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 specified under the proposed Act.

"Any person who has suffered harm or injury as a result of any violation of any provision of this Act, rules or regulations, such person shall have the right to seek compensation from the manufacturer or other economic operator committing a violation in respect of that device," the proposed law reads. The draft legislation also proposed a separate regulator under the Directorate General of Health Services to monitor the medical devices sector.

Currently. both drugs and medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO). The proposed administration will consist of the following divisions -- the Health and Safety Division, the Conformity Assessment Division, the Enforcement Division and the Laboratories and Medical Devices Testing Division. It has also proposed registration of all medical devices in the National Register of Medical Devices before being placed in the market and putting an unique identification number (UID) to be displayed on the label of a product.

All foreign manufacturers "must comply with conformity assessment requirement in accordance with the provisions of this Act, obtain a conformity assessment certificate and register their device in the National Register of Medical Devices prior to the commencement of export into India unless exempted from such requirement by the administration".

"The Bill aims to protect and promote health by ensuring that medical devices that are made available for use in India are safe and effective, to encourage innovation in the development and use of medical devices, and to this end, to create a Medical Devices Administration," a note attached to the draft law read.

The draft bill also has penalty provision including imprisonment for offences related to clinical trials and sale of medical devices. The health ministry in October issued notifications stating all medical devices, intended for use on human beings or animals should be treated as drugs with effect from 1 December 2019 and would be regulated under the Drugs & Cosmetics Act.