At a time when healthcare experts are deliberating on the need of a separate regulatory framework for medical devices, NITI Aayog called for a stakeholders' meeting in New Delhi to discuss the key features of the draft Medical Devices Bill. The new regime aims to bring in a robust regulatory mechanism, facilitate ease of doing business and organize India’s semi-regulated medical device industry with a focus on global harmonization.

Prominent public health and renowned industry experts lauded the government’s efforts to involve multiple stakeholders and emphasized how this move, will bring revolution in the medical devices industry and protect patients’ interests. However, the country’s healthcare policies are at an inflexion point and there is rising need to focus on quality and innovation by building medical infrastructure at par with global standards of safety rather than rationing it in the name of wider accessibility at the cost of quality and safety.

Healthcare in India needs a paradigm shift and one must act as a catalyst to smoothen the journey which lies ahead than putting it in jeopardy altogether. The medical experts also argue that the move will do little to improve the condition of the already “unregulated” medical device sector in India. Others question if a separate regulatory mechanism can act as a yardstick for the safety and efficacy of medical devices. “A robust regulatory mechanism has been a fairly long wait for India’s semi-regulated medical devices industry. At a time when healthcare experts are expecting a separate regulatory framework for medical devices, the true testament of quality can only be attributed to adoption and implementation of international harmonised. Complying with global standards will open the door for global markets, as well as help the local device sector to follow high standards and carry clinical evaluation in line with global players. This regulatory environment improves the ease of doing business and will help create jobs, add economic value and improve patient outcomes,” stated, Malay Mitra, Regulatory Advisor, Retired as Deputy Drugs Controller from CDSCO.

Calling it a positive move, Dr Gajendra Singh, Public Health Expert, asserted, “The government’s move to hold meetings with relevant stakeholders by adopting global regulatory practices for medical devices is highly laudable. It is important that the government stay on a track of progressive reform in the regulatory structure for medical devices and boost innovative technology. The process going forward should continue to be transparent and inclusive and consider efforts of national regulatory authorities at the global level to develop and share best practices to achieve its goals for the ease of doing business and attracting foreign direct investment in the medical devices sector.”

It would be interesting to observe if India is equipped to fill in the gaps in the field R&D, manufacturing and testing facilities with the new medical device authority in place. While India has policy mechanisms and regulatory practices to compare the country’s domestic product, the true testament of quality can only be attributed adoption and implementation of International Harmonised Standards rather than coming up with a new mechanism altogether.

Elaborating on the Indian Governments’ efforts to improve the overall landscape and benefit patients to get quality medical device in line with global regulations, Washington-based device makers’ trade association, AdvaMed stated, “AdvaMed appreciates initial steps by the Government of India to consult with relevant stakeholders on the best way to regulate medical devices and diagnostics. Our industry is eager to work with the government of India to develop a robust regulatory regime for medical devices and diagnostics that ensures patient safety, fosters innovation and helps strengthen the ecosystem for the medical devices industry in India.  As India deliberates to develop a comprehensive regulatory framework for medical devices and diagnostics, AdvaMed and its member companies urge the Government to promote the adoption of a globally harmonized system including global consensus standards that will not only help ensure the quality and efficacy of products but also enable an ecosystem for manufacturing, research and innovation for benefits of patients in India.”