A study on Approval and Marketing of medical products in EU, USA AND INDIA and AUSTRALIA

Abstract

The medical device industry is a powerful economic driver around the world. Although the post-marketing research programs are similar, the medical device approval process is historically different between the US FDA and EU systems. We believe that the future of India’s innovative biomedical industry will depend on the upgradation of several national policies. Whereas this study was not designed to inform such policies, and tools such as stakeholder analysis are better suited for this purpose than the case study method adopted here, we would like to make three recommendations for the development of an innovative medical device sector in India: First, the national regulatory bodies need to offer guidance to industry about product development as the FDA, European Medicines Agency and WHO do. Currently, the scientific capabilities of the relevant agencies are inadequate to do this. Second, government procurement of innovative devices needs to be increased. India has advanced into a “World Pharmaceutical Hub” whereas its regulatory authority is still struggling to keep pace with the international industrial growth. According to the report commissioned by Indian parliamentary committee in 2012, CDSCO struggled with staffing shortage and infrastructural issues affecting its responsibilities to ensure public safety. (16) Following this criticism, CDSCO not only updated its mission statement as “To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices,” but has also moved beyond the past issues to correct its flaw and become a world class regulator comparable to the US FDA and EMA (European Medicines Agency).