UKZN Lecturer Appointed to Medicines Control Council

BY: .

Senior Lecturer in Pharmaceutical Sciences, Mr Andy Gray, has been appointed to serve on the Medicines Control Council (MCC) of South Africa.

The MCC is a statutory body entrusted with the registration of medicines and medical devices on the basis of safety, quality and efficacy. It also regulates clinical trials, both of non-registered medicines and new indications for registered medicines.

‘I am extremely proud to have been appointed to the Medicines Control Council,’ said Gray, who acknowledged there were still serious challenges facing medicines regulatory practice in South Africa.

He said the country was committed to a fundamental reform of the medicines regulatory system in which the MCC would be replaced by a new structure, the South African Health Products Regulatory Authority (SAHPRA).

‘Currently, the final decision-making power is vested in the Ministerially-appointed Council, as advised by a series of expert committees. The decisions of the MCC are then implemented by a secretariat located within the National Department of Health. In future, the decision-making power will be vested in the staff of SAHPRA, as advised by a series of expert committees.’

SAHPRA will be located outside of the civil service, said Gray, adding that the newly appointed MCC would therefore serve until the establishment of SAHPRA. Parliament is currently considering a Medicines Amendment Bill providing for the establishment of SAHPRA.

Gray explained that medicines regulatory practice involved not just the registration (marketing authorisation) of medicines and medical devices, but also interventions to ensure safe and responsible use of such products.

‘South Africa has a mature medicines regulatory system, but one that is under considerable pressure. The MCC needs to deal decisively with the backlog in applications for both new and generic medicines, while at the same time extending appropriate regulatory control over medical devices and complementary medicines. It also needs to address the issue of transparency.’

Gray noted that medicines regulation was just one aspect of an overall national medicines policy. ‘Implementing national policy in this regard requires attention to other aspects, such as industrial policy, procurement, and the regulation of a range of health professions.’

Widely published in leading international journals, Gray’s own research interests include policy analysis, particularly the processes of development and implementation of national medicines policies, rational medicines use, and the application of antiretroviral therapy in resource-constrained settings.

Gray was appointed in 2013 as a Fellow of the International Pharmaceutical Federation in recognition of his contribution to the organisation and the profession internationally. He is a Fellow and Honorary Life Member of the Pharmaceutical Society of South Africa and a past President of the South African Association of Hospital and Institutional Pharmacists.

Gray is also a member of the National Essential Medicines List Committee, the World Health Organization Expert Panel on Drug Policies and Management, and the UNAIDS Scientific Expert Panel.

He continues as Research Associate and consultant Pharmacist in the UKZN-based Centre for the AIDS Programme of Research in South Africa (CAPRISA).

UKZN’s Pharmaceutical Sciences Discipline congratulated him on his new appointment.

        Lunga Memela