A Study on New Regulations for Marketing and Authorization of Pharmaceutical Products in USA and India

Abstract

The marketing authorization is given by CDSCO to different types of drugs under the provision of Drugs & Cosmetics Act 1940 and Rules 1945 and New Drugs and Clinical Trials Rules 2019. Any substance falling within the definition of drug (Section 3b of the Act) is required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import. If the drugs, fall within the definition of New Drug (Rule 2 (w) of the Act), the new drug approval is the pre-requisite for submission of application for Registration and or import of drug. The study aims to assess the regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The goal of ICH is to promote international harmonization by bringing together representatives from the three ICH regions (EU, Japan and USA) to discuss and establish common guidelines. Since year 2003, the authorities in the United States, the European Union (EU) and Japan ask for the Common Technical Document (CTD) format set out by the 2003 International Conference on Harmonization (ICH) which was agreed by the Regulatory Agencies of Europe, Japan and the US and the Research-based Industry and more recently, its electronic version - the electronic Common Technical Document (eCTD). Pharmaceutical product approval process should be seen as a critical step in ensuring access to safe and effective drugs. Although there is a continuous process of harmonization taking place all around the world, still we see a huge challenge, which is yet to be overcome by the Pharmaceutical industry in case of generic drug development and filing. Therefore, to meet these challenges, a lot of strategic planning is required before the development of any generic drug product.