• Tuesday, April 16, 2024
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Local production, others cut pharmaceutical imports by 63% – NAFDAC

NAFDAC recalls J&J’s children’s syrup over toxicity

The National Agency for Food and Drug Administration and Control (NAFDAC) has said that local production among other factors, contributed to the 63 percent dip in pharmaceutical imports recorded in the last two years.

The regulatory body in an official statement reacting to a report published by BusinessDay in August, said efforts made to boost some segments of the local manufacturing sector were not captured in the earlier report.

BusinessDay reported new data from the International Trade Centre, a multilateral agency, indicating that the importation of pharmaceutical products into Nigeria dropped for the second straight time to $1.05 billion in 2022, a 23.4 percent decline from $1.37 billion in 2021.

It also declined by 63 percent from $2.84 billion in 2020 while pharmaceutical exports reduced by 65 percent to $779 million last year.

“The attention of the management of the NAFDAC has been drawn to publications in online tabloids, specifically the BusinessDay edition of August 24, 2023, titled “Nigeria’s Pharmaceutical Import drop 63 percent in two years”.

“While the write-up quoted the data from the International Trade Centre, a multilateral agency, laid claim to the fact that difficulty in accessing forex, devaluation of the naira, and attendant high inflation has reduced imports, and this was also corroborated by the immediate past president of the Pharmaceutical Society of Nigeria. While this may be true, the full story was not captured… In the report, it was not asserted that the decline in pharmaceutical imports is partly due to an increase in local production even though a lot of boosts in local manufacturing are currently taking place as will be emphasised in the following segments.”

NAFDAC admitted that the publication provided largely accurate statistics related to reliance on finished drug importation, importation of active pharmaceutical ingredients, and a huge jump in prices of locally manufactured and imported drugs.

It also provided a mixed bag of marginal revenue loss and increase for stakeholders in the pharmaceutical sector.

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The statement signed by Mojisola Adeyeye, NAFDAC director-general, reiterated that the main goal of the body at its inception was to formulate and implement policies to enhance and promote local pharmaceutical production.

These led to the formulation of policies, including the 5+5 Policy or regulatory directive (RD), which is aimed at the migration of previously imported products to local manufacturing after renewal of the previous five years before the RD date. The renewal for five years post the effective RD date is the last approval to import.

By the end of the third year of that last renewal, the importer or manufacturer must present to NAFDAC a plan to migrate to local manufacturing or partner with an existing local manufacturer through contract manufacturing.

The essence of this policy is to provide the agency with a strong foothold for enhancing local manufacturing and regulatory oversight aimed at improving access to medicines that meet the requirements for quality, safety, and efficacy.

NAFDAC said the outcome of the policy showed that as of July 2023, a total of 57 companies, representing about 30 percent of total number of local manufacturers have provided the blueprint for migration to local manufacturing to the drug registration and regulatory affairs directorate of NAFDAC.

“This migration is either to build and erect brand-new Pharma manufacturing plants or enter contractual manufacturing partnerships with local drug manufacturers,” the agency said.

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Other policies introduced are the expansion of NAFDAC’s Ceiling list; establishment of new pharmaceutical plants in Nigeria; NAFDAC tariff regime on imported products; and international certification and risk-based classification of local drug manufacturers.

The expansionist intervention is to reduce the importation of medicines that can be manufactured locally, stimulating the utilization of the idle capacity of local manufacturers of essential medicines. The ceiling had nine products prior to 2020 but has now been increased to 34.

The policy on the establishment of new pharmaceutical plants enables companies to get their facility design right before commencing construction, all in a bid to eliminate the potential for the manufacture of SF medicines resulting from poorly designed manufacturing facilities.

“As of July 2023, a total of 57 and 18 new manufacturers, many of whom are importers have either received regulatory approval to erect a new GMP-compliant Pharma plant in Nigeria or have their layouts undergoing reviews respectively. This is in addition to the fact that 53 of the existing local manufacturers have either obtained regulatory approval to build new plants or are currently undergoing regulatory reviews of their layouts. The implication of this is that as of July 2023,” the NAFDAC DG said.