The medical device industry has responded positively to the Niti Aayog's proposed Medical Devices Bill which aims to address the concerns on patient safety and reduce import dependency that is currently pegged at almost Rs 39,000 crore.
NITI Aayog floated the Bill after it rejected a proposal floated by the Health Ministry to bring medical devices under the scope of Central Drugs Standard Control Organisation. The Bill titled the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, reportedly has provisions which will address safety concerns of patients and penalise companies which produce and sell (includes importers) faulty devices up to Rs 1 crore.
At a meeting held on Wednesday, the Niti Aayog made a presentation of their proposed Bill to various stakeholders and explained its key features to various stakeholders.
Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) described it as visionary & well thought out road map. “We await the copy of presentation and copy of actual draft Bill to give our studied comments, clause wise." he said.
Industry bodies hope the proposed Bill will help India emerge as one of the leaders in this sector.
The proposed Bill is also tailored for promoting Make In India for medical devices and providing users with access to safe innovative devices. It also proposes to have a Medical Devices Authority, and a new Medical Devices Administration, which will have four divisions — health and safety, conformity assessment, enforcement, and laboratories and medical devices testing.
According to Business Standard, India imports 80-90% of its requirement of medical devices. .
The legislation also reportedly proposes to empower patients who are affected due to faulty medical devices and implants to demand compensation from the producer.
Apart from the above proposals, there is also a proposal to have a National Register of Medical Devices.
Pavan Choudhary, Director General and Chairman of Medical Technology Association of India told Moneycontrol, “We appreciate the wide-ranging consultations which Niti Aayog has begun on the draft act. Our experts will study it for the impact it would have on patient safety, ease of doing business and making investments and innovation."
In 2018, a group of patients who were victims of faulty ASR (articular surface replacement) hip implant by Johnson & Johnson, repeatdly wrote to the Health Ministry for compensation. In 2010, J&J globally recalled hip implants because more patients were found to require revision surgeries than normally reported for such devices.
In August 2018, a committee set up by the government recommended compensation for those who recieved faulty ASR hip implant victims manufactured by DePuy Johnson and Johnson prior to August 2010. A committee was then formed in October 2018 to start the compensation process. However, this was met with serious concerns from patients as it had many deficiencies, exclusions and lacunae. The Supreme Court, with which a public interest litigation had been filed, accepted the compensation set by the Centre, which varied between Rs 30 lakh and Rs 1.22 crore depending on the percentage of disability, age and risk factor.
With IANS inputs