Home India Ministry of Health and Family Welfare Launching of additional Forms on National Single Window Syst...
Date: 2024-01-16 Category: Not Applicable State: Union Government Country: India

Launching of additional Forms on National Single Window System NSWS Portal

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The document is a user guide for both applicants (investors) and CDSCO ministry users on how to use the National Single Window System (NSWS) portal for CDSCO approvals.
  • For applicants, it details the process of identifying applicable approvals, applying for them, tracking application status, and responding to queries.
  • For CDSCO ministry users, it explains how to log in, view applications, process them (including internal actions and investor actions), and generate permissions/licenses.
  • The guide also covers technical requirements for using the NSWS portal and provides contact information for support.

Key Changes

  • The guide provides a step-by-step process for new users to sign up and login to the NSWS portal.
  • It details how to fill the application form, including mandatory fields, pre-populated data, and uploading required documents.
  • The guide explains how to review and submit the application, pay applicable fees through the Bharatkosh portal, and digitally sign the application.
  • It outlines the process for ministry users to review applications, seek information, forward to the next level, send back applications, and generate notesheets.
  • The guide describes how ministry users can generate draft and final permission licenses and covering letters.
  • It explains the process for ministry users to scrutinize individual fields in the application and request additional information from the investor.
  • The document specifies the different actions each level of ministry officer can perform within the NSWS system.
  • The guide describes how ministry users can track the status of approvals for KYA (Know Your Approval) and form linking.

Impact Analysis

Impact on Investors/Applicants

  • Action Item: Ensure that all required documents are prepared in advance and are readily available for upload.

Impact on CDSCO Ministry Users

  • Action Item: Ensure timely review and processing of applications to meet service level agreements (SLAs).

Impact on the Organization (CDSCO)

  • Action Item: Regularly update the user guide and FAQs to reflect any changes in the NSWS system or approval processes.

