The Ministry of Health and Family Welfare (MoHFW) on October 14, 2022 has issued the New Drugs and Clinical Trials (Third Amendment) Rules, 2022 to further amend the New Drugs and Clinical Trials Rules, 2019. This has come into force on October 14, 2022.
The following has been stated namely: -
• Rule 8(3) which states “Registration of Ethics Committee relating to clinical trial, bioavailability and bioequivalence study” the following proviso has been inserted after clause (iI) namely: -
“Provided that, where no communication has been received from the Central Licensing Authority within the said period of forty-five working days, the registration of Ethics Committee shall be deemed to have been granted by the Central Licensing Authority and such registration shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules”
• Rule 53 which states “Grant of permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study, or for examination, test and analysis” after clause (2) the following proviso has been inserted namely: -
“Provided that, where no communication has been received from the Central Licensing Authority within the said period of ninety working days, the permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study or test and analysis shall be deemed to have been granted by the Central Licensing Authority and such permission shall be deemed to be legally valid for all purposes and the applicant shall be authorised to manufacture the new drug or investigational new drug for said purposes in accordance with these rules”
Please refer to the notification to view the amendments
[Notification No. 778(E)]
