135 Clarification if change in a) Polymorphs/crystalline/amorphous/solvates/hydrate etc (b) salt and (c) Derivative/analogue/ester etc of already approved active substance to be considered as new drug

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----- Start of picture text -----<br> .12-01/2 "<br>Government of India<br>i General of Health Services<br>Central Drugs Standard Control Organization<br>(New Drugs Division) FDA Bhawan, Kotla Road<br>New Delhi- 110002<br>Dated: 23/7/ |<br>----- End of picture text -----<br>

CIRC R

Subject: Clarification if change in a) polymorphs/crystalline/amorphous/solvates! hydrate etc (b) Salt and (c) Derivativelanalogue/ester etc of already approved active substance to be considered as new drug if main active moiety (Active Pharmaceutical Ingredient-API) is same? -Reg. Representation has been received seeking clarification, if already approved drugs with change in (a) Polymorphs/crystalline/amorphous/solvates/hydrate etc, (b) Salt, and ; cP (c) Derivative’ analogue/ester etc are manufactured using the new manufacturing process, It is clarifiedbe consideredthat change as oldin (a) drug (b)or& new(c) of drug.already approved active substance may lead to change in drugs specification and may influence on; . Physicochemical properties particle size, hygroscopicity, solubility, density, flowability and compatibilityetc. Hence, change in (a) (b) & (c) of already approved active substance may require validation of Therefore,any new (a) (b) & (c) of already approved active substance is considered as new drug. 1 Incase(a) (b) & (c) of already approved active substance is significantly affecting Bioavailability/Bietc. the new drug will be pr o cessedequivalenceas new active substance and ClinicalTrials Rules, 2019, onphysicochemical properties, manufacturing process, stability, safety and efficacy and __ Bivavailability/Bioequivalence etc. the new drug will be processed as subsequent new drug of already approved new drug and requirements will be same as for new claim for any on already ___approved new drug, asprescribed in New Drugsand Clinical Trials Rules,2019. a Cisiaid submit application asperthe requirement prescribed in the New Drugs I