Key Entities Referenced

NSWS: National Single Window System - A digital portal serving as the national single window system under the Investment Clearance Cell. CDSCO: Central Drugs Standard Control Organization - The national regulatory body for pharmaceuticals and medical devices in India. ICC: Investment Clearance Cell - Cell setup under Invest India, DPIIT, to facilitate investors. KYA: Know Your Approval - A feature within NSWS that helps investors identify the approvals applicable to their business. Bharatkosh: The payment portal used for paying fees related to the application process. DPIIT: Department for Promotion of Industry and Internal Trade
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User Guide: How to apply for CDSCO Approval National Single Window System (https://www.nsws.gov.in/)Table of Contents # How to apply for Foreign Investment Approval Reference slide 1 How to identify the approval 1.1 How to view, add approval from ‘All Approvals’ 1 1.2 How to view, add approval through central KYA 2 1.3 How to add identified approval to the Dashboard 4 2 How to Apply for the Selected, identified Approval 2.1 How to login and apply for approval (New User) 5 2.2 How to fill the application form 6 2.3 How to view the application form (Legal Form) 14 2.4 Checklist Activation 15 3 Technical Requirements and Contact Us National Single Window System (https://www.nsws.gov.in/)11 How to view, add approval from ‘All Approvals’ Hover over ‘Central Approvals’ and click on ‘All Approvals’ Click on “Add to Dashboard” Select “Directorate General of Health Services”from the list of Departments National Single Window System (https://www.nsws.gov.in/)2 How to view, add approval through Central KYA Click on ‘Know Your Approvals’ on the NSWS homepage Click on ‘Continue with Central’to open the central KYA National Single Window System (https://www.nsws.gov.in/)3 How to view, add approval through Central KYA Click on ‘Business Activity Details’ Click here to read more information Select “Healthcare” and Answer 5 the questionnaire and find applicability of different approvals to you Click on ‘My Approvals’ tab to view the list of added approvals To save a draft of the KYA answers, users must be logged into NSWS Click ‘Submit to Know Your Approvals’ Click on ‘Reset form’to remove all to view the list of approvals previous responses to the questions National Single Window System (https://www.nsws.gov.in/)4 How to add identified approval to the Dashboard To add the list of approvals on the Dashboard, log into NSWS Savethe existing list of approvals in pdf format using ‘Save PDF’ Users will be redirected to the ‘Sign In’ Page Existing users can ‘Sign In’ with their credentials New users can create an account using ‘Sign Up Now’ National Single Window System (https://www.nsws.gov.in/)5 How to login and apply for approval (New User) New users can create their login credentials. Add their Email ID & Phone Number and verify both of them Click on ‘Sign Up Now’ Select the applicable option Enter the CIN / LLPIN / Business Name and click on ‘Next’ National Single Window System (https://www.nsws.gov.in/)6 How to fill the application form Add the details in the Profile section Click on ‘Apply Now’ to proceed with the Application Click here to expand all section at once Navigate through different forms for the approval from here Click on the downward arrow against the section names to expand and fill the form National Single Window System (https://www.nsws.gov.in/)7 How to fill the application form The ‘*’ indicates a mandatory field to be filled by the user Some Data will be pre-populated as filled up in the profile This button will create a duplicate section for the selected section National Single Window System (https://www.nsws.gov.in/)8 How to fill the application form This button will create a duplicate group for the selected group Click on ‘(i)’icon to read Additional Information National Single Window System (https://www.nsws.gov.in/)9 How to fill the application form Use this button to save the progress of the filled up application Move to the Checklist form for uploading the required documents Select Document type and Click on ‘Browse File’ to add attachments This button indicates that the user needs to Download a format, fill it up and upload the same on that particular field National Single Window System (https://www.nsws.gov.in/)10 How to fill the application form Once filled, click on Review and Submit Applicable fee will be visible here Review the application and click here for final submission National Single Window System (https://www.nsws.gov.in/)11 How to fill the application form Click on the checkbox and then “Pay & Submit” button Pay the amount using the Bharatkoshportal National Single Window System (https://www.nsws.gov.in/)12 How to fill the application form After payment, user will be redirected to NSWS portal where the user has to Digitally Sign the application This is the document containing the responses of the investor in the application with their DSC. Also knows as Legal Form This screen confirms the submission of application National Single Window System (https://www.nsws.gov.in/)13 How to fill the application form Once submitted, user can track the ‘Application Status’ from here In case the user wants to submit any additional document. They can click here Upload the documents, add the information Click on review and submit, and verify the application again using DSC as shown earlier National Single Window System (https://www.nsws.gov.in/)14 How to view the application form (Legal Form) In Case the user wishes to see the Legal form they can do so by clicking on this button The legal form can be previewed/downloaded National Single Window System (https://www.nsws.gov.in/)15 Checklist Activation User will be presented with multiple tabs containing different checklists. Only one Checklist will be enabled for the investor to fill up, based on