Since last Wednesday, active pharmaceutical ingredient (API) manufacturing seeking CDSCO “written confirmation” need to submit six months of accelerated stability data (as well as six months of long term stability data for three drug batches.
The new data requirement contrasts with the 12 months stability data previously required and follows a recommendation from several CDSCO Zonal offices.
The revised rule comes with the caveat that no major changes are observed and that the firm provides details of its testing protocols within 30 days.
In addition, companies seeking written confirmation need to assign API batches with expiry dates as per International Conference on Harmonisation (ICH) guidelines.
International API firms wanting to ship to the EU have been required to provide "written confirmation" of the quality of their products from local regulators since July 2, 2013.
The CDSCO, which is the organisation responsible for conducting the assessments on which the confirmations are based, has previously set out guidance on the application and submission process and explained how ingredient manufacturers should prepare for facility inspections.
It has also detailed the procedures for reporting non-compliant APIs and facilities to EU authorities.