The Drugs Controller General India (“DCGI”) has identified specific countries under the Rule 101 of the New Drugs and Clinical Trials Rules 2019 (“Rules”), where local clinical trial approval requirements under Chapter X, as well as permissions to conduct clinical trials under Chapter V of the Rules, may be waived during the approval process of five categories of new drugs.
These countries include the United States, the United Kingdom, Japan, Australia, Canada, and the European Union. The categories of drugs eligible for this waiver include:
- Orphan Drugs for rare diseases
- Gene and Cellular therapy products
- New Drugs used in pandemic situation
- New Drugs used for special defense purpose
- New Drugs having significant therapeutic advance over the current standard care.
New drugs from these countries, including orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situation, new drugs used for special defense purpose, and drugs having significant therapeutic advance over the current standard care, will be considered for clinical trial waiver.
A copy of the Order is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
