The National Agency for Food and Drug Administration and Control, a Nigerian regulatory body, provided a list of authorized sources along with an expiration date for adherence. "Pharmaceutical companies and manufacturers must priorities sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products," the FDA said.  

 

The Pharmaceuticals Export Promotion Council of India sent out a communication to its members stating that while the directive for those submitting dossiers for product registration went into effect in January 2024, companies with registered finished pharmaceutical products (FPPs) that have not sourced the APIs or excipients from listed sources must comply by January 2027.

 

Nigeria is India's tenth-largest pharmaceutical export destination; $385.15 million in exports to Nigeria was up year over year (YoY). With a $2,946.02 million ($2,758.92 million) contribution, Africa accounted for almost 14% of India's pharmaceutical export earnings.

 

According to NAFDAC Director General Mojisola Christianah Adeyeye, the quality of APIs used in FPPs directly affects the pharmaceutical products' safety, efficacy, quality, supply chain, reputation, and cost-effectiveness.

 

The approved APIs encompass those that meet certain criteria, including prequalification by the World Health Organization (WHO), certification indicating compatibility with European Pharmacopoeia (CEP) monographs, sourcing from facilities certified by PIC/S participating authorities or stringent regulatory authorities (SRA) or WHO-listed authorities (WLA) and certification by accredited quality control laboratories. It has been stipulated that only product registration applications supported by FPPs or APIs obtained from authorized sources will be considered.

 

As per regulatory requirements, all excipients utilized in FPP production must adhere to pharmacopoeia standards and originate from facilities certified by ISO-9001:2015 or EXCiPACT.