Drugs and Clinical Trials Rules, 2019 Flashcards
To whom The rules will apply?
to all new drugs, investigational new drugs for human use, clinical trials, bio-equivalence studies and ethics committees.
rules has reduced time for approving applications by how much?
has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
what happens to application in case of no communication from Drugs Controller General of India?
the application will be deemed to have been approved.
What is the rule related to local clinical trial?
local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries (EU, U.K., Australia, Japan and U.S.) specified by the Drugs Controller General with the approval of the government.
Saftey related clause?
The new rules will ensure patient safety and an ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
