The Bioavailability/Bioequivalence (BA/BE) Division functioning under the office of the Drugs Controller General (India) [DCG(I)] at CDSCO (HQ), FDA Bhawan, New Delhi, is responsible for the regulatory oversight, evaluation of Bioavailability/Bioequivalence (BA/BE) studies, and approval of BA/BE study centres in India.

Key Functionalities

• Protocol Review and Regulatory Approval
  Study protocols are critically evaluated to ensure compliance with the New Drugs and Clinical Trials Rules, 2019, and applicable CDSCO guidance documents. Approval/No Objection Certificate (NOC) is granted after satisfactory review.

• Ensuring Safety and Tolerability
  The Division ensures that proposed studies adequately demonstrate the safety and tolerability of generic formulations in comparison to their corresponding innovator (reference) products.

• Assessment of Bioequivalence and Interchangeability
  An assessment of therapeutic equivalence and interchangeability between the investigational (test) product and the reference (innovator) product is carried out through evaluation of in vivo bioequivalence studies.

• Regulated BA/BE Submission as per GCP Guidelines
  The conduct of BA/BE studies is monitored to ensure adherence to the Indian Good Clinical Practice (GCP) Guidelines, with emphasis on the protection of study subjects, ethical oversight, and data integrity.

• Inspection and Monitoring of BA/BE Study Centres
  The Division coordinates inspection of BA/BE study centres and bioanalytical facilities to verify infrastructure, quality systems, and compliance with regulatory requirements.

• Export-Oriented BE Approvals
  The Division processes and grants BE-NOC for studies conducted exclusively for export purposes.