their Reponses in the Pre Registration Form Fill up the details on Pre registration Form. Click on the checkbox. Post this, Once the user clicks on Next Form at the bottom of the page, user will be presented with the checklist they have to fill. National Single Window System (https://www.nsws.gov.in/)16 Checklist Activation User will land on checklist enabled for them to fill up The checklists which are disabled for the user to fill in will appear as shown here. The user do not need to fill these up in order to submit their application National Single Window System (https://www.nsws.gov.in/)What are the technical Requirements for NSWS System Requirements for National Single Window Portal ➢ Windows OS (XP or higher) ➢ MAC OS (X 10.9 or higher with latest updates) ➢ View/ Download Pdf: Download the pdf reader to view and download the pdf files from the link: https://get.adobe.com/reader/) ➢ Platform requires a minimum screen size of 976px wide , but using 1024px or higher is recommended ➢ Digital Signature Certificate (DSC): Latest version of emBridgesoftware need to be installed in the system which acts a connecting link/driver between the NSWS and DSC Web browsers best suited for National Single Window System ➢ Google Chrome ➢ Mozilla Firefox ➢ Apple Safari Have any further questions? Please submit your queries and feedback on: https://www.nsws.gov.in/contact-us Email: contactus-nsws@investindia.org.in Ph: 1800 102 5841 (Monday - Saturday, 9am - 6pm) LastUpdated on 14 March 2023 National Single Window System (https://www.nsws.gov.in/)National Single Window System (NSWS) CDSCO Ministry User GuideTable of Contents 1 ABOUT THIS MANUAL ........................................................................................................................................... 2 1.1 PURPOSE OF THIS MANUAL ..................................................................................................................................... 2 1.2 ORGANIZATION OF THIS MANUAL ............................................................................................................................ 2 1.3 ACRONYMS, ABBREVIATIONS, DEFINITIONS ............................................................................................................... 2 2 INTRODUCTION TO NSWS ..................................................................................................................................... 3 2.1 OBJECTIVE OF NSWS ............................................................................................................................................. 3 2.2 SCOPE OF NSWS .................................................................................................................................................. 3 2.3 SALIENT FEATURES AND ADVANTAGES OF NSWS ....................................................................................................... 3 3 PROCESSING APPLICATIONS ON NSWS ................................................................................................................. 5 3.1 MINISTRY DASHBOARD OVERVIEW........................................................................................................................... 5 3.1.1 MINISTRY USER LOGIN ........................................................................................................................................... 5 3.1.2 VIEWING APPLICATIONS ......................................................................................................................................... 6 3.1.3 UNIQUE APPLICATION ID ........................................................................................................................................ 7 3.1.4 DOWNLOAD APPLICATION AND DOCUMENTS ............................................................................................................. 8 3.1.5 VIEWING DOCUMENTS ........................................................................................................................................... 8 3.1.6 PAYMENT STATUS ................................................................................................................................................. 9 3.1.7 COMMUNICATION ............................................................................................................................................... 10 3.1.8 AUDIT LOG ......................................................................................................................................................... 11 3.2 PROCESS FOR APPLICATION REVIEW ....................................................................................................................... 11 3.2.1 TAKE INTERNAL ACTION ........................................................................................................................................ 11 3.2.1.1 SEEK INFO ......................................................................................................................................................... 12 3.2.1.2 FORWARD TO NEXT LEVEL ..................................................................................................................................... 12 3.2.1.3 SEND TO ........................................................................................................................................................... 13 3.2.1.4 PULL BACK AND REASSIGN ................................................................................................................................... 13 3.2.1.5 REVIEW CHECKLIST ITEMS..................................................................................................................................... 13 3.2.1.6 GENERATE NOTESHEET ........................................................................................................................................ 