New rules -notified on January 31, classify medical devices in four classes -- low risk, low moderate risk, moderate high risk and high risk,which may discourage domestic manufacturing of medical devices and is against the "Make in India" policy.
“The purpose of regulations is to filter access to unsafe products and ensure patient safety and consumer protection.
But there's nothing to penalise pseudo manufacturing in these new regulations.
Domestic manufacturers need factory inspection,where as its not necessary for overseas manufacturing plants.its clear cut discrimination and Surely,It may result in the closure of some units of domestic (medical device) manufacturing and drive jobs out of India as more manufacturing of high risk high technology devices will switch to imports!
one silver lining is," These rules remove the need for periodic renewal of licences".
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