Complementary and alternative medicines must be manufactured in manufacturing plants accredited by the Medicines Control Council (MCC) since November 2013 and therefore Wrapsa, South Africa’s biggest pharmaceutical contract manufacturer and packaging company, upgraded its facilities and ensured that it has the necessary accreditation to make these medicines.
“The department of health amended the regulations of the Medicines and Related Substances Act in 2013 to include the licensing of all manufacturers and wholesalers of complementary or alternative medicines. These medicines must also be labelled according to the labelling requirements of the Act and adhere to all other requirements of the Act,” explains Jannie Nel, responsible pharmacist at Wrapsa.
According to Nel the labels of complementary medicines must be in English and at least one other official language and state the category of medicine, the pharmacological classification, the discipline of medicine and the words “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease”.
“The road map for complementary medicines that formed part of the amended regulations required certain categories of complimentary medicines to adhere to the regulations by a certain date. So far all banned and scheduled substances must have been withdrawn and all labelling complies, while antiviral agents, oral hypoglycaemics (Diabetes), cardiac medicines, cytostatic agents, slimming preparations or weight reduction products, sexual stimulation products, immune boosters, medicines acting on the muscular system (body building products) and vitamins or sport supplements containing vitamins and minerals exceeding the upper limit allowed, have all been called in for evaluation by the MCC and is monitored.”
Nel explains that licensed medicines must meet the same standards for pharmaceutical quality, safety and efficacy as conventional medicines and must be manufactured according to the principles of good manufacturing practice (GMP). This ensures that medicines are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the product license. “It is primarily aimed at diminishing the risks inherent in pharmaceutical production, such as cross-contamination and mix-ups,” he says.
This system ensures the consistent production and control of products according to quality standards and is designed to minimise the risks involved in pharmaceutical production that cannot be eliminated through testing the final product. However, Nel says various factors can affect the quality, safety and efficacy of complementary and alternative medicines.
“Plants parts and extractions are often used in these medicines and have no consistent and standardised composition, while it contains numerous chemicals that can vary in the various parts, such as the roots or leaves. The content and concentration of these chemicals can also be influenced by factors such as climate, growing conditions and time of harvesting, as well as post-harvesting factors, such as storage conditions and processing. Therefore the chemical content of various batches manufactured from the same herb can differ and adjustments must be made during the manufacturing process.
“The raw material can also be contaminated through human error, while accidental or intentional botanical substitution or contamination of plant species can also happen. Different manufacturers also use various techniques and processing methods, which also changes the content and quality of herbal products,” Nel explains.
Wrapsa has a manufacturing license to manufacture medicines issued by the Medicines Control Council as well as a Good Manufacturing Practice certificate. It is also accredited with an ISO9001:2015 accreditation and its quality systems comply with the criteria set by the SABS for its ISO certification. According to Nel this facility has made it possible for companies producing complimentary medicines to have their products manufactured in South Africa and benefit from the cost-effective benefits of local manufacture.
Categories: | Tags: | Comments: (0)
| View Count: (988) | Return