**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Import and Registration Division, Government of India, on February 26, 2020, concerns the submission and processing of applications for Registration Certificates and Import Licenses in parallel with New Drug applications. The notice addresses concerns about delays in obtaining these approvals for new drugs.
Currently, the import of drugs is regulated under Chapter III of the Drugs and Cosmetics Act, 1940, and Part IV of the Drugs and Cosmetics Rules, 1945. Overseas manufacturing sites and the drugs themselves must be registered with CDSCO according to Rules 24A and 24. Prior to this notice, permission for New Drugs was required under the New Drugs and Clinical Trials Rules, 2019 *before* a Registration Certificate and Import License could be obtained.
This notice announces a change in policy. Applicants can now submit applications for Registration Certificates and Import Licenses simultaneously with their application for permission to import a New Drug. These applications will be processed concurrently. The granting of the Registration Certificate and Import License, however, remains conditional upon the issuance of New Drug permission under the New Drugs and Clinical Trials Rules, 2019.
The notice was issued by Dr. V. G. Somani, Drugs Controller General of India, and is addressed to all stakeholders.
Key Entities Referenced
Directorate General of Health Services: A department under the Government of India responsible for public health.
Central Drugs Standard Control Organisation: The national regulatory body for pharmaceuticals and medical devices in India.
New Delhi: The location of FDA Bhawan, Kotla Road; the address of the Import and Registration Division.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: Rules under the Drugs and Cosmetics Act, 1940, that provide detailed regulations for drugs and cosmetics.
New Drugs and Clinical Trials Rules, 2019: The regulations governing the approval of new drugs and conduct of clinical trials in India.
Registration Certificate: A certificate required for overseas manufacturing sites and drugs to be registered with CDSCO.
Import License: A license required for importing drugs into India.
Import/Misc/49/2020-DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Import and Registration Division)
FDA Bhawan, Kotla Road
New Delhi
Dated 26" February, 2020.
NOTICE
Subject: Submission and processing of application for Registration Certificate
and Import License in parallel with New Drug application-Regarding.
Import of drugs is regulated under Chapter III of the Drugs and Cosmetics Act, 1940
and Part IV of the Drugs and Cosmetics Rules, 1945. For import of drugs, the overseas
manufacturing sites and the drugs are required to be registered with CDSCO as per the
requirements of Rule 24 (A) and 24 of Drugs and Cosmetics Rules 1945. However, for
New Drug, permission is required to be obtained under the New Drugs and Clinical
Trials Rules, 2019 before obtaining the Registration Certificate and Import License.
Concerns have been raised from time to time seeking a system of simultaneous
submission and processing of such applications to avoid undue delay.
In this regard, it has been decided that the applicant can submit its application for
obtaining Registration Certificate and Import License simultaneously, while submitting
the application for permission for import of any New Drug in the country. These
applications shall be processed simultaneously and Registration Certificate & Import
License shall be granted subject to condition of issuance of the New Drug permission
under New Drugs and Clinical Trials Rules, 2019.
Ye
eve
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:
1. All Stakeholders.