Issues Around Regulation of Medical Devices Industry in India

India’s semi-regulated medical devices industry needs a robust regulatory mechanism as soon as possible. At a time when internationally healthcare experts are expecting that a separate regulatory framework for medical devices is needed, the government of India is in the stages of formulating a Medical Devices Authority (MDA) for the different products the sector has managed to produce over the years. With strong differences between BIS (Bureau of Indian Standards) and CDSCO (Central Drugs Standard Control Organisation) , and with NITI Aayog wanting a greater role in this, we will have to wait and watch how successful the new body will be. Government sources indicate that BIS will continue to frame guidelines for medical devices but those would be regulated by the new organization MDA, the proposed body, MDA, will be completely separate from CDSCO, which will continue to be the regulator for drugs.

In doing so India is going against international norms. For example, in the United States of America, the Food and Drug Administration (FDA) is the federal agency under which medical devices are regulated and controlled, and further FDA’s Center for Devices and Radiological Health regulates companies that in turn manufacture, relabel, repackage, and/or import medical devices sold in the United States. The same standards apply for its European and Japanese counterparts. In such conditions, an entirely separate agency to regulate the medical devices will be unique to India and may pose its own challenges.

Policy experts in the sector must ask if it wouldn’t be a better solution to have the powers and working invested in a self-contained division within the existing CDSCO, this would save additional costs and importantly be within the existing regulatory system to share expertise. Along with this anomaly of having a separate agency will lead to non-compliance with global standards and safety guidelines on the domestic front and inability to ensure the quality of locally-manufactured medical devices is world class. The new mechanism and multiple layers of additional bureaucracy will certainly lead to more confusion amongst manufacturers, further throttling the growth of the ecosystem.

India would face a challenge in being able to fill in the gaps that exist in R&D, manufacturing and testing facilities. The government would do a better service to the domestic industry by adopting and implementing the international harmonised standards rather than coming up with arbitrary domestic ones. Another problem that the Industry faces is the lack of human resources at multiple levels—a shortage of inspectors to carry out quality assessments and appalling state of manufacturing units in the country.