Listen to Story To help make drugs manufactured outside India more accessible and affordable in the local market, the Drugs Controller of India has announced to waive the requirement for clinical trials for several international drugs and medicines. These internationally developed drugs can receive market authorisation in India without the need to present local clinical trial data. Under a new rule, permission has been granted to countries such as the USA, UK, EU, Japan, Australia and Canada under Rule 101, "for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules.
" "Currently, several medicines already approved from regulatory authorities like the US, UK and EU are not currently available in India due to regulatory requirements under the Drugs and Cosmetics Act. There is a need for conducting a local clinical trial to generate efficacy of data locally before they are given market use authorisation in India," official sources in the Directorate General of Health Services said. The move comes as the government feels there is a delay in launching many life-saving drugs in the country.
Drugs under the following category have been proposed for waiver of clinical trials in India: "The most sought-after and latest medications that would help treat diseases like cancer, rare diseases like SMA and DMA autoimmune conditions will become available expeditiously in .