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India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion

India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products: Quality Safety and Efficacy" to guide the MA holders who wish to modify biological products that have been approved for marketing.


This draft guidance specifies the post-approval reporting requirements for biological products, including the submission of annual reports and the notification of any adverse events or product defects.


The objective of this guidance is


  1. To assist with the classification of changes made to biological products approved by CDSCO for import/manufacturing and marketing in India.

  2. To provide Marketing Authorization Holders (MA holders) with recommendations on the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the products.

The Reporting Categories for Quality Changes


  • Level I - Supplements (Major Quality Changes) are changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a biological product as these factors may relate to the safety and/or efficacy of the product.

  • Level II - Notifiable Changes (Moderate Quality Changes) are changes that have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the biological product as these factors may relate to the safety and/or efficacy of the product.

  • Level III -Annual Notification (Minor Quality Changes) are changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the biological product as these factors may relate to the safety and/or efficacy of the product.

  • Level IV (Quality only) changes are changes to a biological product that are not Level I, Level II or Level III and are not expected to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety and/or efficacy of the drug product.


Several changes outlined in this guidance document include recommendations for supporting by bridging clinical studies. Stability studies should be conducted as recommended by CDSCO, ICH, and WHO, if necessary to support a change.

The know more detailed information and documentation that is required to support a PAC submission, including a detailed description of the change, the rationale for the change, and the potential impact on the product, click this LINK.



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