AdvaMed supports India’s proposal to separate device, drug regulation

U.S. medical device makers lauded India’s healthcare officials for progress on a bill that would for the 1st time separate medical device regulation from pharmaceuticals.

The bill was introduced last year and then referred to a standing committee.  The committee’s recommendations were tabled in December 2013 and are now under review by India’s union health ministry, according to the Indo-Asian News Service.

The revisions were welcomed by U.S. medical device industry lobby AdvaMed which called for progress on the bill.  “The medical device industry welcomes the ministry’s recognition of the critical need to differentiate medical devices from pharmaceutical products in the regulatory structure, and as a vital element of the Indian health care delivery system,” AdvaMed global strategy & analysis executive vice president said.  “We believe the revised bill will improve industry’s ability to serve India’s growing health care needs in a safe, effective and timely manner.  We commend and appreciate the government’s willingness to consult all stakeholders on this very important legislation.”

REFERENCE:  Mass Device; 26 FEB 2014; Arezu Sarvestani

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