The Pharmacy and Poisons Board (PPB) has been allowing importation of billions of shillings worth of substandard and fake drugs into the Kenyan market in exchange for bribes from illegal traders, documents with the Ministry of Health show.
The documents supplied to the Office of the President’s Efficiency Monitoring Unit (EMU) by a whistleblower show that the poisons board issued tens of permits to non-registered drugs suppliers between 2005 and 2011, putting millions of lives in danger.
Most of the counterfeits were disguised as genuine drugs and came in under the parallel importation channel that deals with non-conventional medicine.
The EMU has written to the Ministry of Health providing evidence of the PPB’s involvement in the illicit trade, warning that the practice had put millions of lives at risk.
“These documents show how the PPB Chief Registrar authorises cartels to import counterfeits that could kill millions. I request your office to act fast using the leads in the report,” the EMU says in a report that is now with the Ministry of Health.
The Kenya Revenue Authority (KRA) is in possession of the fake certificates, says the report.
The EMU’s investigations also found that parallel importation of pharmaceuticals has negatively impacted the quest to safeguard public safety in the drugs market and that better market surveillance would be possible with mandatory registration of all importers for traceability.
But the whistleblower told the EMU that the pharmaceuticals agency has not registered any traders in parallel medicine, making it difficult to monitor the goings-on in that segment of the market.
“To the best of my knowledge, as one of the most qualified pharmaceutical regulation specialists, there is no single parallel medicine registered in Kenya,” said the whistleblower.
Kipkerich Koskei, the chief pharmacist, however denied the existence of such a counterfeits drugs cartel, arguing that all medical imports are formally processed by the agency.
The EMU report, which was submitted to the Ministry of Health in March, however accuses the agency of abetting corruption and punishing uncooperative staff.
The whistleblower, says the report, has been victimised on several occasions for refusing to be party to the shady dealings in counterfeit medicines.
Health secretary Cleopa Mailu promised to review the documents and forward them to the relevant authorities for action.
“I am surprised that I did not receive the documents earlier,” said Dr Mailu during last Friday’s launch of the ministry’s national strategy for ear and hearing care in Nairobi.
The documents show that the EMU’s informer was once directed in writing to permit a shipment of drugs worth $2,500 without expiry dates for a self-help group in Kakamega.
Dr Koskei wrote the letter, which was later used against the officer in court.
Paper trail on the illicit drugs trail includes 10 illegal permits allowing importation of fake medicines worth nearly Sh100 million, one of which was intercepted by the United Nations’ (UN) Narcotic Drugs and Psychotropic Substance Controller in Vienna in 2008.
The Vienna-based agency also stopped the importation of another 500 kg of psychotropic drugs (including Indian hemp) in May 2005, according to documents submitted to the ministry.
The poisons board authorised Atken Pharmaceuticals import the consignment worth Sh50 million in powder-form from Emmellen Biotech Pharmaceuticals of India against the Vienna International Opium Conventions.
The paper trail also reveals that in December 2009, a consignment disguised as donation for Ogra Foundation, which is affiliated to a former Health minister, received anti-retroviral drug (ARV) donations from a US pharmaceutical company, which were later found retailing in chemist shops in Nairobi.
The same chemist also shipped out several ARVs (Trioimmune and Zidolam-N) consignments to Botswana “for huge profits instead of benefiting the local Aids sufferers,” the whistleblower says.
“The World Health Organisation (WHO) discovered the trade in the fake medicine which had molded and turned black in 2011 — it was an international scandal.”
The fake ARVs had reached more than 3,000 HIV positive patients by the time of action. The list of counterfeit drugs that have been imported with the backing of the poisons board includes oncology drugs (for cancers), anti-diabetics, fertility pills, anti-thyroids, anti-allergies and antibiotics.
The counterfeits are identified by the fact that they come from sources that are not known to be manufacturing centres for the patent owners.
The Swiss firm Norvatis, for instance, has only one registered and approved site for the manufacture of the Tegretol CR Tablets in Italy with Norvatis Pharma Services, Nairobi as the authorised dealer.
But documents supplied by the whistleblower show that Dr Koskei signed a March 2011 permit authorising Wasafiri Pharmacy to import Tegretol, among other counterfeits, worth about Sh1 million from Abeer Pharmacy in Dubai.
The Deputy Director of Medical Services, Izaaq Odongo, said the consignments were suspect because “most of the pharmas do not have manufacturing sites in Dubai”.
Kenya’s counterfeit drugs market is estimated to be worth Sh50 billion, making it one of the most lucrative illicit businesses in the country.
Counterfeits may or may not have any treating molecules and are often poisonous to human health. Medical experts say counterfeits are principal contributors to rising bacterial and anti-biotics resistance in Kenya.
Dr Koskei has in the past dismissed the whistleblower as “a bitter person who was sacked from the board and now is fighting back”.