21 November 2018 - NW3049
Carter, Ms D to ask the Minister of Health
In view of the perceived escalating countrywide shortage of drugs and medicines in our public healthcare system, what is (a) the root cause and (b) being done to rectify the situation?
a) The anti-retrovirals that were affected were the combination products of Abacavir / Lamivudine and Zidovudine / Lamivudine. The active ingredients for most medicines are produced mainly in India and China. The challenges experienced were caused by the new legislation in China relating to industrial pollution which resulted in the closure of manufacturing sites for the production of Lamivudine and Abacavir.
The injectable contraceptive, norethisterone enanthate, is currently not available. The supplier is the only supplier of this drug in South Africa and supply challenges were experienced because of the quality of the pharmaceutical ingredient.
The demand from provinces on Oxytocin exceeded the supply. As a result, the contracted supplier did not have sufficient capacity to meet the increased demand.
b) The National Department of Health assisted the contracted supplier of Zidovudine / Lamivudine to obtain special authorisation from the regulator (South African Regulatory Authority – SAHPRA) to bring stock into the country in terms of Section 21 of the Medicines Act. The stock arrived in tranches over a period of three months and supply is ongoing.
With regards to Abacavir / Lamivudine, stock has arrived and is being released in tranches as well.
With regards to injectable contraceptives, although norethisterone enanthate is not yet available, another injectable contraceptive, medroxyprogesterone acetate is available and health care workers have been advised accordingly. Furthermore, the National Department of Health assisted the contracted supplier of norethisterone enanthate to obtain special authorisation from the regulator (SAHPRA) to bring stock into the country in terms of Section 21 of the Medicines Act.
The National Department of Health sourced stock from the alternative supplier of Oxytocin in the private sector.
Furthermore, the National Department of Health assisted the contracted supplier of Oxytocin to obtain special authorisation from SAHPRA, to bring in sufficient stock, based on the demand until January 2019. This gives the contracted supplier sufficient time to build the capacity to bring in stock in December 2018.