India’s CDSCO Reduces API Stability Testing Data Requirement
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India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three batches.
The accelerated stability data requirement – 6 months – will remain the same, CDSCO said.
In order to obtain the Written Confirmation Certificate (WC) from the CDSCO that is required by the EU, the API exporter must establish that there were no major changes from the specifications under the lowered testing threshold. Moreover, the exporter must submit a stability protocol that commits the manufacturer to an ongoing stability program and requires the manufacturer to assign retest/expiry dating according to ICH guidelines.