Requirement of registration of manufacturing premises of foreign drugs manufacturer prior to their import in the country under Drugs and Cosmetics Rules – reg
Show AI Summary
Registration of foreign drug manufacturers and mandatory import licences now govern all drug imports, with inspections and shelf life conditions.
Foreign manufacturers or their authorised agents must obtain a registration certificate for manufacturing premises and for each drug before importation; registration requires specified documents, prescribed fees, a defined validity, reporting of manufacturing or testing changes, and permits Indian authority inspections with additional fees and testing charges. Registration may be suspended or cancelled for violations. Import licences are required for all drug types after completion of registration, subject to validity periods, prescribed licence fees, deletion of prior exemptions for actual users, and a requirement that imported drugs meet a minimum retained shelf life. Government hospitals have a separate, limited import provision for essential new drugs.