By Jennifer Bakyawa & David MuWanga

The Monitor (Kampala) 3 April 2002

The company that manufactures Nevirapine withdrew its application to register the HIV/AIDS drug with the United States of America's Food and Drug Administration (FDA) because Mulago Hospital wrote to them asking for more time.

"We wrote telling them that we were not ready for a visit. There was difficulty, in obtaining some documents," Prof. Francis Mmiro, who headed the Nevirapine trials in 1997 said.

Nevirapine given to mothers on the onset of labour and babies soon after birth reduces the rate of HIV transmission from parent to child by 50%.

He was speaking at a press conference held yesterday at the Ministry of Health headquarters.

Mmiro said there was difficulty in obtaining source documents because they are stacked up in a container due to the ongoing rehabilitation at the hospital.

The Director General of Health Services, Prof. Francis Omaswa said that though they had entered all the data in computers, the FDA needed original documents for their audit before, they could register the drug.

He said the documents would have been ready for the FDA visit but the authority changed its requirements like source documents for registration when they passed a new law in 1998.

Teams use source documents on the onset of a trial to record personal data of people participating in a study. This information is later transferred to a case record reform.

Boehringer Ingelheim (BI) applied to FDA for, registration of Nevirapine to prevent transmission of HIV from mother to child in November 2001.

The pharmaceutical company continues to donate Nevirapine to programmes in 23 countries where the drug is used to help prevent mother-to-child HIV transmission.

The FDA, group was slated to carry out the audit March this year in conjunction with the National Institute of Health (NHI). The NHL which sponsored the study in Uganda, went ahead and prepared the hospital for the FDA audit.

"BI will reapply to FDA and carry out the audit this year or early- next year," Mmiro said.

Mulago has so far obtained 100 source documents out of the 600 they registered during the Nevirapine trials.