…association calls for stricter market regulation to curb trade in unregulated medicines
A market study, recently commissioned by the umbrella Pharmaceutical Industry Association, has confirmed the existence of unregulated medicines in the country.
The study, sponsored by the Kenya Association of Pharmaceutical Industry (KAPI) and conducted by pharmaceutical applied researchers from the University Of Nairobi School Of Pharmacy, has confirmed an 8% prevalence of unregulated or gray medicinal brands.
According to KAPI Chairperson, Dr. Anastasia Nyalita, the baseline study focused on 9 popular medicine brands and provides a representative sample for a wider market challenge. The study was undertaken among 160 practicing retailers through interviews and literature reviews with purchases for 543 products conducted in 326 retail outlets in all the major towns in Kenya.
Unregulated or gray medicines, Dr. Nyalita said, are those that have entered the market through irregular channels and have not undergone the necessary regulatory scrutiny and market conformity by the Pharmacy and Poisons Board.
“such products unlike those imported through the official channels, pose grave danger to the patients using them as their efficacy and Quality remains questionable,” she added. “Following the study, KAPI is optimistic that these findings will serve as a basis for broad discussion among stakeholders, to further enhance the regulation, while raising awareness among the general public.”
While calling for an inter-agency management programme, KAPI has also petitioned the PPB to consider enhancing its market surveillance activities, and fully utilize digital technologies to track shipments and identify gray products to ensure that all products available in the Kenyan market are regulated.
To curb the prevalence of such gray products, Dr. Nyalita, confirmed that KAPI has beefed up its market surveillance efforts and will continue to undertake wider studies to ascertain the full extent of the current challenge in conjunction with the Ministry of Health and the PPB.
Speaking at the public release of the applied research study, the KAPI leadership disclosed that 8% of the target medicines from the study results had entered Kenya through an unofficial channel.
Majority of these products were found in Nairobi and Nakuru, and some of them in Mombasa and Kisumu.
The research study conducted by the Principal Investigator, Mr. Joel Lehmann from Infospective Research Ltd and the Co-investigators from the University of Nairobi, School of Pharmacy, led by Prof. Anastasia Guantai also confirmed that among the sample size, the most affected was a product used to treat high blood pressure.
For one of the products sampled, the study established that almost 38% of the samples purchased for purposes of the study had entered Kenya through an unofficial channel.
Gray products in the local market present a greater risk of deficiencies and poor efficacy due to potentially incorrect storage by middle-men, product packaging intended for other climates, and languages that are not understood in Kenya including Arabic, Turkish and German.
As part of KAPI’s consumer awareness programmes, the Association has advised local consumers to avoid buying products that do not carry English or Swahili instructions for use or which are not labeled in English and or Swahili. Buyers can also verify each official retail by SMS, using the Pharmacy Registration Code shown on the sticker, or ask for it if no sticker can be seen.
Alongside the KAPI study, The World Customs Organization (WCO) and the International Institute for Research Against Counterfeit Medicines (IRACM) recently announced plans to intensify the fight against illicit and counterfeit drugs in Africa.
The plans by the WCO and IRACM are based on the results of their fourth common initiative in the fight against fake medicines on the African continent. The 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 Africa continent.
A communiqué from the IRACM recently confirmed that plans are at an advanced stage to conduct a field surveillance exercise dubbed Operation ACIM (Action against Counterfeit and Illicit Medicines) following the success of a similar exercise last September.
Featuring 16 African customs administrations including Kenya, Operation ACIM simultaneously inspected cargo containers identified as likely to contain illicit or counterfeit pharmaceutical products posing a dangerous threat to local populations.
Some 113 million illicit and potentially dangerous medicines were seized during Operation ACIM, with a total estimated value of €52 million. Among the medicines uncovered by the African customs officials, were essential drugs such as antimalarial, anti-inflammatories, antibiotics, and analgesics, as well as gastro-intestinal medicines. 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.