From January 2024, the Nigerian Medicines Regulatory Authority will only accept and review applications for product registration if they are supported by raw materials from approved sources. (Shutterstock)
Some industry leaders attributed the stringent measures to global incidents in Gambia, Uzbekistan, Marshall Islands, Micronesia and the United States caused by counterfeit Indian-made drugs.
News18 has learned that the Nigerian drug regulator recently raised its standards for Indian drug manufacturers exporting to the country. Drug manufacturers now have to adhere to the latest specifications and use raw materials strictly following the updated guidelines.
According to the National Agency for Food and Drug Administration and Control (NAFDAC) – Nigeria’s health regulator – the quality of active pharmaceutical ingredients (APIs) used in the manufacturing of finished pharmaceutical products directly depends on “safety, efficacy, quality, regulatory compliance”. Makes an impact. Sustainability, supply chain, reputation and cost-effectiveness of pharmaceutical products”.
API or bulk drugs are raw materials used in making medicines. For example: Paracetamol is the API in crocin.
From January 2024, the Nigerian Medicines Regulatory Authority will only accept and review applications for product registration if they are supported by raw materials from approved sources. These approved sources typically include providers of APIs or finished pharmaceutical products.
NAFDAC Director General, Mojisola Christiana Adeyeye, in a letter sent to the Pharmaceuticals Export Promotion Council of India (Pharmexil), asked pharmaceutical companies to give “priority” to sourcing APIs from “reputed suppliers” while adhering to stringent quality control measures. Has gone. To ensure the highest standards in our products”.
Pharmexil is a branch of the Ministry of Commerce and Industry tasked with overseeing and promoting pharma exports.
Result of past mistakes, new rules may affect exports
According to industry experts, the stringent rules could have a negative impact on Indian exports.
“The Nigerian FDA (NAFDAC) mandates the use of APIs obtained from qualified or designated manufacturing facilities. This is a very stringent requirement aimed at availability of quality medicines in the local market but is likely to have an adverse impact on Indian exports. Nigeria is one of our top 10 exporting countries and its position fluctuates between fifth and sixth in the top 10,” said Dr PV Appaji, former Director General of Pharmexil.
Another industry veteran, who declined to be quoted, attributed the global incidents in Gambia, Uzbekistan, Marshall Islands, Micronesia and the United States to fake India-made drugs.
“These incidents have created a lack of trust and such demands from importing countries are a side effect of those incidents,” he said.
Strict requirements for drug manufacturers
NAFDAC has informed Pharmexil that all stakeholders who wish to submit dossiers for product registration in Nigeria from January 2024 must be supported by documents showing the sources of APIs and other products.
It provides five options listing accepted sources that will be accepted for review.
This includes WHO-prequalified APIs, APIs with certificates of suitability for monographs of the European Pharmacopoeia, products obtained from facilities certified by PIC/S participating authorities and facilities certified by Stringent Regulatory Authorities (SRAs) or WHO Listed Authorities (WLAs). Contains products obtained from. ,
It also contains APIs certified by accredited quality control laboratories.
The agency also asks that “all excipients used to manufacture finished pharmaceutical products must be of pharmacopoeia grade, and from an ISO or Exipact-certified facility.”
“This directive comes into effect with immediate effect. Please note that failure to comply will attract very stringent penalties,” the notice said.
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