Ranbaxy supplied safe drugs, to cooperate with US inquiry

Ranbaxy Laboratories has said that all its medicines, including the AIDS drugs supplied to African countries under United States government supported programmes, are safe and effective.

India’s leading drug maker, which is currently in the process of being acquired by Japan's Daiichi Sankyo, said it will work with the US Food and Drug Administration and Congress members to address their concerns over the safety of Ranbaxy medicines.

The company response has come after four members of the Congressional Committee on Energy and Commerce wrote to the Secretary of State Condoleezza Rice, levelling serious allegations over the marketing application and production process of Ranbaxy and sought all details of medicines supplied by the company under a US government programme (President's Emergency Plan for AIDS Relief - PEPFAR).

“Ranbaxy is confident that all its pharmaceutical products are safe and effective, including the HIV/AIDs drugs it supplies to Africa through various aid programmes, including PEPFAR. Ranbaxy is committed to working with Chairman Dingell (John D Dingell heads the Congressional Committee) and FDA to put these matters to rest and continue and expand its important place in providing safe and affordable medications to the US and global citizens,” a company spokesperson said.  

The PEPFAR, launched in 2003  to combat HIV/AIDS, is the largest commitment by any nation till date to combat a single disease. Estimates suggest that Ranbaxy has received over $9 million from the programme so far. Ranbaxy had a turnover of $1.5 billion in 2007-08, of which a quarter came from US sales.

In a statement posted on the US Congress Committee on Energy and Commerce's website, the senators said for more than three years, the USFDA and the Department of Justice have been investigating possible fraud and other improprieties in Ranbaxy’s applications to sell prescription drugs in the country. On Friday, the committee decided to expand this probe to include medicines that were supplied by the company to developing countries under US government-funded programmes.
 
This is the latest twist in the ongoing travails that Ranbaxy is facing in the US. Last week, the USFDA blocked the entry of 30 medicines manufactured by Ranbaxy at its Indian plants.