Short on the announcement of Johnson & Johnson discontinuing the Acuvue contact lens range in South Africa, Alcon Pharmaceuticals announced that supply of many of its products including the Systane range of artificial tears will be halted, pending a ruling from the Medicines Control Council.
On 26 January 2015, the eye care community receive the following communication:
Dear Valued Customer
As a result of changes in legislation for the regulation of medicines in South Africa, the pharmaceutical industry has been advised by the Medicines Control Council (MCC), that certain products previously marketed as Complementary Medicines and Medical Devices, will no longer be allowed on the market until they have been registered.
As an industry, we are engaging directly with the MCC to seek resolution on this issue, especially since the industry is eagerly awaiting the publication of device legislation, under which many of the products may indeed be categorized.
The immediate impact is that the future supply of many of the artificial tear products has to be held back. This will regrettably affect some of Alcon’s Systane Family of products, i.e. Systane Ultra, Systane Ultra Unit Dose, Systane Gel Drops and Systane Balance, once the current stock available has been depleted.
In addition, our ocular vitamins, iCaps‐R and Systane Vitamin, are now also required to be registered as “Category D” medicines and therefore the supply of these products will also be affected.
Please rest assured that Alcon’s Regulatory Affairs Department is actively engaging with the MCC on a frequent basis.
Our Schedule 0 Artificial Tears, namely Tears Naturale II, Tears Naturale Preservative Free and Duratears Ointment, continue to be widely available and are not impacted by this change in regulation. Please offer these products as alternatives to your patients until the issues have been resolved.
We respectfully request your understanding during this, hopefully short‐lived, transition period.
Business Unit Manager
For our patients effected by this announcement, please rest assured we have already sourced alternative artificial tear products to substitute for the non available products.
Should you have any queries or concerns please contact us at 021 976 8046.