‘A drug, like a scalpel, in an unskilled hand is a dangerous weapon…’ : South African struggles over pharmaceutical regulatory authority, 1930s to 1960s

Worldwide, including in South Africa, from late 1961, the 'thalidomide disaster' demonstrated, unequivocally, the urgency of the implementation of regulatory policies and entities with the power and the capacity to ensure the ‘quality, safety and efficacy’ of medicines. While in retrospect the passage of the South African Medicines and Related Substances Control Act of 1965 (originally, the Drugs Control Bill/Act) may seem unremarkable, in fact, a raft of tightly knotted issues had hindered the realization of such legislation for more than three decades. It is the long genesis of the 1965 Act, and the protracted, often acrimonious, contestations between political parties, pharmaceutical interest groups, pharmacologists, physicians, and commercial lobbyists which is the focus of this paper.