According to Indian Medical Device Regulation may be passed by this Aug 2011
India’s medical device market is worth about US$3 billion and is ranked as the fourth largest medical device market in Asia, after Japan, China and South Korea. With a population of 1.2 billion people and a booming economy, there is increasing demand for medical devices, especially in the private healthcare sector. However, comprehensive guidelines on the standards and use of medical devices in India are still lacking. Certain medical devices are classified as drugs under the Drugs and Cosmetics Act and Rules (DCA), rather than actual medical devices. These include catheters, heart valves, cardiac stents, orthopaedic implants, bone cements and intra-uterine devices. There are many other medical devices which have not been clearly defined by the DCA.
Over the last five years, there have been proposals for a more-effective regulatory system to govern India’s medical device market. One of those proposals was the introduction of the Medical Device Regulation Bill. The bill was put forward by the Department of Science and Technology in 2006 for a comprehensive regulatory framework, specifically for medical devices. A Medical Device Regulatory Authority to regulate the manufacturing, marketing and use of medical devices in India was also proposed in the bill. The Medical Device Regulation Bill was intended for implementation by 31 December 2009, but it was not passed by the Council of States. Recently, however, there have been discussions of the bill being reintroduced in 2011. Many industry players are expecting its passage by parliament in July/August 2011. If implemented, the bill will provide a regulatory regime that differentiates between drugs and medical devices.
India’s medical device market is worth about US$3 billion and is ranked as the fourth largest medical device market in Asia, after Japan, China and South Korea. With a population of 1.2 billion people and a booming economy, there is increasing demand for medical devices, especially in the private healthcare sector. However, comprehensive guidelines on the standards and use of medical devices in India are still lacking. Certain medical devices are classified as drugs under the Drugs and Cosmetics Act and Rules (DCA), rather than actual medical devices. These include catheters, heart valves, cardiac stents, orthopaedic implants, bone cements and intra-uterine devices. There are many other medical devices which have not been clearly defined by the DCA.
Over the last five years, there have been proposals for a more-effective regulatory system to govern India’s medical device market. One of those proposals was the introduction of the Medical Device Regulation Bill. The bill was put forward by the Department of Science and Technology in 2006 for a comprehensive regulatory framework, specifically for medical devices. A Medical Device Regulatory Authority to regulate the manufacturing, marketing and use of medical devices in India was also proposed in the bill. The Medical Device Regulation Bill was intended for implementation by 31 December 2009, but it was not passed by the Council of States. Recently, however, there have been discussions of the bill being reintroduced in 2011. Many industry players are expecting its passage by parliament in July/August 2011. If implemented, the bill will provide a regulatory regime that differentiates between drugs and medical devices.
