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: 73
 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: 74
 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]
Notice (8): Undefined variable: urlPrefix [APP/Template/Layout/printlayout.ctp, line 8]latest-news-updates/to-market-new-drugs-in-india-global-trials-must-include-indians-sushmi-dey-4682943.html"/> LATEST NEWS UPDATES | To market new drugs in India, global trials must include Indians -Sushmi Dey | Im4change.org
Resource centre on India's rural distress
 
 

To market new drugs in India, global trials must include Indians -Sushmi Dey

-The Times of India

NEW DELHI: In a move to ensure efficacy of medicines sold in India, the drug regulator has made it mandatory for companies to include Indian patients in global clinical trials if they want to market in India a new drug developed outside the country.

The decision was taken in a recent technical committee meeting, headed by director general of health services Jagdish Prasad. The committee, which was formed following directions from the Supreme Court, has a mandate to supervise clinical trials on new chemical entities.

"Any firm intending to market a new drug which is being developed outside the country, should include Indian patients in the global clinical trial...," the minutes of the meeting, reviewed by TOI, said.

The committee also decided that if proposal of such global clinical trials are already approved in ICH countries such as the US, Europe and Japan, then it will be reviewed on priority by the Indian drug regulator.

The ICH or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

Please click here to read more.