The National Agency for Food and Drug Administration and Control has promised to ensure improvement in the production of herbal medicines to enable global acceptance.
This was contained in a statement signed by the Director General of NAFDAC, Professor Mojisola Adeyeye, and made available to journalists on Sunday by the media consultant, Mr. Olusayo Akintola.
It was noted that Adeyeye made the promise in a message to commemorate the 2023 International Traditional Medicine Day, celebrated every Aug. 31.
The DG commended the efforts of herbal medicines manufacturers across the country for their resilience.
She noted with pride the development of several herbal formulations and their progress from the clinical trials stage to the approval stage by NAFDAC.
Adeyeye said that the guidelines for the Good Manufacturing Practice (GMP), in herbal medicine production had been prepared by the agency.
According to her, NAFDAC is working on a series of trainings for practitioners to get accustomed to the guidelines.
She said officers of the agency would commence vigorous inspections of facilities, to ascertain the level of preparedness of the herbal practitioners in the business after the training.
According to her, NAFDAC will monitor and ensure compliance with the guidelines after the training, and step down knowledge of the guidelines to the more than 614 herbal medicine facilities nationwide.
Adeyeye said this was imperative to sanitise the sector as the agency could not enforce rules on herbal medicine practitioners who had not been trained.
The DG explained that the facilities had been divided into zones, and the agency’s personnel across the federation would be deployed for the exercise.
She said the strategy would also apply to practitioners in all other zones of the country, stressing that the deployment of NAFDAC personnel in each zone for the job would reduce costs for the agency.
The DG disclosed that the stakeholder’s training would start with Lagos, which has more than 317 facilities, adding that after the training, the herbal practitioners would be given a few weeks to get ready for the inspection visits by NAFDAC personnel.
Adeyeye warned that any herbal practitioner that does not meet the agency’s standards would have the facility either shut down or placed on hold.
She noted that the agency was mostly worried about hygiene in herbal medicine practice, and so was training and counselling owners of the facilities visited to change their filling process.
She identified capsule filling as one aspect of their operations that was posing a big challenge to NAFDAC, as most herbal medicines were in capsule or syrup form and they do not have automated filling machines and were using the manual method which was unsafe.
Adeyeye, therefore, warned that by the end of this year, the agency would not register any company without semi-automated or automated capsule-filling machines.
She noted that many Nigerians were using herbal medicine and that the earlier the standard was raised, the better for the country.
The NAFDAC DG disclosed that the University of Lagos was establishing a manufacturing facility to enable all practitioners who do not have funds for filling automation to use the facility at an affordable and reduced price.
She said, “Herbal manufacturing GMP requires that the personnel be qualified, and the building be constructed to specific standards.
“The floor, walls, and roof must be clean, smooth, and impervious to moisture.
“All these are required to make contamination impossible as the guidelines emphasise the need for hygiene and also how the premises should be.
“We want a building that will make contamination impossible, The inspectors from the agency will be specific about how the equipment is placed to avoid cross-contamination.
“In manufacturing, personnel are the greatest agents of contamination to products, the machines should be well placed to allow free flow of movement of staff.”
Adeyeye promised that the agency would find out how practitioners sourced and stored their raw materials and finished products.
The NAFDAC boss, however, expressed delight that three herbal product manufacturers were being awaited to conclude the clinical trials on some medicines.
She encouraged practitioners to present pilot study results for evaluation, saying that if found satisfactory, they could move to the larger study and later granted approval for full registration.
According to the DG, people react differently to different drugs, hence the need for a larger number of samples for the study in the larger phase three clinical trials.