Bangalore, June 14, 2010: The Government of India is planning to propose a comprehensive legislation to ensure standards, safety, quality and effectiveness of medical devices. The bill on this regard, after receiving the approval of the state governments, is likely to be introduced in parliament during the monsoon session.

Making this announcement Mr Dinesh Trivedi, Minister of State for Health and Family Welfare, Government of India, while inaugurating the National Workshop on Medical Device Regulations in India, organized jointly by Federation of Indian Chambers of Commerce and Industry (FICCI) and Central Drugs Standard Control Organization (CDSCO) on June 11-12, 2010, said, “The increasing population with greater awareness and transforming disease profile of the country has resulted in an increased demand for healthcare services. Medical devices provide the means for complex diagnosis and life support systems. In view of their extensive use, it is necessary to have a proper regulatory control over medical devices so that the patients are provided with safe, affordable and effective tools of healthcare.”

Mr Trivedi also announced that the Health Ministry was venturing into setting up a national health portal to share information in the public domain on standardization and protocols. He said that the ministry had signed a MoU with the Railway Ministry for acquiring railway land for setting up diagnostic centers and hospitals at or near railway stations.

The minister said that India had a large scientific talent and medical expertise for the manufacture and use of medical devices in the country. However, the high cost of medical devices raises healthcare costs and the objective of providing healthcare to the poor and needy patients by the government through government hospitals gets retarded. It was therefore necessary that the medical device industry grows at a faster rate and medical devices are developed indigenously at affordable costs.

Dr Surinder Singh, Drugs Controller General of India, said that the proposed law to regulate medical devices would be specific to India to cater to the country’s socio-economic conditions. The role of the government would be to enforce the law and facilitate the growth of the indigenous industry.

FICCI has suggested the development of a roadmap for training of regulators for Medical Devices. It has called for the creation of an Institutional Development Plan for Medical Devices, involving and allowing participation for the regulators to the global and regional harmonization forums to foster best practices on medical device regulations from various economies and placing dedicated manpower and develop specific and systematic training modules for CDSCO staff handling medical devices.