Flowerbud News

Category: Health and Environment

  • NÀFDAC Vows to Tackle Diversion of Medical Narcotics to Illicit Use

    NÀFDAC Vows to Tackle Diversion of Medical Narcotics to Illicit Use

     

    As Provost, Medical School Laments Doctors, Other Professionals addiction To Illicit Drugs

    By Biola Lawal
    Flowerbudnews:  The Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof Mojisola Adeyeye has vowed to further strengthen NÀFDAC mechanism for prevention of diversion of narcotics meant for medical and scientific purposes to illicit use.

    Prof Adeyeye gave the assurance at launch of the International Narcotics Control Board (INCB) annual report availability supplement and precursor report 2023 by NAFDAC in Lagos on Thursday, Sayo Akintola NÀFDAC Resident Media Consultant disclosed in a statement.

    The NÀFDAC Boss reiterated the Agency’s commitment to ensuring the availability of narcotics and controlled substances for medical and scientific purposes while preventing diversion to illicit use in Nigeria.

    Prof Adeyeye’s assurance was against the , backdrop of the outcry by the Provost of the Medical School, University of Lagos, Prof Adewale Anthonio Oke that some surgeons and other medical professionals involved in the surgical operation of patients tended to be addicted to narcotic drugs used as painkillers for patients after surgery.

    Prof Adeyeye however, noted that narcotics and psychotropic substances were indispensable in the management of pains and other medical conditions.

    The NÀFDAC Boss noted that ”there is a need to balance the access and control of these substances due to the addictive potential of many of them,”

    She stressed that INCB reports the world drug situation yearly to inform governments of countries that were party to the International Conventions on drug control efforts.

    According to her, ”the annual report for the year 2023 has a special focus on the role of the Internet, including social media, in drug trafficking and use. It explores the challenges and opportunities for drug control, prevention, and treatment, in the era of the Internet, with a specific look at the evolving landscape of online drug trafficking.”

    The NAFDAC boss who was represented by the Director, Laboratory Services (Food), Dr Charles Nwachukwu, however, stressed that Competent National Authorities must scale up their activities, and monitor online advertisement and sales of controlled substances to stay ahead of traffickers.

    The report further analyses the global availability of narcotic drugs and psychotropic substances for medical and scientific purposes. It highlights the persistent disparities in access to medicines for the treatment of pain.

    The precursors report x-rays issues related to trafficking in synthetic drugs including non-medical synthetic opioids, cocaine and their precursors which represent a growing threat to public health.

    The DG reiterated some of the measures already put in place by NAFDAC to ensure availability and prevent the diversion of controlled medicines to illegal use.

    E -permit issuance The Agency has commenced the issuance of an electronic permit to import controlled substances since 2017 with the intention to link this process to the international Import and Export Authorization system (I2ES)

    Pre-Export Notification (PEN) Online System- This platform has been of great utility in monitoring international trade in controlled medicines and precursor chemicals. Its use is to confirm the legitimacy of transactions of proposed imports.

    Monitoring the integrity of the distribution chain- The Agency is scaling up its monitoring and surveillance of the distribution chain by verification of sales, documentation review and increasing the frequency of warehouse and facility inspection.

    National Drug Control Master Plan (NDCMP) – This is a multi-agency, multi-sectoral strategic planning and implementation framework that covers key aspects of drug supply and reduction impacting Nigeria. It is aimed at strengthening responses to drugs to contribute to the enhanced health, security and well-being of all Nigerians.

    National Pharmaceutical Traceability- NAFDACs traceability implementation strategy is in line with the Nigeria National Traceability Strategy Policy document published by the Federal Ministry of Health in May 2020.

    The implementation started with controlled substances in January 2024. Other pharmaceutical products will be added in due course.

    Global Rapid Interdiction of Dangerous Substances (GRIDS)- INCB Regional Technical Officer for Central and West Africa has been selecting focal points for multi-agency training courses on real-time communication and intelligence sharing tools (IONICS and GRIDS intelligence) and awareness raising and safe handling of dangerous substances in the region.

