Health officials quell MPs’ fears over counterfeit drugs

HEALTH officials on Wednesday assured the Lower Chamber’s Committee on Social Affairs that Rwandans have very little reason to worry about an influx of counterfeit medicines. Reports in the Ugandan and Kenyan Press reveal that the two countries are grappling with the danger of counterfeit and unregistered medicines. MP Liberata Kayitesi, a member of the Committee, said she had heard of similar complaints from the general public. “I seek clarity on this. We often hear people say that there are medicines that enter, perhaps from India, that are probably cheap. Some of such complaints are even made by pharmacists. So, how do they enter? What process does a drug go through in order to be approved for the market?” she wondered. These concerns were raised as the Committee began examining the draft law establishing regulations on medicines, medical devices, poisons, cosmetics, herbal medicines and other related health commodities. Health Minister, Dr. Agnes Binagwaho, and the Pharmacy Task Force Coordinator in the Ministry, John Patrick Mwesigye, told MPs that there should be no cause for worry since the ministry is vigilant. Binagwaho assured MPs that drugs must pass the World Health Organisation (WHO) standards before they are allowed into the country. “When there are any side effects, we collect a sample of the drug and send it to an international laboratory for assessing, because this [substandard drug] can happen even with the best factory,” said Dr. Binagwaho. “And the other thing is regulations; not everybody can import, not everybody can store, and not everybody can sell, to guarantee the [safe] channel.” The Minister stressed that Interpol is also an active partner in tackling related crimes, globally. “We know that it is possible a drug may come from Europe, or America, or India, or Brazil, and enter the country and cause problems, like it can happen elsewhere. But those responsible have a right to ask for the drug to be put off the market. When we learn that a bad drug is in the country, we immediately halt its sale,” Mwesigye said. “The Ministry has mechanisms to do this, right from health centres, to the extent that if such a drug is identified, or if a patient notices unusual side effects, however minor, a report is given to the Ministry and we follow up. Whenever it’s necessary, we inquire from the manufacturer about the problem”. In September, last year, Kenyan newspaper reports said authorities there scrambled to get rid of thousands of batches of counterfeit antiretrovirals (ARVs) from circulation after patients and nurses reported irregularities in the appearance and texture of a widely used drug, Zidolam-N. It had been discovered that the ARVs were falsified versions of a WHO-certified generic drug purchased through a distributor endorsed by the country’s drug regulatory authority the Kenya Pharmacy and Poisons Board (KPPB). Earlier, in December, the Ugandan National Drug Authority (DNA) described the influx of counterfeit medicines in the country as “very worrying.” It announced that the fake medicines intercepted included Quinine Bisulphate 300mg tablets claimed to be manufactured by Laboratory and Allied Limited of Kenya, Quinine Sulphate 300mg tablets claimed to be from Macleods Pharmaceuticals Limited in India, Metakelfin 500mg tablets from Pharmacia Italy and the Maxaquin 4% injection 30ml manufactured by Mac’s Pharmaceuticals in Kenya. Meanwhile, according to the WHO’s world reports of counterfeit medicines, in 2005, in Kenya, a random survey by the National Quality Control Laboratories (NQCL) and the Pharmacy and Poisons Board found that almost 30 percent of the drugs in Kenya were counterfeit. “Some of the drugs were no more than just chalk or water marketed as legitimate pharmaceutical products. According to figures from the Kenyan Association of Pharmaceutical Industry, counterfeit pharmaceutical products account for approximately US$130 million annually in sales in the country,” says the WHO. james.karuhanga@newtimes.co.rw