CDSCO has issued a draft of revised guidelines on Similar Biologics regulatory requirements for marketing authorization in India and sought comments/suggestions from stakeholders within 30 days. The draft guidelines are prepared on the basis of advance development, knowledge and experience in the field of regulatory as well as Similar Biologics.
CDSCO vide F. No. r-DNA-15011(11)/17/2024-eoffice dated 06-05-2025 has sought comments/suggestions from stakeholders on draft of revised guidelines on Similar Biologics- Regulatory requirements for marketing authorization in India within 30 days.
The draft guidelines are prepared on the basis of advance development, knowledge and experience in the field of regulatory as well as Similar Biologics by a committee comprising of representatives from NIB, DBT and Industries involved in manufacturing of similar biologics.
Additionally, Stakeholder's format is also issued from the CDSCO to provide comments in specified format. The format includes Name, designation of the person along with the Company name and table format for the comments.
The table has seven columns with below mentioned headlines.
- S. No.
- Page No.
- Line No.
- Section/Sub- section/Heading
- Curren text
- Proposed text
- Explanation/Reference