NAIROBI, Kenya, Jul 6 – Pharmaceutical Industry Association has confirmed the existence of unregulated medicine 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 percent prevalence of unregulated or gray medicinal brands.
According to the study the sample size, the most affected was a product used to treat high blood pressure.
Majority of these products were found in Nairobi and Nakuru, and some of them in Mombasa and Kisumu.
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 percent of the target medicines from the study results 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.
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.