**Summary:**
This order, issued by the Drugs Controller General of India (DCGI), Directorate General of Health Services, Ministry of Health and Family Welfare, specifies countries for potential waiver of local clinical trials and for granting permission to conduct clinical trials for new drugs, as per Rule 101 of the New Drugs and Clinical Trial Rules, 2019. With the approval of the Central Government, the order designates the USA, UK, Japan, Australia, Canada, and the European Union (EU) as countries whose regulatory standards may be considered for waiving local clinical trials in India for the following categories of new drugs: (1) Orphan Drugs for rare diseases, (2) Gene and cellular therapy products, (3) New drugs used in pandemic situations, (4) New drugs used for special defense purposes, and (5) New Drugs having significant therapeutic advance over the current standard of care. The order is issued under File No. DCDT1501411852024 and is dated 9/7/2024. The issuing authority is Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India. This information is available on the CDSCO Website. Copies have been sent to PS to Adviser Cost, MoHFW, Nirman Bhawan, New Delhi.
Key Entities Referenced
Drugs Controller General India: The head of the Central Drugs Standard Control Organisation (CDSCO) in India, responsible for drug regulation and control.
Directorate General of Health Services: A department under the Ministry of Health and Family Welfare in India.
New Delhi: The location of the FDA Bhawan and Nirman Bhawan, and thus the office of the Drugs Controller General India and the MoHFW.
New Drugs and Clinical Trial Rules, 2019: A set of regulations governing the approval and conduct of clinical trials for new drugs in India.
Central Licensing Authority: The authority responsible for granting licenses and approvals related to drugs and clinical trials in India.
Central Government: The government of India, which approves the specification of countries for waiver of local clinical trials.
USA: One of the countries specified for waiver of local clinical trials for certain categories of new drugs.
UK: One of the countries specified for waiver of local clinical trials for certain categories of new drugs.
Drugs Controller General (india)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Order
File No. DC-DT-15014(11)/85/2024 Date 9 7 ANG qn74
Subject: Specifying names of countries under the Rule 101 of New Drugs and
Clinical Trial Rules, 2019 related to new drug approval — Regarding
As per Rule 101 of New Drugs and Clinical Trials Rules, 2019 the Central
Licensing Authority, with the approval of the Central Government, may specify, by an
order, the name of the countries, from time to time, for considering waiver of local
clinical trial for approval of new drugs under Chapter X and for grant of permission for
conduct of clinical trial under Chapter V of the said rules.
In exercise of the powers conferred under Rule 101 of the said rules with the
approval of the Central Government, the countries namely; USA, UK, Japan, Australia,
Canada and EU are hereby specified for following categories of new drugs:-
e Orphan Drugs for rare diseases
e Gene and cellular therapy products
e New drugs used in pandemic situation
e New drugs used for special defense purpose
e New Drugs having significant therapeutic advance over the current standard
care.
wt
(Dr. Raféev Singh Raghuvanshi)
Drugs Controller General (India)
Th;
14. CDSCO Website
CC to:
4. PS to Adviser Cost, MoHFW, Nirman Bhawan, New Delhi