**Summary:**
This public notice, issued by the Drugs Controller General of India (DCGI) on June 5, 2018, announces meetings of the Drugs Technical Advisory Board (DTAB) sub-committee from June 5, 2018, to June 22, 2018, at the DCGI office, FDA Bhawan, Kotla Road, New Delhi. The sub-committee will examine 344 Fixed Dose Combinations (FDCs) and 5 FDCs and provide hearings to petitioners/appellants. This notice is a continuation of the public notice dated May 28, 2018. All petitioners/appellants are requested to report to the office at 9:30 AM for the hearings. There is a change in hearing times for June 9th and June 22nd, 2018; the revised time will be 9:30 AM to 4:30 PM instead of the previously announced 9:30 AM to 7:00 PM. Sanjeev Kumar, DDCI, CDSCO HQ, serves as the Convener of the Sub-Committee of DTAB. The notice has been circulated to Indian Drugs Manufacturing Associations (IDMA), FOPECI, and IIPA for wider publicity.
Key Entities Referenced
FDA Bhawan, Kotla Road, New Delhi: The location of the Office of Drugs Controller General India.
Directorate General of Health Services: An agency under the Ministry of Health and Family Welfare, Government of India.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India, responsible for regulating pharmaceuticals and medical devices.
DTAB sub Committee: A subcommittee of the Drugs Technical Advisory Board (DTAB), a statutory body that advises the Government of India on technical matters related to drugs and cosmetics.
344 FDCs: Fixed-dose combinations of drugs being examined by the DTAB sub Committee.
Sanjeev Kumar: DDCI, CDSCO HQ, Convener, SubCommittee of DTAB
CDSCO HQ: Central Drugs Standard Control Organization Head Quarters
Indian Drugs Manufacturing Associations: An association of drug manufacturers in India.
File No. 4-01/2013-DC (Misc. 13-PSC-Part-l)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan, Kotla Road
« New Delhi-110002
Dated: § 5 JUN 2018
PUBLIC NOTICE
Subject: Meeting of DTAB sub Committee w.e.f. 05.06.2018 to 22.06.2018 in the
in the office of DCG (I), 1st floor, FDA Bhawan, Kotla Road, Near
National Bal Bhawan, New Delhi-110002 to examine the 344 FDCs + 05
FDCs and to provide hearing to the petitioners/appellants -regarding.
This is in continuation to this office Public Notice dated 28.05.2018 on the subject
cited above where in Date and Time of hearing have been mentioned under
Annexure ‘A’ of the notice.
In this regard, it may be informed that all petitioner/appellants are requested to report
to this office at 9:30 AM for the purpose of hearing. Further, it may be noted that
there is a partial change in time of hearing for 9" and 224 June 2018. The time of
hearing for these dates will be 9:30 AM to 4:30 PM in place of 9:30 AM to 7:00 PM
as mentioned earlier under Annexure ‘A’.
(Sanjeev Kumar)
DDC(I), CDSCO (HQ) &
Convener, Sub-Committee of DTAB
Copy to:
Indian Drugs Manufacturing Associations IDMA/FOPE/CIPI/IPA-with the request to
communicate it to your members and publicize it widely so that all concerned
can avail this opportunity.