Mandated to ensure the general public has access to safe, effective, and quality drugs, the National Drug Authority also regulates herbal products that exceed home parameters.
The National Drug Authority (NDA) explored guidelines for bringing herbal medicines to the market following an increase in the number of researchers and herbalists developing herbal remedies for the symptoms. linked to covid-19 such as flu and cough, among others.
Appearing in their new weekly report Thursday, Dr Micheal Mutyaba, director of herbal medicine at the NDA, said: “We do not currently regulate homemade concoctions; at home or in a community setting. But any product that goes beyond the domestic part of the commercial supply chain, that product needs to be regulated because we need to see the safety profile in the wider population to ensure that people who access it get a safe and effective product.
For evaluations, herbalists are required to submit analytical reports of their products “because the NDA considers quality to be intrinsic”.
“One of the tests is phytochemical analysis. Simply put, this test ensures that the product contains components of plant origin. The other test is a microbial analysis to make sure that this product does not have germs; bacteria that will affect people taking the medicine again, ”he explained.
Dr Mutyaba further said that they carry out audits of herbal medicine manufacturing facilities and regular visits for quality assurance.
“One of the objectives is to carry out an oriental training to see how best to improve the quality of the product produced on sight. Secondly, you have to do a quality assurance inspection, to make sure that the processes followed by the manufacturers can ensure that at the end of the day, the end product is of good quality.
He revealed that capacity building training for herbalists and leaders of herbal associations has been carried out.
“The NDA has worked with the Ministry of Education and the country now has a training program. This will ensure that the end product is of quality from the garden stage to its manufacture, ”added Mutyaba.
Currently, around 190 herbal products have been notified.
For a product to go through the first step of notification, applicants must submit an application form along with the required fee of Shs 10,000 and analytical reports to support their products, such as phytochemical, microbial and acute toxicity reports, among others.
“We also need two physical samples, representative of what exists on the market. NDA should visit your manufacturing premises to make sure that you are making the product and that you are not a briefcase company, ”he said.
Herbalists without a manufacturing facility were encouraged to engage in contract manufacturing.