drug control organization user manual blood bank
TRANSCRIPT
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Drug Control Organization
User Manual
Blood Bank
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1 Contents 1. Accessing DCO Application ............................................................................................................ 4
1.1 Login page ...................................................................................................................................... 4
2. Registration of Blood Bank Service by Applicant ..................................................................... 7
2.1 New License Registration ................................................................................................................ 8
2.2Applicant’s Form ................................................................................................................................. 9
2.3 Firm Registration Form ................................................................................................................. 17
2.4 Competent Technical Staff Form ................................................................................................. 19
2.5 Uploading of Documents .............................................................................................................. 27
2.6 Blood Component Details Form .............................................................................................. 31
2.7 Adding Equipments/Instrument Details for Manufacturing .......................................... 32
2.8 Add Equipment/Instrument Details for Laboratory........................................................... 33
2.9 Application Status Form ........................................................................................................... 34
2.10 Payment ........................................................................................................................................ 36
3. Documents Scrutiny Process ........................................................................................................ 38
3.1 Documents Scrutiny Process By CDSCO ..................................................................................... 38
3.2Document Scrutiny by Drug Controller(DC) .............................................................................. 45
4. Inspection Process .......................................................................................................................... 46
4.1 Inspection Process by CDSCO .................................................................................................. 46
4.2 Inspection Process by Drug Controller .................................................................................. 49
4.3 Inspection Report By ADC/DCO .............................................................................................. 51
4.3.1 “Re-Inspection Schedule By” Option in Inspection Report ............................................... 56
5. Approval Process ............................................................................................................................ 58
5.1 DC Send File For License Approval to DCGI ......................................................................... 58
5.2 Approve to Grant License By DCGI ......................................................................................... 62
5.3 Grant of License .......................................................................................................................... 65
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Abbreviations
CDSCO : Central Drug Standard Control Organization
DCGI : Drugs Controller general of India
DC : Drug Controller
ADC: Assistant Drug Controller
DCO: Drug Controller Officer
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1. Accessing DCO Application
Users Access through the URL(“dco.rajasthan.gov.in”).Following Screenwill appear.
User Clicks on SSO Login.
1.1 Login page
User is required to login into the application by entering valid SSOID and password.
User Clicks on Drug Control Organization Icon.
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If the profile on SSOID is incomplete, then an alert message will come to the user to complete
the profile on SSOID as given in the below screen.
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The following screen comes if the profile on SSOID is complete.
The user has select his Role, Zone and district from the dropdowns and click on save
Button.
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2. Registration of Blood Bank Service by Applicant
Authorized User: Citizen
Pre-requisites:Applicant gets logged into the application.
Description: The authorized user is required to register the Blood Bank service in
the application.
Once the user is logged into the application through his SSOID, then
Step 1: Click on “New License Registration” link if he is new user orClick on Edit/Update your
application” link if he is already registered or he has completed some part of the
registration.
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2.1New License Registration
On click of “ New License Registration” , following screen comes.
Step 1: Select License Application Type as “Blood Bank”
Step 2: Select License Application Form as “Application for grant of license for the operation of a
Blood Bank for processing of whole blood and/or preparation of Blood
Components”.
Step 3: Click on submit Button.
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2.2Applicant’s Form
Pre-Requisite : Applicant should fill New Registration Form as given in Point 2.1
Step 1 : Enter the aadhar number and click on submit Button. Screen as given below:
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Step 2: One modal pop up comes, select BY Mobile OTP and click on Send OTP Button.
Step 3: OTP will be received on mobile number which is registered with Aadhar. Enter OTP
in Text Box and click on submit Button. Screen as given below:
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Step 4: Basic details of the applicant appear on the form.
Step 5: The remaining details have to be filled by the applicant.
Step 6: Click on the checkbox of correspondence address if the correspondence address is same
as permanent address.
Step 7: Click on the checkbox of Terms&Conditions.
Step 8: Click on ADD Button.
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Step 9: On click of the above ADD button, following Screen appears.
Step 10: Click on Save Button.
