboratories Ltd. on Tuesday became the first Indian drug maker to have regulatory approval for a generic AIDS drug to be included in a major U.S. anti-HIV programme.
Ranbaxy received tentative approval from the U.S. Food and Drug Administration to make and market lamivudine tablets for the $15 billion programme.
The five-year U.S. President’s Emergency Plan for AIDS Relief programme, launched by George W. Bush in 2003, aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 target countries, mostly in Africa.
New Delhi-based Ranbaxy had filed for FDA approvals for four anti-retroviral drugs for inclusion in the programme.
AIDS (Acquired Immune Deficiency Syndrome) is the final and most serious stage of HIV disease, which causes severe damage to the immune system.
According to the Centers for Disease Control and Prevention, AIDS begins when a person with HIV infection has a CD4 cell count below 200. (CD4 is also called “T-cell”, a type of immune cell.) AIDS is also defined by numerous opportunistic infections and cancers that occur in the presence of HIV infection.
Analysts say the approval could mean more sales, but profits will not be affected much given the cheap prices for the drugs.
“It is an important development, and could open up more opportunities for Indian drug makers and their generic AIDS drugs,” said Giridhar Iyengar, an analyst at ABN-Amro Securities.
“But it’s too early to tell how significant the impact would be on Ranbaxy in terms of sales and profits.”
Shares in Ranbaxy, already among the top-10 generic drugs suppliers in the United States, were largely flat at 1,097.75 rupees in a firm Bombay market.
Rival drug maker Cipla Ltd. has been roped in to supply paediatric AIDS drugs as part of former President Bill Clinton’s $10 million fund to help treat children afflicted with AIDS/HIV in 10 countries, particularly in rural Africa.
Ranbaxy withdrew all its anti-AIDS drugs from a World Health Organisation list of approved drugs last November, after discovering discrepancies in tests done to show the generic drugs were equivalent to brand-name drugs.
Ranbaxy has since submitted 11 anti-retrovirals for WHO approval and has said it plans to submit its entire range.
Revision date: July 9, 2011
Last revised: by Sebastian Scheller, MD, ScD