The National Agency for Food and Drug Administration and Control (NAFDAC) will intensify the fight against substandard and falsified medicines in the country with the implementation of a pharmaceutical traceability strategy to safeguard the health of the Nigerian populace.
The Director-General, Mojisola Adeyeye, stated this at a workshop in Portharcourt, organised by the agency while finalising the draft traceability of pharmaceutical products regulations.
This is contained in a statement signed by the NAFDAC spokesperson, Mr. Olusayo Akintola in Abuja.
Adeyeye said:” the task of safeguarding the health of the nation is daunting in the face of the chaotic drug distribution system currently existing in Nigeria”.
She said that the falsification and diversion of health commodities caused serious health and economic consequences.
“The consequences vis-à-vis the mandate of the agency to regulate and control among other things, the distribution of drugs and other regulated products is sufficient motivation for the implementation of pharmaceutical traceability,” she said.
The director-general said there is need to complement the fight against the menace of substandard and falsified medicines and improve the regulatory control of the medicines supply chain in Nigeria.
She said that NAFDAC was committed to the full implementation of pharmaceutical traceability in Nigeria as part of regulatory strengthening and underscoring its mandate.
Adeyeye also said that NAFDAC has developed a five-Year traceability implementation plan in line with the objectives of the Nigeria pharmaceutical traceability strategy.
She said the idea is aimed at achieving supply chain visibility and strengthening interventions against substandard and falsified medicines by the end of her second term.
”Gazetting and dissemination of the traceability of pharmaceutical products and regulations is essential for the adoption and enforcement of the provisions of the Nigeria pharmaceutical traceability strategy.
”Also, regulation, accompanied by guidelines and compliance requirements will provide a legal framework to support advocacy for all stakeholders to implement traceability in distribution of pharmaceuticals or supply chain.
”The participation of relevant stakeholders during the drafting of the traceability regulation is important to ensure there is understanding among stakeholders,” she said.
She said that a major achievement in the direction of reducing the incidence of substandard and falsified medicines in the country was the hosting of the second Africa GSI traceability conference on healthcare in Lagos in Sept. 2019.
The conference, she said, attracted medicines regulatory agencies from about twenty-five countries in Africa, as well as other stakeholder partners from the Americas and Europe.
“The agency is already on a five-year roadmap to establishing a culture of track and trace with regards to pharmaceutical products,” she said.
Adeyeye said that medicines and medical devices can be monitored throughout the supply chain from manufacturing to the end user, the patient, adding that the agency has developed a roadmap to this effect.
She stated that the roadmap has been approved by the Minister of Health, adding that, the traceability strategy document was the outcome of the year’ (1919/2020) work by NAFDAC.
She said that the traceability document work was done in collaboration with the Ministry of Health, USAID and GS1 Technologies.
Adeyeye said that NAFDAC traceability office is being supported by international partners such as USAID, World Bank, World Health Organisation; Bill and Melinda Gates Foundation, and Global Fund.
Describing the gains of implementing pharmaceutical traceability as enormous, Adeyeye said traceability would provide visibility of medicines from plant to patient to promote trust in the pharmaceutical sector and healthcare system.