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The Central Drugs Standard Control Organisation (CDSCO) has directed all state drug controllers to give bioavailability-bioequivalence (BA/BE) study approvals for export within 15 working days and also approvals for manufacturing, import of new drugs for test and analysis within seven days.
Permission to conduct BA/BE study of new drugs for export purpose is granted by Central Licensing Authority (CLA), as per the New Drugs and Clinical Trial Rules, 2019, in Form CT-07.
Import Licence in Form CT-17 is also granted for import of study drug for this purpose. Approvals for clinical trials (CT) and BA/BE study are granted in Form CT- 11, CT-14, and CT-15 for manufacturing or import of new drugs for test and analysis.
This comes in the wake of concerns raised at various forums with respect to the aspects of submission, processing and timeline for stability study and application for grant of permission to conduct clinical trial and BA/BE studies.
Drugs Controller General of India (DCGI) had earlier urged the manufacturers to submit stability studies data as per New Drugs and Clinical Trials Rules, 2019.
The DCGI in its circular stated, “Stability studies data is required to be submitted as per new drugs and clinical trials rules, 2019, which stipulates that 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 is required".
As per New Drugs and Clinical Trials Rules, 2019, clinical trial in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its clinical or pharmacological including pharmacodynamics, pharmacokinetics or adverse effects with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.
Comparative pharmacokinetic studies are generally conducted in the form of bio-equivalence studies which is defined in the new rules.
As per the new rules, bio-equivalence study means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions.
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