The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established
itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.