Reports revealed that the Nigerian pharmaceutical regulatory authority has recently intensified its requirements for Indian drug manufacturers shipping their products to Nigeria. As per the latest guidelines, drug manufacturers must now comply with the most recent specifications and strictly utilize raw materials in accordance with the updated protocols. The Nigerian health regulator, National Agency for Food and Drug Administration and Control (NAFDAC) emphasizes the critical role of Active Pharmaceutical Ingredients (APIs) quality in the manufacturing of pharmaceutical products. It directly influences various aspects such as safety, effectiveness, regulatory compliance, quality consistency, supply chain efficiency, reputation, and cost-effectiveness of these products.
Medicine production heavily relies on APIs or bulk drugs, which serve as the fundamental components. Crocin, an example of this, contains Paracetamol as its active pharmaceutical ingredient. By January 2024, the Nigerian drug regulatory authority will restrict product registration evaluation solely to applications backed by raw materials obtained from authorized sources. Precisely, these authorized sources include suppliers of APIs or finalized pharmaceutical products. Mojisola Christianah Adeyeye, the Director General of NAFDAC, recently penned a letter to the Pharmaceuticals Export Promotion Council of India (Pharmexcil). In this correspondence, she stated that pharmaceutical companies should prioritize sourcing APIs from reliable suppliers and maintaining strict quality control measures to uphold exemplary standards in their products.
Implementing new regulations could affect export activities.
Pharmexcil, a division of the Ministry of Commerce and Industry, has been entrusted with the duty of supervising and enhancing pharmaceutical exports. However, due to previous shortcomings, the implementation of new regulations could have adverse effects on export activities. Experts within the industry anticipate that these strict rules might have a negative impact on Indian exports. NAFDAC obligates the utilization of API obtained exclusively from authorized or prescribed manufacturing facilities. This stringent mandate seeks to ensure the presence of reliable medications in the domestic market, yet it may have a detrimental impact on Indian exports.
Dr. Appaji PV, former director general of Pharmexcil, disclosed that Nigeria ranks within the top 10 countries they export to, with its position shifting between fifth and sixth place. An anonymous industry expert said the shift is believed to be influenced by external factors such as global incidents occurring in The Gambia, Uzbekistan, Marshall Islands, Micronesia, and the United States. These events were triggered by the circulation of counterfeit drugs manufactured in India. He said that a lack of trust has emerged due to these occurrences, and the requests made by importing countries are a consequence resulting from these incidents.
Inclusion of certified APIs has been mandated by NAFDAC.
NAFDAC has notified Pharmexcil that from January 2024 onwards, any parties interested in submitting dossiers for product registration in Nigeria must provide supporting documentation detailing the origins of both APIs and various other products. There are precisely five choices offered, encompassing the endorsed sources that shall be considered for assessment. These comprise WHO-prequalified APIs, APIs possessing certificates validating their suitability to the monographs of the European Pharmacopoeia, products procured from facilities certified by PIC/S participating authorities, and products procured from facilities certified by either Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA).
According to the notice, the inclusion of APIs certified by accredited quality control labs has been mandated by the agency. Moreover, they have requested that all excipients utilized in the production of pharmaceutical products must meet the standards of pharmacopeia grade and originate from an ISO or EXCiPACT certified facility. It is important to highlight that immediate adherence to this directive is required, as severe penalties will be imposed for non-compliance. Remember that in May 2022, the NAFDAC issued a notice to the Pharmexcil concerning the questionable ethical conduct and unprofessional approach of Indian manufacturers in their product packaging and prescription drug formulation.
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It was reported in the notice that there is a widespread occurrence of malpractice activities, whereby numerous prescription drugs made in India and approved in Nigeria are being exported with unacceptable pictorial and alterations in their composition. There was also an additional observation regarding the adoption of unethical methods happening with the cooperation of Nigerian importers. This has resulted in a scenario where manufacturers, exporters, and importers collaborate to modify the authorized formulation, color, and packaging design of prescription drugs, aimed to enhance the visual attractiveness of the medicines for patients.