CDSCO releases updated version of guidance for PAC in biological products

The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out.

The new version, the Version 1.2 of the guidance replaces the previous Version 1.1 published in the year 2008. The new version is updated to align with updated international guidelines, New Drugs and Clinical Trials (NDCT) Rules, 2019 and Sugam application process after consultation with the stakeholders.

The document was published on May 16 for implementation, after considering the public suggestions, comments and objections, said the drug regulator.

The new version is intended to provide guidance to manufacturers and marketing authorisation holders on regulating changes to already licensed biological products in order to assume their continued quality, safety and efficacy, as well as continuity in supply and access.

The objective is to assist the manufacturer or marketing authorisation holder with the classification of changes made to biological products approved by CDSCO for import or manufacturing and marketing in India.

It is also intended to provide the marketing authorisation 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 effective use of the products.

The changes are classified into Level I on Supplements, which deal with major quality changes, that have substantial potential to have an adverse effect on the identity, strength, quality, purity or potency of a biological product which may relate to safety and efficacy of the product; Level II on Notifiable changes, which are moderate quality changes that have a moderate potential to have an adverse effect related to the safety or efficacy of the product; Level III on Annual Notification for minor quality changes that have minimal potential to have an adverse effect on these parameters; and Level IV Changes which is to record changes that are not in the other three levels and are not expected to have an adverse effect on the parameters.

The marketing authorization holders should recognize that any change to a biological product has a potential impact on the quality, safety and/or efficacy of that product and any change to the information associated with the product (that is, product labelling information) may have an impact on its safe and effective use.

“The regulation of changes to approved biological products is key to ensuring that products of consistent quality, safety and efficacy are marketed after they receive authorisation or licensure,” said the regulator.

An attempt has been made in the guidance document to cover a range of possible changes in manufacture, quality control, safety, efficacy and product labelling information and to provide guidance on the data needed to support changes to approved biological products in order to ensure comparability of the pre-change and post-change products with respect to quality, safety and efficacy, it added.

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