โIndirect Tax I Indirect Tax Litigation I Customs & FTP I Central Licensing I Arbitration I Advisoryโ
Dated: 19.03.2026
Streamlining Regulatory Submissions: Online Applications for r-DNA Product Licenses Now Available
The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), has announced a significant update to the regulatory submission process for r-DNA products. โ Effective March 10, 2026, all applications for the grant of licenses in Form 28-O/28-DA for r-DNA products must be submitted exclusively through the Online National Drugs Licensing System (ONDLS Portal) at https://statedrugs.gov.in. โ This move aims to enhance efficiency, transparency, and convenience in the licensing process.
Key Highlights of the Circular:
- Mandatory Online Submission:
- Applicants seeking licenses for r-DNA products under Form 28-O/28-DA are required to submit their applications via the ONDLS Portal. โ
- The offline submission of applications in hard copy will no longer be accepted for processing starting March 10, 2026. โ
- Streamlined Process:
- The online system is designed to simplify the application process, ensuring faster processing and reducing paperwork. โ
- Applicants must follow the checklist provided in the module on the ONDLS Portal to ensure compliance with submission requirements. โ
- Accessibility:
- The ONDLS Portal is accessible at https://statedrugs.gov.in, providing a user-friendly interface for stakeholders to submit their applications. โ
Who Should Take Note?
This update is relevant to all stakeholders involved in the development, manufacturing, and distribution of r-DNA products. โ It is also directed at all Zonal/Sub Zonal Offices of CDSCO and the CRU Section of CDSCO Headquarters. โ
Benefits of the Online System:
- Efficiency: The digital platform reduces the time required for application processing.
- Transparency: Applicants can track the status of their submissions in real-time.
- Convenience: The online system eliminates the need for physical submission, making the process more accessible and less cumbersome. โ
Next Steps for Applicants:
To ensure compliance with the new guidelines, applicants are advised to:
- Familiarize themselves with the ONDLS Portal and its functionalities. โ
- Review the checklist provided in the module to prepare their applications.
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Source: CDSCO
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