The Nigerian drug regulator has recently heightened its standards for Indian drug makers exporting to the country, News18 has learnt. Drug makers are now required to adhere to the latest specifications and strictly use raw materials following the updated guidelines.
According to the National Agency for Food and Drug Administration and Control (NAFDAC) — the health regulator of Nigeria — the quality of Active Pharmaceutical Ingredients (APIs) used in finished pharmaceutical products manufacturing directly impacts the “safety, efficacy, quality, regulatory compliance, consistency, supply chain, reputation, and cost-effectiveness of pharmaceutical products”.
APIs or bulk drugs are raw materials used in making medicines. For instance: Paracetamol is the API in Crocin.
Starting January 2024, the Nigerian drug regulatory authority will only accept and review applications for product registration if they are supported by raw materials from approved sources. These approved sources specifically include providers of APIs or finished pharmaceutical products.
In a letter written by the director general of NAFDAC, Mojisola Christianah Adeyeye, sent to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), pharmaceutical companies have been asked to “prioritise” sourcing APIs from “reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products”.
Pharmexcil is an arm of the Ministry of Commerce and Industry which is mandated to oversee and boost pharma exports.
Fallout of previous lapses, new rules may impact exports
According to industry experts, the stringent rules may impact Indian exports negatively.
“Nigerian FDA (NAFDAC) mandates the use of API sourced from qualified or stipulated manufacturing facilities. It is a very rigid requirement aimed at the availability of quality medicines in the local market but likely to adversely affect Indian exports. Nigeria is among our top 10 exporting countries and its place keeps fluctuating between fifth and sixth of the top 10,” said Dr PV Appaji, former director general, Pharmexcil.
Another industry veteran, who refused to be quoted, blamed the global incidents in The Gambia, Uzbekistan, Marshall Islands, Micronesia and the United States caused due to spurious made-in-India drugs.
“These incidents have created a trust deficit and such demands for importing countries are the side-effect of those incidents,” he said.
Stringent requirements for drugmakers
NAFDAC has informed Pharmexcil that all stakeholders who intend to submit dossiers for product registration in Nigeria, starting from January 2024, must be supported by documents showing the sources of APIs and other products.
It has given five options listing the approved sources that will be accepted for review.
It includes WHO-prequalified APIs, APIs with certificates of suitability to the monographs of the European Pharmacopoeia, products sourced from facilities certified by PIC/S participating authorities and products sourced from facilities certified by Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA).
It also includes APIs certified by accredited quality control laboratories.
The agency has also asked that “all excipients to be used to manufacture finished pharmaceutical products must be of pharmacopoeia grade, and must be from an ISO or EXCiPACT-certified facility.”
“This directive takes immediate effect. Please note that failure to comply will attract very stiff penalties,” said the notice.
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