Nairobi - The proliferation of counterfeit medication on the shelves of Kenyan pharmacies has remained a thorn in the flesh of the government whose ultimate responsibility is to protect its citizens.
Patients on the other hand run a high risk of purchasing and consuming potentially lethal medicine, a chilling reality for millions of innocent Kenyans whose only crime was falling ill.
Recent media reports on this thriving but illicit trade has seen the Pharmacy and Poisons Board (PPB) crank up market surveillance.
The PPB, the industry’s regulator, has since May 2016 closed more than 670 illegal pharmaceutical outlets across the country deemed to have fallen short of the required standards.
Of these, 612 have been arraigned in court.
Despite these commendable efforts, the trade remains in the shadows, partly because the poisons board has never made any of its reports public – leaving room for wild speculation about the extent of the menace.
The World Customs Organisation (WCO) and the International Institute for Research Against Counterfeit Medicines (IRACM) last September did an inspection across 16 countries, including Kenya, South Africa, Ghana, Senegal and Tanzania.
The exercise, dubbed Operation ACIM (Action against Counterfeit and Illicit Medicines), sought – with the help of customs officials such as the Kenya Revenue Authority (KRA) -- to shine the spotlight on this dark and dangerous trade.
€52 billion market value of illicit drugs
An inspection of cargo containers that customs officials flagged as suspect saw 113 million illicit and potentially dangerous medicines with an estimated market value of €52 million seized.
This bust included essential drugs like antimalarials, anti-inflammatories, antibiotics, and analgesics, as well as medication used to treat gastro-intestinal illnesses.
Even if most of the seizures were of everyday medicines, anti-cancer drugs, with over 2 million doses discovered, are also included in this tragic record.
“The biggest interceptions were in Nigeria, Benin, Kenya and Togo – in that order,” says WCO secretary-general Kunio Mikuriya.
“All these potentially dangerous medicines to animal and human health have been withdrawn from the market instead of being sold to the African populations.”
This problem is however global
A report by the World Health Organisation (WHO) shows that 700,000 people are killed globally every year following consumption of counterfeit medicines, with Africa contributing 100,000 of these fatalities.
Counterfeit (or illicit) medicines are drugs that are not allowed into the country either due to infringement of international property rights, licences, false certificates, transport or storage conditions, or those not declared.
The Kenya Association of Pharmaceutical Industry (KAPI) recently commissioned a study seeking to gain insights on the prevalence of unregulated medicines in the country.
The KAPI research study in partnership with the University of Nairobi seeks to quantify the extent and degree of unregulated pharmaceutical products available in the Kenyan retail pharmaceutical market.
“Unregulated Pharmaceutical products include; illicit and counterfeit products not sourced through the established channels including unregulated imports,” said the newly appointed KAPI chairperson, Dr Anastasia Nyalita.
“The study results will provide a foundation for policy and enforcement interventions.”
Dr Nyalita was speaking last week in Nairobi. The Association plans to share the study findings with the sector regulator, Kenya Revenue Authority (KRA), Ministry of Health, KAPI members, and related stakeholders once completed.
The study comes hot on the heels of the recent market rollout of the KAPI Code of Practice, aimed at fostering ethical interactions between the local pharmaceutical companies and healthcare professionals.
The Code of Practice bars pharmaceutical giants from sponsoring doctors through scholarships, consulting contracts and grants, which are believed to influence the prescription of medicine to patients.
Those who breach the rule risk a fine that will be determined by the KAPI ethics committee.
They may also have wrong ingredient size or no active ingredients at all to cure illnesses thus posing dangers of even death to unsuspecting persons.
The ACIM report established that the number of illicit and potentially dangerous pharmaceutical products seizures has now reached “dramatic proportions, with almost 900 million counterfeit and illicit medicines seized at the borders of the African continent.”
But how do counterfeit medicines get their way into the African continent?
The Operation ACIM report 2016 shows the mode of transport, source countries and ports, and the routes used by ruthless distributors of counterfeit medicines into African countries including Kenya. The Mombasa sea port was the major point of entry for counterfeit and illegal medicines.
Trafficking of counterfeit drugs is closely linked to other serious crimes, such as money laundering and funding of terrorist groups.
