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Policy and regulations

India's half-baked medical-device regulation won't reduce patients' sufferings or rein in errant firms

The new rules ignore several critical areas.
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anujgupta
31 Aug 2018 7 Mins Read 0 comment
Cartoon Resource/Shutterstock Shutterstock.com
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The Indian medical-device industry is worth USD5.2 billion, growing at a CAGR of 15.8%, faster than many global markets. The import-dependent country has drawn the attention of the industry, given its large under-served population. However, this doesn't necessarily mean Indian patients can rejoice. The medical-devices market has gained notoriety thanks to a string of incidents where manufacturers and importers
for patient tracking and adverse-event reporting. In the US, in contrast, the company was implicated in a similar case on the basis of data and complaints from country’s robust adverse event reporting structure (it is mandatory to report adverse events in the US) and other stringent regulations. J&J paid more than USD2 billion as compensation to the affected patients.
The Indian medical-device industry is worth USD5.2 billion, growing at a CAGR of 15.8%, faster than many global markets. The import-dependent country has drawn the attention of the industry, given its large under-served population. However, this doesn't necessarily mean Indian patients can rejoice. The medical-devices market has gained notoriety thanks to a string of incidents where manufacturers and importers for patient tracking and adverse-event reporting. In the US, in contrast, the company was implicated in a similar case on the basis of data and complaints from country’s robust adverse event reporting structure (it is mandatory to report adverse events in the US) and other stringent regulations. J&J paid more than USD2 billion as compensation to the affected patients.

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