New Requirement Of Process Validation Report For Permission To Conduct Clinical Trial/BA-BE Studies

CDSCO or the Central Drugs Standard Control Organization has recently made it clear about the need for the process validation report to obtain the permission to conduct Clinical trial/ BA-BE studies. Under this notification, it has ordered all state drug controllers to submit the bioavailability- bioequivalence study agreements for export in 15 days along with approvals for production as well as imports of novel drugs and its complete analysis in seven days.

Clinical trials and BA-BE studies are an important part of the regulatory process of import and export of drugs in India.

The permission needed to do BA/BE analysis of all novel drugs for the sole purpose of export is given by the Central Licensing Authority (CLA), according to the New Drugs and Clinical Trial Rules, 2019, in the form CT-07.

Import license in the form Ct-17 is also given for import of the analyzed drug. The approvals manufacture new and/or unapproved API and finished formulations for doing clinical trials (CT) along with BA/BE study are given in the form CT-11, CT-14 and CT-15.

This issue arose because of the increasing concern in various forums about several aspects of submission, timeline as well as processing for stability study and application for granting permission for conducting clinical trials along with BA/BE studies.

The DCGI has stated in its circular that the data of stability studies are needed for submission according to the new drugs and clinical trial rules 2019, which states that when the application is required for clinical trials only, the international nonproprietary name, the category of the drug, dosage form, data supporting stability in the required container closure system for the total time of the clinical trial is needed.

According to the New Drugs and Clinical Trial Rules, 2019, the term clinical trial of a novel drug implies any study of the novel drug in human subjects for generating data to discover or make verification of its clinical or pharmacological that includes pharmacodynamics along with pharmacokinetics or any side effects with the purpose of determination of the safety, efficiency along with the tolerance of such novel drug or drug under investigation.

Bio-equivalence studies imply study for the establishment of the absence of any difference that exists in the rate as well as the extent of absorption of all active ingredient from any pharmaceutical formulation in comparison to the reference formulation that has the same ingredient when it is administered in the same molar dose under same conditions.

As per rules, BA/BE study must be submitted by pharma companies to CDSCO for approval. Moreover, process validation depends solely on the complexity of the product.