By DAGI KIMANI
Thousands of Kenyan patients are unknowingly taking wrongly formulated or expired medicines, thanks to a thriving illegal trade in counterfeit and illegally imported drugs, the country's pharmaceutical industry has warned.
According to industry sources, anywhere between 20 and 30 per cent of the medicines entering Kenya currently are either counterfeit or illegally imported. The latter are medicines imported into the country by unregistered firms and individuals, the so-called briefcase traders.
Particularly affected, according to Vijay Maini, managing director of Surgipharm pharmaceutical distributors, are antibiotics, anti-malarials and anti-inflammatories, and a wide range of drugs ranging from the simple aspirin to medicines used during surgery.
"Strong, trusted brands and expensive drugs are the main target," said Mr Maini. "We are facing a very serious problem with drugs that fall in these categories."
Speaking to The EastAfrican last week, Dr Frank Aswani, regional manager of the Eli Lilly drug firm, said his company's brands had fallen victim to the illegal trade, adding that sales of one of his company's key drugs, Cialis, had been particularly hard hit.
"Trade in counterfeit or illegally imported Cialis has eroded 70 per cent of our sales in the six months since we launched the drug," Dr Aswani said. "The problem has escalated to a stage that we cannot just ignore."
Cialis, which was launched in the region last year is used to treat erectile dysfunction, the condition in men in which one is unable to attain a sufficient erection for sex. The only other drug which is widely used to treat the condition is Pfizer's Viagra, which makes both drugs keys targets for counterfeiters and illegal importers.
In intellectual property law, counterfeit drugs are defined as medications that differ in some respect from what is stated on the label. They include drugs that contain smaller amounts of active pharmaceutical ingredients than claimed, wrong active ingredients, or no active ingredients at all. Fake drugs also include expired products that have been relabeled with new expiry dates.
Health experts say that such drugs threaten patients' health in a variety of ways, including through actual poisoning, unintended effects, and ineffective treatment. The growing use of the substandard drugs, they add, has been a major factor in the emergence of drug resistant strains of diseases such as malaria and tuberculosis in Kenya.
According to Daniel Ndungu, Nyanza Provincial Drug Inspector, tests by the Government Chemist have shown that many of the counterfeits and illegally imported drugs contain just "chalk," or are completely different drugs altogether from what they are purported to be.
"In Nyamira District, we recently confiscated veterinary drugs being sold as human antimalarials," Mr Ndungu told The East African last week. "Raids in other parts of the country, including Nairobi where our unit is currently prosecuting several cases, have yielded similar results."
Although the industry agrees that part of the problem lies in weak regulation and surveillance by Kenya's Pharmacy and Poisons Board (PPB), which is mandated to oversee the medicines industry in the country, most concede that the problem has been compounded by the growing sophistication of today’s counterfeiters, which is making it increasingly difficult for consumers to distinguish genuine medicines from counterfeit ones.
The pharmaceutical industry however also says that Kenya's Drug Inspectorate Unit is grossly understaffed, with just 10 drug inspectors serving the entire country. The only entry point served by the inspectors is the Jomo Kenyatta International Airport (JKIA), where two of the officers are stationed. Three months ago, the government hired an additional 13 inspectors, but these are yet to be posted pending training.
"Our unit could do with more personnel, resources and support from the government," Mr Ndungu said. "Going by the magnitude of the current problem, we need officers at all entry points, as well as possibly at post-offices handling international mail."
Lack of enough drug inspectors, Mr Ndungu said, has meant that the higher penalties provided for following amendments to Cap 254 last year have not had the desired effect. Following the amendments, fines for offences in trading in counterfeit medicines were made as high as Ksh1 million ($13,000).
The appearance of counterfeit medicines in international commerce was first mentioned as a problem at the World Health Organisation Conference of Experts on Rational Drug Use, held in Nairobi, in 1985.
In 2001, the Kenya Association of Manufacturers (KAM) revealed that five Kenyan pharmaceutical companies had lost as much as Ksh500 million (then $6 million) in sales due to the proliferation of counterfeits.