New Delhi: Through a recent public notification, Directorate General of Health Services Office of Drugs Controller General (India) (FDC Division) has invited the applicants for hearing for deliberation by the Sub-committee of DTAB from 5th June 2018 to 22nd June 2018 to examine the banned 344 FDCs + 05 FDCs.
The Meeting of DTAB sub Committee will be held from 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.
The Sub-Committee of DTAB has been constituted under the chairpersonship of Dr. Nilima Kshirsagar, The Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR) Mumbai, to examine the banned 344 FDCs + 05 FDCs.
Accordingly, in March through a public notification, CDSCO has requested the petitioners/appellants to submit the information in the prescribed format in hard as well as in soft copy.
The notice states that in compliance to the directions of Hon’ble Supreme Court of India vide dated 15.12.2017, it has been proposed to give a hearing to all the petitioners/appellants for deliberation by the Sub-committee.
Accordingly, Sub-Committee invites the concerned applicants for hearing w.e.f. 05.06.2018 to 22.06.2018 w.r.t. FDCs mentioned under annexure A. Date and time of the hearing is also mentioned under annexure A.
The notice further states that it is requested that the concerned petitioners/appellants may kindly make it convenient to give a presentation before the DTAB Sub Committee on these FDCs. It would be highly appreciated if the presentations are `to the point’ using the PPT (if) already submitted. In the event that the petitioner does not attend the hearing, the Sub-Committee reserves the right to make its decision on the basis of the information before it and according to the direction of Hon’ble Supreme Court.
The authority has requested the petitioners/appellants to confirm their participation by e-mail at email@example.com at least 2 days before the scheduled date of the meeting.
Below is the attachment for the same