The regulation, registration and control of medicines in South Africa is (still) chaotic. A What's New DOC (WND) investigation uncovered an MCC trying to pick up the pieces amid a fractured past which includes massive backlogs, political meddling, allegations of bribes and vested commercial interests, lack of control over complementary medicines and quack remedies flooding the country
By ANSO THOM, (award-winning journalist, Health-e News Service)
What's New DOC (WND) contacted several drug companies and offered them an opportunity to comment on the functioning of the Medicines Control Council (MCC).
Aspen was the only company which agreed to respond. All the others either did not respond at all or declined to do so.
Stavros Nicolaou, senior executive of Aspen Pharmacare, said: 'The department of health has commenced a process aimed at clearing the MCC backlog and improving approval timelines. While these are early days, initial progress . . . is encouraging and we look forward to completion of the process.'
Val Beaumont, executive director of the pharmaceutical industry association Innovative Medicines SA, said South Africans were being protected from substandard medicines. 'We are comfortable that scheduled medicines in SA are being checked for safety and that standards set by the MCC are world-class,' she said.
Beaumont added there was a problem with the speed at which things were happening, but they had a sense that the backlog was being cleared. 'For the first time in years, we are seeing a sense of urgency and focus.'
Kirti Narsai, head of scientific and regulatory affairs at the Pharmaceutical Industry Association of South Africa (PIASA), said they were positive about the fact that the MCC was dealing with the challenges and some patience needed to be exercised.
Questions about MCC appointees
A new Medicines Control Council (MCC) was recently appointed, with a number of new members. However, sources point out that the maximum period for membership of the MCC as per legislation is 10 years. Three of the members, including the chairman, Professor Peter Eagles, have served 10 years and have now been appointed for a third term.
Questions about Prof. Eagles' involvement in discussions or decision-making (in Council or the Complementary Medicines Committee) relating to products sold by Clicks while he was still a non-executive director of Clicks, remain unanswered.
The outcome of the 2007 investigation into allegations that the late Advocate Thomani Mulaudzi accepted a bribe, is being kept secret, while the MCC also failed to clarify whether allegations that the wife of a council member apparently runs or owns the laboratory used by the MCC for testing, are
true or false.
(This is an edited extract of an article first published in What’s New DOC, 10th issue, May 2010. What’s New Doc is a publication for medical doctors, produced in association with Health24.)