Covid 19 variants: Nigerians should prepare to take booster shots — NAFDAC DG

Says N997m of the COVID -19 intervention fund spent on laboratory’s equipment

Destroys N2 trillion Tramadol, N4bn unwholesome products in 4 years

Secures 20 prosecutions of drug counterfeiters

By Chioma Obinna, Joseph Erunke  & Gabriel Olawale

The Director-General of the National Agency for Food & Drug Administration and Control, NAFDAC, Prof. Moji Adeyeye on Tuesday said Nigerians who have taken their vaccine should make themselves available for booster doses even as she said the Agency has recovered N639,590,298 evaded administrative charges from stakeholders.

Speaking during her 4th anniversary in office,  Adeyeye who noted that the COVID-19 pandemic has taught the country a lesson as a result of decades of neglected health sector added that the government is realising this fact and is ready to support local manufacturing of vaccines which will commence in few months.

She further hinted that every Nigerian who is fully vaccinated should make themselves available for a booster dose. “You will recall that sometimes in February and March, I took my COVID-19 vaccine as many Nigerians did and the country has not recorded anything strange since then.

“The call for a booster dose is not that the vaccine is not effective but it remains an only sure way to prevent death. I must clarify that booster dose is not going to prevent people from contacting COVID-19 but will prevent people from being hospitalized.

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“There are no COVID-19 vaccines that have been declared as ineffective but the time of protection is limited that is why you need a booster. It’s better to have a vaccine that you can take and prevent death than not take the vaccine and die.

Agency recovered N639,590,298 evaded administrative charges from stakeholders Adeyeye said, “I met N3.2bn debt but confronted this big challenge with great resolve to change the negative narration by working relentlessly with the finance and account directorate. We brought financial sanity to the agency by stepping down all fictitious claims, introducing budget discipline to all financial activities in NAFDAC, and reducing the debt profile of the agency from N3.2bn to zero.

“We recovered the sum of N106, 590,298.52 erroneously credited to another MDA as a result of deep reconciliatory exercise carried out in our financial account unit. We also recovered another N533 million evaded administrative charges between 2014 and 2017 from stakeholders by the Ports Inspection Directorate.”

Says N997m of the COVID -19 intervention fund spent on laboratory’s equipment

Adeyeye disclosed that about N997m of the COVID -19 intervention funds has been spent on the laboratory’s equipment while the agency seized and destroyed Tramadol worth N2 trillion and substandard and falsified medicines of over N4 billion in the last four years.

Secures 20 prosecutions of drug counterfeiters

She noted that out of arrests made so far, 20 prosecutions of drug counterfeiters was recorded with the culprits either serving their jail term or fined for their unscrupulous activities.

 According to her, the street value of falsified medicines and unwholesome food products and cosmetics which were seized and destroyed nationwide between the months of March and August of 2021 alone stood at over N5 billion.

She said: “It is also worthy to mention here that, following my relentless efforts which took the Agency back to the Ports in May 2018; coupled with rigorous inspection and enforcement activities; the Agency

Destroys N2 trillion Tramadol, N4bn unwholesome products in 4 years

In collaboration with Nigerian Customs Service has seized and destroyed SFs, unwholesome foods and other unregulated products worth Four Billion, Two Hundred and Sixty Thousand Naira (N4,000,260,000) in exercises across the nation and Tramadol with an estimated street value of about two trillion nairas (N2,000,000,000,000).

“Over twenty prosecutions of people responsible for counterfeiting or trading in substandard falsified medicines have taken place with most of them ongoing with a few fined or sentenced to imprisonment.

“The impact is there. Most of the Tramadol merchants have gone underground. They have been almost decimated leaving only just a few of them there. And we will continue to pursue them until they turn a new leaf and abandon the dangerous trade.

“As a continuum of ensuring that SFs and counterfeit medical products are removed from the market, the Agency has procured 40 units of detection devices that can be used for on-the-spot detection of SFs in the market. NAFDAC will be the only agency in the world to go to this extent to rid the market of SFs.

“Under this regulatory building block, NAFDAC was expected through the WHO Audit to satisfy 76 recommendations in 2018 and has of today fulfilled the requirements.”

