MFDA Granted Powers to Blacklist Drug Importers Under New Regulation

The Maldives Food and Drug Authority (MFDA) has been granted new powers under the Drug Regulation, including the authority to blacklist drug importers who submit false or misleading information during the drug registration process.

The regulation, which was recently published, will come into force 90 days after publication on October 22. It requires the MFDA to establish registries for medical drugs and indigenous drugs within 30 days of the regulation taking effect, meaning the registries must be completed by November 22.

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Under the regulation, all drug registrations must include the name of the importer or company, manufacturer details and the required technical information for each product. Registered drugs will remain valid for five years, with registrants responsible for submitting the necessary documents for renewal.

The regulation also requires the MFDA to review the drug registry at least once a year, with all amendments recorded and dated.

Essential medicines may still be imported before registration if approved following an evaluation and recommendation by the Pharmaceutical Board. Individuals may also import medicines for personal use for up to three months with a valid prescription, while imports of up to six months are permitted in exceptional circumstances.

The regulation requires all medicines to be manufactured and packaged with MFDA approval and in compliance with Good Manufacturing Practice (GMP) standards. It also prohibits the sale of drugs classified by the MFDA through public retail outlets.

It further bans the import, export, sale and advertisement of medicines that are unfit for human consumption, adulterated, contaminated, counterfeit, manufactured in unhygienic conditions or prohibited by the World Health Organization or other competent authorities. Operating pharmacies without registration and importing, storing or selling medicines without MFDA authorisation are also prohibited.

Enforcement measures include advisories, corrective action notices, fines ranging from MVR 10,000 to MVR 100,000, temporary suspension of permits for periods between two weeks and one year, and the revocation of permits.

In addition to these penalties, the regulation authorises the MFDA to blacklist importers found to have submitted invalid or false information during the drug registration process.