The Present: Research, Regulation, Biopiracy and Safety
What is actually being researched now, how Nigeria regulates traditional medicine and where the regulation stops, who owns knowledge that becomes a drug, and the contamination data that make the contemporary trade a public health problem in its own right.
Yoruba medicine no be relic wey just survive from past. Na big, active, commercial sector wey get modern products, modern advert, modern regulation and modern failures. Herbal medicine wey person buy for Lagos market today dey more likely to come inside branded plastic bottle wey get NAFDAC number pass make e dey inside calabash, and e fit contain lead. Dis file na about dat sector, and about di three questions wey go decide im future: whether di pharmacopoeia fit produce drugs, who get di knowledge if e produce am, and whether di products wey people dey swallow currently safe.
Di last question get di clearest answer, and na im worst pass. Confidence on dis file high because di safety and regulatory claims rest on published measurement and on published policy documents.
Wetin dem dey research
Ethnobotanical documentation na di strongest and most active part of di literature. Surveys dey record wetin practitioners dey use, wetin dem dey use am for, how dem dey prepare am, with voucher specimens and species identification for di better work dem, and inventories now cover di southwestern states well well . Dis documentation dey urgent for one reason wey no get anything to do with drug discovery: di transmission chain dey thin out as practitioners dey age, forest habitat dey lost, and apprentices dey go school instead. Knowledge wey dem no write down for di next generation no go exist again.
Pharmacological screening dey active but e bend to one side, and na funding determine how e bend. E concentrate on malaria, na in vitro and rodent work dominate am, e rarely reach clinical trial, and e dey use extracts wey dem no standardise wey make am impossible to compare results across studies. Toxicology no get enough investigation relative to activity, wey be di wrong way to do things for substances wey people don already dey consume in large quantity. File 03 set out wetin dem don establish and wetin dem never establish plant by plant.
Clinical and health systems research na where di real results dey. E make sense to state dis one clearly because e dey go against di expectation say di interesting work dey inside laboratory. Di two strongest evidence wey dem don produce anywhere for dis field for di last decade na health systems trials instead of pharmacology: di COSIMPO trial wey show say collaborative care between traditional and faith healers and primary health workers dey improve psychosis outcomes, with adjusted mean PANSS difference of -15.01 ; and di Ondo Agbebiye programme evaluation wey show 61.8 percent increase for facility births after dem incorporate traditional birth attendants enter di maternal health system . None of dem require make person isolate any compound. Di two of dem change outcomes on a large scale.
Wetin dey miss. Di intermediate layer: standardised preparations, dose-response characterisation, interaction studies with di pharmaceuticals wey patients dey take concurrently, and clinical evaluation of di actual traditional preparations instead of solvent extracts of single plants. Until dat one exist, di honest position on most Yoruba herbal medicine be say, sophisticated knowledge system don identify plants wey get real pharmacological activity, but whether di medicines as dem actually prepare and give am dey work for humans na open question, no be answered one.
Drug discovery from di pharmacopoeia
Di precedent dey genuine. Quinine from Cinchona and artemisinin from Artemisia annua both come out of traditional medical traditions, and review literature describe artemisinin as di most noteworthy achievement of twentieth-century ethnopharmacological research . Reserpine, from Rauvolfia, one genus wey get Yoruba medicinal use, enter world medicine as antihypertensive and early antipsychotic . Di proposition say ethnobotany fit yield drugs na established fact, no be guesswork.
Di reality of di pipeline hard pass dat. Ethnopharmacology don be active field for decades and di number of new drugs wey e deliver small. Di attrition points na ordinary drug development attrition points: activity in vitro no dey survive reach animals, activity inside animals no dey survive reach humans, di active compound toxic pass or body no dey absorb am well, or di effect size dey real but e too small to matter. None of dat one dey specific to African plants.
Two structural problems dey specific to dis setting. Nigerian pharmacology no get enough resources relative to di size of di pharmacopoeia, so most of di screening wey dem dey do na whoever get equipment dey do am, wey frequently no dey inside Nigeria. And extracts dey vary so much between studies dat positive results no fit be replicated even in principle, because di second team no dey test di same material.
Regulation for Nigeria
NAFDAC na di principal regulator: National Agency for Food and Drug Administration and Control dey regulate herbal medicinal products, test ethnomedicinal preparations, and operate registration regime . NAFDAC don publish guidelines for di registration of herbal medicines and dietary supplements wey dem make for Nigeria, and dem release Herbal and Fruit Infusion Regulations for 2024 wey cover infusions other than di ones for medicinal purposes . Full registration of herbal product dey happen only after di product don show satisfactory efficacy and convincing safety profile .
