India Ponders New Medical Device Regulatory Body

The Institute of Nuclear Medicine & Allied Sciences released a proposal to the Indian government in the summer of 2003 to establish a system to regulate and supervise medical devices in the country. Currently, India does not have a regulatory body to oversee medical devices and equipment. The need for such a system is obvious in order to regulate the quality of medical devices in India and to protect the domestic consumers. The proposal includes the establishment of a system called the Indian Medical Devices Regulatory Authority (IMDRA) based on the US Food and Drug Administration and the European model.

IMDRA is envisioned as an independent organization rather than a ministerial body. Due to the multifaceted nature of the organization, an independent body would be more capable of utilizing resources from multiple organizations rather than relying on only one area of the government. IMDRA would also be more of an infrastructure agency dealing with the administrative portions of medical device regulations while the technical work of the system would be assigned to various technical institutes in India. IMDRA would serve as a guide that would assist Indian businessmen to develop their medical products and nurture the growth of the local industry.

The Indian government has yet to announce the exact timeframe for implementation of a new medical device regulatory body. However, the government realizes the urgency of establishing such a system. India’s medical devices market has grown 25% in the past several years and currently the overall market is valued at $1,250 million.