New Drugs and Clinical Trials Rules amended to introduce deemed approval for conducting clinical trials

In line with the Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022 proposed on 21st January, 2022 the Ministry of Health and Family Welfare has amended New Drugs and Clinical Trials Rules, 2019 to introduce deemed approval for applicants (please refer to e-mail in trail for further details).

When applicants do not receive any communication from the Central Licensing Authority within 90 workings days of making an application, the application for registration of ethics committee will be deemed to have been granted and will be legally valid. Applicants who have got deemed approval are required to submit prescribed forms to the Central Licensing Authority before initiating clinical trial, manufacturing new drug or investigational new drugs, manufacturing unapproved new drug or its pharmaceutical formulation or conducting bioavailability or bioequivalence study of the new drug or investigational new drug applicants.

Source: Ministry of Health and Family Welfare