    This aims to support law enforcement and regulatory agencies to identify and dismantle criminal organisations through the identification of modus operandi, risk profiling operations, and the exchange of information for launching and supporting investigations and enforcement operations against the trafficking of new psychoactive substances (NPS), non-medical synthetic opioids, and other dangerous substances.

    Drug Demand Reduction Activities- the Agency carry out education and awareness campaigns in schools, workplaces, religion organizations, marketplaces etc. and collaborate with National Drug Law Enforcement Agency (NDLEA) NGOs and other relevant organization to create drug abuse sensitization across the country.

    She, however, acknowledged the collaborative efforts and cooperation of sister agencies like the Nigeria Customs Service, National Drug Law Enforcement Agency (NDLEA), and The Nigeria Police, who have all been of tremendous help to the agency.

    Speaking in the same vein, Provost of the Medical School, University of Lagos, Prof. David Adewale Anthonio Oke, underscored the aptness of the occasion, given the fact that in clinical practices, several drugs and derivatives of narcotics, particularly opium and their derivatives are used in pain management, most especially in some critical conditions that involve excruciating pains.

    Prof Oke, who was represented by Prof Olatunji Aina, a professor of Psychiatry at the College of Medicine disclosed that not only the members of the public indulge in abuse of medical narcotics.

    He lamented that doctors and other professionals that have these drugs in custody at the hospitals overtime tend to be addicted to the drugs they administer to the patients.

    Even amongst our colleagues in the health practice, especially those that work in the theater including professionals that are directly in charge of these drugs, some of them overtime tend to be addicted to the drugs., he said, describing it as a big public health problem that only a collaboration between NAFDAC and NDLEA could nip in the bud.

    He explained that some medical conditions like sickle cell disease crisis, orthopedic cases, particularly fracture cases and in the management of cancer, would warrant giving some of these narcotics to the patients to relieve them of severe pain.

    He averred that severe pain is one of the symptoms in most cases of cancer when the tumor is exerting pressure on a certain part of the body, adding that in post-surgery, quite a number of these drugs are used in management of pain after surgery.

    According to him, the dilemma of the physician is when the patient now becomes addicted, stressing that it is very important to know at what point a patient no longer requires analgesics and has become addicted.

    In some cases, he said sometimes when you think the clinical situation has improved and would not warrant demand for analgesics, such patient still demands for the drugs.

    Im very happy about the control of these medicines by NAFDAC because its one of the commonest problems we have in psychiatry, particularly patients that are addicted to the controlled medicines and injections, he said. (Flowerbudnews)

  • NAFDAC Intensifies Sensitisation of Potential MSMEs Entrepreneurs in Kaduna

    NAFDAC Intensifies Sensitisation of Potential MSMEs Entrepreneurs in Kaduna

     

    By Biola Lawal
    Kaduna (Flowerbudnews): The National Agency for Food and Drug Administration and Control (NÀFDAC) has intensified efforts to enlighten and educate potential Medium, Small and Micro Enterprises (MSMEs) entrepreneurs in Kaduna.

    During the enlightenment efforts which was spearheaded by NAFDAC’s North West Zonal Director, Mrs Josephine Dayilim participants at the recently concluded Kaduna International Trade Fair were enlightened on process of registering their products with NÀFDAC to boost their economic impact.

    (NWZ Director, Mrs Daliyim sensitising potential MSME Entrepreneurs)

    She encouraged the intending SMS manufacturers to get their products registered with NÀFDAC as the process had been streamlined.

    NÀFDAC registration process had been successfully ”streamlined and decentralized to make it easier for micro and small business operators to get their products registered within the timeline of Ninety (90) days”.

    The NWZ Director commended Prof. Moji Adeyeye, the NÀFDAC Director General for the achievements, saying; Prof Adeyeye had repositioned the Agency to become ‘Customer Focused, Agency Minded,’.

    Mrs Daliyim urged potential entrepreneurs to visit NÀFDAC office for proper guidance or avail the Agency’s excellent online platforms

     

    ”You can use the NAFDAC online platforms in order to get your products registered,” she told them, adding ”you can easily upload your documents even from the comfort of your bedrooms and source for other current and relevant information.”

