Medicines Control Council to fast-track sourcing of pharmaceutical ingredients

10 June 2015 - 19:17 By Rdm News Wire

Health minister Aaron Motsoaledi announced on Wednesday that the statutory Medicines Control Council is to fast-track sourcing of active pharmaceutical ingredients pre-qualified by the World Health Organisation in order to cope with the shortage of certain medicines in the country. The minister confirmed recently that South Africa was experiencing a limited supply of approximately 155 medicines mainly due to the global shortage of active pharmaceutical ingredients.However‚ he said on Wednesday that manufacturers had been working around the clock to address these supply problems and some of the supply problems with certain medicines had been resolved.So far the supply of about 82 medicines had been resolved‚ he said.“In the next group of 51 medicines the supply problems are not completely resolved since not all orders have been delivered. However‚ over the next three to four weeks all outstanding orders would have been supplied.“In the next group of 21 medicines the supply problems remain since suppliers would not be able to resolve medicine supplies within the next four weeks and therefore the National Department of Health will secure supplies of medicines from other international suppliers‚” Dr Motsoaledi said.In the interim‚ alternative therapeutic medicines would have to be prescribed. These medicines included certain antibiotics‚ cardiovascular medicines‚ analgesics‚ anaesthetic agents and central nervous system medicines‚ he added.Certain pack sizes of furosemide tablets were in short supply. However‚ alternative pack sizes were freely available and alternative suppliers were also available.According to the minister‚ antiretroviral medicines are not affected by manufacturer supply problems.“Most patients on ARVs are taking the fixed dose combination tablet. This FDC is fully stocked at manufacturers and provincial depots. Additionally there is a buffer stock of the FDC kept by the National Department of Health to be used in the case of emergencies.“There were problems with the supply of Abacavir‚ Ritonavir/Lopinavir combination and Ritonavir however suppliers have resolved these problems and now all outstanding orders have been delivered to depots‚” Dr Motsoaledi pointed out.With regards to penicillins‚ particularly benzyl penicillin‚ a global supply problem was still being experienced‚ but a potential source of active pharmaceutical ingredients (API) supply had been identified in Germany.“When the stock is made available‚ it will need to be used judiciously. In the interim clinicians will be advised on how to manage infections with appropriate alternatives‚” Dr Motsoaledi said.“In the case of vaccines there is a shortage of the BCG Vaccine due to the usual supplier withdrawing their product from the market. As a result‚ the Department of Health has imported the product from alternative international suppliers. This stock is currently in South Africa and awaiting quality release from the National Control Laboratory.”The cardiac medication Digoxin was also in short supply due to manufacturing problems - limited availability of the active pharmaceutical ingredients. The local manufacturer had‚ however‚ received supplies and released some stock into the market last week.“Patients may receive less stock than usual due to supply constraints‚” the minister added.On the fast tracking of active pharmaceutical ingredients‚ Dr Motsoaledi said the MCC had resolved to allow for the sourcing of APIs from alternative manufacturing sites that had been pre-qualified by the World Health Organisation (WHO).“This will allow for expedited availability of some medicines‚ once an application for an API variation has been submitted‚ as MCC will use the WHO information to facilitate approval to ensure that any medicine that is in short supply is accessed.”-RDM News Wire..

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