Fix the Missing Link

The medical device industry forms a vital pillar of healthcare, playing a central role in patient care from diagnosis through to treatment and beyond. However, as Dr Kale argues in Analysis: Fix The Missing Link, an article published in one of India’s largest and most respected business magazines, Business World, the fact that it remains neglected by policy-makers, regulators and industry associations in India has serious implications for the development of a safe and effective healthcare system for all.

This regulatory vacuum has created a market that is dominated by multinational corporations at one end and counterfeit manufacturers at the other. Hospitals, driven by profits, often choose the cheapest option, and this can have serious implications for patients’ health. Examples highlighted include poor-quality X-ray machines that fail to pick up fractures, and a patient who needed three operations after the original bone implants used were found to be fake.

Although in 2013 India took a small step forward when it introduced new amendments to the Drugs and Cosmetics Act in the Upper House of Parliament – amendments that recognise medical devices as a distinct category and incorporate new regulations in line with standard international practices – the Bill is still awaiting approval. As Dr Kale concludes, it’s about systems, controls, measures and integrity. And a smart and appropriate regulation that brings all these together remains the missing link in the Indian healthcare system.

Read Analysis: Fix The Missing Link.