Govt of India released New Drugs and Clinical Trials Rules 2019

Whoever intends to conduct clinical trial or bioavailability study or bioequivalence study shall be required to have the approval of an Ethics Committee for clinical trial registered under rule 8. 

The Ethics Committee shall apply for registration with the Central Licencing Authority under rule 8.

Clinical trial of new drug or investigational new drug.― (1) No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug,― 

(i) except in accordance with the permission granted by the Central Licencing Authority; and 

(ii) without the protocol there of having been approved by the Ethics Committee for clinical trial registered in accordance with the provisions of rule 8. 

Download link for official Gazette Notification New Drugs and Clinical Trials Rules, 2019. 

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