NAFDAC’s war on cheap drugs: New rules favor multinationals

The National Agency for Food and Drug Administration and Control (NAFDAC) has intensified efforts to regulate generic medicines across Nigeria.

NAFDAC’s Director-General, Prof. Mojisola Adeyeye, made this known during a press briefing on Thursday in Lagos.

She said the agency is committed to enforcing bioequivalence studies for all generic medicines in the Nigerian market.

According to her, the move is to guarantee safety, quality, and effectiveness of generics consumed by Nigerians.

Prof. Adeyeye explained that bioequivalence studies are scientific tests to prove that generics are equal to their branded counterparts.

She stressed that these studies confirm that generics produce similar clinical outcomes and are safe for public use.

The agency’s boss maintained that only generics passing these standards will be approved and circulated within the country.

“This bold step aims to eliminate fake and substandard medicines from Nigerian pharmacies,” Adeyeye said during the briefing.

She added that this approach would help restore public confidence in generic medicines nationwide.

NAFDAC believes that promoting well-tested generics will support rational prescribing and better treatment outcomes in Nigeria.

Adeyeye noted that the agency has rolled out a strategic roadmap to guide pharmaceutical stakeholders through the new process.

The plan includes newly issued guidelines, rules, and detailed procedures for conducting bioequivalence studies locally.

NAFDAC has also released a “Note to Industry” on the roles of Contract Research Organisations (CROs) in this effort.

Both the guidelines and the note are accessible on NAFDAC’s official website for public awareness.

Prof. Adeyeye disclosed that capacity building remains key to this initiative’s success.

She revealed that NAFDAC is training its staff, researchers, healthcare workers, and pharmaceutical stakeholders across the country.

“These sessions will ensure everyone understands the bioequivalence standards and how to comply,” she said confidently.

The agency said it will continue to uphold high scientific and regulatory standards in Nigeria’s pharmaceutical industry.

NAFDAC also urged companies to submit only generics that meet its new regulatory benchmarks for approval.

“We need stakeholders’ cooperation to make Nigeria’s drug system more reliable,” Adeyeye said.

She concluded that the briefing is part of wider engagements aimed at involving every player in the sector.

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