14 3.2.1.7 SEND BACK ........................................................................................................................................................ 16 3.2.1.8 VIEW NOTESHEET ............................................................................................................................................... 16 3.2.1.9 DRAFT PERMISSION LICENSE ................................................................................................................................. 17 3.2.1.10 GENERATE DRAFT COVERING LETTER .................................................................................................................... 19 3.2.1.11 APPROVE APPLICATION ...................................................................................................................................... 20 3.2.1.12 REJECT APPLICATION ......................................................................................................................................... 21 3.2.1.13 GENERATE PERMISSION/LICENSE ......................................................................................................................... 21 3.2.1.14 GENERATE COVERING LETTER .............................................................................................................................. 23 3.2.2 TAKE INVESTOR ACTION ....................................................................................................................................... 25 3.2.2.1 SCRUTINIZE INDIVIDUAL FIELDS ............................................................................................................................. 26 3.2.2.2 REQUEST ADDITIONAL INFORMATION .................................................................................................................... 28 3.3 MINISTRY USERS AND ACTIONS THEY CAN PERFORM ................................................................................................. 30 4 APPROVAL AND FORM LINKING .......................................................................................................................... 31 5 NSWS SUPPORT CENTER ..................................................................................................................................... 33 Page 11 About This Manual 1.1 Purpose of this Manual The purpose of this manual is to provide guidance to the CDSCO Ministry/Department users concerning: ❖ Services and Functionalities provided by National Single Window System (NSWS) for approval application processing. ❖ Step-by-step guide on how to evaluate approvals applications received through NSWS. 1.2 Organization of This Manual This manual has been organized into the following parts: ❖ Overview of NSWS ❖ NSWS Ministry/Department User Services 1.3 Acronyms, Abbreviations, Definitions Term /Abbreviation Definition / Full Form Approval Approvals, as used in this document, refer to any regulatory or legal clearance to be obtained from the government by any investors, entrepreneurs, businessperson, or business entity before commencing any business activity in India, including but not limited to Approvals, Registrations, Licenses, Permits, Clearances, Certifications etc. ICC Investment Clearance Cell Investment Clearance Cell setup under Invest India, DPIIT, to facilitate investors. Cell Responsible for developing and maintaining NSWS KYA Know Your Approval National Single Window The digital portal serving as the national single window system System (NSWS) under the Investment Clearance Cell Page 22 Introduction to NSWS 2.1 Objective of NSWS The Hon’ble Minister of Finance, Government of India, during the budget speech on 1st February 2020, announced the setting up of an Investment Clearance Cell (ICC). The proposed ICC has been developed as an online portal, named NSWS, which will act as a National Single Window System (NSWS) for investors, entrepreneurs, and businesses. NSWS enables investors to identify, apply, track and obtain approvals needed before starting any business operations in India. This eliminates the need for investors to visit multiple IT platforms and authorities to gather information and obtain approvals from different stakeholders. NSWS aims to fulfill the following objective: ❖ Establish a single window mechanism to integrate the services provided by various central government ministries, departments, and select state governments related to starting and operating any business activity. ❖ Provide a single window interface for procuring approvals required to commence a business in India. ❖ Provide efficient, convenient, transparent, and integrated electronic services to investors. ❖ Provide a uniform and seamless experience to the investor through a unified interface. 2.2 Scope of NSWS NSWS covers Central and State approvals required by any investor, both foreign or domestic, before starting any business operations or activities in India, including but not limited to registrations, licenses, permits, NOCs and approvals. It provides a platform for any investor to identify, apply track and obtain final decision on their applications. The final authority of approving or rejecting applications resides with the respective authorities. 