Committee adopts draft guidelines for verification of herbal cure claims - The Guardian Newspapers

Thursday, 19 September 2013 00:00 By Chukwuma Muanya Features - Natural Health

THE National Expert Committee on Verification of Herbal Cure Claims (NECVHCC) set up in February 2013 by the Director General of the National Agency for Food Drug Administration and Control (NAFDAC), Dr. Paul Orhii, on Tuesday adopted a draft guideline.
  The 16 man Committee made up of professors of medicine and pharmacy, traditional medicine practitioners, relevant government agencies, The Guardian’s Natural Health Desk, among others also promised to present at least six herbal products within one year or less to President Goodluck Jonathan for global marketing.
  Members of the Committee include: NAFDAC’s Director of Drug Evaluation and Research (DER), Mrs. Hauwa Keri, as the chairman, Director of Food and Drug Safety (FDS) at the Federal Ministry of Health (FMoH), Mrs. Mary Okpeseyi, President National Association of Nigerian Traditional Medicine Practitioners (NANTMP), H.R.H. Omon Oleabhiele, NAFDAC’s Director of Pharmacovigilance (PVG), Mrs. Adeline Osakwe, Professor of Pharmacy at Obafemi Awolo University (OAU), Ile-Ife, Anthony Elujoba, Director at Nigerian Institute of Pharmaceutical Research and Development (NIPRD), Prof. U. A. Osunkwo, Director of Research at NIPRD, Prof. Emeje Martins, Managing Director, Nigerian Medicinal Plants Development Company (NMPDC) Hajia Zainab Sheriff, Dr. Olufunsho Awodele of the University of Lagos.
  Other members of the Committee include NAFDAC’s Director of Special Duties, Abubakar Jimoh, Consultant Ophthalmologist at Lagos University Teaching Hospital (LUTH), Prof. Adefule-Ositelu, Chief Executive Officer (CEO) of Halamin Nigeria Limited, Dr. Ben Amodu, NAFDAC’s Deputy Director DER, Mrs. P. Odu, NANTMP Secretary Yobe State, Dr. Muhammad Ibrahim Jawa, President Moringa Development Association of Nigeria, Mr. Dammy Kadashi and Head Science/Health/Natural Health Desk of The Guardian Newspapers, Chukwuma Muanya.
  Osunkwo and Emeje, who were given the responsibility of drafting the guidelines for the verification of claims and modalities for funding of the studies, said the draft guidelines for the verification of claims towards developing full monograph should among other things include: the name of the plant and general description such as the scientific name with author, synonyms, family, vernacular names, botanical description, plant part used, and possible alternative source species.
  Chairman of the Committee, Mrs. Hauwa Keri, said the guideline is not supposed to discourage the NANTMP. “Do not be frightened. We need to do this because Nigeria is not an island. We have got to do this and this committee is not representing any interest or specific group but that of all Nigerians.”
  Keri said that the Terms of Reference (TOR) for the Committee included verification of claims on herbal medicinal products, selection of listed herbal medicinal products for verification with reference to the NAFDAC list, Nigeria Herbal Pharmacopeia, other relevant monograph, determination of centres for study with NIPRD as focal reference; development of guidelines for verification of claims, selection of fellows, vetting and consideration of the study design plan developed by the Fellows, advocacy to collaborating partners such as Nigeria Broadcasting Cooperation (NBC), Advertising Practitioners Council of Nigeria (APCON), Federal Ministry of Information (FMoI), among others and presentation of at least six herbal products within one year or less to the President of the Federal Republic of Nigeria.
  Keri at the third meeting of the Committee but first meeting of the expanded Committee said the TOR should also include documentation. “Documentation is very necessary for traditional medical practitioners. They should do everything to make sure their products are registered. NAFDAC is ready to identify with such practitioners who documents the patients progress and extra mile report that the patient can be seen physically if the need arises,” she said.
  The NANTMP President said assured that his members are going to do cooperate with the Committee. “We agree to cooperate with NAFDAC to make sure that traditional medicine is accepted in Nigeria without conflict,” Oleabhiele said.
  He added: “We have set up a task force in all the zones that will go into the field and make sure that traditional doctors making claims have registered NAFDAC products. The taskforce is also going to report non-compliance to NAFDAC and advise them to register their products.”
  Osunkwo said the issue of pharmacovigilance should be ensured. “This has to sink down into the minds of traditional medicine practitioners. It is unfortunate that at the pharmacovigilance centre, little or no information is coming from NANTMP,” he said.
  The draft guideline also contains ethno botanical information like major ethno pharmacological uses, other relevant uses, chemical constituents and compounds.
  Emeje and Osunkwo said that there should also be quality control, which will include identification, organoleptic properties; macroscopic characteristics, microscopic characteristics, solubility, moisture content, TLC/HPLC/GC, markers and quantitative methods, FTIR spectroscopy, DNA finger printing, purity tests/requirements, adulterants and adulterations, standard preparations and standard specifications.
  The guideline also contains test for pharmacological properties such as pharmacodynamic properties, in vitro experiments, in vivo experiments, clinical studies and pharmacokinetic properties.
  According to the guideline, herbal cures should also be tested for safety data like ethnic use safety data, preclinical safety data, single dose toxicity, repeated dose toxicity, mutagenic potential, carcinogenicity, sensitizing potential and clinical safety data.
  The guideline contains provision for key proposed usage for the herbal product such as therapeutic indications, dosage, method and duration of administration, contraindications, special warnings and precautions for use, effects on ability to drive and use machines, interactions, pregnancy and lactation, adverse effects, overdose and evaluation of efficacy.
  Another important component on the proposed draft guideline is trade information. These include volume of production in the country, volume of domestic consumption, volume of export, average price, nature of plant material, nature of plant product, processing and storage.
  According to the guideline, the herbal product must contain regulatory information such as pharmacopeias/monographs, regulatory/registration status, patents, traditional information, possible developments, outlook on further uses and research, antidotes and references.