Of the 113 million illicit and potentially dangerous medicines that got its way into the six African countries most came through the sea, showing legal loopholes by maritime authorities. About 57 per cent that is 102 cases of illicit medicines - (that is 125,868,567 units) arrived via sea ports.
At least 63 cases (256,459 units) making about 63 per cent of the total came through air cargo and the remaining 14 cases (26,126 units) eight per cent included consignments arriving by lorries or cars via land borders.
India and China accounted for more than 96 per cent of the interceptions.
“Generally speaking, India is the number one source country for illicit pharmaceutical products and China is the number one source country for counterfeit products,” said Mr Mikuriya in the report.
“Illicit pharmaceutical products originating from China and India were respectively loaded in the ports of Ningbo, Shanghai and Yangshan and in the ports of Nhava Sheva, Mundra and Chennai respectively.”Singapore emerged as a key transhipment port for maritime cargo while air cargo from China went through Hong Kong to South Africa and Dubai.
Another route for counterfeit medicine was from or via Nigeria to South Africa, while using Istanbul as a hub.
Togo was cited as the main transit country to the landlocked countries of Central and West Africa and also a hub to the neighbouring countries.
“Benin is the main hub for containerised cargo to Niger. Cargo destined to Mali tends to go via Dakar, Senegal,” read the report.
Some of the interesting cases as reported was intercepted consignments with counterfeit erectile dysfunction pills that came from China by air to Senegal.
Over 400,000 forbidden dermatological agents from Nigeria and China were also intercepted in the port and airport of Durban.
Over 188,000 veterinary products including Bimectin (treatment and control of wide range of internal and external parasites of cattle and swine) intercepted in Kenya were due to inappropriate transport conditions; too high storage temperatures.
Some undeclared 983,476 sex hormones pills were also intercepted in Durban, and were headed for Lesotho from the port of Shekou, China.
The illicit 2,380,000 cloxaval antibiotic pills and millions of Tramadol pills seized in Benin was also a shocker.
The pills, which originated in China were in transit to Niger with no authorisation to enter the country. The authorisation code of the Nigerian Food and Drug Agency did not match with the name of the product. “The cloxaval were seized based on inappropriate transport condition; according to the information on the packaging the medicines needed to be stored below 25 degrees,” read the report.
“Niger is a French speaking country and all the information on the Tramadol packaging was in English. The product was seized based on inappropriate packaging condition.”
The law only allows products in Swahili and English to enter the Kenyan market to weed of unsafe and potentially harmful products into the country.
PPB acting registrar, Fred Siyoi told the Business Daily last week that they are putting measures in place to protect the public against imported medical commodities that do not comply with local quality standards and technical regulations.
Dr Siyoi said there is a danger in pharmaceutical products that have no verified origin since one will neither know their country of origin nor be assured of quality.
“A certificate of compliance must be issued to ensure public safety, without which goods must be disposed. If an importer is consistently non-compliant they would be deregistered,” said Dr Siyoi.
“If a food supplement is packaged in Chinese language, for instance, how do you know if it has lactose, which you could be allergic to?”
The ACIM report said that fraudsters are taking advantage of ‘weak’ African legislation to smuggle harmful pharmaceutical products in the continent, for the rush of profits.
“Customs administration give priority to Tax and revenue collection rather than to fight counterfeiting. No action plan for combating counterfeiting is in place.”
Mr Mikuriya in the report said it should be highlighted that in many cases where illict medicines were intercepted by Customs because of inappropriate transport or packaging conditions, the medicines were released by the Health Authorities. This was despite the fact that the storage conditions were clearly mentioned on the transport papers and the packaging.
“It appears that as long as the imported has an import license the inappropriate storage temperature is not an issue, not even for medicines in vials,” he said.
The report also shows that majority of the selected consignments could not be inspected for a variety of reasons including corruption.
PPB Head of the Directorate of Inspectorate, Dr Jacinta Wasike said their objective is to ensure supply chain integrity through inspection of distribution outlets, verification of pharmaceutical imports and exports, and market surveillance for elimination of unregistered, poor quality and falsified products and health technologies.