Threat or opportunity?
Afriplex recently positioned itself to be able to offer unique scientific, technical, legal and regulatory assistance by partnering with strategic role players in the cams industry. This network of experts include regulatory consultants, pharmacists and doctors who are equally passionate about overcoming the challenges associated with the recent legislative changes published into law on 15 november 2013.
Recent amendments to the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as outlined by the Department of Health (DoH) and Medicines Control Council (MCC) have set new boundaries for the marketing and sales of Complementary and Alternative Medicines (CAMs) in South Africa. Many companies see this as a threat and are uncertain about the future of their products due to substantial capital investments required. However, Afriplex sees this as an opportunity to offer integrated solutions to our clients, ultimately developing the market in a safe and efficacious way.
With regards to scientific and technical support, Afriplex assists clients by reformulating existing products in terms of quality, safety and efficacy, and ensuring that products comply with the prescribed shelf life through in house stability testing. Afriplex also has an in-depth knowledge of indigenous plants due to successful collaborations with many Universities and research institutions. This has enabled us to assist with Common Technical Document (CTD) compilation, specifically Module 3, by incorporating data generated through our Active Pharmaceutical Ingredient Master File (APIMF) development program.
Furthermore, our state-of-the-art laboratories include HPLC, FT-IR, GC and TLC equipment for analytical analysis as well as a full microbiological laboratory. As part of this service, Afriplex also supplies method validations, holding time studies and process validations to the respective regulatory consultants appointed to assist clients with their product registrations.
Afriplex is also proud to be associated with Pharmalaw (Pty) Ltd which was established by Prof. Karen du Toit, a pharmacist who holds a PhD in Applied Chemistry from the University of KwaZulu-Natal as well as an LLB degree (Cum Laude) from the University of South Africa. Prof. du Toit offers expert advice on the legislative and regulatory aspects during the whole life-cycle of pharmaceutical products including development, registration, distribution and customs issues whilst also taking into consideration the legal frameworks and intellectual property with regards to medicine.
Going forward, all complementary medicines will need to be manufactured in a MCC-licensed pharmaceutical plant and Complementary Medicine importers, retailers, wholesalers and marketers are required to obtain a license to import and sell CAMs products. In the midst of these current challenges, Afriplex is determined to offer integrated solutions, ultimately equipping clients to view these amendments as an opportunity rather than a threat.