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PSN disagrees with NAFDAC, PTF on search for local COVID-19 cure

PSN disagrees with NAFDAC, PTF on search for local COVID-19 cure

The umbrella body of pharmacists in the country, the Pharmaceutical Society of Nigeria, has disagreed with the Federal Government and the National Agency for Food and Drug Administration and Control over the search for cures for COVID-19.

The Secretary General of the  PSN, Emeka Duru, in an interview with The PUNCH on Wednesday, stated that the National Institute for Pharmaceutical Research and Development had several relevant drugs waiting to be developed.

The Director General of NAFDAC, Prof Mojisola Adeyeye, had  in a statement earlier  on Wednesday, said the agency had received only one application for the treatment of COVID-19 symptoms.

According to her,  claims on the  COVID-19 cure  are domiciled in either the conventional news media or the social media.

Also, the Chairman of the Presidential Task Force on COVID-19 and Secretary to the Government of the Federation, Mr Boss Mustapha, had,  at the PTF press briefing on Tuesday, challenged Nigerian researchers to produce drugs and vaccines for COVID-19.

On Monday, Mustapha said the President, Major General Muhammadu Buhari (retd.), had directed that COVID Organic,  a herbal drug produced by Madagascar, be airlifted to Nigeria.

But the PSN, in a statement on Tuesday by its President, Mazi Ohuabunwa, kicked against the directive, saying it was “thoroughly disgraceful.”

Nobody is seeking approval for COVID-19 cure – NAFDAC

Commenting on COVID-19 cure,   NAFDAC DG, Adeyeye, noted that the rush to mitigate the mortality and morbidity from the  pandemic had resulted in acceleration of product development, repurposing of formulations, off-label use of therapeutics and the search for a vaccine to prevent the virus.

She said, “Because no vaccine yet exists to prevent further spread of the virus, the huge burden of developing a cure or, at best, a treatment for this deadly virus rests squarely on the shoulders of the medical world, of which Nigeria is no exception.

“In a bid to discover a cure, therefore, the public has witnessed quite a number of claims from different quarters – complementary and alternative medicine practitioners, traditional healers, and the academia. It is pertinent to note, however, that these claims are domiciled in either the conventional news media or the social media.

“NAFDAC, as of the time of this press release, has only received an application from one company for a product the company is presenting (for approval) to the agency for the treatment of the symptoms of COVID-19, and not for the cure of COVID-19 as a disease.”

Adeyeye explained that a claim of a cure must be subjected to clinical evaluation through well-controlled, randomised clinical trials, following an approved clinical trial protocol.

She said, “That Africa as a continent is blessed with diverse plants and herbs that constitute a source of food and medicine is incontrovertible. The drugs of today’s modern society are products of research and development by major pharmaceutical companies.

“Among the most important raw materials researched and developed are naturally occurring materials obtained especially from plants. It should be mentioned also, however, that many plants are similarly very poisonous.

“As the agency that has been saddled with the mandate of safeguarding the health of the citizenry, NAFDAC will continue to make sure that only medicinal products (including herbal remedies) that have proven safety data will be approved for use by the public.”

According to her, the agency currently lists herbal medicines based on historical perspectives on the use of the products after carrying out toxicological and microbiological evaluations in the laboratories to ensure that they are, at the minimum, safe.

She added that the listing status was valid for two years and renewable.

Adeyeye stated, “It does not validate the efficacy claims being made for the products hence, the labels must bear a disclaimer informing the consumer, ‘The claims have not been evaluated by NAFDAC’. This minimum requirement of ‘proof of safety’ is the agency’s way of encouraging production of herbal remedies from the country’s rich diversity of plants.

“Part of the efforts to advance herbal products development informed the setting up of the Nigerian Herbal Medicine Product Committee by the DG, NAFDAC.

“The platform brings together manufacturers, academia, researchers and relevant stakeholders by bridging the gap often created between traditional medicine practitioners (possible patent holders) and drug manufacturers, whose responsibility it would be to formulate the products.”

FG not doing enough – PSN

But the PSN Secretary General, Duru, said the Federal Government was not doing enough to encourage production of COVID-19 drugs in the country.

Duru said, “People are saying, ‘We are here, we can do this.’ The Ministry of Health just made available a cough syrup that can be used to ameliorate the kind of cough you have in COVID-19 patients.

“That drug now has been sent to NAFDAC for it to validate, list that drug after clinical trials and tell the producer it can be brought into the market for use.

“If you go to the NIPRD  also, it has a lot of research products on its shelves and nobody is looking its way. It has malaria medicines, antiviral medicines, and cough syrups that only require money to develop them into products.”

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