    The NÀFDAC Zonal Director was joined by Representative of the Plateau State Governor Mr. Sule Musa Haruna, The Commissioner of Commerce & Industry and other dignitaries in inspecting some MSMEs products at the Plateau State pavilion during the recent 45th Kaduna State International Trade Fair (Flowerbudnews)

  • Tinubu suspends REA boss, directors over alleged N1.2bn fraud

    Tinubu suspends REA boss, directors over alleged N1.2bn fraud

    President Bola Tinubu has indefinitely suspended the Managing Director/Chief Executive Officer of the Rural Electrification Agency, Ahmad Salihijo, alongside three executive directors of the agency, from office.

     

    This followed “new findings unearthed during a comprehensive investigation into the financial activities of the Rural Electrification Agency,” the State House revealed in a statement signed by the President’s Special Adviser on Media and Publicity, Ajuri Ngelale.

     

    The statement is titled, ‘President Tinubu suspends Rural Electrification Agency managing director and team from office.’

     

    Aside from Salihijo, the President also suspended the Executive Director, Corporate Services, Olaniyi Netufo; Executive Director, Technical Services, Barka Sajou and Executive Director, Rural Electrification Fund, Sa’adatu Balgore.

     

    Tinubu also ordered a wider investigation into the conduct of the officials in “a fraudulent mis-expenditure amounting to over N1.2bn over the past two years, some of which has already been recovered by anti-graft agencies,” Ngelale revealed.

     

    Consequently, the President appointed a new management team of the Agency who will serve in acting capacity with immediate effect.

     

    They include: Abba Aliyu as Managing Director/CEO, Ayoade Gboyega as Executive Director, Corporate Services, Umar Umar as Executive Director, Technical Services, Doris Uboh as Executive Director, Rural Electrification Fund and Olufemi Akinyelure as Head of Project Management Unit, Nigeria Electrification Project.

    The President “expects all appointees in his administration to uphold the highest standards of transparency and accountability in the discharge of their duties and reiterates his determination to elevate the yearnings of Nigerians for good governance and qualitative service delivery above the narrow interests of individuals who are entrusted to provide critical services to the Nigerian people,” the statement concluded.

  • NÀFDAC Warns Against Sale or use of Falsified Mislabelled Paracetamol Injection

    NÀFDAC Warns Against Sale or use of Falsified Mislabelled Paracetamol Injection

    By Biola Lawal
    Abuja ( Flowerbudnews)’ The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned the public against the sale or use of a falsified Paracetamol Injection mislabelled as  Paracetamol Injection 300mg/2ml I.M I.V Aminoglycoside Antibacterial.

    NAFDAC Director General, Prof. Moji Adeyeye said in a public alert that the falsified product was discovered during a surveillance activity carried out by the post-marketing surveillance (PMS) unit of the Agency in FCT, Abuja.

    The falsified product was sampled for laboratory analysis and the result of analysis conducted on the product by NAFDAC Laboratory Kaduna showed that the product contained only paracetamol, the DG disclosed.

    Paracetamol Injection is an analgesic and antipyretic used to treat mild to moderate pain and to reduce fever. It is not an Aminoglycoside Antibacterial as labeled on the product. Aminoglycosides are a class of antibiotics used to treat serious infections caused by bacteria that are difficult to treat, she stated.

    The genuine Paracetamol Injection 300mg/2ml I.M I.V is manufactured by Shandong Shenglu Pharm. Co. Ltd, China, and marketed by Sifam Life Care Pharmaceutical Ltd, Kano, Nigeria.

    ” It is registered by NAFDAC as an analgesic and not aminoglycoside antibacterial. The Certificate of Registration Holder (Sifam Life Care Pharmaceutical Ltd) has confirmed the product to be a falsified paracetamol injection,” Prof. Adeyeye said.

