Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 148]
Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 181]
LATEST NEWS UPDATES | Law on medical devices has waited 12 years -Ritu Sarin

Law on medical devices has waited 12 years -Ritu Sarin

Share this article Share this article
published Published on Dec 3, 2018   modified Modified on Dec 3, 2018
-The Indian Express

NITI Aayog meeting notes it will bring in ‘more control, curb growth’

New Delhi:
Successive governments in India have neglected the medical devices sector. For over 12 years, a proposed legislation, the Medical Device Regulation Bill, has awaited enactment.
Advertising

The Bill was first drafted in 2006 when the UPA was in power. It was never legislated.

Under the NDA, a Group of Ministers (GoM) was constituted under Finance Minister Arun Jaitley but in 2016, a decision was taken to postpone its legislation and introduce instead the Medical Device Rules and Regulations.

For the government, this seemed adequate for the sector. As recently as July this year, at a NITI Aayog Committee of Secretaries (CoS) meeting chaired by CEO Amitabh Kant, it was noted how views have been expressed by some Secretaries who felt there was no need to bring in an exclusive piece of legislation to govern medical devices. Their logic: having a separate legislation will bring in “more control” and “curtail growth and innovation” in the fast-expanding medical devices industry.

The new Rules were circulated in 2017 and notified on January 1, 2018. The 241-page guidelines laid down the fundamental design and manufacturing requirements for 594 medical devices, and classified them into four categories (A,B,C and D) depending on their being high-risk or low-risk. A statement from the Health Ministry stated that the new Rules brought medical devices in conformity with the framework of the Global Harmonization Task Force (GHTF) and did away with the system of periodic renewal of licences for medical device manufacturers or importers.

While the new Rules might be a step in the right direction, experts and medical device bodies see this as an easy way out for politicians of the day. They remain critical of the single factor which has remained the bane for the medical device industry in India — the fact that despite India emerging as the fourth-largest medical device market in Asia, its regulation and management is done under the 1940 Drugs and Cosmetics Act. Medical Devices, thus, ride piggyback on the drug and pharma industry and have never got their share of sectoral importance.

Please click here to read more.

The Indian Express, 3 December, 2018, https://indianexpress.com/article/india/implant-file-medical-device-regulation-bill-cdsco-5475513/


Related Articles

 

Write Comments

Your email address will not be published. Required fields are marked *

*

Video Archives

Archives

share on Facebook
Twitter
RSS
Feedback
Read Later

Contact Form

Please enter security code
      Close