Nigeria: NAFDAC targets a 70% reduction in Nigeria’s pharmaceutical imports by 2025
Abuja – As part of efforts to ensure drug safety in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has stated that it has set itself the goal of reducing drug abuse. current imports of 70% of medicines from the country to about 30% by 2025..
Likewise, the agency said it has made rigorous efforts to win the battle against the importation of illicit drugs, unhealthy food and unregulated products over the past four years.
NAFDAC also said that it has successfully implemented the 868 recommendations given by the World Health Organization (WHO), the ground is ready for Nigeria to start local vaccine manufacturing by 2022.
Speaking at a press conference to mark his fourth year in office yesterday, NAFDAC chief executive Professor Mojishola Adeyeye said the agency had taken many steps to improve local production of pharmaceuticals in Nigeria,
She said companies would now be required to submit draft proposed partnership plans with Nigerian companies or plan to set up a local manufacturing plant within seven years of starting operations in Nigeria.
Adeyeye said, “NAFDAC has focused on local manufacturing of our regulated products to ensure Nigeria will have drug safety and reverse the trend from 70% of imports to around 30% of imports of drugs. ‘by 2025. Part of the goal is also to mitigate security and counterfeiting, as it is much easier to guarantee quality compared to an imported product. “
She said that in order to improve local production of pharmaceuticals in Nigeria, the agency has reviewed and updated its five-year and longer validity policy.
She explained that a product registration license was valid for five years and that at the end of the fourth year of license validity, companies would be required to submit draft proposed partnership plans with Nigerian companies or / and to set up a local manufacturing plant.
“In the event of a successful renewal for another five years for companies with verifiable plans, NAFDAC will monitor the migration of imported drugs to local production. At the end of year 7 (the first 5 years plus 2 years after renewal), if there is no progress on migration to local manufacturing as detailed in the master plan, a deregistration alert will be sent to the company at the start of the year, ”she said.
Adeyeye said, however, that the migration to local manufacturing would be limited to products that local manufacturers have the capacity to produce or that the partnership would improve manufacturing capacity.
According to her, the measure was aimed at reducing the number of imported products registered and encouraging local manufacturing and innovation.
Regarding the decision to start local manufacture of vaccines, the CEO of NAFDAC said that the agency had signed a memorandum of understanding with Bio Ventures for Global Health (BVGH) to improve collaboration on capacity building of health care staff. clinical trials and principal investigators in the research space for the conduct and oversight of clinical trials in oncology.
She said that NAFDAC had successfully implemented the 868 recommendations set for the country to be able to regulate the local manufacture of vaccines.
“In 2018, around 80% of our laboratory facilities were not functioning, but since then NAFDAC laboratories have seen rapid improvement, with the purchase of equipment worth over 2 billion naira.” , she said.
Adeyeye said the huge chunk of revenue generated by the agency was spent on renovating and equipping its laboratories, especially the Yaba and Oshodi facilities, both in Lagos State, for meet WHO requirements.
She said the agency is also developing capacity in the area of clinical trials and an electronic clinical trial application platform (eCTAP) in collaboration with BMGF and NOVOTEQ to facilitate trial dossier submission. clinics and improve the transparency and tracking system of all applications.
Also in preparation for the revival of local vaccine manufacturing in Nigeria, Adeyeye said NAFDAC had re-equipped its main laboratories across the country.
In addition, Adeyeye said the agency has significantly improved in its regulatory function and met the 53 recommendations requested by the WHO.
She said NAFDAC has also developed a one-stop-shop link that houses all relevant clinical trial guidelines.
Other key steps, she said, included developing a guidance document for conducting clinical trials, reducing review times for COVID-19-related trials (new molecule – 15 days while for reconverted medicine -10 days) and the skipping of the phase 1 study and in some cases Phase II studies for herbal medicine.
Speaking about the agency’s efforts under his leadership to rid the country of the illicit drug trade, Adeyeye said NAFDAC has successfully confiscated and destroyed tramadol, unhealthy food and other unregulated products from ” worth over 2,400 billion naira:
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“It is also worth mentioning here that, following my tireless efforts which brought the Agency back to ports in May 2018 (all thanks to the Office of the National Security Advisor); coupled with rigorous inspection and enforcement activities; the Agency in conjunction with the Nigerian Customs Service seized and destroyed SF, unhealthy food and other unregulated commodities valued at N4,000 260,000 in drills across the country and Tramadol with an estimated market value of around 2,000 billion N.
“The impact is there. Most of the Tramadol traders have gone underground. They were almost wiped out, leaving only a few of them there. And we will continue to pursue them until they are killed. ‘they’re taking another leave and leaving the dangerous business,’ she said. .
Adeyeye said the market value of counterfeit drugs and unhealthy food and cosmetics seized and destroyed across the country by the agency between March and August 2021 was over 5 billion naira.
She said: “Over the years, the agency has developed strategies to tackle the ever growing challenge of counterfeit regulated products and the trafficking of substandard falsified medicines.”
Adeyeye also said that NAFDAC has doubled its internally generated revenue in the last four years of its tenure.