Manufacturing Inspection: NAFDAC To Visit 614 Herbal Medicine Practice Facilities
The National Agency for Food and Drug Administration and Control (NAFDAC) has mapped out its strategic plans to take the herbal medicine practice to a greater height where products would be globally acceptable and competitive in the international market.
The Director General, Prof Mojisola Adeyeye dropped the hint on Friday in her message to commemorate the 2023 International Traditional Medicine Day which is celebrated on the 31st of August of every year.
Prof Adeyeye who commended the efforts of herbal medicines manufacturers across the country for their resilience, noted with a sense of pride the foray of several herbal formulations at the clinical trial preparatory to getting approval for NAFDAC registration number.
” The Guidelines for the Good Manufacturing Practice in herbal medicine production has been prepared by the Agency”, she said, adding that the Agency is working on a 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 in the business after the training.
Based on the training they will receive, she said” 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 DG explained that the facilities have been divided into zones, with the Agency staff across the federation to be deployed for the exercise.” In the Southwest, our staff in Lagos, Ibadan, and Ogun will be deployed for the exercise. Likewise, people in the North, Southsouth and other zones”, she said, noting that deploying NAFDAC staff in each zone for the job would reduce the cost on the Agency.
Prof Adeyeye disclosed that the stakeholder’s training will start with Lagos which has over 317 facilities, noting that” we can’t enforce the rules when we have not taught them what to do”.
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 visit them for inspection, adding that anyone who is not functioning well will 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. Admitting that sometimes the herbal medicines are in capsules or syrup, she said, they don’t have an automated filling machine for capsules.
She noted that the manual method is not safe, warning that after December, the Agency would not register any company without the semi-automated or automated capsule filling machines. She stressed that a lot of people are using herbal. ” The earlier we raise our standard the better for us”.
She disclosed that the University of Lagos is 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.
Giving an insight into the GMP guidelines, Prof Adeyeye said It will help the practitioners to know how to run their manufacturing plant, 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.”
Prof Adeyeye said that the guidelines emphasized the need for hygiene, adding that the guidelines also talk about the premises. How the premises should be, insisting 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, however, expressed delight that three herbal product manufacturers are being awaited to conclude the clinical trial. She disclosed that the three products piloted phases one and two, adding that they are 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, stressing that people react 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.
