Nigerian government’s effort at harnessing indigenous cure to curb the spread of COVID-19 pandemic, which has now spiked to over 30,000 cases in the country with 709 deaths, got a significant boost at the weekend. This followed the official approval by the National Agency for Food and Drug Administration and Control (NAFDAC) of the drug
Nigerian government’s effort at harnessing indigenous cure to curb the spread of COVID-19 pandemic, which has now spiked to over 30,000 cases in the country with 709 deaths, got a significant boost at the weekend.
This followed the official approval by the National Agency for Food and Drug Administration and Control (NAFDAC) of the drug PAXHERBAL CUGZIN, produced by Pax Herbal Research and Laboratories, Ewu, Edo State.
According to the Chief Executive Officer of the Centre, Rev. Fr. Anselm Gbenga Adodo, the drug had been approved for the treatment of the symptoms associated with COVID19-19.
Fr. Adodo who made this known in an exclusive chat with the Catholic Herald, said the approval marks a major breakthrough in the treatment of symptoms associated with the virus.
“After series of screening spanning a period of 8 weeks, NAFDAC has approved our herbal drug, PAXHERBAL CUGZIN, for public use. It is the first to be so approved and presently the only one. The drug is specifically for treating the symptoms associated with the coronavirus.”
The drug, PAXHERBAL CUGZIN, bears the NAFDAC approved number: A7-4358L.
“With this development, an official approval has been given by the federal government through the Ministry of Health for the mass production and use of GUCZIN for the treatment of symptoms associated with COVID-19 in Nigeria,” the monk of the Benedictine Monastery also located in Ewu said.
Adodo explains, “It is 100% formulated, developed and produced by our Ewu research team. We decided to go it alone since it became a highly political issue which we didn’t envisage. The next stage is to conduct clinical trials. We will apply to NAFDAC for the approval shortly. But we will do so in particular with the Federal Ministry of Health. We can’t do it alone.
“It’s for the treatment of the symptoms. It’s confirmed safe for public consumption. Same way as hydro chloroquine is used to treat covid-19. It’s not the official drug but approved for the treatment of the symptoms,” he said.
But the Director General of NAFDAC, Prof Mojisola Adeyeye dismissed the claim that it’s a drug for the cure of Covid-19 since no clinical trials had been done to validate its efficacy.
According to her, “Paxherbal applied for Listing of Pax Herbal Cugzin capsule 290mg which was approved by NAFDAC and Listed as “Safe to use”.
“The applicant claimed that it is an immune booster and an anti-infective.
“However, as part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label which clearly states that the claims have not been evaluated by NAFDAC.
“Therefore, the statements 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” Adeyeye said.
Explaining further, she says, “NAFDAC is currently processing twenty one (21) herbal medicinal products for “Safe to use” or Listing status. Many of the applicants claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.
“However, 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 manufacture 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 claims have not been evaluated by NAFDAC.
“The applicant can arrange for clinical trials that will involve use of human subjects in order to prove efficacy or claim for treatment following laid down procedures and with the approval of NAFDAC.
“However, Listing of a herbal product is not a requirement for the conduct of Clinical Trials.
“Most of the applicants that submitted herbal medicines that are currently undergoing processing have been issued compliance directives to provide additional information or/and evidence of Good Manufacturing Practice or environment fit for production of the medicines,” the NAFDAC DG added.
In an exclusive interview with Nigerian Democratic Report (NDR), Adodo said, “We have done the preclinical trials which confirm that the drug is safe for human consumption. Clinical trial is expensive, and we cannot do it alone. Preclinical trials involve acute toxicological text, sub-acute toxicity test, in-vivo and in-vitro studies, safety studies, dosage determination etc
“We don’t need NAFDAC approval for preclinical. But we work with registered public analysts and consultants. We have a very good animal house here at paxherbal. We also have very good laboratories. So we have the capacity to do many of the trials. Clinical trial is when you begin to administer the drug to human beings under strict monitoring. NAFDAC will need to issue a permit for that, but the trial itself can take place in any recognised health centre,” he said.
A Specialist in Alternative and Complementary Medicine and Phytomedicine Research, Adodo had in April 29th given some inkling about the work of his Centre in respect to finding indigenous cure for Covid-19.
“Many of you have asked what Paxherbals is doing regarding the current COVID-19 pandemic, which is ravaging the world, Your inquiry is based on your faith, trust and confidence in the Paxherbals brand. We will never take such trust and confidence for granted
“Plant-based drugs, whether crude or refined, are seemingly the best alternative approach to the COVID-19 menace. The new generation of vaccine development for combating emergent diseases needs time because of safety profiling. On the other hand, plant-based formulations are easily manufactured, stored and distributed and are readily acceptable by the local population. Moreover, they can easily be handled by both professional and non-medical research personnel with no risk of contamination.
He then revealed that “Paxherbals has developed a novel drug, called CVO PLUS specifically for the treatment of COVID-19. Pax CVD PUIS contains herbs and active phytoconstituents with documented scientific evidence based on clinical reports of their efficacy and safety These herbs have been used in several therapeutic formulations of Paxherbals over the past 25 years for the treatment of hepatitis C Tuberculosis, HIV/A1DS. Bronchitis, Pneumonia and Malaria.
“Some bioactivc constituents of CVD PLUS are potential antiviral agents and immunomodulatory agents that can stimulate antibody production against Coronavirus related diseases. However, since herbal medicines are mostly crude, subsequent development requires some level of high-tech for extraction, purification and much screening with advanced facilities, The key focus is safety, sustainability, efficacy, standardization and availability.
“We are grateful to the Director-General of the National Institute for Pharmaceutical Research and Development (NIPRD). Dr Peter Adlgwe. The Director-General of Nigeria Institute of Medical Research (NIMR), Prof, Tunde Salako and the Director-General of NAFDAC, Prof Catherine Adeyeye for their interest, support and encouragement so far. Each of them has appointed their experts to work with Paxherbals on this special project Paxherbals is also working with scientists from the University of Benin. University of Lagos and Irrua Specialist Teaching Hospital, Edo State.
“We are happy to note that NAFDAC is ready to speed up the drug regulation, evaluation and approval process of CVD PLUS. The Nigerian law does not permit the use of any drug or medicine by the public unless it has passed through some basic processes of standardization and scientific evaluation, in line with global practices. Anyone or any organization who claims to have a cure for any disease is expected to submit the product for critical screening and scientific analysis. No sentiments. No cultural bias. No subjectivism
“In the meantime, Paxherbals hereby recommend the following NAFDAC approved Pax products for the management of many of the symptoms associated with COVID-19.1 Paxherbal Bitters. 2, Paxherbal Bitter tea. 3. Paxherbal Health tea.
“We thank the Catholic Bishops of Nigeria for their words of encouragement and expression of confidence in Paxherbal. May God continue to bless and protect us all,” Adodo said.