Pharmacists seek regulatory agency

Lack of a regulatory body is undermining the administration of the country’s pharmaceutical sector to crackdown on counterfeit and illegal importation of drugs, a government official has said. In an exclusive interview with The New Times, John Patrick Mwesigye, the coordinator of the Pharmacy Taskforce in the Ministry of Health, said the establishment of the regulatory body would address the challenges.“Currently, we have few staff in the ministry charged with regulation of the pharmaceutical sector, we are understaffed. There is need for an independent body with enough capacity – stationed at the Customs Department – to aid in their activities,” Mwesigye explained.In 2010, the five member states of the East African Community (EAC) conducted an operation codenamed ‘Mamba III’ to combat counterfeit medical products and other forms of pharmaceutical crimes within the bloc.Locally, the operation was spearheaded by Interpol Rwanda and the Pharmacy Task Force in conjunction with the Customs Department, Rwanda Bureau of Standards and the Rwanda Drug Consumables and Equipment Central Procurement Agency (CAMERWA).At the time, about 90 kilograms of counterfeit and unauthorised drugs were seized in 37 wholesale and retail pharmacies, hospitals and clinics in Kigali, Rubavu and Rusizi districts.This followed the impounding of hundreds of kilos of smuggled drugs in the Rwanda Revenue Authority warehouses in Rubavu town.Most of the drugs were found to have been smuggled into the country mainly from the Democratic Republic of Congo through the border districts of Rubavu and Rusizi.In September 2010, a meeting was convened in Zanzibar to present the findings of the operations in the five EAC member states.Drugs worth millions had been seized in all the member countries.The meeting, among others, set strategies that they believe would help fight counterfeit and illegally imported drugs, both at the country and regional levels.“The mechanisms are already in place, bringing together the Rwanda Revenue Authority, the police, Ministry of Health, civil society and CAMERWA,” Mwesigye noted.“We have also trained people to identify counterfeit products. Drug importers have to hold importation visas and licence. We screen all products imported to see if they fulfil all the requirements, and identify where they come from” he added.During the operations, some pharmacies and dispensaries were said to be selling smuggled products and lacked storage facilities.“There are set guidelines for storing pharmaceuticals and we do the supervision to see if they are followed. Good enough, we haven’t had a report of drugs going bad because of being poorly stored,” Mwesigye maintained.“For a pharmacy to be given an operational licence, its workers have also to be scrutinised to see if they hold relevant qualifications,” he added.Whereas cases of importation of counterfeit drugs are reportedly on the increase in the region, Mwesigye insisted that the situation is “not alarming”.The World Health Organisation estimates that 50 percent of drugs are wrongly used and up to 20 percent of drugs in many developing countries are counterfeit.Currently, a bill to establish the Rwanda Food and Medicines Regulatory Authority is in parliament and the task force believes it will help ensure appropriate regulation of the pharmaceutical sector in the country.“The establishment of the institution will ease the management of the sector since it will be mandated with specific tasks.”Meanwhile, Mwesigye disclosed that companies, pharmacies, hospitals have to be accredited by the Health ministry to sell HIV/AIDS (ARV) drugs.Currently, only very few of these entities, among them La Croix du Sud hospital, Carrefour Pharmacy and BRALIRWA, are authorised dealers.ARVs are only supplied by the government and all drugs from the national drug store are marked, which also helps the government in identifying illegal imported and unauthorised products.

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Pharmacists seek regulatory agency