Regulatory approval process for advanced dressings in India: an overview of rules

Abstract

Objective: There is a high rate of death due to burns and wound infections in India. Innovators and manufacturers of wound and burn dressings need to keep themselves abreast of the most current rules governing medical devices. The concept of advanced dressings is emerging in India. However, local manufacturing is hindered by an absence of clear regulatory guidelines. The lack of advanced wound and burn dressings on the market critically affects patient survival rates, while imports from other countries make dressings unaffordable and beyond the reach of most patients. This article presents the details of an approval procedure for advanced dressings and provides manufacturers, innovators and investors with a better understanding of the classification rules, import, export and marketing approval processes. We also discus the reasons for high levels of imports and costs, as well as suggestions on how to address this. Method: A critical analysis was conducted of 54 research and review articles, including regulatory guidelines to control the marketing of wound and burn care dressings recommended by international regulatory agencies. Conclusion: India is highly dependent on imports of advanced dressings. Due to lack of clear, quality regulatory guidelines, innovators and manufacturers are facing issues while showcasing their product in the Indian market. Thus development of clear quality regulatory guidelines is crucial. Therefore, this article may guide and encourage manufacturers to develop advanced dressings in India