The regulatory agency said the approved applications, which were selected from a total of 143, meet the Good Manufacturing Practice (GMP) guidelines of the World Health Organisation (WHO) and NAFDAC GMP for Medicinal Products Regulations 2021.
According to the Director General of NAFDAC, Mojisola Adeyeye, 35 per cent of the approved applications have completed construction and are at different stages in the registration stream as prescribed by extant NAFDAC’s guidelines on the establishment of pharmaceutical plants in Nigeria.
The agency also revealed that over 20 newly registered local drug manufacturers have cumulatively invested over $2 billion in the erection and completion of WHO-compliant facilities that manufacture quality pharmaceuticals and essential medicines for Nigerians.
This figure, according to NAFDAC, represents an increase of 12 per cent in the number of active local manufacturers.
Sequel to its over-dependence and reliance on importation, Nigeria is currently battling a national shortage in drug supply as multinational pharmaceutical companies, like GlaxoSmithKline (GSK) and Sanofi, exit the country.
But Mrs Adeyeye said though the local manufacturing companies are not replacement for the global giant drugmakers exiting the country, they are signs of progress for Nigeria.
More development
NAFDAC also announced that Emzor Pharmaceuticals Industries Limited is commencing the commercial manufacturing of four antimalarial Active Pharmaceutical Ingredients (APIs) following technical collaboration with NAFDAC and Indian-based WHO prequalified API manufacturers partners- Mangalam Drugs and Organics Limited.
It added that another cohort of six local manufacturers has concluded plans to initiate the local manufacture of different classes of widely used APIs and pharmaceutical excipients.
The agency added that it is preparing regulatory officers, manufacturers, and students with their professors in capacity building through an international workshop on Local Manufacturing of Active Pharmaceutical Ingredients and Excipients, developed by NAFDAC.
“The first workshop took place in October 2023, and it attracted experts in the subject matter from China, USA, UK and Nigeria,” Mrs Adeyeye noted.
“Without high technical competence in manufacturing of these raw materials, the domestication may be challenged. A second workshop is being planned for the second quarter of 2024.”
Strengthening local manufacturing
NAFDAC also revealed that Swiss Pharma Nigeria Limited, one of Nigeria’s local manufacturers, recently had its pediatric formulation pre-qualified by the WHO following a stringent evaluation of its manufacturing and quality control processes.
While several other products manufactured by the company are awaiting WHO prequalification, it noted that other local drug producers and manufacturers of medical devices have also expressed interest in attaining global recognition and acceptability.
“All these are in addition to initiation of patronage of our local manufacturers by UN Agencies (notably UNICEF) and contract manufacturing of quality pharmaceuticals for multinationals such as GSK, Sanofi, Merck, Bayer etc. by a handful of our local manufacturers,” she noted.
The NAFDAC boss added that the agency’s attainment of maturity three (ML3) status, the WHO prequalification of the Central Drug Control Laboratory in Yaba, Lagos, and other interventions “all point to the fact that a lot is being done to achieve a stable and well-regulated environment for the manufacturing of essential medicines in Nigeria.”
NAFDAC said “with the right policies, enabling business and regulatory environment, our country can attain self-sufficiency in the manufacture of medicines that meet requirements of quality, safety, and efficacy regardless of our current but transient economic travails.”
Exit of multinationals
In August 2023, GlaxoSmithKline (GSK) Consumer Nigeria Plc, the second-biggest drug producer in Nigeria, ceased operation in the country by terminating its marketing and distribution agreement and appointed third-party distributors to sell their medications and vaccines.
GSK is the producer of vaccines such as Ambirix for hepatitis A & B, Cervarix for human papillomavirus bivalent 16 & 18, cancer drugs such as Zejula and other general medicines such as Amoxil, and Augmentin.
Sanofi and many other foreign pharmaceutical companies have also announced leaving Nigeria.
Speaking at a recent event, the Vice President of the African HealthCare Federation, Clare Omatseye, raised concern over the hike in the prices of cancer drugs as manufacturing companies of chemotherapy drugs exit the country.
According to Mrs Omatseye, some pharmaceutical companies exited Nigeria due to challenges such as foreign exchange, ease of doing business, importation bureaucracy, multiple taxation, and malpractice within the industry.