India’s Proposal for a Medical Device Regulatory Framework

India’s Department of Science and Technology (DST) has recently prepared a draft legislation on a regulatory framework for medical devices. Currently, some medical devices are classified as drugs and are regulated by the Central Drugs Standard Control Organization. However, since many of the forms and regulations are tailored towards drugs, doing device applications is often difficult and impractical.

Because there is no mechanism or regulation specifically for ALL medical devices, this new framework would provide the initial steps in establishing a separate section for medical device registration in India. For example, validation would be required before any medical device is certified for use in India.

The Srichitra Tirunal Institute of Medical Sciences in Kerala worked on this regulatory framework for two years to help the DST. The Minister of Science and Technology, Kapil Sibal, said they will submit the draft legislation to the Ministry of Health soon, and hopes that the legislation will be approved by Parliament in a couple of sessions.

Because India depends heavily on imported medical devices, the DST hopes that this new regulatory framework would encourage international companies to increase exports and also to manufacture in India. India has some high quality manufacturers and cheaper labor costs which encourage manufacturing there. Medical software is another area India should excel in.