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Step 11: The user can add more applicant by clicking on the “Add more Applicant” Button as
given below screen:
Step 13: The user can see the declaration form on Click of the View link as given below:
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Step 14: On Click of the E signed Buttonin the above grid , one modal pop up opens up.The
applicant will receive OTP on his mobile number which is registered with Aadhar.
Step 15: Hehas to enter the OTP in the Textbox and click on “Validate OTP and generate
Declaration with sign” Button
Step 16: The declaration form gets digitally signed by the applicant.
Step 17: The user has to click on Next Button to move on to the Next Screen of Firm
Registration.
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Step 18: On click of Name in the above Grid , the applicant can view his details
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2.3 Firm Registration Form
Pre-Requisite – Applicant’s details should be filled first
Step 1: User click on the firm available in the left menu Or he can come to this page by clicking
on the next Button available in the applicant Details page.
Step 2: The user has to fill the details given in the Screen and click on Save Button.
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Step 3: On click of Save Button in the above screen,
One modal pop up comes.On Click of yes button in the modal pop ,the following screen
appears.
Step 4: The data of the firm can be edited by clicking on edit Button as appearing in
front of Firm Details Header as given in above screen.
Step 5: Click on Next button to move on to the Next Screen of Competent Technical
Staff.
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2.4 Competent Technical Staff Form
Pre-requisite : Firm’s Details should be filled .
There should be minimum four competent Technical staff. They are as follows
Medical Officer
Technical Supervisor
Blood Bank Technician
Registered Nurse
Step 1: User clicks on competent Technical Staff in the left menu or he clicks on the next
button available in the firm page.
Step 2: Enter the aadhar number and click on submit Button.
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Step 3: One modal pop up comes, select BY Mobile OTP and click on Send OTP Button.
Step 4: OTP will be received on mobile number which is registered with aadhar. Enter
OTP in TextBox and click on submit Button.
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Step 5: Basic details of the competent technical staff appear on the form as given in
below screen
Step 6: The remaining details have to be filled by the competent technical staff .
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Step 7: Fill the professional Experience Details and Click on ADD Button.
Step 8: The data will appear in the grid of Professional Experience Details
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Step 9: Fill the Approval Section Details and Click on ADD Button.
Step 10: The data will appear in the grid of Approval Section Details
Step 11: Fill the License Authority Approval Details.
Step 12: Fill the Registered with Medical Council of Rajasthan.
Step 13: Fill previous Firm Details.
Step 14: Click on the checkbox of Terms&Conditions.
Step 15: Click on ADD Button.
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Step 16: On click of the above ADD buttonin the above Screen, following Screen appears.
Step 17: The user can add more competent technical staff by clicking on the “Add more
Competent” Button.
Step 18: Click on Next Button to move on the next Screen of Upload Documents.
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Step 19: On click of View Link in the grid the competent’s technical staff can see the declaration
form.
Step 20: On Click of the E signed Button in the grid , one modal pop up opens up. The
competent technical staff will receive OTP on his mobile number which is registered
with Aadhar.
Step 21: He has to enter the OTP in the Textbox and click on “Validate OTP and generate
Declaration with sign” Button
Step 22: The declaration form gets digitally signed by the competent technical staff.
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Step 23: On click of name the competent Technical Staff can view his details.
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2.5 Uploading of Documents
Pre-Requisite: Competent Technical Staff Details should be filled
Step 1: Click on the “Upload Document” link on the left menu or click on the Next Button on the
Competent Technical Staff form.
Step 2: Click on the firm tab.
Step 3: The documents pertaining to the firm appear on the screen.
Step 4: All the files to be uploaded should be in PDF Format and should be of the size as
specified in the given Screen.
Step 5: The current Photo and the current Signature of the applicant and Competent Technical
Staff can be uploaded in a jpg Format.
Step 6: The documents marked with red star are the mandatory documents to be uploaded.
Step 7: Browse the file by clicking on Choose File Button.
Step 8: Click on the arrow of green color to upload the file.
Step 9: Click on Cancel of red color if you want to cancel the file.
