Pharmacy, Medicines and Poisons Board (PMPB) has expressed concern on the proliferation of herbal and traditional medicine on the market, stating that the use of such drugs may have harm to the users since they are not scientifically proven to be safe for the body.
The medicine regulator has made the statement amidst fast growing market of numerous herbal drugs advertised to treat or heal various health problems and chronic conditions such as HIV/AIDS, diabetes, high blood pressure and cancer.
Public Relations officer for the board, Mphatso Kayuwe, said in an interview with Malawi News Agency that their board has not certified any herbal medicine such that patients should source medicine from regulated places like pharmacies, drug store, hospitals and clinics.
“Currently, no traditional medicine dealer is certified by the PMPB to produce and sell traditional medicines in Malawi because the products themselves have not been assessed for quality, safety, and efficacy,” Kayuwe said.
“Realizing the potential harm, we have drafted regulations for these products which clearly classify them based on safety risk profiles (plant sources used and history of traditional use) and prescribed data requirements for registration and advertisement of traditional/herbal medicines which will be presented to the Ministry of Health for approval.
“Licenses for traditional medicines that were initially registered as nutritional supplements were suspended in July 2017 until such a time when the current draft regulations for traditional and complementary medicines are in force,” Kayuwe Explained.
Kayuwe also warned medical dealers to follow the law and shun misinforming the public.
“Any product advertised using medical claims (e.g. intended to treat, to cure or to prevent a disease) is purporting to be a medicine.
“A dealer cannot, however, claim to sell a medicine unless they have submitted comprehensive safety, efficacy and quality data from well conducted clinical studies to justify its use,” he added.
The PRO further explained that dealers in medicines are obliged by law to comply to the prescribed measures namely; registration of manufacturer of medicine, registration of the medicinal product, registration of pharmaceutical wholesalers, import permit requirements for every consignment of medicines and the presence of qualified personnel in premises that engage with clients/patients at all times,” he further explained.
Kayuwe also explained that the PMPB, through the Ministry of Health, has facilitated the repealing of the current Pharmacy, Medicines and Poisons (PMP) Act of 1988 which has no provision for herbal medicine and replaced with the Pharmacy and Medicines Regulation (PMR) Act.
He said that the PMR, with clear provisions on the regulation of allied substances which includes traditional/herbal products, was approved by Cabinet on 6th April, 2018 and is expected to be tabled in parliament soon.
Meanwhile, Malawi Branch Manager for Green World, a supplier of imported herbal drugs, Noel Banda, has commended the provisions by PMPB on the regulation of herbal medicine, saying they will ensure safety for the consumers.
“Currently, numerous traditional/herbal drugs are all over making it hard to ascertain their credibility,” Banda said.
“Some herbal suppliers also take advantage of the herbal proliferation to bring in anything, which poses threat for the consumers.
“The regulations will, therefore, ascertain that only those herbs that are screened and proven should be available on the market,” he said.