Why in news?

The government is in the process of formulating a Medical Devices Authority (MDA) for the vast range of products in the sector.

What is the proposal?

• The MDA would function as a regulator for India’s semi-regulated medical devices industry.
• There is now a dichotomy between CDSCO (Central Drugs Standard Control Organisation) and BIS (Bureau of Indian Standards).
• Reportedly, the 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.

What are the concerns with the proposal?

• Seemingly, the decision goes against the international norms.
• E.g. in the US, the FDA (Food and Drug Administration) is the agency under which medical devices are controlled.
• The FDA’s Center for Devices and Radiological Health regulates firms that manufacture, repackage, relabel, and/or import medical devices sold.
• Similarly, the European Medicines Agency has a medical devices agency.
• Given these, a separate agency to regulate medical devices will be unique to India and may pose its own challenges.
• 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.
• Given this, the new mechanism and multiple layers of a separate MDA might lead to more confusion amongst manufacturers.

What could have been done?

• There are already 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.
• So, aligning with international standards would be better than coming up with a new mechanism altogether.
• Instead of forming a new body, it would 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.

What is the priority now?

• 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.
• The ongoing US-India trade talks and speculations around the pricing mechanism remains another concern.
• This highlights the need for a scientific and promising alternative that goes beyond capping prices of select devices (cardiac stents, knee implants).
• Another problem to be addressed 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 other major challenges.
• So, the government needs to create a holistic environment that supports the establishment of a new regulatory regime.
• This would facilitate realising the need of wider accessibility of healthcare services.
• Any new mechanism should also be able to fill in the gaps in the fields of R&D, manufacturing and testing facilities.