Pharmacists back proposal for drugs regulatory body

Pharmacists are backing plans for enact a new legal instrument to regulate food safety, medicines and herbal drugs. This comes in the wake of debate in Parliament on the Food and Medicine draft law that seeks to set up the Foods and Medicine Authority (RFMA). The Bill has already been debated by the Standing Committee on Social Affairs and it is expected to be presented to the Plenary after lawmakers return from recess on June 5, according to Augustine Habimana, the director-general of Communications and Outreach at Parliament. What difference it will make in health in the health sector is the question for many. RFMA’S responsibilities RFMA will be a regulatory and supervisory body which will regulate all matters relating to food safety, medicines, herbal drugs, medical devices, medical cosmetics, poisons and other health commodities. The body will also be in charge of regulating importing, manufacturing, labelling, marking and identifying food supplements medicines and herbal drugs. It will also store, sell and distribute the items. Patrick Mwesigye, the head of the Pharmacy Task Force in the Ministry of Health, said once the medicines authority is established, it will also ensure that clinical trials on medicines, drugs, medical devices and herbal drugs are conducted in accordance with prescribed drugs. “This authority will also be the one to regulate Camerwa and other drug depots to ensure that they only import registered and quality drugs. This will minimise cases of counterfeits and substandard medicines in the country,” he said. The foods and medicines authority will not procure, but regulate procured stock. Under RFMA, Mwesigye adds, there will be food and medicine inspectors at border points to ensure good quality is imported. ‘Good framework’ The Ministry of Health has been doing all this work, but the new agency will boost investor confidence, thus, giving credibility to health system, said Mwesigye. MP Ezechias Rwabuhihi said the authority will make pharmacists and other medics gain confidence in the medicines provided in the country. “This body will ensure that all medicines that is used and supplied in the country are certified, have licences and are of good quality,” the former health minister said. Erwin Wumurenzi, a pharmacist and, said the envisaged Foods and Medicines Authority will improve the regulation of drugs on the market, thereby improving public health. “In most cases, it has been observed that some patients take drugs and they don’t recover. This can be interpreted in many ways, chief of which is the poor quality of drugs,” he said. Wumurenzi also said cheap counterfeit drugs will be tackled more aggressively with a more independent and organised workforce at RMFA. He added that one of the existing challenges is lack of harmonisation of the drug companies for better functioning. Service delivery With the setting up of a Medicines Authority, much is going to improve, such as internal inspection, licence issuing, and quality assurance by continuous inspection of companies that import drugs and improving locally-manufactured pharmaceutical products, Wumurenzi said. Lambert Ingabire, a pharmacist at King Faisal Hospital, said the lack of such a regulatory body derails efforts to improve procurement of pharmaceuticals but once the RFMA is in place, it will check the quality of drugs in detail, thus reducing counterfeits. The public will be assured of good quality drugs which will lower risk of substandard ones, according to the Pharmacist. Joseph Kabatende, the coordinator of the National Logistics Management Unit in the Ministry of Health, said Rwanda does not just accept medicines in the country and at times carries out inspection of some drugs along with the World Health Organisation. He said they at times visit the plant where the medicine in question is manufactured and inspect the different levels of the clinical trials it goes through. RFMA will be a self-financing institution that will also generate resources to the government.