Effective inspection of drug products and manufacturing facilities is critical to ensuring the quality, safety and efficacy of drugs. It is also necessary in order to ensure compliance with the statutory requirements relating to the storage, supply, distribution and sale of drugs, etc. Therefore, national regulatory authorities shall establish effective mechanisms for inspection in all drug manufacturing establishments, public and private health institutions, as well as, in drug sales and distribution outlets.

Government shall also establish suitable mechanisms for inspecting the import/export of drug products, in line with the various regulations, and apply appropriate sanctions where violations are committed.