2.3 Salient Features and Advantages of NSWS NSWS has been designed keeping the investor at the centre, and boasts of the following features: ❖ Provides a single unified interface to investors to identify, apply, track and obtain approvals. ❖ Helps investors identify applicable approvals depending on the specific business activities being planned and other investor-specific context. ❖ Provides an ‘Approval Repository’ where the investor can select and apply for any approvals, as needed. ❖ Reduces the need to fill in same information at multiple places through intelligent auto- population. ❖ Provides ability to track status of an application and raise reminders to authorities, as per agreed process, if any. Page 3❖ Provides a unified document repository to where investors can upload and save their documents, and view and download documents issued to them by authorities. ❖ Provides an intuitive and easy to use communication module to respond to any clarifications or additional information requests raised by processing authority on submitted applications. ❖ Guides investor in situations where multiple forms or approvals need to be submitted in a specific sequence and timing. ❖ Provides a scheduler to arrange and conduct meetings online with concerned authorities, as per agreed process, if any. Page 43 Processing Applications on NSWS 3.1 Ministry Dashboard Overview 3.1.1 Ministry User Login The authorised ministry officer can Login into the NSWS Ministry portal with the credentials available with them. The user can open the Ministry Login page from the Homepage of NSWS. Page 5The Ministry Dashboard on Login: Upon logging-in the Ministry User will be redirected to the Dashboard. The Dashboard contains the count of Applications: ❖ Assigned to me: The applications that are pending for the specific logged in Ministry User to review. ❖ New Application: The fresh application that are applied by the investor and are yet to be reviewed. ❖ Total Applications: The total of the above stated Applications. 3.1.2 Viewing Applications Upon opening Application tab, the system shall display status for the applied licenses. A fresh application will appear on top of the “Total Application” tab, or they can be opened by clicking on the “New Application” tab which will show all the new applications submitted by the users. To open an application for scrutinization the user should click on the name of the approval Page 6User can click on each section name to review the inputs filled by the investor Ministry User can navigate the through a single form vertically. 3.1.3 Unique Application ID For each application there will be a Unique Application ID which will be displayed on Investor as well as the Ministry portal throughout the entire scrutinization journey. Page 73.1.4 Download Application and Documents An option to download the whole application submitted and the payment details is also provided to the Ministry User which will enable to easily visualize the Applicant’s Input by the Ministry User. The button to preview the application is given on the top right corner as shown in the above image. This Document will include application inputs by the investor and the Payment Receipt Details On downloading it the application can be previewed as shown below, the same can be downloaded / printed. 3.1.5 Viewing Documents To view the documents submitted by the Investor, the Ministry User can click on the field and click on the Attached button beside such field. The Ministry User can click on the “Attached” button on the right side of each field to download the corresponding documents. Page 8Upon clicking the attachment option, Ministry User will be presented with a split screen which will have two drop down lists having all the documents submitted by Investor in that particular Application in both of them. Thus, the Ministry user can view all the documents along with the option of comparing different documents. 3.1.6 Payment Status User will be shown with the payment details of the submitted application by clicking on the Payment tab. Page 9The download invoice button will download a PDF having the payment receipt as shown below 3.1.7 Communication This tab will show all the Scrutiny and Query raised between the Ministry and Investor. The terms will be explained in the guide. Page 103.1.8 Audit Log Audit log shows all the actions taken on the particular application taken the Ministry users and Investor 3.2 Process for Application Review Ministry User will be provided with two tabs as shown below 3.2.1 Take Internal Action A ministry user can use this option when they have to communication regarding the application within the ministry. Click on checkbox for “I accept that I have reviewed the form carefully” and then click on “Take Internal Action” Page 11A ministry user can perform the following Internal Actions: 3.2.1.1 Seek Info In case the ministry user wants to ask some specific information from any other user from the workflow, the application still remains with the same officer. 3.2.1.2 Forward to next level In case the user wants to forward application for review to his immediate superior officer. Page 123.2.1.3 Send to In case a ministry user wants to assign or reassign this application to any level user in the workflow. This will transfer the application to the assignee on which they can act upon. 3.2.1.4 Pull Back and Reassign If the application is with a particular officer and they may not be able to process it (for example a leave or any official engagement), then the higher-level user to such officer can use this function to pull back the license from such user and reassign it to another officer. 3.2.1.5 Review Checklist items A ministry user has to review the checklist documents one by one in order to move the application to his higher-level officer. This process has to be done from Level 2 onwards till final level officer. There onwards, Each level officer has to complete this process. User has to click on Checklist from the top vertical tab and open each item. Then click on the downward arrow beside each line item. Page 13User can either raise query on the document which will be communicated to the investor, or they can provide their confirmation. 