    Product details:


    The details of the falsified paracetamol injection are as follows;

    Product NameParacetamol Injection 300mg/2ml I.M I.V Aminoglycoside antibacterial
    Stated MarketerSifam Life Care Pharmaceutical Ltd. No. 33 Keffi Street, Kano, Nigeria.

    PackagingThe product pack registered by NAFDAC is not same as the package below.Product photo

    All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified product within the zones and states.

    Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the falsified product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

    Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

    Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng. (Flowerbudnews)

     

  • NÀFDAC Vows to Close Down any Distribution or Sale Outlet Aiding Spread of fake drugs

    NÀFDAC Vows to Close Down any Distribution or Sale Outlet Aiding Spread of fake drugs

    As DG  Assures; No Proliferation of Fake Drugs in Nigeria

    By Biola Lawal
    Abuja (Flowerbudnews): The National Agency for Food and Drug Administration and Control (NAFDAC) has assured that there was no proliferation of fake drugs in the country as it vows to close down any Sale and Distribution Outlet that facilitate Spread of Fake Drugs.

    NÀFDAC Director General, Prof Mojisola Adeyeye, who gave the assurance at a stakeholders meeting organized by NAFDAC on Thursday, expressed the Agency’s resolve to effectively safeguard the health of Nigerians.by effectively combating incidences of falsified and substandard medicines.

    Prof. Adeyeye emphasised the need to explore how to combat the sale and distribution of Substandard and Falsified Medical Products within the supply chain to end its incidences., Sayo Akintola NAFDAC Resident Media Consultant disclosed in a statement.

    The meeting was held for NAFDAC to forge partnership with pharmaceutical supply chain’s stakeholders in the review of the national strategic action plan on prevention, detection and response to substandard and falsified medicines.

    Prof Adeyeye expressed NÀFDAC resolve to effectively safeguard the health of Nigerians,
    insisting that the Agency would not hesitate to clamp down on wholesale and retail outlets where fake drugs are dispensed for public use.

    She said that the engagement with Pharma supply chain stakeholders in Nigeria ”serves as a means of thinking together and putting in place a position that will represent or guide collective efforts and strategy to prevent, detect, and respond to substandard and falsified medicinal products”

    The NAFDAC Boss added that ‘:the goal is to ensure that medical products in circulation are of the quality standard required and safe for public use.’:

    The NAFDAC boss noted that the high prevalence of SF in Africa is a major threat to public health, attributing this to the fact that regulation in the region is limited with about 10% of African National Regulatory Agencies NRAs having achieved ML3.

    Prof Adeyeye noted with dismay that this allows for poorly regulated manufacturers to supply their products in Africa where technologies to detect SF and track/trace are limited.

    She added that the menace of substandard and falsified medical products threatens access to safe, efficacious, and affordable medicines, undermining health systems and the achievement of Universal Health Coverage globally.

    With the mandate to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs, cosmetics, chemicals, detergents, medical devices, and packaged water generally referred to as Regulated Products, she noted that this puts a burden on the Agency to lead the fight against SF medical products in Nigeria and support efforts that will see a reduction in the prevalence of SF medical products both locally manufactured and imported.

    The DG explained that NAFDAC is not the only regulatory agency in terms of substandard falsified medicines, adding that the Pharmacy Council of Nigeria (PCN) probably has more to do in the fight against fake drugs. She, however, relished a cordial relationship that exists between the two sister agencies, insisting that we must do this fight together.

    Prof Adeyeye explained that currently, NAFDAC is doing its best to fight this issue of Substandard and Falsified products, stating that the fight against Substandard/Falsified medical products is based on three broad thematic areas Prevent, Detect, and Respond (PDR).

    She said that NAFDAC operatives are not just going on the streets to look for substandard falsified medicines, but also going after products that have been approved in Southeast Asia en route Nigeria.

    She reiterated that 70 per cent of medicines used in Nigeria come from outside which necessitated the establishment of a Pre-shipment testing scheme that has stopped over 124 products that were approved from coming into the Nigerian market.

