If implemented, the draft legislation, Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 which has been put up for consultation within Ministries will ensure that pharma majors are bound to pay compensation in case their implants or medical devices are found to have adverse effects.
The proposed law comes on the heels of a controversy surrounding hip implants marketed by US medical device giant Johnson & Johnson, which was found faulty and toxic to patients using them. Affected patients had to move to court to get the compensation for the disability they suffered due to the faulty devices.
Currently, India does not have any legal provisions to compensate patients facing health problems due to faulty medical devices.
The draft law proposes a penalty of up to Rs 1 crore and jail term extending three years to the manufacturers or importers for faulty medical devices having adverse impacts on patients.
As per the new regulatory framework proposed by the Government think tank Niti Aayog, patients suffering from adverse effects of faulty medical devices and implants will be able to demand compensation from the manufacturer or the firm importing them. The draft legislation aims at regulating all locally-made and imported medical devices. 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).
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 draft bill also has penalty provision including imprisonment for offences related to clinical trials and sale of medical devices.