1) Introduction:
Government organizations worldwide are adopting digital platforms to improve public service delivery and streamline operations in an era characterized by technological advancements and a paradigm shift toward digitization. On January 1, 2024, a notice was published on the National Single Window System (NSWS). The National Single Window System (NSWS) Portal has been launched by the Central Drugs Standard Control Organization (CDSCO). Since launching its forms on the Online Submission of Applications and Monitoring System (NSWS) portal, the Central Drugs Standard Control Organization (CDSCO) has made tremendous progress.
This portal aims to create a system that makes it easier to do business by acting as a one-stop shop for all investor approvals. For submitting applications and keeping track of different regulatory procedures, the NSWS portal serves as a central hub.
As the stakeholders know, the central government created the NSWS to create an accurate single-window system that would be a one-stop shop for all investor approvals and make business easier. Every applicable license, registration, clearance, and approval falls under the purview of NSWS.
2) Goals of NSWS:
With the following goals in mind, the National Single Window System was conceptualized to streamline the application process for regulatory approvals and registrations in India at a single location:
1) To combine the services offered by different Central Ministries, Departments, and State Governments to create a single-window system.
2) To offer a one-stop shop where entrepreneurs can obtain the pre-operation and pre-establishment permissions and permits needed to open a business in India.
3) To offer investors, businesses, and industries an integrated, transparent, easy-to-use, and efficient electronic service.
4) To give the business user a consistent and smooth experience.
The SUGAM Portal and the cdscomdonline portal will not be connected to the NSWS Portal for CDSCO. The following is a list of medical device applications that were accepted via the NSWS portal as of January 15, 2024:
- Form MD-01: Application for the grant of registration of a Notified Body.
- Form MD-12: Application for a license to manufacture medical devices for clinical research, testing, evaluation, examination, demonstration, or training. [P2]
- Form MD-16: Request for Permission to Import Medical Equipment for Clinical Research, Examination, Assessment, Illustration, and Instruction.
Additionally, the following forms were created and went “live” on NSWS on January 16, 2024:
- Form CT – 10: Application for approval to manufacture new drug or investigational new drug for use in a clinical trial, bioavailability or bioequivalence study, or for examination, test, and analysis.
- Form CT -12: Application for approval to manufacture unapproved active pharmaceutical ingredient formulation for use in a clinical trial, bioavailability or bioequivalence study, test, analysis, and formulation development.
- Form CT – 13: Application for approval to manufacture unapproved active pharmaceutical ingredients to develop a formulation for use in a clinical trial, bioavailability, or bioequivalence study.
- Form CT – 16: To import novel or experimental medications for clinical trials, bioavailability or bio equivalency research, testing, analysis, and inspection, you must obtain permission.
- Form 12: Application for license to import drugs for examination, test, or analysis.
3) Critical aspects and preliminary work on the National Single Window System (NSWS)
1) Identification of Necessary Approvals: Medical device manufacturers can quickly ascertain the required approvals, including MD-15 regulations and the recently added functionalities, thanks to the ‘Know Your Approvals (KYA)’ feature.
2) Submission of an Application: Via the NSWS Portal, an Indian Agent may apply directly.
3) Tracking and Status Updates: Instantaneous updates regarding a submitted application via the NSWS portal.
4) Examine Legal Form: The user can examine the filed legal form.
5) Application Preparation and Submission: Medical Device Manufacturers wishing to register their devices in India can use the comprehensive checklists available on the portal to assist in preparing the required paperwork.
NSWS’s Effect on the Medical Device Industry in India – By 2030, India’s need for medical devices is anticipated to total $50 billion. An estimated $12 billion worth of medical devices are needed annually in India, with more than 60% coming from imports. It will be easier for medical device manufacturers to register their products in India if the regulatory approval process, import requirements, state specifications, and other processes are streamlined. This will give them a clear understanding of all the rules and compliances. Additionally, this will simplify government processes in India, making it easier for the country to meet rising demand.
4) USER GUIDE:
Please take the actions listed below:
Step 1: Click the https://www.nsws.gov.in/ website link to access the NSWS website.
Step 2: As seen in the screenshot below, hover your cursor over the Login button and choose Investor Login.
Step 3: As indicated in the screenshot below, newly registered users can click the Sign Up Now button to register, while already registered users must enter their login information and click the Sign in button.
Step 4: Please enter your full name, email address, mobile number, and password to register before clicking the “Sign Up Now” button. The user must click the verify link, as indicated in the screenshot below, to confirm their email address and mobile number.
Step 5: As the screenshot below indicates, choose the legal entity type from the available options.
Step 6: Click the following button after choosing the preferred entity type and entering a name. Enter the PAN No. And select the “Get Details” button on the following page, as indicated by the screenshot below.
Step 7: Check the name on the PAN card, acknowledge the declaration, and press the “Next” button, as indicated in the screenshot below.
Step 8: Enter the address information on the following page and click the NEXT button, as indicated in the screenshot below.
Step 9: Enter the information about the authorized signatory and hit the save button on the following page.
Step 10: Go to the “Central Approvals” menu and type AICTE. As seen in the screenshot below, click the AICTE Approval icon to add the approval to your dashboard.
Step 11: As seen in the screenshot below, click the “Apply now” button.
Complete the application and select “Review and Submit.”
Conclusion:
The advent of the National Single Window System (NSWS) Portal by the Central Drugs Standard Control Organization (CDSCO) marks a significant milestone in India’s journey towards digital governance and efficient regulatory processes. With its aim to simplify the complexities of regulatory approvals and streamline operations for medical device and pharmaceutical industry stakeholders, NSWS stands as a symbol of innovation and progress. As India strives to meet the demand for medical devices and uphold global quality and safety standards, NSWS emerges as a vital tool in achieving these objectives. With its user-centric design, robust functionalities, and commitment to excellence, NSWS exemplifies the transformative power of digital technology in driving inclusive development and sustainable progress.
