This notice, dated April 20, 2018, from the Drugs Controller General of India, pertains to the reconsideration of 344 Fixed Dose Combinations (FDCs) previously prohibited under S.O. No. 705(E) to 1048(E) dated March 10, 2016, and S.O. No. 1851(E) to 1855(E) dated June 8, 2017, in compliance with directions from the Supreme Court of India. It extends the deadline for all petitioners/appellants, including AIDAN (All India Drugs Action Network), to submit information in the prescribed format (Annexure A-Annexure D). The new deadline for submission is May 2, 2018, until 5:00 PM. This is an extension of the previous deadline of April 7, 2018. Sanjeev Kymar, Convener of the Sub-Committee of DTAB (Drugs Technical Advisory Board), issued the notice. Copies were sent to Dr. Nilima Kshirsagar (Chairperson of the Sub-Committee of DTAB), All India Drugs Action Network, CDSCO (Central Drugs Standard Control Organization) website, Indian Drugs Manufacturing Associations (IDMA), and Federation of Pharma Entrepreneurs (FOPE).
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India related to health services.
Drugs Controller General India: Authority responsible for drug regulation and control in India.
FDA Bhawan, Kotla Road New Delhi: Location of the Drugs Controller General India office.
Supreme Court of India: The highest judicial body of India.
344 FDCs: Refers to 344 Fixed Dose Combinations of drugs that were subject to legal proceedings.
All India Drugs Action Network: An advocacy group working on issues related to access to medicines and drug regulation in India.
Drugs Technical Advisory Board: DTAB is the highest advisory body under the Drugs and Cosmetics Act in India.
Indian Drugs Manufacturing Associations: Association of drug manufacturers in India.
File No. 4-01/2013-DC (Misc. 13-Part 1)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated:
cae 20 APR 2018
Subject: Consideration of the directions of the Hon’ble Supreme Court of India in the
case of 344 FDCs + 05 FDCs prohibited vide S.O. No. 705(E) to 1048 (E) dated
10.03.2016 and S.O. No. 1851(E) to 1855 (E) dated 08.06.2017 and constitution
of a sub-committee for having a relook in these cases-regarding.
This is in continuation to this office notice 4-01/2013-DC (Misc. 13-Part 1) on the subject
cited above whereby all the petitioners/appellants including AIDAN were requested to submit
the information in the prescribed format as per Annexure A/Annexure D by 7" April 2018 till
5:00 P.M. for further action in compliance to the directions of the Hon'ble Supreme Court.
be permitted to submit the information in the prescribed format by 24 May 2018 till 5:00 p.m.
In view of above, all the petitioners/appellants including AIDAN to note that date for the
submission of information in the prescribed format is extended upto 02.05.2018 till 5:00 p.m.
(Sanjeev Kymar)
Convener
Sub-Committee of DTAB
Copy to:
1. Dr. Nilima Kshirsagar, the Chairperson, Sub-Committee of DTAB.
2. All India Drugs Action Network
3. Website of CDSCO for information and necessary action of AIDAN for complying the
hearing and subsequent report submission process.
. Indian Drugs Manufacturing Associations (IDMA)/Federation of Pharma Enterpreneurs
(FOPE)