Sunday Times (Johannesburg) - September 17, 2006
Bobby Jordan

The backlog, which means delays of over three years for some drugs, has also blocked plans for a new one-pill-a-day Aids drug that could transform the country's plan to treat the illness.

This week the Sunday Times established that:

* The government is considering flying in emergency supplies of a vital new TB drug, capreomycin, from Indianapolis in the US because it is not yet registered in South Africa - despite the application having been filed seven months ago;

* A new one-pill-a-day Aids drug, already available in other countries, is unavailable in South Africa despite an application eight months ago by a local drug company to produce the key ingredient, tenofovir (Viread);

* The average registration time for new drugs entering the South African market is between two to three years;

* Approval for drug trials takes up to six months, harming the country's reputation as a research destination; and

* A group of 38 Aids patients are in danger of running out of a life-saving unregistered antiretroviral drug they receive via Medecins Sans Frontieres.

MCC registrar Mandisa Hela initially denied any drug registration backlog, but later conceded the organisation would soon announce measures aimed at streamlining the process. "There is a process already under way where we are looking at how we can deal with the whole organisation of the unit," she said.

Hela said Aids drug applications were automatically fast-tracked, but declined to comment on the pending tenofovir application. "That is confidential information," she said.

However, Hela could confirm that a currently unregistered TB drug would be made available in "about a week or so" to help in the fight against drug-resistant TB.

Experts working for the MCC said registration delays were due largely to the exodus of skilled staff and increasing numbers of new drug applications.

Reviews and evaluations of new drugs prior to registration were mostly outsourced to busy academics.

One drug reviewer, Andy Gray, who sits on an MCC expert panel, said delays were sometimes difficult to explain: "We actually don't have an accurate idea of how long medicines take to get registered; it's somewhere between two and three years."

The MCC needed to prioritise urgent drugs, particularly in the field of HIV/Aids, he added.

The drive for new drugs follows an outbreak of extremely drug-resistant TB (XDR TB) that killed 52 of 53 people known to be infected in Tugela Ferry. The strain is particularly lethal for Aids patients.

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