Recommendation to make a separate law on the subject of ‘medical device’

This report on ‘Medical Devices: Regulation and Control’ was submitted to the Chairman of Rajya Sabha on Monday.

A committee of Parliament has recommended to the Ministry of Health and Family Welfare to enact a separate law on medical devices and set up a ‘National Medical Devices Commission’ instead of preparing a joint Bill on Drugs, Medical Devices and Cosmetics. This was stated in the report of the Parliamentary Standing Committee on Health and Family Welfare, headed by Samajwadi Party (SP) MP Ram Gopal Yadav.

This report on ‘Medical Devices: Regulation and Control’ was submitted to the Chairman of Rajya Sabha on Monday. According to the report, the committee is of the view that the new legislation on medical equipment should contain such provisions which can revolutionize the medical device industry of the country. The Parliamentary Committee noted that the medical device sector has become a vast industry in recent years due to improved economy and life expectancy, income levels and health awareness and the need for better regulation and control has been felt.

The Committee is of the view that there is a need for a well-organised, inclusive and deeply researched legal framework for regulation of activities related to manufacturing units, medical institutions, laboratories, clinical trials, with the role and accountability of all the stakeholders of this industry. The U.S. has welcomed the setting up of a committee to prepare a new ‘Drugs, Medical Devices and Cosmetics Bill’ with separate provisions for medical devices, but believes that the government needs to support the medical device industry rather than prepare a joint bill on these subjects. Considering the potential, a separate law should be made on medical equipment.

The committee said that instead of setting up a committee on the subject, the government should set up a ‘National Medical Devices Commission’ to look into all aspects of the industry in detail and bring a comprehensive legislation with a comprehensive policy and institutional framework.

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