Step 10: Click on the image of eye to view the uploaded document.
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Step 11: Under Firm Tab, upload the documents as given below
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Step 12: Click on the applicant tab to upload the documents of experience certificate and
educational Certificate,Current photo and Current Signatureof the applicant.
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Step 13:Click on the competent technical staff tab to upload the documents of experience
certificate and educational certificate, approval certificate, registration certificate,current
photo and current Signature ofeach competent technical staff.
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2.6 Blood Component Details Form
Pre-Requisite: Uploading of Documents should be done by applicant
Step 1: Click on Whole Human Blood/Blood Components in the left menu or click on the
Next Button in the upload Document page.
Step 2: Click on the Checkbox for the components to be added in Blood bank.
Step 3: Click on Save Button.
Step 4: Click on “Add More” Button If you want add more components later on.
Step 5: Click on Next Button to move on the Equipment Page.
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2.7 Adding Equipment’s/Instrument Details for
Manufacturing
Pre-Requisite:Blood components should be added by applicant
Step 1:Fill the details given on the screen.
Step 2:Upload the files in the PDF format.
Step 3: Click on save Button.
Step 4: The data appears in the grid and the uploaded documents can be seen on
the click of image of eye.
Step 5: The data in the grid can be edited and deleted.
Step 6: User clicks on Next Button to move on the Equipment/Instrument
Detailsfor Laboratorypage.
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2.8 Add Equipment/Instrument Details for Laboratory
Pre-Requisite:Equipment/Instrumental Details for Manufacture should be filled
Step 1: User has to fill the details given on the form.
Step 2: User has to upload the mandatory documents in the PDF format.
Step 3: User Clicks on Submit Button.
Step 4: The data appears in the grid and the uploaded documents can be seen on the
click of image of eye.
Step 5: The data in the grid can be edited and deleted.
Step 6: Once the payment is done by the user , he will not be allowed to add the
equipments/Instruments for laboratory.He can only see the data available in the
Grid.
Step 7: User clicks on Next Button to move on the application Status form.
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2.9 Application Status Form
Pre-Requisite:Equipment/Instrumental Details for Laboratory should be filled
Step 1: Click on “Application Status” link in the left menu or click on the Next Button on the
Equipment/Instrument Details for Laboratory Page.
Step 2: The details of the license, firm, applicant, technical staff, blood components,
License Amount, Inspection amount and Total Amount can be seen.
Step 3: Click on the image of eye to view the documents related to firm.
Step 4: Click on the image of eye to view the declaration forms of both applicant and
competent Technical staff.
Step 5: Click on edit button to view the documents uploaded by the applicant and
competent technical staff.
Step 6: Click on the checkbox and then click on the Pay Button.
Step 7: On click of pay Button the user is redirected to the payment form
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2.10 Payment
Pre-Requisite:All the details required for Blood Bank Service Registration should be
filled by Applicant.
Step 1:The user comes to this page when he clicks pay Button on the Application Status
Form.
Step 2: Click on Proceed to Pay Button.
Step 3: On Click of paybutton the user is redirected to e-Mitra payment gateway.
Step 4: On Click of Receipt, the payment receipt can be generated.
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3. Documents Scrutiny Process
3.1 Documents Scrutiny Process By CDSCO
Authorized User:- CDSCO and Drug Controller(DC)
Description: The application for Blood Bank Service will be landed on dashboard of
CDSCO and DCO. Joint Document Scrutiny will be done by both CDSCO and Drug
Controller(DC).
Pre-Requisite : CDSCO gets logged into the application through their SSOID and when
CDSCO successfully scrutinized the document . DC can also scrutinizing the document
simultaneously but Document scrutiny by DC is explained in Point 3.2
Step 1: Click on the reference ID
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Step 2: The documents uploaded by the user will be scrutinized by CDSCO.
Step 3: Click on the firm panel to scrutinize the firm documents as given below:
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Step 4: Click on the image of eye to view the uploaded document as given below screen.
Step 5: Click on the image of correct to accept that the uploaded document is correct.
