Ranbaxy Going All Out To Meet WHO Norms

New Delhi, Aug 30 | Updated: Aug 31 2004, 05:30am hrs
The de-listing of Ranbaxy Laboratories three anti-retroviral (anti-AIDS) drugs from the pre-qualification list of World Health Organisation (WHO) has forced the pharma major to initiate work on fresh bio-equivalence studies. The studies are likely to take most of this year before the products are ready to be put back on WHOs list.

Ranbaxy Laboratories managing director and CEO Brian Tempest told FE, It was not something we were expecting but we are reproducing the data and doing the bio-equivalence studies, which will take most of the current year.

WHOs move has taken the company a few steps back with respect to this particular range of products.

Ranbaxy was selling these anti-AIDS drugs mostly in the African countries, including South Africa.

Bio-equivalence study refers to a comparative chemical study the company has to compile to prove that the drug being planned for launch is equivalent to the existing drug.

The de-listing of drugs by WHO from its pre-qualification list does not stop any country from sourcing the drugs from the companies.

It is at the sole discretion of the country whether its wants to source from that company or not.

It is something we are reacting to. Although we are still waiting for reports from WHO, we have already started repeating the bio-equivalence studies, Dr Tempest said.

For now, the company is just focusing on reproducing the bio-equivalence studies and re-filing with authorities for approvals, so that they have updated information.

Its not a question of money, he said. Overall, we have always said that this will be done for social responsibility reasons and we dont make bunch of profits out of this. We make a little bit of profit, but it is not really a financial issue, Dr Tempest said.

Earlier, Ciplas drugs, Duovir formulation of zidovudine (AZT) and lamivudine (3TC), were also termed undesirable by the South African Medicines Control Council (MCC). The council has sought certain explanations regarding the bio-equivalence data of the drug.