Two other bodies dey. Dem don establish Department of Traditional Medicine inside Federal Ministry of Health to conduct research into traditional medicines, and dem don approve Council for Traditional, Alternative and Complementary Medicine Practice, though di operational detail still few .
The main gap na licensing of practitioners. The 2024 review inside African Health Sciences talk the matter straight: no national agency dey responsible to give license to traditional medicine practitioners . Na products dem dey regulate; dem no dey regulate the people. Practitioner fit treat anybody for anything without license, without accreditation, without boundary on wetin dem fit treat, without any place to report complaint, and without any way to ban dem. Everything inside file 02 say verification depend on reputation and family lineage still dey true because nothing don replace am.
Education na the second gap. Formal institutional training for complementary and alternative medicine practically no dey Nigeria, as most teaching on herbal medicine dey end for inside pharmacology departments, while the rest knowledge dey pass by word of mouth without formal documentation . The review propose six-year Doctor of Traditional African Medicine degree with six months hospital training, plus shorter diploma and certificate programs, join with separate licensing agency, government portal for regulations, standard product testing, bigger university programmes, and government-funded training for practitioners wey already dey rural areas .
How much of this one dey reach the real market na the big question. Registration rules dey only affect manufacturer wey come register. E no touch market herb stall, mobile vendor wey dey waka sell, medicine wey dem advertise for radio come dey sell from car boot, or the practitioner wey dey mix medicine directly for patient front, and na there most of the business dey happen.
Safety: the contamination data
Na this part of the file get the clearest and heaviest numbers, and nobody suppose tone am down.
Heavy metals, the national picture. The study wey Obi, Akunyili, Ekpo and Orisakwe do, wey publish inside Science of the Total Environment for 2006, check cadmium, copper, iron, nickel, selenium, zinc, lead and mercury inside random sample of Nigerian traditional products wey dem buy for open market, digest am and measure am with atomic absorption spectrometry . The result: 100 percent of the samples contain high amount of heavy metals, with levels of iron, nickel, cadmium, copper, lead, selenium and zinc wey reach to cause bad health problems if person dey take am regularly as dem recommend .
That study deserve attention for one extra reason. Dora Akunyili, wey be one of the authors, na Director-General of NAFDAC at that time, wey be the regulator itself. Na the regulator own top leadership publish this finding say contamination dey everywhere for the sector wey dem dey regulate.
Heavy metals for inside Yoruba market specifically. Dem analyse ten common herbal plants wey people dey take, wey dem buy for Ado Ekiti urban market, with full health risk assessment . Estimated daily intake for lead, nickel, chromium, copper and manganese pass the upper tolerable daily limit for all the plant species wey dem study, both for children and adults . Health risk index for lead pass 1 for children inside Alstonia congensis, Terminalia avicennioides, Aframomum melegueta, Cymbopogon citratus and Napoleona vogelii, and copper and manganese also high well-well; the order of risk index na Mn > Cu > Ni > Pb > Cr, and dem no see cadmium for any sample . Estimated cancer risk for lead, nickel and chromium range from 10⁻⁶, low, to 10⁻³, high, for children, and from 10⁻⁵, acceptable, to 10⁻², unacceptable, for adults . The authors conclude say to dey consume these plants dey bring long-term cancer risk .
Make we note say two of those plants, Aframomum melegueta and Cymbopogon citratus, dey inside the pharmacopoeia table for file 03 as plants wey get documented traditional use and laboratory-proven activity. The same plant fit dey pharmacologically interesting and, as dem actually dey sell am, still expose person to lead. These things no be say dem dey contradict each other about the tradition; na facts about two different things, the plant and the product.
Violation of guidelines. Another study report percentage of how Nigerian herbal remedies break WHO and EU limits for six metals: arsenic 0 percent, cadmium 58.3 percent, chromium 4.16 percent, cobalt 0 percent, lead 54.1 percent and nickel 54.1 percent, with the highest concentration inside solid dosage forms and the lowest inside liquid preparations .
Microbial contamination. Organisms wey dem find inside herbal remedies include Escherichia, Salmonella, Pseudomonas, Streptococcus, Staphylococcus, Klebsiella, Bacillus and Enterococcus species, join with different fungi . Fungal contamination dey also carry extra risk of aflatoxin inside material wey dem dry and store for place wey get moisture.
Where the contamination dey come from. Plant wey suck dirt from contaminated soil, roadside drying, contamination during grinding and processing, contact with metal tools and containers, adulteration, and for some cases, deliberate mixing. The ways wey e dey happen no complex at all, and ordinary manufacturing controls fit solve each of dem.