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Step 6: Click on the image of wrong to reject the uploaded document. On click of image of
Wrong, one modal pop up opens up.The user has to give the reason in the textbox
for rejecting the document and click on submit Button. See the screen given below.
Step 7: One message and email will be sent to the responsible person of the firm regarding
the documents rejected in order to complete the compliances found.
The user will login with his SSOID .He will go the application Status form and can
update the documents which were in compliance.
Re Scructining will be done by CDSCO again. Only the documents which were in compliance
will be rescrutinized by CDSCO.
Step 8: In the same manner, DC has to login to the application and click on “Document Scrutining”
tabin the left menu . Click on the same Reference No. which is scrutinized earlier by CDSCO.
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Step 9: In the same manner as that for Firm,Click on the applicant tab to view applicant details
and to scrutinize the documents of the applicant. Screen as given below:
Step 10: In the same manner as that for Firm and applicant , Click on the competent technical
Person to view Competent Technical Person details and to scrutinize the documents of
the competent Technical Staff.Screen as given below:
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Step 11: Once all the documents are scrutinized by CDSCO ,a final remark is given in the
textbox and click on Submit Button.
Step 12: On click of submit button one modal pop up comes. Click on “completed” Button to
complete the scrutiny process.
Step 13: On click of Pending Button, the file remains there itself.
Step 14: The file goes to further level that is Inspection process.
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3.2 Document Scrutiny by Drug Controller(DC)
Step 1: When the DC logins through his SSOID for document Scructining, the following screen
comes.
Step 2: Select from the dropdown the type of license as “Blood Bank Service” for which
the scrutiny has to be done.
Step 3: Click on the reference id for document Scructining.
Step 4: Follow the same process which is done by CDSCO that is repeat the above steps
from Step 2 to 15 of Point 3.1 to complete the document scrutiny process by Drug
Controller.
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4. Inspection Process
Authorized User:Inspection Process is done by three members:-
Drug Inspector invited by CDSCO.
Medical Expert invited by Drug Controller.
Assistant Drug Controller (ADC) or Drug Controller Officer (DCO).
4.1 Inspection Process by CDSCO
Pre-Requisite:Document Scrutiny is done by CDSCO and DC. CDSCO logs into the
application through his SSOID . Click on “ List of Institution to be Inspected “ under
“Inspection” Tab in the left menu.
Description : For Inspection, CDSCO is required to appoint Drug inspector and also
appoint Inspection Date.
1. Initially the CDSCO gets logged into the application through his SSOID.
2. Select from the license dropdown the type of license for which the inspection is to be
done and the status as “Pending”.
3. Click on the “To be Appointed” button on the registration number for which the
inspection is to be done as given in below screen.
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4. One modal pop up opens up.
5. CDSCO will assign a drug inspector and will assign a date of inspection to him. CDSCO will
also inform the date of Inspection to Drug Controller.
6. Fill the details in the modal pop up and Click on Appoint Expert Button as given in below
screen.
7. An email and SMS will be send to the drug inspector and the drug controller about the date
of Inspection and the location at which the inspection is to be done.
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4.2 Inspection Process by Drug Controller
Pre-Requisite: CDSCO appointed Drug inspector for Inspection. DC logs into the
application and Click on “ List of Institution to be Inspected “ under “Inspection” Tab
in the left menu.
Description : For Inspection, Drug Controller will appoint a date same as appointed
by CDSCO and appoint ADC and Inspector (Medical Officer).
1. Select from the license dropdown the type of license for which the inspection is to be
done and the status as “Pending by DC”.
2. Click on the “To be Appointed” button on the registration number for which the
inspection is to be done.
3. The drug Controller can change the date of Inspection which is provided by CDSCO if
required. If he want to change the date he need to click on the checkbox of yes where it
is asked “Do you want to change the date of inspection. If not then click on the checkbox
of NO.
4. Drug Controller will assign a (Medical Officer) and will assign a date of inspection to
ADC and Inspector (Medical Officer).
