NAFDAC vows to implement pharmaceutical traceability to complement war against substandard, falsified medicines in Nigeria

The National Agency for Food and Drug Administration and Control, NAFDAC has vowed to confront the menace of substandard and falsified medicines in the country with the implementation of pharmaceutical traceability strategy with a view to safeguarding the health of the Nigerian populace.

The Director General, Prof. Mojisola Adeyeye, dropped the hint at the Traceability workshop in Port Harcourt, Rivers State. The workshop organised by NAFDAC was aimed at finalizing the draft Traceability of pharmaceutical products regulations in the country.

According to Prof. Mojisola Adeyeye, in a statement by NAFDAC Resident Media Consultant, Sayo Akintola, in Lagos on Sunday, the onerous task of safeguarding the health of the nation is daunting in the face of the chaotic drug distribution system currently existing in Nigeria. 

She emphasised that the falsification and diversion of health commodities carry very serious health and economic consequences.

The NAFDAC boss said the consideration of these 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 to implement pharmaceutical traceability 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 explained that NAFDAC was committed to the implementation of pharmaceutical traceability in Nigeria as part of the regulatory strengthening and underscoring of its mandate.

According to her, NAFDAC had developed a five-year Traceability Implementation plan in line with the objectives of the Nigeria Pharmaceutical Traceability Strategy to achieve supply chain visibility and strengthen interventions against the scourge of Substandard and Falsified Medicines by the end of her second term.

Prof. Adeyeye, however, stated that the development, gazetting and dissemination of the Traceability Of Pharmaceutical Products Regulations is essential for the adoption and enforcement of the provisions of the Nigeria Pharmaceutical Traceability Strategy.

She said that the Regulation, accompanied by guidelines and compliance requirements would provide a legal framework to support advocacy for all stakeholders to implement traceability in distribution of pharmaceuticals or supply chain.

She noted that the participation of relevant stakeholders during the drafting of the Traceability Regulation is important to ensure there is understanding among stakeholders of the provisions of the Regulation, and to welcome feedback, with the goal of improving compliance.

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 September 2019. 

The Conference 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 & Trace with regards to pharmaceutical products.

With this, Prof Mojisola 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 which has been approved by the Honourable Minister of Health.

She disclosed that the traceability strategy document was the outcome of the year’ (1919/2020) work by NAFDAC in collaboration with Ministry of Health, USAID and GS1 Technologies.

The NAFDAC Traceability Office governance and current funding were subsequently supported by international partners such as USAID, World Bank, World Health Organisation; Bill and Melinda Gates Foundation, and Global Fund. All these have resulted in an enabling environment for the implementation of the track and trace of medical commodities using global standards.

Describing the gains of implementing pharmaceutical traceability as enormous, Prof Adeyeye said traceability would provide visibility of medicines from plant to patient to promote trust in the pharmaceutical sector and healthcare system.

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