Drug regulatory authorities

Drug regulatory authorities need to ensure that the manufacture, importation, distribution, supply and sale of drugs are carried out under specific licences/authorisation in licensed/approved premises under the supervision of qualified persons. They should conduct regular monitoring and surveillance of premises to ensure that practices employed in the manufacture, import, distribution and sale of drugs comply with the specified requirements and standards. They should ensure that all drugs in the national drug distribution channels have been authorised/licensed. The ports of entry and drug establishments, including drug-manufacturing industries, wholesalers and retail pharmacies must be regularly inspected and samples collected and tested.

DRA inspectors play a crucial role in the identification and investigation of counterfeit drugs and in the prosecution of counterfeiters. There should be sufficient and adequately trained drug inspectors with authorisation to enter premises and seize any drugs suspected of being counterfeit. Countries that do not have full-fledged drug quality control laboratories should look for simpler and less resource demanding testing/screening methods for the identification of counterfeit drugs. Thin-layer chromatography, test-tube colour reactions, melting point determination could be considered to serve the purpose. However, such simple tests or screening methods must not be considered as a replacement of pharmacopoeal, compendial or legally accepted test methods. Products considered to be potentially counterfeit have to be subjected to further testing according to the pharmacopoeal, compendial or legally accepted reference method(s).