|
Incomplete applications delay generic drug exports
Balakrishnan Nair - Mumbai
Deficiencies in generic drug applications may one of the reasons that result
in delay in exports of generic drugs. Some of the commonly observed deficiencies
pertain to drug master files (DMF), drug chemistry, developmental pharmaceutics
issues, manufacturing, process validation, drug product specifications and stability,
said Sultan Ghani, director, Bureau of Pharmaceutical Sciences, Therapeutic
Products Directorate, Canada.
Sultan Ghani was a key speaker at an international conference
held recently here. The two-day event was organised by Drug Information Association
and Indian Pharmaceutical Association.
Health Canada, in an effort to harmonise its guidance and
policy documents, has implemented the guidelines of International Conference
on Harmonization to both innovative and generic drug submissions. Health Canada
has provided significant contribution to the development of quality guidelines
since 1992 through the participation of expert working groups.
Speaking to Express Pharma Pulse, Ghani said ‘‘In
DMF, the deficiency has been due to filing the incorrect format to the regulatory
authority or insufficient information on the route of synthesis where a key
intermediate is regarded as the starting material.’’
In chemistry, the issues comprise incomplete characterisation
of the drug substance by the sponsor of the ANDS. This can include information
on physicochemical properties, structural elucidation, particle size distribution
and level of polymorphism.
Process validation studies are not to be considered a procedure
to optimise the manufacturing process or formulation but to verify the robustness
of the manufacturing procedure, added Ghani.
Inappropriate specifications for assay at the time of release,
degradation or problems with the analytical methods or its validation are some
of the deficiencies in drug product specifications and stability testing.
Further, the International Conference on Harmonization (ICH Q7) will have a
significant impact on the review of generic drug submissions in Canada which
source the active pharmaceutical ingredient ingredients (API) from various countries
including India, said Sultan Ghani. ICH Q7 pertains to Good Manufacturing Practice
Guide for APIs.
balakrishnannair@expressindia.com
|
