Nigeria mandates sourcing APIs for domestic pharmaceuticals from approved suppliers, ensuring adherence to stringent quality standards. Companies must comply by January 2027 or face regulatory action.

Nigeria: Nigeria, a significant market for Indian pharmaceutical exports, has announced stringent regulations regarding the procurement of active pharmaceutical ingredients (APIs) for finished products sold within its borders. According to the new measures, the sourcing of APIs from approved sources is now mandatory for pharmaceutical products marketed domestically.

The approved list of APIs includes those that have been prequalified by the World Health Organization (WHO), possess certificates of suitability to the monographs of the European Pharmacopoeia (CEP), originate from facilities certified by stringent regulatory authorities (SRA) or WHO-listed authorities (WLA), are certified by accredited quality control laboratories, and are sourced from facilities certified by PIC/S participating authorities. Consequently, only applications for product registrations supported by APIs or finished pharmaceutical products (FPPs) from approved sources will be accepted.

Furthermore, all excipients utilized in the manufacturing of FPPs must meet pharmacopoeia grade standards and must originate from facilities certified under ISO-9001:2015 or the EXCiPACT certification.

Pharmaceutical companies and manufacturers are urged to prioritize sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products. Those with registered FPPs that have not sourced their APIs or excipients from approved sources are required to provide evidence of a change of source to a compliant manufacturer by January 2027. This evidence must be submitted to the regulatory agency as a variation or post-approval change before the deadline.

Nigerian regulator National Agency for Food and Drug Administration and Control said, “Pharmaceutical companies and manufacturers must prioritise sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products.”

Pharmexcil Director General Ravi Uday Bhaskar said, “the new Nigerian regulation is bound to have implications for exporters not complying with the requirement.”

NAFDAC Director General Mojisola Christianah Adeyeye said, “The quality of APIs used in FPPs directly impacts safety, efficacy, quality, regulatory compliance, consistency, supply chain, reputation and cost-effectiveness of pharmaceutical products.”

According to TechSci Research, the implementation of stringent regulations regarding the sourcing of active pharmaceutical ingredients (APIs) in Nigeria is poised to significantly impact the growth trajectory of the healthcare market in several ways.

By mandating the procurement of APIs from approved sources, the Nigerian government is prioritizing the quality and safety of pharmaceutical products available in the domestic market. This move instills greater confidence among consumers regarding the efficacy and reliability of medications, which is essential for fostering trust in the healthcare system. As a result, the increased assurance in product quality is likely to drive up demand for pharmaceuticals, leading to market growth.

Moreover, the requirement for APIs to originate from reputable suppliers and adhere to stringent quality control measures ensures that healthcare providers have access to medications that meet international standards. This not only enhances patient outcomes by reducing the risk of counterfeit or substandard drugs but also strengthens Nigeria's position as a reliable player in the global pharmaceutical market. As the country continues to align its regulations with international best practices, it becomes more attractive to foreign investors and partners, potentially stimulating further growth and collaboration within the healthcare sector.

Furthermore, the deadline imposed for companies to comply with the new regulations by January 2027 serves as a catalyst for industry players to expedite their efforts in sourcing APIs from approved sources. This may lead to increased investments in manufacturing facilities and supply chain infrastructure to meet the regulatory requirements. Consequently, the growth of ancillary industries supporting pharmaceutical production, such as logistics and packaging, is also anticipated.

However, it is crucial to acknowledge that while these regulations are beneficial for enhancing product quality and safety, they may also pose initial challenges for some companies, particularly smaller manufacturers or those with existing supply chain dependencies. Such entities may face hurdles in sourcing APIs from approved suppliers or upgrading their facilities to meet certification standards. Nevertheless, with proactive measures and support from regulatory authorities, these challenges can be overcome, ultimately contributing to the long-term growth and sustainability of the healthcare market in Nigeria.