5. DC Clicks on “To be Appointed” Button for appointing the inspection officer and giving
the inspection date to the expert and ADC or DCO. One modal pop up opens up
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6. Fill the details in the modal pop up. Initially the inspection date will be given by the
CDSCO to the drug inspector and Drug Controller. The Drug Controller can change the
inspection date if required and need to inform to CDSCO about change of date of
Inspection. Accordingly the Inspection Date will be finalized.
7. If Drug controller do not want to change the inspection date he need to click on the
checkbox of No of “Do you want to change the date given by CDSCO.
8. If the Drug controller clicks on yes checkbox of “Do you want to change the date given
by CDSCO, then he can change the date.
9. Click on Appoint Expert for appointing the medicalExpert and ADC/DCO giving the
inspection date to the medicalExpertand ADC/DCO.
10. One SMS and email will be send to inspection officer and ADC/DCO and the responsible
person of the firm containing the date of inspection and address of the site to be
inspected.
11. A Re-Inspection fee of Rs 1500 will be charged for the second round of inspection if any
compliances are found at the first time.
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4.3 Inspection Report By ADC/DCO
Pre-Requisite:For Inspection, Drug Controller will appoint a date same as appointed
by CDSCO and appoint ADC and Inspector (Medical Expert). ADC logs into the
application and Click on “ List of Institution to be Inspected “ under “Inspection” Tab
in the left menu.
Description : Inspection will be done on site by ADC/DCO in presence of Inspection
Experts(MEDICAL OFFICER) AND Drug Inspector invited by CDSCO.
Step 1: The ADC Logins with his SSOID.
Step 2: Click on the “Manage” in the left menu.
Step 3: Click on List of Institutions to be inspected in the left menu.
Step 4: Select “Blood Bank” from the license category dropdown.
Step 5: Click on “Inspection Pending” from the grid for which the inspection is to be done
as given in below screen
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Step 6: The inspection report will open as given in below screen
Step 7: Click on the checkbox of yes if the firm is ready for Inspection.
Step 8: Click on the Checkbox of NO if the firm is not ready for inspection.
Step 9: The Inspection report will be filled by ADC or DCO in presence of Inspection
Experts(MEDICAL OFFICER) AND Drug Inspector and will be send to the Drug
Controller for approval.
Step 10: On Click of checkbox of YES, the whole inspection report will open or else not.
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Step 11: Fill the complete report and observation remarks.
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Step 12: Fill the Recommendation Textbox and click on the checkbox of the competent technical
staff whose name we want to be printed in the license.
Step 13: Click on the “Send for License Issuance Approval to DC”.
Step 14: The ADC has to click on e sign in the grid then one modal pop up opens up.
Step 15: The ADC will receive OTP on his mobile number which is registered with Aadhar. He has
to enter the OTP in the TextBox and Click on Submit Button
Step 16: The inspection report gets digitally signed by the ADC and needs to be send to DC.
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Step 17: The inspection report can be viewed in the PDF format
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4.3.1 “Re-Inspection Schedule By” Option in Inspection
Report
Step 1: Under “Re-Inspection Schedule By” of Inspection Report which has three options as
given below:
By SLA
By CLAA and SLA
No Re-Inspection Required
Step 2: Click on checkbox of “No re inspection Required” if re inspection is not required.
OR
If the By SLA Checkbox is checked then re inspection will take by State level
Authority(ADC/DCO).
Step 3: The file will be send to the user to complete the compliances if any found.
Step 4: An inspection fee of Rs 1500 will be charged to the user for re inspection.
Step 5: Once the re inspection payment is done by the user , the drug controller will assign the
ADC or DCO for re inspection.
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Step 6: REPEAT the above of Point 4.2 AND 4.3
OR
If the By CLAA AND SLA Checkbox is checked then re inspection will take by State Level
Authority(ADC/DCO) AND Central level Authority(Drug Inspector from CDSCO).
Step 3: The file will be send to the user to complete the compliances if any found.
Step 4: An inspection fee of Rs 1500 will be charged to the user for re inspection.
Step 5: Once the re inspection payment is done by the user , the drug controller will assign the
ADC or DCO for re inspection.