    According to her, some of the SF medicines do not have content, some will not disintegrate, and some will not dissolve. In contrast, some of them have wrong labelling and all sorts of non-compliance, adding that the Agency is dealing with that now with the World Health Organisation (WHO).

    Prof Adeyeye further disclosed that most of the products stopped from coming into the Nigeria market have fake certificates of pharmaceutical product. Noting that it takes two to tango, Prof. Adeyeye opined that its not just India bringing substandard falsified medicines to us, it is us; Nigerians that connive with them to bring in cheap products at the detriment of lives in Nigeria.

    Furthermore, She disclosed that over 124 shipments have been stopped, adding that these are products that had been approved, that couldl have been in circulation in Nigeria for five years. So, if ten containers per year for one particular product or two containers per year should find their way into Nigeria, you can figure out what the consequences might be.

    The NAFDAC boss, however, announced the berth of a new regulatory directive with emphasis on the source of raw materials used in the production process. For those that are registering new products, she said they must procure raw materials from approved sources like WHO Prequalified sources, FDA, or other stringent Regulatory Authorities.

    If you dont source from a prequalified source, we will not register the product, she said.
    She, however, dispelled the news going around, over the alleged proliferation of fake drugs in the country, saying the proliferation news that has been going on is false.

    There is no proliferation of substandard medicines. We do national survey, sampling of products using scientific methods from different parts of the country., she said, adding that the survey was done in 2021 and 2022 for ant-malaria with a 10 per cent prevalence level.

    We couldnt do it in 2020 due to the COVID-19 Pandemic. She explained further, If you live very close to the border where people come in and out the prevalence may be higher there. Thats statistics.
    .
    The average is about 10%, she said, insisting that proliferation is not synonymous with shortage because the two words are now used together. The fact that we have a shortage of medicines does not mean there is a proliferation of substandard falsified medicines. The survey for 2023 is not ready yet. We will publish 2021 and 2022

    She noted that the Pharmaceutical Supply chain plays a vital role in ensuring that safe, quality, and efficacious medicines reach the end users, adding that there is therefore a need to foster complementary partnerships that will seek to identify lapses in the supply chain system to improve the chances of winning the war on substandard and falsified medical products in Nigeria.

    We have formal and informal markets. Do not buy medicines from the informal market. We do a lot of raids in Oke- Arin, Idumota markets Lagos, Onitsha head bridge where you can buy a product maybe 50 per cent or 80 per cent cheaper because of low quality, she added, the state of the economy shouldnt be an excuse for people to buy poison under the guise of cheap products.

    I enjoin you to sustain your support to NAFDAC to ensure that only safe, efficacious, and quality medicines are used in Nigeria. NAFDAC, as the regulatory agency is seeking the support of all stakeholders in the pharma industry and supply chain system to improve our chances of winning the war on SF medical products.

    The Supply chain stakeholders made very useful contributions for input into the National Strategic document to guide our collective efforts towards combating the menace of the SF in the country.

    The stakeholders present at the supply chain engagements include the World Health Organization (WHO), United States Pharmacopeia (USP), Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria ( PMG-MAN), Association of Community Pharmacist of Nigeria (ACPN), Pharmaceutical Wholesalers Association of Nigeria (PWDAN), Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM), Association of Pharmaceutical Importers of Nigeria (APIN), Association of Hospital and Administrative Pharmacist of Nigeria (AHAPN), Nigeria Army Medical corps, Nigeria Medical Association (NMA), National of Veterinary Medical Association(NVMA). Others are different companies represented under PMG-MAN, APIN, PWDAN, and Niropharm. (Flowerbudnews)

     

  • NAFDAC, PCN Warn Manufacturers Against Supplying Medicines to Sabon Gari Market, Kano 

    NAFDAC, PCN Warn Manufacturers Against Supplying Medicines to Sabon Gari Market, Kano 

     

     

    By Biola Lawal
    Abuja (Flowerbudnews):. NÀFDAC and the Pharmacy Council of Nigeria (PCN) have
    warned pharmaceutical products manufacturers etc to stop supplying regulated products to companies etc in Niger Street and Sabon Gari market in Kano.

