06/12/2019 - Health | Mainstorming

IAS Parliament 5 years

KEY POINTS

· A separate agency to regulate medical devices will be unique to India and may pose its own challenges.

· 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.”

· 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.