Tramadol and Codeine have been banned by the Ministry of Health.

The ban has to do with the importation and sale of both drugs.

The Food and Drugs Authority (FDA) issued a statement indicating that no person shall offer for sale Tramadol or Tramadol-containing products with a dosage form and strength above the dosage form and strength registered by the Food and Drugs Authority.

It added that all dosage forms and strengths of registered Tramadol and Tramadol-containing products shall be dispensed as “Prescription Only Medicines” and shall not be prescribed and dispensed at health facilities below the level of District Hospitals.

According to the Food and Drugs Authority, one of the regulatory agencies ensuring full compliance of the new directive, market surveillance will be intensified to ensure that the market is free from such drugs.

The ban on Tramadol comes after growing public concern over the abuse of tramadol and codeine in the country especially among young people.

Similarly, FDA noted that Codeine containing cough syrups are banned, their registration and market authorisations is also revoked.

FDA indicated that the Executive Instrument for the Restriction of Importation, Manufacture and Registration of Codeine containing Cough Syrups (E. I. 167) is promulgated in accordance with the powers conferred on the Minister for Health by section 116 of the Public Health Act, 2012 (Act 851).

It added that all approved dosage forms and strengths of the codeine drugs registered by the Authority shall be re-classified as “Controlled Drugs” and “Prescription Only Medicines” and subsequently dispensed only upon proof of a valid prescription.

 

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