India's push to modernize its medical device regulations for the first time in six years appears close to fruition.
The Economic Times reports that the country's health ministry has moved its proposed new regulations up the bureaucratic chain for some final stages in what is a complex approval process. According to the story, if the country's Union Cabinet (the prime minister and cabinet ministers) signs off on the measure, they will send the bill to Parliament, where it gets a final vote.
India is modernizing its healthcare system, and its homegrown device industry is also maturing rapidly. Also, the country's surging population offers a fertile market for medical device companies seeking to grow, both for international corporations and those based in India. But as the article explains, the use of medical equipment in the country remains essentially unregulated. Another roadblock to industry growth: Devices and medical equipment in general are treated as drugs under current regulatory law (passed in 2007), and that's an archaic way to handle the sector in today's globalized healthcare market.
An updated law would establish separate standards and regulations for medical devices and equipment, covering how they are monitored, made and used. Medtronic ($MDT), Boston Scientific ($BSX) and many others have all targeted India as one of the major emerging markets in Asia ripe for expansion (China is, of course, the other). India's legislators are surely aware that modernized regulations will help draw long-term investments from the global industry and help nurture its own companies as they plan their own international expansions.
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