The National Agency for Food and Drugs Administration and Control, NAFDAC, says it will not register any company without the semi-automated or automated capsule filling machines after December this year.
Registration of the herbal capsule filling medicine which is one of the guidelines for Good Manufacturing Practice in herbal medicine production will raise the standard of the products for global acceptability and competition in international market.
The Director General, NAFDAC, Prof Mojisola Adeyeye who gave the warning in a message to commemorate the 2023 International Traditional Medicine Day which is celebrated on the 31st of August every year, noted that the manual method is not safe, adding that since a lot of people use herbal, the earlier the standard is raised, the better for us for the country.
” 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”. Adeyeye
She identified 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.
The DG explained that the Agency is working on a series of training for the practitioners to get them accustomed to the guidelines and
officers of the Agency will begin 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, 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 “. She said
Giving an insight into the GMP guidelines, Prof Adeyeye said It will help the practitioners to know how to run their manufacturing plant, as 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
However, the University of Lagos is establishing a manufacturing facility so that all the herbal practitioners who do not have funds can use the facility for production at a token.
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’’. She said
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.
” According to her, the practitioners are expected to present the pilot study results from evaluation and if satisfied, they move to the larger study and later grant approval for full registration”, 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 “. Adeyeye.