The Central Drugs Standard Control Organization (CDSCO) has introduced a new protocol for the submission of documents related to regulatory affairs. This notice was issued on 12th October, 2023.
This change comes as CDSCO utilizes a separate domain for its e-office operations (eoffice.cdsco.gov.in), marking a significant step towards a paperless work environment.
The CDSCO’s Clinical Research Unit (CRU) Division has encountered challenges in receiving documents in soft copy from various divisions and stakeholders. As a result, the CRU Division has been receiving numerous documents, including bulky dossiers, query replies, and other related materials, in hard copy format.
To address this issue effectively and promote a more streamlined approach, the CDSCO has issued a set of instructions for stakeholders with immediate effect. These instructions are aimed at facilitating the transition to soft copy document submission. Key points include:
1. Submission of Soft Copies: Stakeholders are now encouraged to submit bulky dossiers, documents, query replies, and other materials in the form of soft copies. These soft copies should be saved on a CD or pen drive and submitted to the CRU Division. The documents should ideally be less than 20 MB in size and be in PDF format. This facilitates the efficient forwarding of the materials to the relevant division, accompanied by a covering letter.
2. E-Mail Submission: In addition to submitting physical copies, stakeholders may also forward bulky dossiers, documents, query replies, and similar materials via email. The designated email address for this purpose is cru.division@cdsco.nic.in. Documents sent via email should also be less than 20 MB in size and in PDF format.
These measures are designed to expedite the processing of documents within the CDSCO, reducing paperwork and enhancing the overall efficiency of regulatory affairs. The move towards digital documentation aligns with the broader global trend of modernizing administrative processes and promoting sustainable practices.
