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Janet Ogundepo
The National Agency for Food and Drug Administration and Control has said its Five Plus Five Year Validity policy, which requires pharmaceutical companies to locally manufacture or partner for local production of 29 essential medicines previously imported into Nigeria, has resulted in a 70 per cent reduction in the importation of products under the policy’s coverage.
The Director-General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Channels Television’s Sunrise Daily on Thursday, describing the policy as a turning point that had pulled Nigeria’s pharmaceutical industry back from what she called the brink of collapse.
She said, “In 2019, we started what is called 5 Plus 5. The products that we have been importing into the country that we can also produce, we give you five years to migrate to local manufacturing or to partner. That has changed the industry.
“We have decreased importation of products under those categories, 5 Plus 5 and ceiling list. We have decreased importation by 70 per cent. We have saved our pharmaceutical industry from oblivion because of our policies.”
According to documents on the policy published by NAFDAC, the Five Plus Five Year Validity, formally known as the “Five Plus Five-Year Validity (Migration to Local Production)” policy, was instituted in March 2019 and published on May 1, 2019.
The policy was designed to promote and support the growth of the pharmaceutical industry by encouraging local manufacture, with the stated aim of ensuring dependable and prompt access to necessary medications by shortening the supply chain and preventing shortages and stock-outs of essential medicines.
Under the policy, 29 products can now only be registered as locally manufactured pharmaceuticals, meaning foreign manufacturers can no longer import finished versions of these products into Nigeria without local production arrangements.
The 29 products covered by the policy span a broad range of essential and commonly used medicines.
The products include commonly used antibiotics such as Ampicillin and Ciprofloxacin; antiparasitic medicines such as Albendazole; pain relievers including Diclofenac and Paracetamol; gastrointestinal medicines such as Omeprazole and Cimetidine; Oral Rehydration Salts; Vitamin C; Chlorhexidine gel; Hydrochlorothiazide; and several herbal products including Moringa, Aloe Vera, Garlic and Bitter Leaf.
Topical preparations on the list include Shea Butter cream, Topical Sulphur ointment, Benzyl Benzoate emulsions used in the treatment of scabies, and topical products containing salicylic acid. Vitamin C in both syrup and tablet forms across all strengths also appears on the list.
Adeyeye said the policy had shortened the pharmaceutical supply chain and reduced the vulnerability of Nigeria’s medicine supply to the disruptions that had historically accompanied dependence on imported finished products.
PUNCH Healthwise earlier reported that only 30 per cent of drugs are produced locally, while 70 per cent were imported.
The NAFDAC boss added that the Federal Government’s 2024 Executive Order had further strengthened local pharmaceutical manufacturing by providing incentives to drug manufacturers.
She noted that NAFDAC was also developing a similar policy for the food industry to encourage more local production.
The agency boss advised Micro, Small and Medium Enterprises to apply directly for NAFDAC registration rather than through consultants, noting that many business owners had been scammed by fraudsters posing as registration agents.
The DG explained that some regulatory processes could not be rushed because it involves laboratory testing and inspection.
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