Medical Devices Industry Welcomes Changes in the Drugs and Cosmetics Amendments Bill

The representatives of the global medical devices industry agreed to 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.

EU Improves Safety of Medical Devices After PIP Breast Implant Scandal
The EU's executive has moved to improve the safety of medical devices following the worldwide scandal over faulty PIP breast implants from France that seriously affected many women.

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.

FDA Will Track Medical Devices Through New System
The US Food and Drug Administration has announced a new system through which it will be tracking millions of medical devices.

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.

Medical Devices Could be Responsible for Higher Than Expected Numbers of Pressure Ulcers in Children
Medical devices could be the reason behind higher than expected number of pressure ulcers in children according to a new study conducted by researchers at Cincinnati Children's Hospital Medical Center

"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.

Cyber Attacks on Medical Devices, a New Problem
US authorities warn hospital networks and makers of medical gadgets against cyber attacks and encourage them to make efforts to guard against these attacks

The AdvaMed is a trade association of international medical device manufacturers.

Source-IANS