By IANS,
New Delhi : Representatives of the global medical devices industry Monday welcomed the health ministry’s move to examine the recommendations of the standing committee on the drugs and cosmetics amendments bill.
The Drugs and Cosmetics (Amendment) Bill, 2013, proposes changes in the regulation of the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices, including measures to ensure product safety, efficacy and quality in clinical trials.
The bill is significant because it recognises medical devices as distinct from pharmaceuticals for the first time and brings needed clarity to device regulation.
It was introduced in the Rajya Sabha in August last year, and was later referred to the standing committee.
The standing committee’s recommendations, which were tabled in parliament in December 2013, are currently being examined by the union health ministry.
On Feb 9, Minister of State for Health Abu Hasem Khan Choudhury emphasised the need to ensure that there is sufficient dialogue with stakeholders before submission of the revised bill.
The Advanced Medical Technology Association (AdvaMed), along with other representatives of the global medical device industry, welcomed the ministry’s resolve on the issue, according to a release.
“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,” Ralph Ives, executive vice president, Global Strategy and Analysis at AdvaMed 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,” Ives said.
The AdvaMed is a trade association of international medical device manufacturers.