**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), FDC Division on October 17, 20[Year], pertains to the examination of the safety and efficacy of Fixed Dose Combinations (FDCs) licensed for manufacture and sale in India without prior approval from the Drugs Controller General of India (DCGI). The notice follows up on a previous communication dated January 15, 2013. An Expert Committee reviewed applications from manufacturers, and its reports are available on the CDSCO website. The notice categorizes FDCs based on the Kokate Committee's recommendations (category c) and those requiring Phase IV clinical trials (category d). Manufacturers who applied to CDSCO, paid the necessary fees, and whose products were licensed by State Licensing Authorities (SLAs) before October 1, 2012, but have not received communication from CDSCO, are requested to notify the office via email at fdcdivision@gmail.com. The notification should include proof of application (Treasury challan copy) and the SLA product permission issued before October 1, 2012. This action aims to facilitate the resolution of pending FDC applications. The notice is issued by Dr. G.N. Singh, Drugs Controller General of India.
Key Entities Referenced
Directorate of General of Health Services: An organization under which Central Drugs Standard Control Organization functions.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
FDCs: Fixed Dose Combinations, referring to pharmaceutical products combining two or more active ingredients in a single dosage form.
DCGI: Drugs Controller General of India, the head of the Central Drugs Standard Control Organization.
Expert Committee: A committee constituted to examine the applications related to FDCs.
Kokate Committee: A committee that recommended certain FDCs, indicated in category c.
Phase IV clinical trial: Post-marketing surveillance trials for FDCs, indicated in category d.
SLAs: State Licensing Authorities, responsible for issuing licenses for manufacturing pharmaceutical products within their respective states prior to 1.10.2012.
F.No.4-01/2013-DC(PSC-1
3PSC)
Directorate of General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
_ Dated: ;
NOTICE
17 OCT 20M
Subject: Examination of safety and efficacy of FDCs licensed for manufacture
for sale in the country without due approval from DCG(I)-regarding
This has reference to this Directorate letter of even number dated 15.1.2013 on the
subject cited above. In this regard, various applications filed by the manufacturers
have been examined by the Expert Committee constituted for the Purpose and
accordingly the reports were published on the website of this office. The FDCs
recommended by Kokate Committee are indicated in category ‘c’ whereas FDCs for
which Phase IV clinical trial is required, are indicated in category ‘d’.
It is stated that those applicants, who have paid fees and applied to CDSCO and
who are having their products licensed by SLAs prior to 1.10.2012 and till date have
not received any communication or letter from this office are required to bring to the
notice of this office preferably on mail at fdcdivision@qmail.com
along with the proof
of application with Treasury challan copy and SLA product permission issued prior to
1.10.2012 so that necessary action can be taken in such cases.
This is issued to facilitate the disposal.
(Dr. G.N. SINGH)
Drugs Controller General (I)