Step 6: REPEAT the steps given in 4.1 and 4.2 and 4.3
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5. Approval Process
5.1 DC Send File For License Approval to DCGI
Authorized User: Drug Controller
Pre-Requisite: Inspection Process should be done successfully and the
inspection report digitally signed by ADC/DCO should be available with
Drug controller.
Description: DC sends file for License approval to DCGI
Step 1: Drug Controller gets logged into the application through SSOID.
Step 2: DC Clicks on the “Remark List”
Step 3: The inspection report can be viewed by DC on click of image of eye.
Step 4: DC clicks on “Send for license approval” Button to send to DCGI for approval of the
license.
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Step 5: One modal pop up opens up. DC has to enter the remarks.
Step 6: Click on “Send for license approval” Button.
Step 7: Click on Grant License in the left menu.
Step 8: Click on “List of Institutions to Grant License” in the left menu.
Step 9: Select the license “Blood Bank” from the dropdown of license and status as “pending
approval for license”.
Step 10: Click on “Approve for Grant” Button to Grant the license.
Step 11: A message comes “Approved Successfully”.
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Objection Button
The DC can also click on Objection Button if he want to raise the objection and click on
the checkbox of “send to applicant to resolve issue.SMS will be send to the responsible
person of the firm to complete the compliances .
If the checkbox of “Check if inspection is required is checked, then re Inspection will take
place by the ADC and a re inspection fee of Rs 1500 will be charged to the user.
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Reject Button
If the reject Button is clicked following screen comes
Fill the remarks in the given Text Box and click on “reject
Application”.A SMS and Email will be send to the user informing
him that his application is rejection along with reasons.
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5.2 Approval of Grant License By DCGI
Authorized User: DCGI
Pre-Requisite: DC has already send file for License approval to DCGI
Description: DCGI Approval to Grant License and send to DC for digitally
signed License Generation
Step 1:DCGI logs into the application through his SSOID.
Step 2: DCGI clicks on the “Grant License “in the left menu.
Step 3: DCGI Clicks on the List of Institutions to Grant license”.
Step 4: Select from the dropdown the type of the license and the status as Pending.
Step 5: The generated license can be viewed on the click of image of eye.
Step 6: Click on the “Approve to Grant License”.
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Step 7: One modal pop up opens up.
Step 8: DCGI enter his remarks in the modal pop up and clicks on Grant license button.
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Generate Objection Button
The DCGI can also click on the “objection” button if he want to raise objection.
On click of “Objection” Button one modal pop up comes.
The remarks has to be entered in the modal pop up.
If the license is objected, an SMS and email will be send to user to complete the
compliances which are found by DCGI and also the DC can see at his end that the
objection is raised by DCGI for that particular license.
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5.3 Grant of License
Authorized User: DC
Pre-Requisite: File approved by DCGI and sent to DC for digitally signing
License
Description: DC generate digitally signed Blood Bank License.
Step 1:DC logs into the application through his SSOID.
Step 2: DC Clicks on “Generate OTP TO E Sign License” Button to grant the license.
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Step 3: Enter the OTP which is received on the registered mobile number of DC.
Step 4: Enter the remarks and click on “Validate OTP and generate Certificate with E –sign”
Button to digitally signed the license.
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Step 5: Digitally Signed Blood Bank License will be generated
IF DC Clicks on Objection Button in the grid
Step 1 :- If the Objection Button is Clicked in the Grid , one modal pop up comes.
Step 2 :- Remarks has to be entered in the textbox given.
Step 3 :-Click on the checkbox “Check if inspection is required”. then re Inspection will take place by the ADC and a re inspection fee of Rs 1500 will be charged to the user.Repeat the steps given in 3.1 and 3.3 Step 4 :- If the checkbox of “Send to applicant to resolve issue is checked then” then an SMS and Email will be send to user to complete the compliances found.
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If Reject Button is clicked by DC
If the reject Button is clicked following screen comes
Fill the remarks in the given Text Box and click on “reject
Application”.A SMS and Email will be send to the user informing
him that his application is rejection along with reasons.