NAFDAC trains stakeholders in pharmaceutical ingredient production

The National Agency for Food and Drug Administration and Control has trained stakeholders in comprehensive knowledge and practical skills on various aspects governing active pharmaceutical ingredient manufacturing.

APIs are the essential components of pharmaceutical products responsible for the intended therapeutic effect.

The training, held in Ikeja was titled, ‘Unlocking the Healthcare Value Chain: second Regional Workshop on Manufacturing Active Pharmaceutical Ingredients and Excipients in Nigeria.’

NAFDAC in the two-day program which ended on Tuesday said it recognised the need to encourage, build capacity and strengthen the regulators and local manufacturers with all that’s required to explore this critical area in the healthcare system, thereby improving access to safe, effective, and affordable medicines.

Speaking at the event, NAFDAC Director General, Prof. Mojisola Adeyeye, said the executive order issued two weeks ago was a significant step forward, adding that it would facilitate easier importation of manufacturing goods by reducing customs duties and other fees, substituting one challenge for another.

She said, “This workshop is essential for preparing us before we start manufacturing. If we lack the capacity and understanding of what we’re working with, it’s only a matter of time before we fail. We are committed to building quality from the beginning, which involves capacitating regulators, manufacturers, and the future workforce. It’s about being mentally and intellectually prepared before we start manufacturing.

“Failure is not an option because NAFDAC is fully dedicated, with the support of partners like WHO, the Gates Foundation, USAID, and USP. We cannot do it alone, so we also rely on resourceful colleagues who have joined us from the US and other countries. This collaboration is crucial for building a solid foundation, not just for immediate success but for long-term sustainability.”

She revealed that Emzor was building up a facility for antimalarials, and a consortium led by FIDSON, including about five or six manufacturers, focusing on analgesics, antibiotics, and some cardiovascular medicines.

The lawmaker representing Idemili North and South Federal Constituency and Deputy Chairman of the House of Representatives Committee on Food and Drug Administration and Control, Mr Uchenna Okonkwo, said, “As legislators, we can enact laws to facilitate manufacturing in Nigeria. For example, the executive arm has already helped by allowing no VAT and no levies on the importation of active ingredients for pharmaceutical manufacturing. Our role is to ensure that these ingredients and laws passed by the executive translate into better productivity, efficiency, and efficacy in the pharmaceutical and food manufacturing industries.”

A representative from the United States Pharmacopeia, Dr Jude Nwokike, revealed “We are here as part of the Promoting the Quality of Medicine Plus program, funded by the United States Agency for International Development. Our work, as staff of the United States Pharmacopeia, involves setting standards for medical products and active ingredients. These standards guide regulators and the industry to ensure that medical products are of the highest quality.”

WHO representative in Nigeria, Dr Walter Mulombo, mentioned that WHO participation aims to gather the necessary information to better support NAFDAC in achieving its goals.

He added that the workshop focused on developing guidelines and training relevant stakeholders, in collaboration with key partners such as the USP, the US Government, the Bill & Melinda Gates Foundation, and most importantly, the manufacturers themselves.

Mulombo said, “Currently, Nigeria, like many African countries, depends heavily on imported APIs, with over 90 per cent being sourced from abroad. We need to rethink our approach to health products for our continent and developing nations. This workshop is a significant step towards enabling Nigeria to start producing APIs locally.

“It’s important to highlight that local manufacturing does not equate to low quality. The WHO works closely with the Nigerian government, supporting them at the policy and regulation levels.”