CDSCO issues clarification on the requirement of process validation report for permission to conduct Clinical trial/BA-BE studies
New Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services has clarified the requirement for process validation report for permission to conduct Clinical trial/BA-BE studies.
The notice for the same was issued by Dr V G Somani, Drugs Controller General (India) (DCGI) to all the stakeholders.
Under the New Drugs and Clinical Trials Rules, 2019, CDSCO grants permission for import/manufacture of new drugs for sale and distribution.BA/BE study are mandatory to be submitted by pharma companies to the CDSCO for its approval.
Bioavailability (BA) refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
Bioequivalence (BE) of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Concerns have been raised regarding the requirement of process validation report for permission to conduct clinical trial/BA-BE studies.
In this regard, the notice mentioned that data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs (new molecule) for sale in the country are specified in Table 1 of Second Schedule of New Drugs and Clinical Trials Rules, 2019.
As per the said table when the application is for clinical trials only, the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting stability in the intended container-closure system for the duration of the clinical trial (information covered in item numbers 2.1, 2.3, 2.6, 2.7 of the table) are required.
" Process validation as required for commercial batches may not be required for Phase I, Phase II studies, However, the proof of process standardization may be required. Further, for the phase III clinical trial batches, the requirements of the process validation though may not be required as per commercial batches, however, it will vary depending on the complexity of the product ( biological, high tech etc)," the DCGI clarified.
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