The National Agency for Food and Drug Administration and Control (NAFDAC) says that the number of active local manufacturers of drugs in Nigeria has increased by 12 percent.
The Director-General of the agency, Mojisola Adeyeye made this assertion in a statement made available in Abuja on Wednesday.
According to her, available objective evidence from NAFDAC’S record shows that over 20 newly registered local drug manufacturers have cumulatively invested over two billion dollars in the erection and completion of World Health Organisation (WHO) compliant facilities that manufacture quality pharmaceuticals and essential medicines for Nigerians.
This figure according to her represents an increase of 12 percent in the number of active local manufacturers.
According to her, more impressive as of February 2024, is the statistic of 143 applications received for regulatory review and approval of new pharma layouts intended for local manufacturing of pharmaceuticals.
She said 105 out of the 143 received regulatory approval to commence construction and erection of manufacturing facilities that meet WHO GMP guidelines and NAFDAC GMP for Medicinal Products Regulations 2021.
The NAFDAC boss said that of the 105 applications that received regulatory approval, 37 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.
She said 68 out of the approved applications are undergoing construction.
The director-general said, “another cheering development is the upsurge in local manufacturing and NAFDAC policies; interests are on the crescendo as it concerns domestic manufacture of Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients.”
Adeyeye said Emzor Pharmaceuticals Industries Limited, one of the indigenous FPP manufacturers, is on the verge of commencing commercial manufacture of four (4) antimalarial APIs.
She said that the development followed technical collaboration with NAFDAC and Indian-based WHO-prequalified API manufacturers Partners (Mangalam Drugs and Organics Limited).
According to her, another cluster/cohort of six local manufacturers has also concluded plans to initiate local manufacture of different classes of widely used APIs and Pharmaceutical Excipients.
Adeyeye said that “the agency is preparing her regulatory officers, manufacturers, and future workforce (university students with their professors) in capacity building through an international workshop on Local Manufacturing of Active Pharmaceutical Ingredients and Excipients, developed by NAFDAC.”
She said that the first workshop took place in October 2023, and attracted experts in the subject matter from China, USA, UK, and Nigeria, adding that without high technical competence in manufacturing of these raw materials, the domestication may be challenged.
She noted that a second workshop is being planned for the second quarter of 2024, stressing that long-term capacity building will continue for sustainability.
“Swiss Pharma Nigeria Limited, one of our local manufacturers, recently had its pediatric formulation (pediatric Zinc Sulphate tablet (20mg dispersible tablet)) prequalified by the WHO following stringent evaluation of its manufacturing and quality control processes.
“Several other products manufactured by the company are awaiting WHO pre-qualification. Other local drug producers and manufacturers of medical devices have also expressed interest in attaining global recognition and acceptability through the WHO prequalification and other certification programs.
“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.
“NAFDAC’s attainment of ML3 status, the WHO prequalification of our Central Drug Control Laboratory in Yaba, Lagos, the satisfactory outcome of a recent WHO observed audit of our pharma inspection process, and our collective aspiration to attain ML4/WLA status, are essential for manufacture of medicine in Nigeria.
“This also coupled with our prominent roles and membership of global (ICH, ICMRA, WLPF etc.) and regional (WA-MRH, AMRH), harmonization effort to support indigenization of pharma manufacturing, all point to the fact that a lot is being done to achieve stable and well regulated environment.
“The information presented is a strong evidence that the domestication of local manufacturing is increasing in Nigeria.
“This will continue to wax strong with the thrust that President Bola Tinubu is giving local manufacturing and the support to ease the Forex and import duties of the pharmaceutical machinery and materials,” she stressed.
NAN
