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Pharmacists are protesting formation of a new agency to regulate drugs, which may in turn scrap off the existing Pharmacies and Poisons Board (PPB).
Pharmaceutical Society of Kenya (PSK) has expressed fears the new agency - Kenya Food and Drug Authority (KFDA) - will not cater for the needs of the market and does not have the interest of health professionals at heart.
Instead, the pharmacists want PPB's mandate to be expanded and strengthened, rather than lumping both food and medicines under one regulator.
The idea to have KFDA, copied from US’ FDA, was reached in October 2014 by East African ministers and donors during a meeting in Arusha, Tanzania.
All East African Community countries were supposed to create similar authorities, which will make it easier for pharmaceutical companies to set up manufacturing businesses locally.
The KFDA Bill is under discussion between the Ministries of Agriculture and Health.
The bill will be tabled in the National Assembly in February after Parliament resumes from recess.
“Our current regulators in both food and pharmaceuticals are fully operational and the point of reforming the regulatory system is to improve it,” said Dr Louis Machogu, PSK president.
Machogu said creation of another agency as proposed in the bill will bring confusion in the sector as the two areas, food and drugs, should be handled separately.
He said so far no one has reached out to them to have their input in the bill which is under consultation between the Ministry of Health and that of Agriculture.
Machogu said the urgency to create a new regulator is not only misplaced but also a waste of resources.
He said other countries, including the US, are moving away from Food and Drug Authorities, as they have already seen the confusion such agencies bring.
“We are concerned to see the creation of a new regulator rather than an upgrade in the scope and methodology of the existing and functioning of the PPB. The urgent action was to align PPB’s remit with the Health Act and the needs of Universal Health Care (UHC),” said Machogu at a press briefing on Thursday.
FDA in June 2018 disbanded its advisory committee which was key in issuing guidance on food and drug safety.
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