The anti-retroviral drug, nevirapine, was finally registered yesterday (18 April) for use in preventing HIV transmission from mothers to their babies by the Medicines Control Council (MCC).

This opens the way for babies nationwide to get the drug, which manufacturer Boehringer Ingleheim has offered free to all SADC countries for a period of five years.

Drug trials completed nine months ago proved the safety and efficacy of the drug, which can cut the transmission rate of HIV from mothers to their babies by up to 50%.

However, the MCC was extremely cautious in its approach to registration of the drug, leading to speculation of government interference in the process.  

The health department has, however, decided to offer HIV positive pregnant women free nevirapine at 18 pilot sites countrywide.

Cabinet has yet to approve the plan, which could save the lives of hundreds of babies. An estimated 1 800 HIV positive babies are born each day in this country.

MCC chairperson Professor Helen Rees confirmed yesterday that the drug had been registered after a “very satisfactory” agreement had been reached with its manufacturer, Boehringer Ingleheim.

Rees had earlier said that the MCC was concerned about the development of drug resistance, and this had been a stumbling block to the drug’s registration.

Kevin McKenna, Director of Technical Affairs for Boehringer Ingleheim, confirmed that his company had agreed to provide the MCC with “any information on adverse effects or non-effects” of the drug on an ongoing basis.

McKenna said a number of other countries including Uganda and Thailand had already approved nevirapine for prevention of mother-to-child HIV transmission.

The nevirapine programme has been in the pipeline since July last year, when it was approved by the health Minister and provincial MECs.  

The Western Cape has already started giving Gugulethu women nevirapine, while KwaZulu-Natal, the Free State, Northern Cape and parts of Gauteng are ready to go ahead with their nevirapine programmes.