New Drug Regulation grants MFDA authority to blacklist violators

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

Under the regulation, MFDA must compile registries of medical drugs and indigenous drugs within 30 days of the regulation coming into force. The regulation will take effect 90 days after publication, meaning it will come into force on October 22.

According to the regulation, which outlines the categories of medical drugs, indigenous drugs and accepted traditional/herbal medicines, MFDA must complete the drug registry by November 22. The registry must be reviewed at least once a year, with all updates recorded and dated.

Drug registration must include the importer’s or company’s name, manufacturer details and all required technical information about the product.

However, essential medicines may be imported even if they are not yet registered, following an evaluation and recommendation from the Pharmaceutical Board. Individuals may also import medicines for personal use for up to three months with a valid prescription. In exceptional circumstances, imports for up to six months are permitted.

Drugs will be registered for a period of five years. The regulation states that the registrant is responsible for submitting all required documents when renewing the registration.

The regulation also requires that all drugs be manufactured and packaged with MFDA approval and in accordance with Good Manufacturing Practice (GMP) standards.

In addition, the regulation prohibits the sale of MFDA-classified drugs in public retail outlets.

The regulation bans the import, export, advertising and sale of drugs that are unfit for human consumption, adulterated or contaminated, manufactured in unhygienic premises, counterfeit, or banned by the World Health Organization or other competent authorities. It also prohibits operating pharmacies without registration and importing, storing or selling drugs without MFDA permission.

Penalties under the regulation include advisories, time given to rectify violations, fines ranging from MVR 10,000 to MVR 100,000, temporary suspension of permits for periods between two weeks and one year, and revocation of permits.

The regulation further empowers MFDA to blacklist drug importers who submit invalid or false information during the registration process.