India has released draft guidance
on stability data needed to support approval of Phase I to III clinical trials.
Like its US counterpart India’s
Central Drugs Standard Control Organization (CDSCO) proposes unique stability
data requirements for each phase of clinical development. Outlining these
demands in draft guidance is intended to help biopharm companies support their
applications with suitable data.
"This guidance will ensure
that sufficient data is submitted to CDSCO to assess the safety as well [as]
the quality of the proposed clinical trials from chemical and pharmaceutical
information perspective", the regulator wrote. The guidance does not apply
to biologics and vaccines.
For Phase I trials CDSCO, like
the US Food and Drug Administration (FDA), has minimal requirements. However,
the approach is different, with CDSCO asking applicants to "submit
whatever stability study data [is] available" and the FDA calling for
samples to be tested for the duration of the Phase I trial.
As a compound advances through
drug development CDSCO’s stability data requirements increase. In Phase II a
minimum of one month accelerated and real-time stability study data is needed.
CDSCO also asks for quarterly updates on stability and to be told of
significant changes within 10 days.
The FDA guidance differs by
making no mention of specific Phase II requirements, such as the one month of
stability data. Also, the FDA asks firms to "consider the development of
stability-indicating analytical procedures that will detect significant changes
in the quality of the drug product".
CDSCO Phase III needs are
identical to its Phase II draft. In contrast, the FDA adds data requirements in
Phase III, asking for one-time stress tests of certain products and development
of a protocol for use in formal stability studies. This ensures data for the
NDA (new drug application) is generated.
