A Regulatory Perspective To Streamline Rules, Regulations and Requirements For Importing Pharmaceuticals (Drugs And/Or Medical Devices) In Four Asian Countries: India, Nepal, Bhutan and Singapore

Abstract

Health demands of the world are rising day by day. These demands not only include a strong health infrastructure but also an incessant accessibility to high quality, safe and effective pharmaceuticals. The responsibility to cope up with such demands lies with the government of all countries worldwide and the pharmaceutical companies of large, medium or small scale. Import is a significant element of trade. Trade of pharmaceuticals from one place of the world to another is empowered and enhanced by import. Thus not only on international but also on national level it is crucial to have stringent standards and controls for handling of pharmaceuticals within the distribution chain after they are manufactured. Imports of pharmaceuticals within a country can be done for various reasons like for its sale and distribution, for conducting clinical evaluation or for personal use of patients that are suffering from life threatening diseases. Pharmaceuticals in particular drugs and medical devices are the major players of an import market and are highest in demands. To provide a country’s population pharmaceuticals continuously and prevent adulterated, substandard and spurious drugs entering into the distribution chain, Acts, Rules, Regulations and Requirements pertaining to IMPORT have been defined by Drug Regulatory Authorities of various countries. Economic constraints and lack of manufacturing sources act as stimulus for Imports in developing countries. Further, Legal aspects like Pharmaceutical Patents may affect and impede imports of drugs and medical devices around the world. Parallel Imports and compulsory licensing are some of the legal solutions to provide cheaper quality medicines to populations worldwide. Imports during COVID-19 have been drastically impacted. Several countries are taking various measures to combat this situation by easing import through leveraging importing requirements, fees and conversion of various procedures online. All such aspects have been discussed exhaustively in this project in relation to these 4 Asian countries: India, Nepal, Bhutan and Singapore.