**Summary:**
This circular, issued by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, addresses the extension of validity for Bioavailability and Bioequivalence (BABE) study centers. The circular clarifies the status of BABE study centers permitted by CDSCO before the implementation of the New Drugs and Clinical Trial (NDCT) Rules, 2019, which require registration under Rule 44 of the NDCT Rules, 2019.
Due to representations from stakeholders citing the COVID-19 outbreak, CDSCO has examined the matter of expiring validities of BABE study center registrations. CDSCO clarifies that if a BABE study center submits an application for renewal of registration in Form CT-08 ninety days prior to the expiry date, as per the NDCT Rules, 2019, the existing registration remains valid until an order is passed by the CDSCO on the application.
Therefore, BABE study centers that have already applied or will apply for renewal of registration at least 90 days before the expiry of their existing registration, using Form CT-08 with the necessary fees and documents, will maintain valid registration until further notice from CDSCO.
The circular is addressed to all stakeholders and is issued by Dr. V. G. Somani, Drugs Controller General of India.
Key Entities Referenced
Directorate General of Health Services: A department under the Government of India involved in health services.
Central Drugs Standard Control Organisation: National Regulatory Authority (NRA) of India. It is responsible for approval of licences of specified categories of drugs, cosmetics, pharmaceuticals and medical devices.
New Delhi: The location of Central Drugs Standard Control Organisation (CDSCO) office, in Delhi State.
BABE Study Centres: Centers conducting Bioavailability and Bioequivalence studies of new drugs in humans.
New Drugs and Clinical Trial Rules 2019: The set of rules under which the BABE study centers are registered.
CDSCO: Abbreviation for Central Drugs Standard Control Organisation.
COVID19: The pandemic considered as a factor for extending the validity of BABE study center registrations.
Dr. V. G. Somani: Drugs Controller General of India.
7-5/2020/Misc/070
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(International Cell)
FDA Bhawan, Kotla Road,
New Delhi- 110002.
Dated:- 3e\4\we
Circular
Subject: Extension of validity of BA/BE Study Centres - Regarding
To conduct the Bioavailability and Bioequivalence study in of New Drugs in human in the
country, the centre shall be registered under rule 44 of New Drugs and Clinical Trial (NDCT)
Rules 2019. Before the implementation of the NDCT Rules, 2019 on 19/03/2019 the
permissions were issued to the study centers to conduct the BA-BE studies having the validity
of 3 years. However all such centers permitted by CDSCO before implementation of the NDCT
Rules, 2019, need to be registered under the NDCT Rules.
This office has received representations from stakeholders requesting to extend
validity of BA/BE study Centers registration whose validities are expiring between now and
August 2020 in view of COVID-19 outbreak.
The matter has been examined by committee of CDSCO in light of pandemic COVID-
19, and it is clarified that, in accordance with NDCT Rules, 2019, if application for the renewal
of registration of BA/BE study centre in Form CT-08 is received by CDSCO ninety days prior to
the date of expiry, the registration shall continue to be in force until order passed by the said
authority on the application.
In view of above, the BA/BE study Centres who has already applied or will apply for
renewal of the registration 90 days prior to the date of expiry of its existing registration, in Form
CT-08 along with requisite fees and documents, the registration of such centers will remain
valid until any order is issued by CDSCO otherwise.
ee
Dr. V. G. Somani
Drugs Controller General (India)
To
All stakeholders through CDSCO website
Copy to ;
PS to JS (R), MoOHWF, GOi, Nirman Bhawan, New Delhi