Last Updated on January 21, 2022
A finished pharmaceutical or biological drug for human or veterinary use is registered based on quality, safety, and efficacy. Any intended change in quality or safety parameters of the registered drugs is to be intimated to or approved by DRAP based on significance of the change as laid down in the relevant guidelines.
Post registration variations are broadly categorized as:
- Administrative Changes, for example change in name of title or manufacturer of a registered drug, change in (proprietary or brand) name of a registered drug, etc.
- Quality Changes, for example change of manufacturing site, change or addition in source of API, change of excipient in a formulation, extension, reduction of shelf-life, etc.
- Safety, Efficacy and Pharmacovigilance related changes, for example change in prescribing information, etc.
You can get applicable fee for various post registration variations here.
Post Registration Variation (PRV) application is submitted to Post Registration Variation Committee who considers the changes according to specified categories and if required may send cases to Registration Board for its consideration.
Procedure for Post registration variations of pharmaceutical or biological drugs for human or veterinary use is described below (for complete description of procedure)
Guidance Document on Post registration Variation can be downloaded from below links:
Post Registration Variation Guidance (draft for comments)