In a groundbreaking move to streamline processes for the pharma and medical devices industry, the Central Drugs Standard Control Organisation (CDSCO) introduced the National Single Window System (NSWS) portal on January 1, 2024.
Initially targeting the medical devices sector, this innovative platform aimed to enhance the ease of doing business for industry stakeholders.
Fast forward to January 16, 2024, and the CDSCO has expanded its services, adding four more essential forms to the NSWS portal.
1. Forms for New Drug Permissions
The CDSCO, recognizing the evolving needs of the industry, has incorporated Form CT-10.
This form is dedicated to applications seeking permission to manufacture new drugs or investigational new drugs for clinical trials, bioavailability, bioequivalence studies, or examination, test, and analysis.
Additionally, Form CT-12 is introduced for permissions related to manufacturing formulations of unapproved active pharmaceutical ingredients.
2. Forms for Active Pharmaceutical Ingredients
Two more forms, CT-13 and CT-16, have been added to address specific requirements.
Form CT-13 is designed for permissions to manufacture unapproved active pharmaceutical ingredients for the development of formulations, while Form CT-16 focuses on granting licenses to import new drugs or investigational new drugs for various purposes.
3. Upcoming Form Release
Looking ahead, Form 12, an application for a license to import drugs for examination, test, or analysis, is set to go live on January 24, 2024.
This comprehensive expansion aligns with the CDSCO’s commitment to providing a centralized platform for diverse regulatory activities.
The existing Sugam online portal will be disabled from February 10, 2024, onwards, marking a pivotal shift in the application submission process.
The NSWS Portal Advantage
Established by the central government, the NSWS Portal aims to serve as a one-stop-shop, consolidating all necessary approvals for investors in the pharma and medical devices sector.
The portal covers a broad spectrum of approvals, licenses, and clearances, simplifying the regulatory landscape for stakeholders.
Developed by Invest India in collaboration with IT giant Tata Consultancy Service (TCS), the NSWS portal stands as an independent portal, distinct from the existing SUGAM portal and cdscomdonline portal for the medical devices industry.
Medical Devices Rules, 2017
The NSWS portal initially focused on three activities under the Medical Devices Rules, 2017.
These activities include applications for the Certificate of Registration of a notified body, licenses to manufacture medical devices for clinical investigations, and licenses to import medical devices for various purposes.
These measures, effective from January 1, 2024, signify a strategic approach to enhance regulatory processes.
User Assistance and Future Endeavors
In a bid to ensure user-friendly navigation, the CDSCO has released a user guide and provided a dedicated contact number for users to address any queries.
Looking forward, the CDSCO is actively pursuing the establishment of a Digital Drugs Regulatory System (DDRS) to further elevate the efficiency and transparency of regulatory activities.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
- What is the purpose of the NSWS portal?
The NSWS portal serves as a centralized platform for obtaining approvals, licenses, and clearances for investors in the pharma and medical devices industry.
- Which forms have been recently added to the NSWS portal?
Forms CT-10, CT-12, CT-13, and CT-16 have been added, covering permissions for manufacturing new drugs, formulations of active pharmaceutical ingredients, and importing new drugs.
- When will Form 12 go live on the NSWS portal?
Form 12, the application for a license to import drugs for examination, test, or analysis, is scheduled to go live on January 24, 2024.
- Why is the Sugam online portal being disabled?
The Sugam online portal is being disabled to encourage stakeholders to use the NSWS portal, providing a unified and efficient application submission process.
- How can users get assistance with the NSWS portal?
The CDSCO has released a user guide for reference and provided a dedicated contact number for users to address any queries or concerns.
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