The Central Drugs Standard Control Organisation (CDSCO) has urged the manufacturers to submit stability studies data as per New Drugs and Clinical Trials Rules, 2019.
This comes in the wake of concerns raised at various forums with respect to the requirement of stability study to be submitted along with application for grant of permission to conduct clinical trial and bioavailability – bioequivalence (BA-BE) studies.
The Drugs Controller General of India (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.
“Further, it is also clarified in that the new rules may not be applicable to all drugs and for explanation, text of First Schedule, Second Schedule and Third Schedule of the new rules shall be referred,” the DCGI circular clarified.