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 government is in the process of formulating a Medical Devices Authority (MDA) for the vast range of products in the sector. With the dichotomy between CDSCO (Central Drugs Standard Control Organisation) and BIS (Bureau of Indian Standards)—and the NITI Aayog also having its say—divided in opinions, one will have to wait to assess how successful the new body might prove to be. According to sources, BIS will continue to frame guidelines but these would be regulated by MDA. Also, the proposed body will be separate from CDSCO, which will continue to be the regulator for drugs.
Here, we are going against international norms. For instance, in the US, the FDA is the agency under which medical devices are controlled, and FDA’s Center for Devices and Radiological Health regulates firms that manufacture, repackage, relabel, and/or import medical devices sold in the US. Similarly, the European Medicines Agency has a medical devices agency. Same is in Japan. In such a scenario, a separate agency to regulate medical devices will be unique to India and may pose its own challenges.
One must ask if instead of forming a new body, wouldn’t it be better to have the powers and working invested in a self-contained division within CDSCO? This would save costs and, more importantly, be within a regulatory system to share expertise. Also, non-compliance with global standards and safety guidelines on the domestic front is a major loophole in ensuring the quality of locally-manufactured medical devices; India lacks infrastructure to test the quality of such devices. The new mechanism and multiple layers of a separate MDA might lead to more confusion amongst manufacturers, further hampering the ecosystem growth.
It would be interesting to see if India is able to fill in the gaps in the fields of R&D, manufacturing and testing facilities, with MDA in place. While we have policy mechanisms and regulatory practices to compare India’s domestic produce, the true testament of quality can only be attributed to adoption and implementation of international harmonised standards rather than coming up with a new mechanism altogether. Another problem is the human resource crunch at multiple levels—a shortage of inspectors to carry out quality assessments, crippling state of manufacturing units and poor regulatory environment are major challenges.
A Deloitte report had noted that “India has not been able to develop itself as a strong manufacturing base for medical technology. The industry remains dependent on imports for meeting its domestic requirements.” This also raises eyebrows towards the ongoing US-India trade talks and speculations around the pricing mechanism, which highlights the need for a scientific and promising alternative that thinks beyond capping prices of select devices (cardiac stents, knee implants).
For the government to realise the need of wider accessibility of healthcare services, one needs to create a holistic environment that supports the establishment of a new regulatory regime. With its primary objective of ensuring safety, quality and efficacy of medical devices, MDA would be able to focus on globally harmonising the standards of domestic as well as imported devices only with universally-accepted and harmonised norms like in the rest of the world. In what looks like a mutual (the government and the industry) inclination as per ongoing negotiations between the two countries (US-India trade deal) towards trade margin rationalisation (TMR), it could be the next scientific step to solving the crisis around price capping in the medical devices industry. If calculated the right way, TMR could be the hope the healthcare industry in India needs. However, it would be incorrect to jump to any conclusion regarding the success or failure of the new MDA before it is even formulated.-Financial Express