According to health department spokesperson Sibani Mngadi, Mseleku, who has no experience in medicine regulation, will remain in his post at Director-General, but will also take on the registrar position until ‘we have identified a possible replacement’.
Mngadi said it was a temporary arrangement to allow the ‘administrative activities’ of the MCC to continue. He said the Medicines Act did not allow for an acting-registrar to be appointed, in which case Mseleku was then appointed by the Minister.
There was also no clarity on whether the position would be advertised or whether the Minister would appoint a new Registrar in due course.
‘I am not certain how long it will take,’ Mngadi added.
Maureen Kirkman, head of regulatory affairs at the Pharmaceutical Manufacturers’ Association of South Africa welcomed the announcement.
‘We would like clarity and finality on who the eventual appointment will be, but we are happy that an interim arrangement has been made,’ said Kirkman.
Kirkman did not foresee any problems with Mseleku’s lack of expertise in the field. ‘He has the resources in the department to support him,’ she said.
An industry source who asked to remain anonymous expressed concern over the current backlog in the registration of medicines. ‘There are huge backlogs and long delays, up to 40 months,’ he said. The international average for the registration of drugs is between 20 and 22 months.
The Registrar of Medicines is the executive secretary of the MCC.
The MCC is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa.
It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.
The MCC operates through external experts who are members of Council Committee structures.
The office of the Registrar provides administrative and technical support to Council and its activities. ‘ Health-e News Service