In a recent development, Nigeria has intensified its regulations concerning Indian pharmaceutical exports, introducing new standards that may raise concerns within the industry. The Nigerian drug regulator, the National Agency for Food and Drug Administration and Control (NAFDAC), has mandated that drug manufacturers comply with updated guidelines, emphasizing the use of raw materials and adherence to the latest specifications.
NAFDAC underscores the critical role of Active Pharmaceutical Ingredients (APIs) in the manufacturing of finished pharmaceutical products. The quality of APIs significantly impacts the safety, efficacy, and overall quality of pharmaceutical products. APIs, also known as bulk drugs, serve as the raw materials for medicines, such as Paracetamol being the API in Crocin.
Effective from January 2024, the Nigerian drug regulatory authority will only consider and review applications for product registration if they are supported by raw materials from approved sources. These approved sources specifically pertain to providers of APIs or finished pharmaceutical products.
In a communication addressed to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), NAFDAC’s director general, Mojisola Christianah Adeyeye, highlighted the need for pharmaceutical companies to prioritize sourcing APIs from reputable suppliers. The directive also emphasizes stringent quality control measures to ensure the highest standards in the manufactured products.
Pharmexcil, an entity under the Ministry of Commerce and Industry, is tasked with overseeing and promoting pharmaceutical exports.
Industry experts anticipate potential negative impacts on Indian exports due to these stringent regulations. The Nigerian FDA (NAFDAC) now requires the use of APIs sourced exclusively from qualified or stipulated manufacturing facilities. While this requirement aims to ensure the availability of quality medicines in the local market, it is likely to adversely affect Indian exports. Nigeria consistently ranks among the top 10 exporting countries for India, with its position fluctuating between the fifth and sixth spots in the top 10.
Dr. PV Appaji, former director general of Pharmexcil, acknowledges the rigidity of the Nigerian FDA’s mandate, emphasizing its focus on securing quality medicines locally. However, he also notes the potential adverse effects on Indian exports, given Nigeria’s significant standing as one of the top destinations for pharmaceutical exports from India. The outcome of previous regulatory lapses and the introduction of these new rules may indeed pose challenges for the Indian pharmaceutical industry in its export endeavors to Nigeria.