NEWS
Nigeria can attain self-sufficiency in medicine production with right policies – Adeyeye
The Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), says Nigeria can attain self-sufficiency in the manufacturing of medicine if the right policies are made.
She made this assertion in a statement made available in Abuja on Wednesday.
She stated that “with an enabling business and regulatory environment, the country can meet the requirements of quality and safe medicines,
regardless of the current transient economic travails.”
regardless of the current transient economic travails.”
Adeyeye stated that on her resumption at NAFDAC in late 2017, the top management of the agency formulated policies targeted at enhancing
the capacity of local drug manufacturers to meet global Good Manufacturing Practice (GMP) standards.
the capacity of local drug manufacturers to meet global Good Manufacturing Practice (GMP) standards.
She added that the management also had the idea of promoting collaboration with regulatory institutions, “which led to the conduct
of a nationwide GMP roadmap, supported by our technical partners (UNIDO and USAID).
of a nationwide GMP roadmap, supported by our technical partners (UNIDO and USAID).
“As a follow up to the outcome of the GMP roadmap, several Regulatory Directives (RDs) which include the 5+5 RD, the expansion of NAFDAC’s
ceiling list, new RD on establishment of Pharmaceutical Plants in Nigeria and the centralised GMP inspection for Pharma plants were formulated.
ceiling list, new RD on establishment of Pharmaceutical Plants in Nigeria and the centralised GMP inspection for Pharma plants were formulated.
“The whole essence of these directives was to improve local drug manufacturing in line with global best practice and improved competitiveness of Nigerian Pharma Industry in the global space, while projecting self-sufficiency in local production of essential medicines.
“NAFDAC was set up by act of the parliament to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food and drugs, as well as
cosmetics, medical devices, packaged water, chemicals and detergents (collectively known as regulated products).
cosmetics, medical devices, packaged water, chemicals and detergents (collectively known as regulated products).
“This mandate no doubt bestow on the agency the onerous responsibility of ensuring that only regulated products that are safe, effective and of the right quality are always available and accessible for Nigerians.”
She said that the impact of COVID-19 pandemic is still a fresh one, adding that Nigeria’s pharmaceutical sector was badly hit by the refusal of exporting nations to open their borders for global trade in Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs).
According to her, the challenge led to national shortage in drug supply as a result of the country’s dependence on importation.
Adeyeye said that the formulation of enabling policies, like the 5+5 policy, the expansion of NAFDAC’s ceiling list, new policy on establishment of Pharmaceutical Plants in Nigeria and the centralised GMP inspection for Pharma plants, was targeted at increasing and stimulating local production of medicines.
She said that this couldn’t have come at better time to safeguard the nation against drug shortage and alter the skewed narrative that favoured importation of FPPs.
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.
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 per cent 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 guideline on 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 manufacturer, is at 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 have 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 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.
