The Central Drugs Standard Control Organization (CDSCO) has released draft guidance on postapproval changes to biological products for consultation, proposing to add new sections on safety and efficacy changes.
Indian officials formed a committee in 2013 to update version 1.1 of the guidance on postapproval changes to biological products with an aim to “strengthen the processing of applications” and “update the quality information of already licensed products in a better systemic manner.”
Version 1.2 of the guidance has undergone significant changes. CDSCO is proposing to add a new category of quality changes, level IV, that marketing authorization holders can implement without prior regulatory review. Level IV changes are not expected to adversely affect the identity, strength, quality, purity or potency of the drug product. Examples of level IV changes, such as replacement of filter housing and changes to the color of stopper caps, are listed in an appendix.
CDSCO is also planning to add information on the supporting data for level IV changes and a new section on the classification of safety and efficacy changes. The draft guidance advises marketing authorization holders to put changes related to clinical use and product labeling into one of four categories based on the likely impact on safety and efficacy.
The agency defines level I changes as any revision to the label of a drug “that has the potential to change the exposure levels of the drug, either by expanding the population that is exposed (i.e. related to market expansion), or by increasing individual exposure.” Examples of changes that may increase exposure levels include the addition or expansion of a safety or efficacy claim.
At the other end of the scale, changes that are not expected to affect safety or efficacy can be made without prior review by CDSCO and communicated in annual notifications. Changes to labels that “add clarity and maintain consistency with common label phrase standards” can be made without first being reviewed by CDSCO.
Other proposed updates to the guidance include the addition of sections on administrative product labeling information changes, comparative studies and quality by design. CDSCO is accepting feedback on the draft for 45 days. The agency said it prepared the draft in consultation with stakeholders and in alignment with documents from other regulators and the World Health Organization.
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