Kenya to set up new medicine and food safety regulatory body

Internal production of medicine will significantly reduce volumes of counterfeit and substandard medication on local shelves. PHOTO | FILE

Kenya will form a new regulator to control foods and medicine business as part of regional efforts to curb counterfeits and boost pharmaceutical manufacturing.

Under a deal reached between donors and East African ministers on Friday, the new body will be established to replace the Kenya Pharmacies and Poisons Board and will also license food products.

“The ministers urge Republic of Kenya to enact a law for the establishment of Kenya Food and Drug Authority (KFDA),” reads part of a communiqué issued after the Friday meeting.

KFDA is expected to tighten entry rules of food and medicinal products amid reports that up to 30 per cent of drugs in circulation are counterfeit.
The agency is also expected to craft a legal framework that will encourage local firms to enter the pharmaceutical business.

Sources privy to the Arusha deal said the ministers are of the view that internal production of medicine will significantly reduce volumes of counterfeit and substandard medication on the shelves.

“Just like in developed nations which have low volumes of counterfeits, the ministers believe boosting internal capacity to manufacture drugs will significantly reduce counterfeits, which get into the region through the porous borders,” a health of official who requested anonymity told the Business Daily on Monday.

The ministers also committed to boost pharmaco-vigilance (drug safety) and post-market surveillance, to harmonise regulatory regimes and strengthen regulation of medical devices and diagnostics.

Uganda, Rwanda and Burundi are also expected to set up similar national food and drug agencies to be at par with Tanzania’s Food and Drug Authority as a precursor to the East African Community Medicines and Food Safety Commission.

The Friday meeting was organised by the EAC Secretariat in partnership with World Health Organisation, Nepad Agency and the African Medicines Regulatory Harmonisation.

The region’s ministers in charge of Health, Finance and EAC Affairs as well as heads of national medicines regulatory agencies and members of East African Legislative Assembly attended the meeting held in Arusha.

The EAC Secretariat undertook to coordinate establishment of policy, legal, institutional and capacity building initiatives to strengthen medicines regulation in the region.

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