Nigeria tightens API sourcing norms for finished pharma products

February 16, 2024 06:30 am | Updated 06:30 am IST - Hyberabad

West African nation Nigeria, which has emerged as an important market for Indian pharma exports, has made procurement of active pharmaceutical ingredients from approved sources mandatory for finished pharmaceutical products sold in its domestic market.

“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,” Nigerian regulator National Agency for Food and Drug Administration and Control said, listing the approved sources and setting timeline for compliance.

While January 2024 was when the directive came into force for those submitting dossiers for product registration, companies with registered finished pharmaceutical products (FPPs) who have not sourced the APIs or excipients from listed sources are required to comply by January 2027, it said in a communication that Pharmaceuticals Export Promotion Council of India has circulated to its members.

Nigeria is 10th largest pharma export destination for India. Pharma exports to Nigeria increased 2.65% from $573.17 million in 2020-21 to $588.34 million in 2021-22. In 2022-23, it declined 12.30% to $515.96 million or 2.03% of the total pharma exports from India, Pharmexcil data shows.

For nine months ended December this fiscal, exports to Nigeria were 1.82% higher year on year (YoY) at $385.15 million. At $2,946.02 million ($2,758.92 million), Africa contributed to more than 14% of the India’s pharmaceutical exports.

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

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

The list of approved APIs comprise those prequalified by WHO; with certificates of suitability to the monographs of the European Pharmacopoeia (CEP); from facilities certified by stringent regulatory authorities (SRA) or WHO listed authorities (WLA); certified by accredited quality control laboratories; and APIs and FPPs sourced from facilities certified by PIC/S participating authorities. It has been decided to accept only those applications for product registrations that are supported by APIs or FPPs sourced from approved sources.

All excipients to be used in the manufacture of FPPs must be of pharmacopoeia grade and must be from an ISO-9001:2015 or EXCiPACT-certified facility, the regulator said.

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