On Saturday Director General of National
Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola
Adeyeye in a statement she signed and made available to the News Agency of Nigeria
(NAN) in Abuja disclosed that 21 herbal medicinal products are currently being
processed by the agency for Safe use or Listing status.
Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola
Adeyeye in a statement she signed and made available to the News Agency of Nigeria
(NAN) in Abuja disclosed that 21 herbal medicinal products are currently being
processed by the agency for Safe use or Listing status.
She said that the 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.
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.
In the statement, the director-general
said that no clinical study has yet been conducted on any of the products to
prove their claim to effectiveness.
said that no clinical study has yet been conducted on any of the products to
prove their claim to effectiveness.
Listing status includes reviewing the
formulation composition, product labeling, manufacturing process and testing
‘Safe to use.
formulation composition, product labeling, manufacturing process and testing
‘Safe to use.
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.
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.
that the medicine is an immune boosters and an anti-infectives.
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.
requirements, a listing status is granted with a clear disclaimer that states
clearly that the claims have not been evaluated by NAFDAC.
Adeyeye said 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.
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.
She said that in order to provide
additional information and evidence of good manufacturing practice for their
medicines, most of the applicants who submitted herbal medicines that are
currently being processed were issued compliance directive.
additional information and evidence of good manufacturing practice for their
medicines, most of the applicants who submitted herbal medicines that are
currently being processed were issued compliance directive.
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.
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 social media that NAFDAC has specifically approved the Paxherbal
product for treating coronavirus-related symptoms is wrong and inaccurate.
circulating in social media that NAFDAC has specifically approved the Paxherbal
product for treating coronavirus-related symptoms is wrong and inaccurate.
No herbal medicine manufacturer can
claim efficacy for treating associated symptoms of COVID-19 until a clinical
study is conducted in a scientific manner.
claim efficacy for treating associated symptoms of COVID-19 until a clinical
study is conducted in a scientific manner.
