News

Importers required to submit safety lab reports for medicines

The Maldives Food and Drug Authority (MFDA) has stated that importers are now required to submit laboratory test reports verifying the safety of medicines and pharmaceutical products.

The MFDA has implemented stringent measures to ensure the safety of medicines in response to the recent discovery of harmful chemical substances in numerous imported medicines within the Maldives. The World Health Organisation (WHO) urged member countries, including the Maldives, to exercise caution in importing medicines in January this year.

Speaking to PSM News, Senior Pharmacist at MFDA Aishath Jaleela emphasised the country's commitment to enhancing safety in accordance with WHO safety guidelines. She said that all necessary arrangements are being made to conduct thorough testing of pharmaceutical products available in the market. As such, she said that importers are now mandated to submit a laboratory test report confirming the absence of harmful chemicals in medicines brought to the country.

Additionally, Jaleela highlighted the strengthening of standards for companies registering medicines in the Maldives. As such, she said that product registration guidelines have been amended to require that the excipients used in manufacturing medicines also undergo testing for the absence of chemicals during the registration process.

Furthermore, Jaleela disclosed that the Maldives was the first country to identify the harmful chemicals, specifically diethylene glycol (DEG) and ethylene glycol (EG), in medicines manufactured by Pharmix Laboratories Private Limited in Lahore, Pakistan. She said that the Maldives informed other nations about the issue and is taking steps to prevent the entry of such unsafe medicines in the future.

The MFDA highlighted its commitment to conducting more frequent testing by collecting samples directly from the market to enhance preventive measures against the importation of harmful medicines.