Last Updated on December 31, 2023 by The Health Master
The Drugs Controller General (India) has said that certain changes in the active substance of an approved drug may lead to change in drug specification and require validation of the manufacturing process.
In a circular, the DCGI has said that his office has received representation seeking clarification on if already approved drugs with change in (a) polymorphs, crystalline, amorphous, solvated or hydrate etc, (b) salt and (c) derivative, analogue, ester etc. are manufactured using the new manufacturing process, will be considered as old drug or new drug.
The circular clarifies that the change in these properties or already approved active substance may lead to change in drugs specification and may influence on the physiochemical properties particle size, hygroscopicity, solubility, density, flow ability and compatibility etc.
It will also impact the dissolution, bioavailability and bioequivalence classifications, manufacturing of drug substance / drug product, and stability of drug substance / drug product.
Hence, changes mentioned above in already approved active substance may require validation of manufacturing process, stability studies, additional clinical and non-clinical studies, bioavailability/bioequivalence studies, to demonstrate its safety and efficacy, said the drug regulator.
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“Therefore, any new (a) (b) & (c) of already approved active substance is considered as a new drug,” added the Circular.
However, applications of such new drug may be processed considering factories including that in case (a), (b), & (c) of already approved active substance is significantly affecting physicochemical properties, manufacturing process, stability, safety and efficacy and bioavailability/bioequivalence etc., the new drug will be processed as new active substance and requirements will be the same as for any new active substance as prescribed in New Drugs and Clinical Trials Rules, 2019.
In case of any (a), (b) and (c) of already approved active substance, if there is no significant effect on physicochemical properties, manufacturing process, stability, safety and efficacy and bioavailability/bioequivalence etc., the new drug will be processes as subsequent new drug of already approved new drug and requirements will be the same as for new claim for any on already approved new drug, as prescribed in New Drugs and Clinical Trials Rules, 2019.
Accordingly, the applicant should submit an application as per the requirement prescribed in the said rules, added the Circular.
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