**Summary:**
This notice, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, addresses the granting of permissions in Form CT-11, CT-14, CT-15, and CT-17 under the New Drugs and Clinical Trials Rules, 2019. It pertains to the manufacturing and import of new drugs for test and analysis, Clinical Trials (CT), or Bioavailability and Bioequivalence (BABE) studies.
The notice clarifies the submission and processing of applications, referencing Notice No. 120120DC Pt. 51 issued on February 18, 2020, which provided clarity on applications for manufacturing trial batches of new drugs or investigational new drugs for test and analysis, CT, or BABE studies. To further streamline the process, the CDSCO has decided that these applications will be processed by CDSCO HQ/Zonal/Sub-zonal offices within seven working days of receipt.
The notice is addressed to all officers of CDSCO HQ, Zonal, and Sub-zonal offices, and all stakeholders. The Drugs Controller General of India, Dr. V.G. Somani, issued the notice on February 25, 2020.
Key Entities Referenced
Central Drugs Standard Control Organization: A department under the Directorate General of Health Services, Government of India, responsible for drug regulation.
New Drugs and Clinical Trials Rules 2019: A set of regulations governing the approval and conduct of clinical trials and the import/manufacture of new drugs in India.
Form CT14: A form related to applications for manufacturing or import of new drugs under the New Drugs and Clinical Trials Rules 2019.
Form CT15: A form related to applications for manufacturing or import of new drugs under the New Drugs and Clinical Trials Rules 2019.
Form CT17: A form related to applications for manufacturing or import of new drugs under the New Drugs and Clinical Trials Rules 2019.
Dr. V.G. Somani: Drugs Controller General of India (DCGI), the head of the CDSCO.
CDSCO HQ Zonal Subzonal office: The head office and regional branches of the Central Drugs Standard Control Organization responsible for processing applications.
New Delhi, Delhi: Location of the Public Grievance Cell of the Central Drugs Standard Control Organization.
F.No.PG/298/import/TL/2019-DCGI
Government of India
Directorate General of Health Services.
Central Drugs Standard Control Organization
(Public Grievance Cell)
FDA Bhawan, Kotla Road
New Delhi-110002,
Dated 25/2 (rer
NOTICE
Subject: Grant of permission in Form CT-14/ CT-14/ CT-15/ CT-17 under New Drugs
and Clinical Trials Rules 2019; - reg.
Under the provision of New Drugs and Clinical Trials Rules 2019, CDSCO receives
applications for grant of permission in Form CT-11/ CT-14/ CT-15/ CT-17 for manufacturing/
import of new drugs for test and analysis, CT or BA/BE study.
Concerns have been raised on certain aspects of submission and processing of such
applications.
In this regard, recently, a Notice No. 12-01/20-DC (Pt. 51) has been issued on
18.02.2020 giving clarity on submission and processing of such applications for grant of
permission to manufacture trial batches of new drug or investigational new drug for test and
analysis , CT or BA/BE study.
Further, to streamline the processing, it has been decided that, such applications will
be processed by CDSCO (HQ)/ Zonal/Sub-zonal offices, as the case may be, within 07
working days of receipt of the applications.
we
be
(Dr. V.G. Somani)
Drugs Controller General (India)
To,
1. All officers of CDSCO (HQ)/ Zonal / Sub-zonal office.
2. All Stakeholders.