6th DIA Regulatory Conferenc. To view document please click this
Approval of the safety and efficacy of Fixed Dose Combinations(FDCs) permitted for manufacturer for sale in the country without due approval from office of DCG(I).
As per the policy the idmla application URL will be https://idmla.guj.nic.in instead of http://idmla.guj.nic.in
( there is a difference in http & https ).
All of you are kindly requested to use https://idmla.guj.nic.in url only in daily use and also kindly the FAVOURITES in your browser.
The http://idmla.guj.nic.in url will not work from 1st April onwards...
As per DCGI Letter dtd: 23-9-2011 all manufacturers are reguested to limit content of Paracetamol to 325 mg in FDC of Tablet/Capsule & display box warning on label about liver toxicity.Please see the news itesm to view the details
Government of India has suspended manufacture, sale and distribution of drug “LETROZOLE” for indication: “for induction of ovulation in anovulatory infertility” with immediate effect from 12/10/2011 vide notification no. G.S.R. 752(E) dated 12/10/2011. click here
All manufacturers are requested to fill the details of Annual Survey in their My Profile--> Annual Survey for the year 2009-10 & 2010-11
All manufacturers are requested to fill their mobile number at My Profile--> Mobile. On this number an SMS may be send by this adminsitration
Flash Message :- 19/07/11
All Mfgr (OWN & LOAN) are hereby asked to up-date the data which they have already entered in their profile and which are already freezed by Officers of this administration. For this purpose they should contact their concern Circle Assistant Commissioner FDCA .
Single Ingredient product permission has become compulsory online from 01/04/2011.
NPPA Survey regarding...please see the news menu for futher details.....29/03/2011
All are requested to read the recent Govt. resolution issued. This is available in News published on 21/02/2011.
Regarding iDMLA password
As a part of security policy enforcement, the password of all Firms have been re to abcd@abcd. All firms are requested to please provide the password abcd@abcdwhile login . System will immediatly ask to change the password of your choice. You may provide a password of your choice there.
Guideline for new Password
1] Minimum length of password should be 8 character
2] Atleast one special character such as !,@,$,%,^,&,(,)
A document is available in news section which gives clarification on Addtional Product/Additional Brand/Revised Product Permission
DCGI Circular click here to View
DCGI Circular click here to view
Dt. 9-8-2010 COPP application and attachments regarding
Many complaints are reported from the manufacturer stating that they are not able to attach the document while applying for COPP Certificates.
It has been observed while talking to the operator that the file name of the document being attached is not valid. If the either extension of the file is valid or name of the file is invalid, the system will not accept the document.
In most of the cases it is found that the file name contains more then one dots within it, like test..pdf, which is invalid file name.
For detail please see the news published on Dt. 9/8/2010
As department is planning to start processing & finalizing any application on
online only, from 1st August - 2010 and the physical application
submitted to HQ will be processed only, if the online application is
complete & perfect in all respect with respect to the software, for giving
final approval on online applications.
All manufactures here by instructed (own & loan) should complete all the relevant back data entry in the available field in the software, so as to process their online applications, as fast as possible.
All manufactures here by instructed now onwards (own & loan) must apply for the any applications made to the FDCA. HQ Gandhinagar such as miscellanies Applications / Certificates / Fresh Licences / amendments etc. on On line in the software with the complete perfect data as required to be field up in the on line applications.
Dtd. 16-03-2010 TUESDAY
Application format for COPP certificate has changed according to the feedback. The revised help is available in Help section. Please have a look. or clcik here
Manufacturer can see their application status by clicking Registration ID on iDMLA portal
At the time of view application status most of the manufacturer is not getting proper status of application. It is not an application problem but it is web bowers ting problem.
For Internet Explorer ting needs to be done in following manner:
1. From Menu Bar Go to Tools option
2. From the Tools menu-item choose Internet Options
3. In Internet Option Popup go to General
4. In General go to Browsing History click on tings option
5. On clicking of ting button popup is open and choose option Every time I visited webpage
6. clicking on ok button popup will close.
7. Click on Apply button and Ok button.