East African Community partner states have embarked on harmonisation of medicines regulatory requirements in a drive to check importation, manufacturing and circulation of fake and substandard drugs in the region.
Drug regulatory authorities from the five partner states - Uganda, Kenya, Rwanda, Tanzania and Burundi are now working on key concepts for harmonising medicines - importation and manufacturing standards and systems. Already some drug experts, officials, including inspectors, from the bloc’s drug regulatory authorities and other private players in the sector -- have started training on the best and standard medicines.
“In fact, we want to expose all key players -- drug inspectors, experts, importers, manufacturers, to internationally accepted medicine standards and systems related to importation, manufacturing and supply of drugs,” said Hiiti Sillo, Director General of the Tanzania Food and Drug Authority (TFDA) at a sensitisation workshop on regulatory requirements for pharmaceutical manufactures, importers and wholesalers.
Sillo said training, among other things, seeks to set the pace for harmonisation of medical regulatory systems, a move which he believed would help to check quality and standards of medical products manufactured, imported and circulated in the region.
According to the TFDA chief, harmonisation of regulatory requirements is part of the regional initiative which seeks to improve the quality of locally produced and imported drugs.
“It is also used as a weapon in the regional crusade against substandard medical products, which are threatening lives of people in Tanzania and across the region,” said Sillo.
Deo Kimea, Country Director of Supply Chain Management System), which plays instrumental role in supporting EAC partners in quality control initiatives, said harmonisation of regulatory requirements could serve as “a fake and substandard drugs” preventive measure in the region.
Yesterday’s training was facilitated by experts from the World Health Organization (WHO) and other international bodies, with Kimea describing it as “an important step in the regional efforts to combat circulation of substandard drugs and enhance quality of locally-manufactured and imported drugs.”
“Global experts in drug standards and quality are here. I believe that they would give our regional drug stakeholders the required skills and knowledge on quality assurance, drug inspection, manufacturing, importation and supply of drugs in the region.”
Last year, The World Health Organization (WHO) cautioned three EAC States-Tanzania, Kenya and Uganda against the importation of counterfeit human medicines as they may result in deaths.
Local media quoted WHO Representative Dr Ritha Njau as saying at a forum that counterfeit drugs often contributed to deaths. “These countries should come up with a proper system of drug importation and educate their people on the use of medicines only prescribed by their doctors,” she said.