FDA MP Online Inclusion of Products in your Drug Manufacturing Licenses


A great initiative by FDA, MP  (Food & Drugs Administration Madhya Pradesh) of Online Inclusion of Formulations in your drug manufacturing licence, online issue of non conviction certificate and food and Sale licenses have been launched..
 
Now onwards Pharma manufacturers have to apply for the inclusion through FDA MP’s online website only connected through MP Online Portal.
 
Here is the process..and know how’s
 
Login…. You must have been received your login id and password (default is manufacture#123) for site https://www.mponline.gov.in/PORTAL/SERVICES/FDA/DRUG/HOME.ASPX
 
login MP FDA Online

After filling your email id and password …you can login to the site. (Must change your password after first login)

Inclusion Process….. Now I am going to share the process for inclusion of product in your drug manufacturing licenses., which you will register with your FDA Madhya Pradesh after updation of your company profile.

Update your Company Profile :- The First Step is update your company profile to use other facilities at Online FDA Site.
image
On clicking the update profile you will get a form for Manufacturing Firm Details.

Specifically contains details like
  • Company contact details name address etc,
  • Details of Powder of Attorney Holder which you can get from your legal or accounts section.
  • Details of Directors
  • Details of Approved Testing Labs (Names can be found on your drug licence and further details can be taken from referred testing labs, like their license no and validity of license)
  • Details of Manufacturing Chemist with Name of Father/Husband with Approval Category and Approval Card No.
  • Details of Analytical Chemist with Name of Father/Husband with Approval Category and Approval Card No.
  • Details of QA Chemist with Name of Father/Husband with Approval Category and Approval Card No. (You can use category other QA for this section or can consult with your Legal deptt. For guidance.)
After successful Submission you can processed for updation of your drug manufacturing licence, (after updation of this all further inclusion will go to the specific licence no only which you will be select during inclusion process) (Below is image is after updation of licence you will get add licence form if doing for the first time.)
Update Licence FDA MP
What Documents you should be required before proceeding for inclusion. (Use Signed scanned copies in pdf/jpg format)
  1. Pharmacopeial Monograph
  2. Method of Analysis
  3. Master Manufacturing Formula
  4. Stability Data
  5. Any other documents which you want to submit other than above. (Like draft label/proforma/list of products etc)
  6. Also you will be required to have digital signature .pfx file of signing Authority on the PC before proceeding for the Inclusion of Products
Inclusion Process
Add Product.. Now once you are having all the scanned copies ready you can proceed for Product updation.

Click on Step-2  Inclusion License

Click on  Your License No in which product inclusion is required.
image

Now you have to update the Products one by one which needs to be included in your License.
Product Inclusion FDA MP
Now Fill following details for your first item.
  • Name of Product :- Use Generic Name with which inclusion is required Like Paracetamol Tablets IP 500 mg etc.
  • Category :- Select whether the product is liquid/tablet/capsule whatever is !!
  • Each:-  Composition like 5 ml /10 ml/Tablet are whatever is applicable.
  • Name of Active Ingredient : Like Paracetamol in above example.
  • Pharmacopoeial Monograph:- Choose IP/BP from List.
  • Strength of Active i.e. how much quantity in each Tablet of Paracetamol is.
  • Strength Unit :- in Mg or mcg…or whatever applicable.
  • Reference: Mentioned relavant reference i.e. IP-2014 or whatever applicable.
Click on add button  if your formulation having more than one active ingredient and follow the above steps again.
Once All active ingredients updated choose whether product is for local /export market , for export market click the box 
Now upload the required documents which are ready with you in PDF files
image

On No. 5 you can upload any other documents you want to update like product proforma/draft labels list of products etc.
Finally Click on Add Product and update other products following above steps and after this you can Submit your application or can Save Draft for editing or final check.
On Submitting the same you will see…a Covering Application Letter in Next Step like below 
image

After this click on next and It will ask for digital signature..   (for which a .pfx file must be available on your pc.) 

You will get two options to choose the digital signature. I prefer to chose the next one Signed PDF with File. (Make sure your java addon is active) The first Method required a digital signature software with dongle.
image

Since when you select this option you just have to choose the pfx file
image

Click Browse button and chose the Pfx file from your system than enter the password of your digital signature and click OK and you will see the signed copy of your covering letter in next step.
That's all….if done successfully you will get the next option for payment through Net Banking Credit card /Debit card charges are Rs. 300/-per item + Portal charges+Bank Charges (Except SBI)
On Successful completion you will get the email/sms for successful submission of your application and can also download the digital copy of your application.
Difficulties you may find during the process
  • As usual Slow working of the site MP Online since having lots of pressure it has taken me 3-4 logins to follow each steps.
  • While trying for digital signature it can show some error…if yes than first of all check your java adon is active and updated
  • Errors during payment , try to change any other payment option and try and then try try and try
Note:- Do not forgot to change your password from default password to avoid unwanted access to your account.
Hope this will help you to fill your applications online with MP FDA with ease and clarify any doubts.  Will Appreciate your  Helpful Comments.

1 comment :

Your comments are Valuable to us..