West African nation Nigeria, which has emerged as an vital market for Indian pharma exports, has made procurement of energetic pharmaceutical components from permitted sources obligatory for finished pharmaceutical products bought in its home 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 stated, itemizing the permitted sources and setting timeline for compliance.
While January 2024 was when the directive got here into pressure for these submitting dossiers for product registration, firms with registered finished pharmaceutical products (FPPs) who haven’t sourced the APIs or excipients from listed sources are required to conform by January 2027, it stated in a communication that Pharmaceuticals Export Promotion Council of India has circulated to its members.
Nigeria is tenth largest pharma export vacation spot for India. Pharma exports to Nigeria elevated 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 full pharma exports from India, Pharmexcil knowledge exhibits.
For 9 months ended December this fiscal, exports to Nigeria had been 1.82% larger 12 months on 12 months (YoY) at $385.15 million. At $2,946.02 million ($2,758.92 million), Africa contributed to greater than 14% of the India’s pharmaceutical exports.
Pharmexcil Director General Ravi Uday Bhaskar stated the brand new Nigerian regulation is certain to have implications for exporters not complying with the requirement.
The high quality of APIs utilized in FPPs straight impacts security, efficacy, high quality, regulatory compliance, consistency, provide chain, repute and cost-effectiveness of pharmaceutical products, NAFDAC Director General Mojisola Christianah Adeyeye stated within the communication.
The listing of permitted APIs comprise these prequalified by WHO; with certificates of suitability to the monographs of the European Pharmacopoeia (CEP); from services licensed by stringent regulatory authorities (SRA) or WHO listed authorities (WLA); licensed by accredited high quality management laboratories; and APIs and FPPs sourced from services licensed by PIC/S collaborating authorities. It has been determined to just accept solely these functions for product registrations which are supported by APIs or FPPs sourced from permitted sources.
All excipients for use within the manufacture of FPPs have to be of pharmacopoeia grade and have to be from an ISO-9001:2015 or EXCiPACT-certified facility, the regulator stated.
