Ranbaxy will discontinue drugs lines
Ranbaxy Laboratories (Ranbaxy) has decided to discontinue all its rofecoxib formulations from India with immediate effect. Rofecoxib is currently being marketed by Ranbaxy in India, Peru, Myanmar and Jordan, where it has a small market share. The decision follows Merck's withdrawal of Vioxx (rofecoxib) from the market at the end of September 2004. In response, Ranbaxy had earlier issued a statement advising only short term use of rofecoxib while data was being reviewed.
The company also announced it has withdrawn all its anti-AIDS drugs off the World Health Organisation's (WHO) approved list after failing to prove that the generic antiretrovirals were equivalent to the branded products.
However, the New Delhi-based company plans to submit new studies of the seven drugs, which could see them readmitted to the WHO list. The first such study is expected to be finished in March.
WHO said that Ranbaxy voluntarily withdrew the AIDS drugs after discovering 'discrepancies' in tests to show the anti-retrovirals were equivalent to brand-name drugs.
Seven medicines were affected, WHO said, including Indinavir, Lamivudine and Nevirapine.
Ranbaxy's voluntary withdrawal follows the WHO's removal from the list of approved products earlier this year of three other antiretroviral medicines manufactured by Ranbaxy and two antiretroviral medicines manufactured by Cipla.
WHO removed these drugs from the list after inspections at the independent laboratories that conducted bioequivalence studies revealed discrepancies between the original results and the ones presented to the UN's health agency. WHO also noted non-compliance with international guidelines on good clinical and good laboratory practices.
Following the products' removal, WHO sent a warning letter to all manufacturers of HIV/AIDS drugs participating in the pre-qualification project. The letter urged companies to verify the data they had submitted to WHO and to ensure compliance with good practices at the sites where the studies were conducted.