Mixing with pharmaceuticals na documented problem inside herbal products all over the world, where corticosteroids, NSAIDs and antidiabetics na the normal things wey dem dey add, because na dem dey give that quick relief wey dey make the product sell. The person wey compile this work no find Nigeria-specific prevalence number, so e no put any.
The honest summary. The evidence of contamination no be small quality matter. E show say serious part of the herbal products wey dem dey sell for Nigeria carry measurable toxic exposure on top of whatever the plant dey do, and that exposure worse pass for the exact products wey patient dey take every day for long time. Na public health problem be this, whether the traditional indications correct or not, and e go still remain problem even if every plant inside the pharmacopoeia work perfectly.
Biopiracy and who get the knowledge
The question dey real and e get legal answer wey still no solve the matter.
Di framework. Di Nagoya Protocol to di Convention on Biological Diversity enter force on 12 October 2014, and e set up international legal framework for access to genetic resources and how benefit from dia use go share well and fairly . E dey give each country sovereign rights over dia biological resources, na wetin make biopiracy illegal under international law be dat, and e cover traditional knowledge wey join with genetic resources plus di benefits from using am .
Di scenario wey e dey address. Researcher go record say one Yoruba herbalist dey use one particular plant for one particular sickness; dem go isolate di compound; dem go file patent; dem go sell drug. Di traditional knowledge dey very necessary, because without am nobody for screen dat plant out of tens of thousands of candidates, and under di system before Nagoya, di community wey hold di knowledge no receive anything. Scholars don argue specifically say Nigerian traditional medicine need stronger protection on top dis grounds .
Wetin make di framework no fit settle am. Four wahala dey, and na practical wahala instead of theoretical.
Who be di holder? Nagoya dey consider how to share benefit with indigenous and local communities. Yoruba plant knowledge dey for hand of practitioners across two countries and diaspora, e dey pass down through family lineages instead of corporate bodies, and e no get any representative institution wey fit receive payment or give consent on top anybody behalf.
Prior publication. Verger book wey be Ewé and hundreds of ethnobotanical surveys don put plenty of di pharmacopoeia inside public domain. Knowledge wey dem don publish generally no fit get patent like dat, and dis thing cut both sides: e dey block crude appropriation, but e dey also remove di leverage wey community for need to negotiate.
Enforcement. Nagoya dey give obligation to parties, and na inside di jurisdictions where dem develop and sell drugs dem dey capture di value. Di practical capacity wey Nigeria get to detect and pursue violation dey limited.
Di counterproductive equilibrium. Practitioners wey know about di risk of appropriation dey less willing to open up to researchers, wey dey slow down di documentation wey file 03 identify say dey urgent. Restriction dey protect against rare harm wey get high value, but di price na common, ongoing harm, and to balance di two things really hard.
Di framing wey stand well. Di stronger recent argument for dis literature na say di biopiracy frame self na colonial relic, and wetin dem need na collaborative concepts where African institutions go be principals inside di research instead of just sources of material for am . Dat reframing no be legal solution, but e dey point to di right thing: di lasting answer to appropriation na African-led pharmacology with African institutional ownership of di results, no be tighter restrictions on wetin fit leave.
Integration: wetin don actually work
Three cases for dis section don bring measurable outcomes, and dem share one structure wey make sense to point out.
Di Ondo Agbebiye programme raise facility deliveries by 61.8 percent inside three years when dem register traditional birth attendants and pay dem to refer patients, instead of training dem to deliver better . Di COSIMPO trial improve psychosis symptoms well well as dem make healers and primary care workers deliver one shared protocol together . Literature on bone-setting don agree on training and integration instead of prohibition, based on di calculation say traditional bone-setters dey treat most of di fractures for Nigeria and nobody fit replace dem .
Di common structure: none of dem try to validate or eliminate traditional practice. Each of dem treat di traditional practitioner as existing part of di health system, because na wetin e really be, and dem work on di interface. Na dat approach get evidence for back.
Wetin to expect
Di trade go grow, because biomedical system capacity no dey grow fast enough and because herbal product market get commercial value.
Di contamination problem no go solve itself. E require manufacturing standards and enforcement wey go reach di informal trade, where di products dey.
Documentation na window wey dey close. Practitioners dey age, habitat dey lost, and apprenticeship dey compete with schooling.
Di drug discovery yield go probably modest, as e don be from every other traditional pharmacopoeia, and make dem talk dis one before hand so dat dem no go later take modest yield as final judgment on di tradition. Di value of di knowledge system no depend on producing blockbuster drug.
Di health systems results na dem be di ones to watch. Na dia di evidence strong pass, di effects big pass, and di implementation cheap pass.