NAFDAC woos global partners as local gap stalls WHO Level 4 ambition

Stakeholders in Nigeria’s pharmaceutical and consumer protection sectors have called for stronger border controls, tighter regulation of the drug supply chain and increased consumer education to curb the circulation of fake and substandard drugs and other products in the country.

Speaking on a national TV programme over the weekend, the stakeholders said weak border surveillance, illicit supply chains and weak enforcement remained the key challenges undermining efforts to keep counterfeit and unsafe products out of the Nigerian market.

The Chairman of the Pharmaceutical Wholesalers and Distributors Association of Nigeria (PWDAN), Ogheneochuko Omaruaye, said one of the immediate steps the government must take, as part of efforts to prevent fake drugs from entering the country, is to fully implement the National Drug Distribution Guideline approved in 2012.

He explained that the guideline was designed to establish a defined route for the movement of medicines and other healthcare products from manufacturers and importers through wholesalers and distributors to pharmacies and hospitals.

He further said implementing the guideline would also help the government to distinguish between the legitimate pharmaceutical supply chain and the parallel networks through which illegal products are distributed.

Meanwhile, Nigeria’s effort to strengthen local pharmaceutical manufacturing is facing a major test in vaccine production, with the country yet to develop the capacity needed to complete the regulatory requirements for vaccine lot release.

The gap has implications for the country’s ambition to attain World Health Organisation (WHO) Maturity Level 4 for vaccine regulation, the highest maturity level in the WHO Global Benchmarking Tool for national regulatory systems.

While the National Agency for Food and Drug Administration and Control (NAFDAC) has met eight of the nine functions and requirements for medicines and vaccines, the release of vaccine lots remains outstanding.

The situation has consequently placed greater emphasis on establishing fill-and-finish modular vaccine manufacturing facilities in Nigeria, while also raising the need for stronger investment and support for local pharmaceutical production.

NAFDAC Director General, Prof. Mojisola Adeyeye, during the eighth Nigeria Pharma Manufacturers’ Expo in Lagos, called on international partners that have supported the agency’s regulatory development to contribute to the establishment of the facilities.

She acknowledged the continued support of international partners in the agency’s journey towards attaining Maturity Level 3 and appealed to them to extend their contribution to vaccine manufacturing.

Adeyeye said the estimated cost of meeting the requirement had been calculated and would not be prohibitive, adding that NAFDAC would share the details with the relevant partners.

She recalled that NAFDAC used to manufacture vaccines, stressing that it was time for Nigeria to return to vaccine manufacturing.