Nigeria’s target to begin local production of Active Pharmaceutical Ingredients (API) would be achieved before the end of 2024, Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), has said.
Active pharmaceutical ingredients are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. They are produced by processing chemical compounds.
Nigeria is currently heavily reliant on imported APIs and about 70 percent import of its pharmaceutical products.
Adeyeye, speaking in an interview with BusinessDay, informed that the API plant being built at the Emzor Pharmaceutical Industries Limited in Sagamu Ogun State was about 90 percent completed.
Emzor had secured a €13.85 million EIB loan to develop a $23 million plant with a planned capacity of 400 MCT yearly.
In addition to Emzor, Adeyeye said six firms under a consortium – Fidson Consortium, would also begin production of 14 APIs, including antibiotics and cardio drugs.
She equally stressed the government’s resolve to ensure only quality APIs are manufactured in the country for export.
The DG said the agency has begun training its employees and manufacturers, noting that production of APIs “is completely different from making tablets, syrups, among others.”
“It’s pure chemistry, it’s pure science. We are building capacity because you cannot make mistakes. So, we are preparing and it could happen by the end of the year, and it’s going to happen, it will be a reality.
“I told them (manufacturers) that it must be sellable all over the world; it must be quality, else we will not approve it. So any API made in Nigeria must be sellable”, Adeyeye said.
Speaking further, Adeyeye reiterated the government’s resolve to boost local manufacturing. As part of efforts to achieve this, the DG disclosed that the government has ordered Chief Medical Directors (CMDs) of hospitals across the country to only buy locally manufactured syringes.
Tunji Alausa, Minister of State for Health, gave the order during a recent virtual meeting with CMDs, she said.
The minister decried that substandard, and falsified syringes coming from China, Malaysia and others have flooded the market.
The Senate Committee on Health in March 2021, had decried that despite the capacity of the local firms to meet the market demands, an estimated over 1 billion units of syringes and needles were being imported into the country yearly.
“We were addicted to importation, we were addicted to being given something, weakening internal capacity. We are now thinking. The minister of state called a virtual meeting and called all the CMDs in the country, and you told them they must patronise the syringe manufacturers in Nigeria.
“I went to a syringe manufacturing company in Lagos and I couldn’t believe my eyes; they have state-of-the-art equipment”, she said.
Adeyeye also said that the agency was taking seriously its 5+5 regulatory directive to boost manufacturing.
The policy stipulates that after pharmaceutical firms have marketed drugs for five years, they should domesticate their production.
“So after their last renewal, they must show us a migration plan to local manufacturing or to partner with a local manufacturer if they don’t have the money at the beginning”, the DG explained while stating that Nigeria has seen a 12 percent increase in local companies, but the foreign exchange crisis has affected their capacity.
He further pointed out that among several benefits, local manufacturing would mitigate substandard, falsified medicines which according to her is currently over 17 percent.
“About a year ago, we got intelligence that a company in Nigeria was making bad medicine, within two hours we were there, if it were China, how can we be there? We may not even know where the place is to shut them down”, she explained.
SOURCE: Business Day