**Subject: Processing Post Approval Changes to BABE Permission and Import Licenses for Export**
This notice, issued on December 27, 2020, by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), BABE Division, addresses the processing of post-approval changes to Bioavailability and Bioequivalence (BABE) permissions issued in Form CT-07 and import licenses issued in Form CT-17 for export purposes.
The notice clarifies procedures for handling post-approval changes, particularly those related to Clinical Trial import licenses granted following the New Drugs and Clinical Trials Rules, 2019. It references earlier guidance, specifically regarding the requirement for prior approval for changes to Form CT-07, including changes received via protocol or study design.
The policy stipulates that any proposed changes to an approved protocol must be submitted for prior approval. This includes changes that could potentially impact data or outcomes of the BABE study. The CDSCO will review these changes and communicate its decision within 15 working days.
For any questions, stakeholders are advised to contact the CDSCO.
The notice is addressed to all stakeholders and has been posted on the website by the IT Cell. The Drugs Controller General of India, Dr. V.G. Somani, is the issuing authority.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India.
Central Drugs Standard Control Organization: A national regulatory body for Indian pharmaceuticals and medical devices.
BABE Division: Division within the Central Drugs Standard Control Organization responsible for Bioavailability and Bioequivalence studies.
New Delhi: The location of FDA Bhawan, where the Central Drugs Standard Control Organization's BABE Division is located.
Form CT 07: Form for BABE permission.
Form CT17: Form for Import licence.
Dr. V.G. Somani: Drugs Controller General of India
Drugs Controller General India: Designation of Dr. V.G. Somani
F. No. 12-09/BA-BE/2020/Misc-02/DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(BA/BE Division for Export)
FDA Bhawan, New Delhi,
Date: 27/1} 2t0
NOTICE
Subject: Processing of Post Approval Changes to BA/BE permission issued in
Form CT- 07 and Import licence issued in Form CT-17 for Export - regarding.
pCL uTi r-c pe 0 on 7 ss , ei .n Ig m pA ou rth to r li it cy e n( cC eL A i) n, Fa os r mp er C Tt -he 1 7N e isw aD lr sou g gs r aa nn td e dC li fn oi rc a il m pT ori ra tl s o fR u sl te us d, y 20 d1 r9 u, g i fn o rF o thr im s
utT h nh e de e s rc a o i Fn d od ui rRt tui hlo en Sss c. hof eD dep t ue a lr i em l i e os d fs ti r ho e en q suf aio ir r
d
ec m Ro e un n ld t eu s sc
.
t a no df B gA u- idB eE l is nt esu dy in a tr he i sp r re es gc ar ri db ed a ru en d ale sr o R pu rl ee ss c r3 i5 b eo df
PnS rou itb i nf cs i ie c pq a atu li e o In n nst v e sft too ir g apt toh ose rt , p eae tp cr p .m ri os vs ai lo n c hi an n gF eo sr m w hiC cT h- 07 in, c lC udD esS C cO ha nr ge ec sei v ie n s prv oa tr oi co ou lss , a sp tp uli dc ya t si io ten ,/
dtI h an a yto , sr d s oe fur c r h et c o ec is a pt s tr e e osa f m o al f pi pPn loe i s ct t ah tAe i p oP p nr r fo o oc v re a as l ps pi C rn h og a v n ao lf g e /s su a c cwh kil nla op b wp e ll i epc da r gt oi eco men es s/ nsn teo d t oi rf b i y oc ta C ht ei D ro Sn w, iC sei Ot
.
h wa is th ib ne e 1n 5 d woe rc ki id ne gd
\as
° e
(Dr. V.G. Somani)
Drugs Controller General (India)
To,
All stakeholders
IT-Cell for posting on website