BA/BE study

Bioavailability (BA):
Bioavailability refers to the rate and extent of availability of active pharmaceutical drug in systemic circulation of our body or available at site of action. It is measurement of the relative amount of drug absorbed from administered dosage form to reach the systematic circulation and become available at site of action.

Bioequivalence (BE):
Bioequivalence refers to the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

BA/BE studies are conducted generally for new drugs, any modification of already existing molecule/dosage form, approval of generic version of any off patent molecule etc. In case of generic drugs, BE study is required to ensure generic versions are equally safe and efficacy profile, and has same rate and extent of absorption of active ingredients as of its innovator product.

How to submit for BA/BE study data for export purpose in India?
Application has to be submitted to the office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhawan, New Delhi. The applicants submit the application for BE NOC & Test Licence through online Sugam Portal in applicable checklist to meet tenets of Schedule Y of Drugs and Cosmetics Act 1940 & Rules 1945 and also Indian Good Clinical Practices (GCP) guidelines.
The application will be processed by the Assistant Drugs Inspector/Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for recommendation for approval then DCG(I) (Licensing Authority) will grant the BE NOC & Test Licence to the applicant through Online Sugam Portal.

Read related: How to export pharmaceutical products from India?

Hope above information is helpful to you...

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