    The warning was given in a joint statement issued on Sunday, and titled: Urgent Call to Action- Manufacturers and importers Urged to Cease Supplying medicines to Niger Street and Sabon Gari market in Kano

    The two organisations warned manufacturers, importers, company representatives and all distributors that ”any company found contravening the warning ”risks losing site licence as well as the product licence”.

    ” From this very moment, (Companies must) cease supplying pharmaceuticals, medical devices, and other regulated medical products to facilities or companies in Niger Street, Sabon Gari or elsewhere outside the coordinated wholesale centre in Dangwauro”, NÀFDAC and PCN warned.

    They stated that all pharmaceutical supplies must, henceforth be made at the coordinated wholesale centre in Dangwauro,, Kano state.

    NÀFDAC and PCN recalled judgement delivered by the court of Appeal ordering Kano Medicine Dealers to vacate Niger Street/Sabon Hari market and to relocate to the coordinated wholesale centre in Dangwauro, Kano.

    The measure was designed to ensure good distribution of pharmaceuticals, medical devices and thereby, help to prevent the circulation of substandard and falsified medicines, the two organisations explained.

    They urged retailers, hospitals etc to take note of the warning (Flowerbudnews)

  • NAFDAC Blocks Over 140 Fake Drug Products from Being Shipped to Nigeria

    NAFDAC Blocks Over 140 Fake Drug Products from Being Shipped to Nigeria

     

     

    By Biola Lawal
    Abuja (Flowerbudnews): NÀFDAC’s Pre-Shipment Inspection Initiative has Yielded positive Result with about 50 per cent of pharmaceutical products destined for Nigeria  found to be fake and successfully Blocked from being Shipped to Nigeria.

    Flowerbudnews reports that NAFDAC Director General, Prof Mojisola Adeyeye stated the good news while giving clarification on misquotation by a section of the media, reporting erroneous news about the quality of drugs entering the country.

    Prof Adeyeye recalled that NAFDAC set up the Pre-shipment Inspection Scheme, also called the Clean Report of Inspection and Analysis (CRIA) Scheme, to support and strengthen the Agency’s efforts to prevent export of substandard, fake, and falsified pharmaceutical products into Nigeria from high-risk countries.

    ”’The CRIA scheme has led to the stoppage of the export of over 140 products to Nigeria after laboratory evaluation of those products revealed that they were substandard and did not meet quality and safety standards, ” the NAFDAC Boss stated.

    She explained that one of the required documents normally submitted for processing of the CRIA Reports is the Certificate of Pharmaceutical Products (CPP).

    ”The CPP is a reliance document issued by a National Regulatory Authority to a receiving country which guarantees that a medical product for export meets quality, safety, and efficacy requirements and that the production process conforms to Good Manufacturing Practice (GMP) as internationally accepted,” Prof. Adeyeye said .

    The Director General explained that NAFDAC found out that 50% of the CPPs submitted by Manufacturers for the failed products were found to be fake and did not follow regulatory requirements for issuance.

    Prof. stated that all the products found to have failed laboratory evaluation were blocked from being not shipped into Nigeria, and were not shipped into Nigeria.

    It is incorrect and a misplacement of facts to misreport the good news that 50% of drugs set for shipping to Nigeria were efficiently checked by NAFDAC CRIA Agents, found to be falsified and prevented from being shipped to Nigeria, Prof Adeyeye reiterated.

    It is also important to clarify that the level of substandard, fake, and falsified pharmaceutical products in Nigeria stood at between 10-12% and NAFDAC is making every possible effort to reduce this to around five per cent.

    As a stable maturity level 3 regulatory Agency, NAFDAC has gained international recognition for her efforts at curbing the influx of substandard, fake, and falsified pharmaceutical products through the CRIA scheme and the interception of several consignments of such products, she stated.

    ”This has led to other countries within Sub-Saharan Africa understudying NAFDAC and embracing the Pre-Shipment Inspection and Analysis Scheme for medical products exported to their countries,” the NAFDAC Boss noted.

