FEDERAL REPUBLIC OF NIGERIA

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FEDERAL REPUBLIC OF NIGERIA
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AFRICA HERBAL ANTIMALARIAL MEETING

• PRESENTATION BY
• HASHIM UBALE YUSUFU
• NAFDAC NIGERIA
• 20 22 MARCH 2006
• NAIROBI KENYA.

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ABOUT NIGERIA

• Population over 130 million people
• Growing at about 3/annum
• Most populous nation in Africa
• Several languages/dialects and cultures
• English official language

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Nigerias Healthcare System

• Primary
• LGA responsibility
• Oversees
• Health posts, health clinics, health centers
• Community health worker
• Secondary
• State responsibility.
• Oversees
• General and Cottage hospitals (One in each of 774
  LGAs.
• Other secondary health care providers
• Tertiary
• Largely Federal responsibility
• Teaching and specialist hospitals
• At least one in each of 36 states and FCT
• Few private hospitals with limited but highly
  specialized services

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HISTORY.

• The use of herbal medicines' in Nigeria dates
  back to the earliest history of mankind, as in
  other cultures worldwide.
• People have relied totally on traditional
  remedies for all their healthcare needs.
• They use herbs, animal or mineral based medicines
  often laced with spiritual ingredients such as
  incantations.

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• It is a source of livelihood for a significant
  number of our population.
• The closest to the people.
• High cost of allopathic medicines have encouraged
  demand.
• Lack of adequate primary healthcare have made
  people resort to TMPs for their immediate
  treatment.
• As the population increases, demand for
  traditional medicine will increase.

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NAFDAC MANDATE
To Control and Regulate the

• Manufacture
• Importation
• Exportation
• Distribution
• Advertisement
• Sale
• Use

• Foods
• Drugs
• Cosmetics
• Chemicals and Detergents
• Medical Devices
• All Packaged Drinks

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PROBLEMS WITH EARLY REGULATION OF HERBAL PRODUTCS.

• Very little attention from Government.
• Resistance and lack of co-operation of
  practitioners due to lack of trust of government
  intentions.
• Insecurity due to fear of loss of traditional
  knowledge.

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• STRATEGIES undertaken for successful
  implementation of regulation and control of
  herbal medicines
• Organized a workshop on Standardization and
  Regulation of Herbal Medicines (1997) in
  collaboration with BDPC and WAPF.
• Consultative meeting with NIPRD, to develop draft
  regulations and guidelines.
• Review of the draft guidelines by committee of
  experts leading to categorized protocol for
  listing/registration of traditional/herbal
  medicines.
• In line with WHO recommendation of accepting
  herbal products based on long history of safe use
  in a locality, decided to use acute toxicity
  tests as safety parameter for simple herbal
  preparations.
• Efficacy tests, detailed analysis and clinical
  trials for drugs for complex diseases such as
  Hepatitis, HIV/AIDS etc.

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GUIDELINES FOR REGISTRATION/ LISTING OF HERBAL
MEDICINES AND RELATED PRODUCTS

• GENERAL RULES
• Herbal medicinal products to be considered for
  registration or listing were categorized as
• Herbal medicinal products manufactured locally.
• Imported Herbal medicinal products.
• Homeopathic herbal medicinal products.

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APPLICATION.

• Applicants shall obtain an application form upon
  payment of prescribed fees.
• The applicants/manufacturers shall submit
  completed application forms with relevant
  documents vis -
• Receipt of purchase of application form.
• Certificate of Registration of Business.
• An acceptable certificate of analysis testifying
  that the medicine is of proven quality and safety
  from accredited centers recognized by NAFDAC.
• Appropriate Dossier Format (containing method of
  analysis or assay of the medicine, stability data
  etc) for product to get registered /listed.
• Any other relevant documents.

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• Pre-registration inspection shall be carried out
  on the production premises by NAFDAC Inspectors
  after payment of prescribed fees to assess Good
  Manufacturing Practice (GMP) standards
• If inspection is satisfactory, NAFDAC inspectors
  will collect samples for Laboratory analysis.
• All herbal medicinal products must be adequately
  labeled before samples are sent to the laboratory.