The NAFDAC boss added that “About N997m of the COVID -19 intervention fund has been spent on the laboratory’s equipment. OPCW gave us N735m, and everything was spent on lab equipment.  As part of strengthening the Agency’s processes, the Yaba Drug and Biologics/Vaccine laboratories are currently being expanded and under construction.  Based on this continual improvement, the 114 recommendations have been met as of October 2021”

Speaking on the agency’s plan to rid the country of substandard and falsified medical products, she said NAFDAC has placed “a premium on local manufacturing of regulated products to ensure that Nigeria will have drug security and turn the tide from 70% imports to about 30% imports by the Year 2025.”

 “Part of the goal is to also mitigate SFs and counterfeiting since ensuring the quality is much easier compared to an imported product.

 She explained that to enhance local production of pharmaceuticals in Nigeria, the agency has reviewed and updated its Five Plus Five-Year Validity policy.

 “A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up a local manufacturing plant. Upon successful renewal for another five years for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production. At the end of Year 7 (First 5 years + 2 years into renewal), if there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of the year.

 “The migration to local manufacturing will be limited to products the local manufacturers have the capacity to produce or that partnership would enhance the capacity to manufacture. This is with a view to reducing the number of registered imported products and encouraging local manufacturing and innovation.

 “NAFDAC has also placed emphasis on local herbal medicines by stepping down approval of imported herbal medicines that have equivalence in Nigeria”, Prof. Adeyeye explained that,” This is to create a renaissance of our herbal medicines and mitigate possible falsification and counterfeiting.”

 “In this bid, NAFDAC inaugurated the Herbal Medicine Product Committee in March 2019 and has fostered collaboration between herbal researchers and local practitioners. This has led to the joint submission of research proposals for funding for clinical trials of products that have been given listing approval by NAFDAC so that the product can be given full approval.”

READ ALSO: COVID-19 Variant: Okowa urges Nigerians to embrace vaccination

 She explained that to enhance local production of pharmaceuticals in Nigeria, the agency has reviewed and updated its Five Plus Five-Year Validity policy.

 “A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up a local manufacturing plant. Upon successful renewal for another five years for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production. At the end of Year 7 (First 5 years + 2 years into renewal), if there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of the year.

 “The migration to local manufacturing will be limited to products the local manufacturers have the capacity to produce or that partnership would enhance the capacity to manufacture. This is with a view to reducing the number of registered imported products and encouraging local manufacturing and innovation,” she said.

Noting that “NAFDAC has also placed emphasis on local herbal medicines by stepping down approval of imported herbal medicines that have equivalence in Nigeria”, Prof. Adeyeye explained that,” This is to create a renaissance of our herbal medicines and mitigate possible falsification and counterfeiting.”

 “In this bid, NAFDAC inaugurated the Herbal Medicine Product Committee in March 2019 and has fostered collaboration between herbal researchers and local practitioners. This has led to the joint submission of research proposals for funding for clinical trials of products that have been given listing approval by NAFDAC so that the product can be given full approval,” she further explained.

 She said the investigation and enforcement activities of the agency geared towards riding the country of the menace of substandard and falsified medical products have yielded a lot of dividends with arrests, prosecution, seizures and destruction activities recorded include interception and destruction of 25 containers of Tramadol worth N1, 708,750,000.

 “To further protect the health of consumers, the Agency destroyed fake, adulterated, counterfeit, banned and unwholesome NAFDAC Regulated Products worth N8, 000,260,000 in exercises across the nation, while also clearing its Apapa warehouses that had been filled to the brim since 2013.

 “Over twenty prosecutions of people responsible for counterfeiting or trading in substandard falsified medicines have taken place with most of them ongoing with a few fined or sentenced to imprisonment,” she stated.

 Adeyeye, who said about N997m of the COVID -19 intervention fund has been spent on the laboratory’s equipment, explained that: “OPCW gave us N735m, and everything was spent on lab equipment.”

“As part of strengthening the Agency’s processes, the Yaba Drug and Biologics/Vaccine laboratories are currently being expanded and under construction.  Based on this continual improvement, the 114 recommendations have been met as of October 2021,” she added.

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