No late-age trials for some drugs
06 March 2015 | News | By BioSpectrum Bureau
No late-age trials for some drugs
This would significantly speed up the approvals process for new drugs
At a recent meeting of the Drugs Technical Advisory Board, a panel of advisors to the government that late-stage clinical trials be waived under certain conditions for some new drugs already being sold on international markets, says reports.
The panel said that clinical trials for new drugs already selling in a well regulated country may be waived, if the safety and efficacy of the drug is found to be favourable. The evaluation of such new drugs should be made in consultation with experts on specific therapeutic areas, the panel advised.
This would significantly speed up the approvals process for new drugs and will likely be cheered, chiefly by foreign drugmakers who have decried India's strict rules and red tape around clinical trial approvals.