3.2.1.6 Generate Notesheet Once completed with the review of all items in the checklist, user has to generate Notesheet from the showed option in order to move forward with the application Page 14Provide confirmation through the comments and Generate Notesheet A Ministry user has to complete “Review Checklist Items” and “Generate Notesheet” action as shown in 3.2.1.5 and 3.2.1.6, respectively, to forward the application In case the user has missed a checklist item to verify, the system will communicate the same by showing this screen Page 153.2.1.7 Send Back In case the ministry user wants to send it back to the last user for reviewing it again 3.2.1.8 View Notesheet Notesheet captures actions taken by ministry users on checklist documents Page 163.2.1.9 Draft Permission License ❖ Ministry user can generate draft license using this option. User can click on the button and update or edit the required details. ❖ Click on Generate “Draft Permission License” as shown Page 17❖ Click on “Generate Certificate” on bottom of the page ❖ The Draft License will be generated Page 183.2.1.10 Generate Draft Covering Letter Ministry User can generate Draft Covering Letter using this option. Click on the buttons shown and add remarks. c c The document will be generated Page 19Condition: In case the user wants to “Generate Draft Covering Letter” , the ministry user has to first generate the “Draft Permission License” first. Otherwise, user will be provided with such a message 3.2.1.11 Approve Application In case final level Ministry User finds the Application correct they would provide Final Approval using this option attaching the License Certificate. User has to first generate the “Generate Permission/License” for such Approval Page 203.2.1.12 Reject Application In case the ministry user is the final approver they would provide Final Rejection using the “Reject Application” option. 3.2.1.13 Generate Permission/License ❖ Ministry user can generate final license using this option. User can click on the button and update or edit the required details. Page 21❖ Click on “Generate Final Permission License” as shown ❖ Click on “Generate Certificate” on bottom of the page Page 22❖ The Final License will be generated 3.2.1.14 Generate Covering Letter Ministry User can generate Final Covering Letter using this option. Page 23c Click on the buttons shown and add remarks. The document will be generated Page 24Condition: In case the user wants to “Generate Covering Letter” , the ministry user has to first generate the “Permission License” first. 3.2.2 Take Investor Action In order to have communication with the investor, user needs to click on “Take Investor Action” User will be provided with two options. Page 253.2.2.1 Scrutinize Individual Fields Scrutiny process is a functionality added by NSWS in the Mistry User’s Dashboard which is used as an intimation sent by Ministry to the Investor in cases where the Ministry thinks that Investor has given incorrect information in any field(s). Consequently, the Investor will be given an option to re-fill those fields and Resubmit the Application. Note: User will have to generate Notesheet before performing such scrutiny. Process for the same is captured below: ❖ Click on “Scrutinise individual fields”. ❖ Click on the arrow for the desired section Page 26❖ Click on the Circle against the field(s) where action is required and add the required remarks and click on “Save” ❖ Finally click on “Submit Scrutiny” tab provided at the end of the page. Page 27❖ Ministry User can also add some remarks in case they want to explain the issue more clearly. ❖ The new input of the field will be visible on Ministry End once the investor will correct it and resubmit the Application. Note: After the Investor resolves such query raised by Ministry user of any level, the application will automatically be assigned to the Reviewing Officer (Level 2). 3.2.2.2 Request Additional Information ❖ In case the Ministry User want some general clarifications from the investor they can use this option. ❖ Ministry User has to click on “Request Additional Information” button. Add the required remarks and send the request. Page 28❖ Once the investor replies on it, the same will appear on the commination tab as shown below Page 293.3 Ministry Users and Actions they can perform Level Officer Actions they can perform • Seek Info 1 N.O. (Nodal Officer) • Pull Back and Reassign • Send To • Notesheet Generation • Forward to next level 2 R.O (Reviewing Officer) • Send To, Seek Info • Generate Draft Covering Letter • Generate Draft Permission/License • Send To • Send Back • Seek Info 3 N.O. (Nodal Officer) • Generate Draft Covering Letter • Generate Draft Permission/License • Notesheet • Send To • Send Back • Seek Info 4 D.D.A. (Deputy Deciding Authority) • Generate Draft Covering Letter • Generate Draft Permission/License • Notesheet • Send To • Send Back • Seek Info 5 D.A. (Deciding Authority) • Generate Draft Covering Letter • Generate Draft Permission/License • Notesheet • Send To • Send Back • Seek Info • Generate Draft Covering Letter 6 L.A. (Licensing Authority) • Notesheet • Approve • Reject • Generate Final Permission Letter • Generate Final Covering Letter Page 304 Approval and Form Linking Ministry User can also use the Ministry Dashboard for knowing the status of their Approvals for KYA and Form Linking. Ministry User upon login to the Ministry Dashboard should select the “Department and Licenses” tab. The page will show the list of Approvals under CDSCO. The table will show status of each approval for their KYA and Form Alignment. To know which forms are linked to an Approval the User should click on the Approval name (If the Form Uploaded Status is given as Yes). Clicking on the form name will open it in “Preview Mode”. Page 31Page 325 NSWS Support Center NSWS has set-up a dedicated team for catering to the queries by Ministry personnel. NSWS also answers the queries of the users through the FAQs provided on the Help Page. The SPOC (Single Point of Contact) from NSWS for CDSCO are Mr. Agni Jasthi <ganesh.agni@investindia.org.in> Mr. Vaibhav Yadav <vaibhavyadav@investindia.org.in> Ministry users can directly coordinate with the SPOC for clarification of their queries. If the Ministry wants to change anything on their Ministry Portals then they can contact the Invest India SPOC for the same. --- END OF GUIDE --- ? Help Page 33

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