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Comprehensive Regulation Of Medical Devices
Why in news?
- In a conference organised last week by AiMed, the Biotech Consortium India Ltd and supported by Dept. of Pharmaceuticals, manufacturers had sought for a comprehensive regulatory framework for medical devices and also seek a patient medical device safety law.
More in news
- As per the manufacturers of medical devices a regulatory framework is needed because
(1) Medical devices are not drugs though both are medical products but differ in approach in marketing.
(2) The manufacturers have been specifically seeking trade margin caps on devices notified as drugs.
(3) The indian govt, therefore needs to take policy decisions to give at least a level playing field, if not a strategic advantage to domestic manufacturers while safeguarding consumers.
(4) All medical devices must be regulated under the patient safety medical devices law to protect patients and aid responsible manufacturing.
(5) The manufacturers currently are confused with informally choosing and notifying them as drugs.
(6) They even suggested that the govt. Should expedite steps to end the 80-90% import dependence forced upon them.
(7) There is an urgent need for integration efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry for society
Sources
The Hindu