The draft legislation — made public for comments — envisages setting up of a medical device regulatory authority (MRDA) with whom all manufacturers and the importers of medical devices have to register. 
The authority will also be responsible for maintaining the correct standards for medical devices and non-compliance may result into a monetary fine up to Rs 5 lakh or imprisonment up to six months.
The manufacturers and importers will have to comply with the standards laid down by the authority and any violation will lead to withdrawal of the devices from the market.
Since medical devices require an entirely different system for regulation involving multiple branches of science and engineering, the Government has decided to set up the MRDA, instead of putting additional responsibility on the over-burdened set up of the Drugs Controller General of India (DCGI), sources told Deccan Herald.
A new legislation has been proposed instead of amending the Drugs and Cosmetics act of 1940 with the objective of bringing out the regulation regime quicker.
Since the Act predates Independence, amendments require necessary approvals from both the Parliament and all state legislatures, which will be a time consuming affair, sources said.
Though the medical device market is growing at an annual rate of 12-14 per cent and more than 85 per cent of the needs are met by the imports, in the absence of a regulatory authority, there is no way to check the devices’ standards, said Dr K Mohandas, director of Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram.
The institute, which developed a range of indigenous medical devices including a low cost heart valve in the last decade, has drafted the legislation though its seeds were sown almost three years ago when the Society for Biomedical Technology and Indian Council of Medical Research proposed to create the regulatory authority.
Besides officials from the Union Science and Health Ministries, the nine-member authority is proposed to have a jurist, two independent doctors and the secretary general of the Quality Council of India.
After collecting and collating the public’s comments, the draft legislation would be fine-tuned and an updated version of the bill would be placed before the Union Cabinet for approval, said Union Science Minister Kapil Sibal.