The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) has said that Nigeria can achieve self-sufficiency in medicine manufacturing with the right policies in place.
In a statement released in Abuja on Wednesday, she emphasized the potential of creating an enabling business and regulatory environment to meet global standards for quality and safe medicines.
The right policies
- Since assuming office in late 2017, the top management of NAFDAC has implemented policies aimed at enhancing the capacity of local drug manufacturers to meet global Good Manufacturing Practice (GMP) standards.
- Collaborations with regulatory institutions and the nationwide GMP roadmap, supported by technical partners UNIDO and USAID, have played a crucial role in this effort.
- The newly launched policies, such as the 5+5 Regulatory Directives and the expansion of NAFDAC’s ceiling list, are geared towards improving local drug manufacturing in line with global best practices.
- The focus is on boosting the competitiveness of the Nigerian Pharma Industry globally and achieving self-sufficiency in the production of essential medicines.
- The impact of the COVID-19 pandemic on Nigeria’s pharmaceutical sector is acknowledged, especially concerning the refusal of exporting nations to open borders for the global trade of Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs).
- This challenge led to a national shortage in drug supply due to the country’s dependence on imports.
- The formulated policies, including the 5+5 policy, expansion of NAFDAC’s ceiling list, and new policies on the establishment of Pharmaceutical Plants in Nigeria, aim to stimulate local production of medicines.
- These policies are designed to address drug shortages and shift the narrative towards favoring the local production of FPPs.
NAFDAC’s Director-General highlighted positive outcomes, revealing that over 20 newly registered local drug manufacturers have invested over two billion dollars in WHO-compliant facilities.
This represents a 12% increase in the number of active local manufacturers. Additionally, 143 applications have been received for regulatory review and approval of new pharmaceutical layouts for local manufacturing.
The director-general stressed the surge in local manufacturing and NAFDAC policies, emphasizing the heightened interest in the domestic manufacture of Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients.
Local manufacturers, such as Emzor Pharmaceuticals Industries Limited, are making strides towards commencing the commercial manufacture of antimalarial APIs through collaboration with NAFDAC and WHO prequalified API manufacturers.
The director-general highlighted achievements such as Swiss Pharma Nigeria Limited’s pediatric formulation receiving WHO prequalification and expressed optimism about Nigeria’s increasing domestication of local manufacturing.
