CDSCO to switch to online submission of Form 44

Last Updated on October 5, 2024 by The Health Master

CDSCO

The Central Drugs and Standard Control Organisation (CDSCO) has taken a significant step towards digitization and efficiency in the regulatory process for veterinary drugs.

The veterinary division of the CDSCO has announced the transition from offline to online submission of Form 44, a crucial form for obtaining permission to import or manufacture new veterinary drugs.

Transition to Online Submission

• Form 44 and Other Forms: The offline submission of Form 44, as well as Forms 45A/46A, 45/46, and Field Trial Permission, will no longer be accepted for processing.
• Sugam Portal: The online submission process will be conducted through the Sugam Portal. Applicants seeking new drug permissions for vaccines, drugs, bulk substances, or finished formulations, as well as field trial permissions, will need to apply using the online system on this portal.
• Checklist-Based Process: Applicants will be required to follow a checklist provided within the developed modules on the Sugam Portal.

Understanding the Forms

• Form 45 and 46: These forms are used for obtaining permission to import or manufacture finished formulations of new drugs, respectively.
• Form 45A and 46A: These forms are used for obtaining permission to import or manufacture raw materials (new bulk drug substances), respectively.

CDSCO’s Ongoing Digitization Efforts

• PSURs: Earlier this year, the CDSCO switched the submission of Period Safety Update Reports (PSURs) for new drugs to an online system.
• Other Applications: The drug regulator has been actively working to move various application and approval processes online, aligning with its e-governance initiatives.
• PACs and Test Licenses: In recent years, the CDSCO has transitioned the submission of Post Approval Changes (PACs) for human vaccines and antisera, as well as test licenses for veterinary vaccines and drugs, to online platforms.

National Single Window System (NSWS)

• Launch: The CDSCO launched the NSWS portal in January 2024, initially focusing on medical devices.
• One-Stop Shop: The NSWS aims to provide a single platform for obtaining all necessary approvals and licenses, streamlining the business process for investors.
• Development: The portal was developed by Invest India in collaboration with Tata Consultancy Services (TCS).

Digital Drugs Regulatory System (DDRS)

• Initiation: The CDSCO announced plans to establish a DDRS in November 2023.
• Objectives: The DDRS aims to enhance trust in drug quality, improve transparency and accountability, strengthen enforcement, and ensure compliance with regulatory standards.

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.

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