Innovation and Regulatory Challenges of the Drug Delivering Medical Devices in India, Europe and U.S.

Abstract

The combination product market is generally seen as an area with high growth potential and provides greater profit margins and significant positive benefits to the patients. As the combination product regulations and the guidance document evolves in the US, manufacturers of these type of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The EU is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the combination products. In the framework of improved synergies with other legislation including medicinal products, the draft regulations focus on compliance of drugs-device combination products. The new changes in the regulations, represent an important step forward in the growing philosophy of combination products in Europe. In India, the combination products are regulated as medical devices, and the regulations are still emerging. International Standards are also being revised and updated, such as the IEC 60601 family, causing additional pressures on the industry. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the Patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, it requires to understand the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.