199 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb

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----- Start of picture text -----<br> , ,<br>: File No.4-01/2013-DC (Misc. 13-PSC) -<br>. : CentralDirectorateDrugs StandardGeneral ofControl HealthOrganization,Services ,<br>: FDA(O/o Bhawan, Drugs ControllerKotla Road, GeneralNew Delhi(I)) : ;<br>; a FDA Bhawan, Kotla Road<br>‘ F : New Delhi-110002<br>: _<br>Dated: SEP<br>All States / UTs Drugs Controllers :<br>Subject: Database of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the ‘<br>country -Regarding. :<br>,<br>: Sir, Please refer to this office vide letter of even no. dated: 15.01.2013 regarding fixed dose<br>combinations (FDCs) falling in the category of new drugs defined under rule 122(e) of Drugs. and ;<br>Cosmetics Rules licensed by State Licensing Authority (SLAs) without the prior approval of the licensing :<br>authority defined under rule 21(b). a<br>; In this regard, concerns have been raised from time to time regarding lack of proper database 4 3‘2<br>of FDCs licensed for manufacturing and marketing in the country. - .<br>. In view of above, it has been considered necessary to have a comprehensive database of all Fa:<br>i _ FDCs that have been licensed by various State Licensing Authorities (SLAs) in the country. |<br>, *<br>[in][ your][ state,] [as]<br>| . You are therefore requested to provide list of all FDCs licensed by you [till] [date] ‘ jos<br>per the format given below:<br>‘ |<br>streng . {<br>1<br>; It is requested to fill above format in the manner as given below as an example. Fy ee.<br>! ; °<br>(ERa[ Ranestrengthatte FOC wi [Seonah[Deatvottiomnes| Pre sie |<br>eg. 1. Azithromycin Dihydrate + | 250 mg + 250 mg 1. Mls. ABC Ltd. Chennai 4. 15.07.2010<br>Levofloxacin Hemihydrate Tablets 2. Mis. XYZ Ltd. Chennai - 05.01.2012<br>Azithromycin Dihydrate + | 500mg + 500mg —7Ws ABC Lid. Chennay | 1, 25.05.2010<br>Levofloxacin Hemihydrate Tablets : : ; 2. Mis. XYZ Ltd. Chennai § 03.08.2011<br>- You are requested to forward the above details at the earliest in a hard copy as well as through é<br>an e-mail at fdcdivision@amail.com. The matter may be given priority.<br>{<br>: - 3 Yoursours faithfullyly, i<br>(Dr. G} N. Singh) a<br>Drugs Controller Gereral (India)<br>8<br>Copy forwarded to: ‘ ; ; .<br>4. Under Secretary, Drugs, Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi. °<br>2. All Zonal / Sub-Zonal Offices of CDSCO ———With the request to.follow up with the concerned<br>. State Licensing Authority.<br>----- End of picture text -----<br>

. File No.4-01/2013-DC (Misc. 13-PSC) Directorate General of Health Services ' Central Drugs Standard Control Organization aa FDA Bhawan, Kotla Road, New Delhi (O/o Drugs Controller General (!)) FDA Bhawan, Kotla Road «New Delhi-110002 Dated: 1 7 SEP 2014 To, ‘ All States / UTs Drugs Controllers es : . Subject: Database of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the country -Regarding. . Sir, This is in continuation to this office letter no. 4-01/2013-DC (Misc. 13-PSC) dated: 05.09.2014 regarding furnishing furnishing of list of all FDCs licensed list of all FDCs licensed of all FDCs licensed all FDCs licensed FDCs licensed licensed by you you till date in your in your your State for creation for creation creation of a comprehensive comprehensive database. In this regard, it is clarified that ‘Date of issue’ as mentioned in the format format shall be considered as the date on which permission was granted for the first time for that particular product for that manufacturer that manufacturer manufacturer (Licensee).

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----- Start of picture text -----<br> Sir, :<br>This is in continuation to this office letter no. 4-01/2013-DC (Misc. 13-PSC) r<br>dated: 05.09.2014 regarding furnishing furnishing of list of all FDCs licensed list of all FDCs licensed of all FDCs licensed all FDCs licensed FDCs licensed licensed by you you till date in your in your your is<br>State for creation for creation creation of a comprehensive comprehensive database. 3 :<br>In this regard, it is clarified that ‘Date of issue’ as mentioned in the format format shall E<br>be considered as the date on which permission was granted for the first time for that .<br>particular product for that manufacturer that manufacturer manufacturer (Licensee). ;<br>Yours faithfully, - Ries<br>a |... (Dr. GEN. Singh) l,<br>Drugs Controller General (India) |<br>eh, |.<br>Copy forwarded fo:-<br>All Zonal/Sub-Zonal Offices of CDSCO-With the request to follow up with the concerned<br>; State Licensing Authority ;<br>\ |<br>eal<br>----- End of picture text -----<br>