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• On receipt of satisfactory laboratory report, the
  product is approved for listing. For full
  registration, satisfactory report of local
  clinical trials will be required.
• Note that listing is for two (2) years period
  while registration is for (5) years.
• All applicants/manufacturers shall pay the
  prescribed fee for registration/listing
  Certificate after approval.
• Applicants/manufacturers shall submit mandatory
  post marketing surveillance report on the use and
  adverse reactions of the herbal medicinal
  products periodically.

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IMPORTED HERBAL MEDICINAL PRODUCTS

• In addition to General rules, the following
  documents are required for imported herbal
  medicinal products.
• Power of Attorney issued by the manufacturer and
  notarized by a notary public from the Country of
  Origin.
• Certificate of pharmaceutical production (COPP).
• Application for permit to import samples for
  registration/listing purpose.
• Evidence of satisfactory clinical trials
  conducted in the Country of origin as
  appropriate.
• Any other relevant information on the products

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• OTHER REQUIREMENTS INCLUDE
• Applicants shall submit dossiers containing
  relevant information on the products format.
• Oversea GMP INSPECTION will be carried out on the
  premises of the manufacturer of herbal medicinal
  products.
• A mandatory local clinical Trial in an approval
  Institution to be funded by the applicants
  /manufacturers must be carried out for full
  registration.
• On receipt of satisfactory laboratory reports,
  the products may be approved for registration/
  listing.
• Applicants shall also pay a prescribed fee for
  registration /listing Certificate after approval.

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LABELLING REQUIREMENTS

• The herbal medicinal preparations manufactured
  locally or imported to Nigeria shall carry the
  following basic labeling information in English
  and may include other languages.
• Name of the product (Not suggestive of
  therapeutic claim).
• Generic name if applicable.
• Quantitative list of Ingredients by their
  Botanical or common names.
• Dosage for and Net contents in terms of
  weight/measure count.

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• Directions for use
• Indications (shall be on the leaflet). No claim
  of cure is permitted until proven through
  clinical trial. Also subject to advertisement
  regulations.
• Batch number.
• Manufacturing date
• Expiry date
• Special storage conditions.
• Name and full location address of manufacturer.
• Provision for NAFDAC registration number.

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• Dosage
• Mode of administration.
• Duration of use (e.g. specify if expected
  response is not felt within a certain number of
  days consult your doctor)
• Specific symptoms of overdose and antidote on the
  leaflet
• Contra-indications/drug interactions
• Warnings, if any.
• Precautions. (E.g. use in pregnant and lactating
  mothers not recommended).

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PROMOTION OF TMP

• Public Enlightenment Campaigns throughout the
  country
• Developed a Standard Pharmacognosy Laboratory
• Conducted international and local trainings to
  build capacity.
• Sponsored the TMP to build strong associations.
• Supported Research Institutions and Universities.

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CONTROL OF ADVERTISEMENT

• Conducted a workshop to educate the media on the
  dangers of advertising the claims of HMPs which
  have not been substantiated.
• Media houses were warned that advertisement
  without clearance from NAFDAC will be sanctioned.
  
• Called on the NBC to support us in the crusade.
• The Director General also advocated to the State
  Governors to stop State Media houses from
  advertising the unapproved claims of herbal
  medical practitioners.

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PUBLIC AWARENESS CAMPAIGNS
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CONCLUSION

• NAFDAC has put in place appropriate mechanisms
  for the regulation and control of Herbal
  Medicines.
• We have encouraged practitioners to come out and
  market their products without much fear.
• The Agency is building strong collaboration
  between the Ministry of health, Research
  Institutes, Universities and the Practitioners.

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• THANK YOU

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Website www.nafdacnigeria.org Email naf
dacdg_at_nafdacnigeria.org nafdac_at_yahoo.com
nafdac.lagos_at_alpha.linkserve.com CONTACT
PHONE NUMBERS ABUJA 234-9- 5240994-6 LAGOS
234-1-2693104-5 GSM 234-80 33112282
OR
234-80 441 83109
FEDERAL REPUBLIC OF NIGERIA
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