National Agency for Food and Drug Administration and Control (NAFDAC) says 21 herbal medicinal products are currently being processed by the agency for “Safe use” or Listing status.
Prof. Mojisola Adeyeye, the Director General of the agency, disclosed this in a statement she signed and made available to the News Agency of Nigeria (NAN) in Abuja on Saturday.
According to Adeyeye, manufacturers of these products who have applied to the agency claimed that their products are only immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.
The director-general said in the statement that no clinical study has been done yet on any of the products to prove their claim of efficacy.
“Listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufature and ‘Safe to use’ testing.
“Once the product is able to meet all requirements, a listing status is granted with a clear disclaimer that states clearly that the claims have not been evaluated by NAFDAC.
“The applicant can arrange for clinical trials at this stage, that will involve use of human subjects in order to prove efficacy of claim for treatment following laid down procedures and with the approval of NAFDAC,” Adeyeye said.
She said that most of the applicants that submitted herbal medicines that are currently undergoing processing have been issued compliance directive to provide additional information and evidence of good manufacturing practice for their medicines.
According to her, PAXHERBAL, a pharmaceutical company applied for listing of Pax Herbal Cugzin Capsule 290mg, which was approved by the agency and listed as “Safe to use”.
She said the applicant only claimed that the medicine is an immune boosters and an anti-infectives.
Adeyeye added that as part of the labeling of the product, and in line with global practice, a disclaimer is on the product label that clearly states that the claims have not been evaluated by NAFDAC.
According to her, the statement circulating in the social media that NAFDAC has approved Paxherbal product “specifically for treating symptoms associated with coronavirus is wrong and inaccurate.
“Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms”.