    Prof Adeyeye assured that ”NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria”. (Flowerbudnews)

  • Domestication of Pharmaceutical Manufacturing Attracts $2 Billion Dollars into Nigerian Economy in 5 Years -NAFDAC

    Domestication of Pharmaceutical Manufacturing Attracts $2 Billion Dollars into Nigerian Economy in 5 Years -NAFDAC

     

    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.”
    .
    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)

  • NAFDAC Debunks Erroneous Report, Says 50% of Imported Pharmaceutical Products in Nigeria are not Fake

    NAFDAC Debunks Erroneous Report, Says 50% of Imported Pharmaceutical Products in Nigeria are not Fake

     

    By Biola Lawal
    Abuja (Flowerbudnews): NAFDAC Director General, Prof. Mojisola Adeyeye has assured Nigerians that close to 90% of medicines on sale in Nigeria are safe and of good quality.

    Flowerbudnews reports that Prof Adeyeye gave the clarification in a statement titled: REJOINDER: Fifty percent of imported pharmaceutical products in Nigeria are fake;
    issued to specifically debunk some erroneous media reports quoting her as saying that 50% of drugs imported into Nigeria were fake.

    ”This is to assure the public that NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria,’ the NAFDAC DG stated.

    She explained that NAFDAC set up Pre-shipment Inspection Scheme, also called the Clean Report of Inspection and Analysis (CRIA) Scheme, to support and strengthen the Agency’s efforts to prevent export of substandard, fake, and falsified pharmaceutical products into Nigeria from high-risk countries.

    ‘Prof Adeyeye clarified that NÀFDAC statement on 50% fake drugs blocked at source from entering, or from being shipped to Nigeria was misplaced and erroneously reported by a mass media as 50% fake drugs in Nigeria.

    She explained that through the efficacy of the CRIA, about 50% of pharmaceutical products manufactured for shipment to Nigeria were proved falsified, rejected and blocked at source from being shipped to Nigeria.

    Full Statement Reads:

    REJOINDER: Fifty percent of imported pharmaceutical products in Nigeria are fake!

    The attention of the National Agency for Food and Drugs Administration and Control (NAFDAC) has been drawn to various news publications on an interview with the Director General (NAFDAC) on efforts by the Agency at curbing the influx of substandard, fake, and falsified pharmaceutical products.

    This is to inform the public that the Director General’s statement during the interview was seriously misunderstood. NAFDAC set up a Pre-shipment Inspection Scheme also called the Clean Report of Inspection and Analysis (CRIA) Scheme to support NAFDAC’s efforts at prevention of export of substandard, fake, and falsified pharmaceutical products into Nigeria from high-risk countries.

    The CRIA scheme has led to the stoppage of the export of over 140 products to Nigeria after laboratory evaluation of those products revealed that they were substandard and did not meet quality and safety standards.

    One of the required documents submitted for processing of the CRIA Reports is the Certificate of Pharmaceutical Products (CPP). The CPP is a reliance document issued by a National Regulatory Authority to a receiving country which guarantees that a medical product for export meets quality, safety, and efficacy requirements and that the production process conforms to Good Manufacturing Practice (GMP) as internationally accepted.

    The Director General explained that NAFDAC found out that 50% of the CPPs submitted by Manufacturers for the failed products were found to be fake and did not follow regulatory requirements for issuance.

    This does not mean that 50% of imported products in circulation are fake as all the products found to have failed laboratory evaluation were not shipped into Nigeria. It is also important to clarify that the level of substandard, fake, and falsified pharmaceutical products in Nigeria stands at between 10-12% and NAFDAC is making every possible effort to reduce this to around 5%.

    NAFDAC as a stable maturity level 3 regulatory Agency has gained international recognition for her efforts at curbing the influx of substandard, fake, and falsified pharmaceutical products through the CRIA scheme and the interception of several consignments of such products. This has led to other countries within Sub-Saharan Africa understudying NAFDAC and embracing the Pre-Shipment Inspection and Analysis Scheme for medical products exported to their countries.

    This is to assure the public that NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria. (Flowerbudnews)