By Biola Lawal
Abuja (Flowerbudnews): NÀFDAC efforts and policies for domestication of pharmaceutical production has attracted investment of over $2 billion dollars into the Nigerian economy from 20 newly registered local drug manufacturers.
NAFDAC Boss, Prof Moji Adeyeye made the disclosure in a statement on INCREASED DOMESTICATION OF PHARMACEUTICAL MANUFACTURING in Nigeria from 2019-2023,a copy of which was made available to Flowerbudnews.
”Available objective evidence from NAFDAC’S record showed that over 20 newly registered local drug manufacturers have cumulatively invested over $2billion in the erection and completion of WHO compliant facilities that manufacture quality pharmaceuticals and essential medicines for Nigerians, Prof Adeyeye stated.
The figure represented a 12% increase in the number of active local manufacturers.
More impressively, as of February 2024, NÀFDAC had received a total of 143 applications for regulatory review and approval of new pharma layouts intended for local manufacturing of pharmaceuticals.
Over 73% (105) of this number have received regulatory approval to commence construction and erection of manufacturing facilities that met World Health Organisation (WHO) Good Manufacturing Practice (GMP) guidelines and NAFDAC GMP for Medicinal Products Regulations 2021.
Of the 105 applications that have received regulatory approval 35% (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.
The rest of the approved applications 65% (68) are undergoing construction which would be completed in the near foreseeable future.
Prof Adeyeye disclosed that the upsurge in local manufacturing and NAFDAC policies had boosted interests in domestic manufacture of Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients.
Emzor Pharmaceuticals Industries Limited, one of the indigenous FPP manufacturer is at the verge of commencing the commercial manufacture of four (4) antimalarial APIs following technical collaboration with NAFDAC and Indian based WHO prequalified API manufacturers Partners (Mangalam Drugs and Organics Limited).
She disclosed that another cluster/cohort of 6 local manufacturers have concluded plans to initiate the local manufacture of different classes of widely used APIs and Pharmaceutical Excipients.
Prof Adeyeye said that her 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 disclosed that the first workshop was held in October 2023, and attracted experts from China, USA UK and Nigeria. stressing that ”Without high technical competence in manufacturing of these raw materials, the domestication may be challenged.”
A second workshop was being planned for second quarter of 2024. Long term capacity building will continue for sustainability., She added.
”Swiss Pharma Nigeria Limited, one of our local manufacturers, recently had its pediatric formulation (pediatric Zinc Sulphate tablet (20mg dispersible tablet)) pre-qualified by the WHO following stringent evaluation of its manufacturing and quality control processes.
” Several other products manufactured by the company are awaiting WHO prequalification. 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, Prof Adeyeye disclosed.
”’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, 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 of is being done to achieve stable and well regulated environment for manufacture of essential medicines in Nigeria”.,the NAFDAC Boss stressed.
”The information presented is very strong evidence that the domestication of local manufacturing is increasing in Nigeria.
“”This will continue to wax strong with the thrust that President Bola Ahmed Tinubu is giving local manufacturing and the support to ease the Forex and import duties of the pharmaceutical machinery and materials.
Prof Adeyeye emphasised that the above narrative ”indicated that 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.”
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She recalled that ”at the inception of the current National Agency for Food and Drug Administration and Control (NAFDAC) administration in late 2017, the top management had a mission to formulate policies and implement a strong collaboration targeted at enhancing capacity of local drug manufacturers that meet global Good Manufacturing Practice (GMP) standards.”
She emphasised that ”this led to the conduct of a nationwide GMP roadmap which was 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 centralized 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 assure improved competitiveness of Nigerian Pharma Industry in the global space while projecting toward self-sufficiency in local production of essential medicines,”
She noted that ”the National Agency for Food and Drug Administration and Control (NAFDAC) was set up by act of the parliament to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents” (collectively known as regulated products).
Prof Adeyeye stressed that ”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.”
”While the global impact of Covid-19 pandemic is still fresh on our minds, it is pertinent to remind ourselves that Nigeria Pharma sector was badly hit by refusal of exporting nations to open their borders for global trade in active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) leading to national shortage in drug supply sequel to our over dependence and reliance on importation,”
”Consequently, the formulation of enabling policies, (i.e., the 5+5 policy, the expansion of NAFDAC’s ceiling list, new policy on establishment of Pharmaceutical Plants in Nigeria and the centralized GMP inspection for Pharma plants), targeted at increasing and stimulating local production of medicines couldnt have come at better time to safeguard our nation against the bitter agony of drug shortage and alter the skewed narrative that favored importation of FPPs,” she recalled. (Flowerbudnews)
