Lagos, Sept. 10, 2023 – The National Agency for Food and Drug Administration and Control (NAFDAC) plans to take the herbal medicine practice to greater heights where the products would be globally acceptable and competitive.
Prof Mojisola Adeyeye, its Director General, said this on Friday in her message to the 2023 International Traditional Medicine Day celebration.
She commended efforts of herbal practitioners across the country for their resilience, noting their sense of pride to foray into several herbal formulations to get approval for NAFDAC registration number.
Adeyeye said that guidelines for the good manufacturing practice in herbal medicine production had been prepared for them and the Agency was also working on series of training for the practitioners to get them accustomed to the guidelines.
According to her, officers of the Agency would, thereafter, commence vigorous inspections of facilities to ascertain the level of preparedness of the herbal practitioners after the training.
“We will be able to make sure that they follow the guidelines to the letter”, stressing that the Agency would pass down the knowledge of the guidelines to the over 614 herbal medicines facilities in Nigeria.”
The NAFDAC boss said the visit to the facilities had been divided into zones.
“In the Southwest, our staff in Lagos, Ibadan, and Ogun will be deployed for the exercise. Likewise, people in the North, South-south and other zones,” she said.
She said the deployment of NAFDAC staff in each zone for the job would reduce the cost on the Agency.
Adeyeye said the stakeholder’s training would start with Lagos which had over 317 facilities,
She said after the training, the herbal practitioners would be given about a month or two to get themselves ready before the Agency’s staff would visit them for inspection.
Adeyeye said anyone who is not functioning well would either have his facility shut or placed on hold.
” In herbal production, the level of hygiene is not so high. We have been telling those facilities that we visited that they needed to do something about their filling”.
She identifies capsule filling as one aspect of their operations that has posed a big challenge since don’t have an automated filling machine for capsules.
Adeyeye said the manual method was not safe, warning that after December, the Agency would not register any company without the semi-automated or automated capsule filling machines.
She said that since many people were using herbal,” the earlier we raise our standard, the better for us”.
NAFDAC boss said the University of Lagos had been trying to establish a manufacturing facility so that all the herbal practitioners who don’t have funds can go there and use the facility for production at a token.
She said this would help the practitioners to know how to run their manufacturing plants, adding that the guideline talks about personnel, qualifications of the personnel amongst others.
” 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.”
Adeyeye said the guidelines emphasized the need for hygiene, adding that the guidelines also talked about the premises, stressing that “we want a building that will make contamination impossible”.
She said the inspectors from the Agency would be concerned about how the equipment is placed to avoid cross-contamination because 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.
“It also talks about the Stores, where the raw materials are kept in such a way that contamination should be avoided. The production flow and the finished products. We will find out how they source and store their raw materials and finished products’’.
The NAFDAC boss expressed delight that three herbal product manufacturers are abot to conclude the clinical trial.
She said the three products piloted were in phases one and two, adding that they were still being awaited to come back and validate their claims with a larger population sample size.
”We encourage the practitioners to present the pilot study results and we will evaluate and if satisfactory, they can move on to the larger study and later grant approval for full registration”, she said,
Adeyeye said people reacted differently to different drugs, hence the need for a larger number of samples for the study in the larger phase 3 study of the clinical trial. (GBN)
