Key Points
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...
A surge in demand among affluent Indians for weight-loss medications has led to a concerning trend: drugs like Ozempic from Denmark's Novo Nordisk and Mounjaro from America's Eli Lilly are illicitly entering Indian pharmacies, sidestepping regulatory checks...
