Draft law proposes compensation for faulty medical devices, implants

Patients suffering from adverse effects of faulty medical devices and implants will soon be able to demand compensation from the manufacturer or the firm importing them under a new regulatory framework proposed by the government think tank Niti Aayog.

At present, there are no legal provisions to compensate patients facing health problems due to faulty implants or medical devices.

The draft legislation, titled Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, has been put up for consultation within ministries.

It aims at regulating all locally-made and imported medical devices.

The draft law proposes a penalty of up to Rs 1 crore on the manufacturers or importers for faulty medical devices having adverse impacts on patients.

It has suggested a jail term extending up to three years or fine up to Rs 50 lakh or both for placing a medical device in the market without a valid certificate of conformity, obtaining a registration and without complying with conditions as may be