BA-BE Studies: SOP for Filing Form 44 to CDSCO for BA/BE Studies – V 2.0

Standard Operating Procedure for Filing Form 44 to CDSCO for BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/009/2025
Supersedes	SOP/BA-BE/009/2022
Page No.	Page 1 of 13
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the process of preparing, compiling, and submitting Form 44 to the Central Drugs Standard Control Organization (CDSCO), India, for obtaining approval to initiate Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP is applicable to the Regulatory Affairs team responsible for initiating BA/BE study approvals from CDSCO in accordance with the Drugs and Cosmetics Act, Rules 122A and 122DAA.

3. Responsibilities

Regulatory Affairs: Prepares Form 44, compiles supporting documents, and liaises with CDSCO.
Clinical Team: Provides study protocol, site details, and PI credentials.
Legal or Admin: Assists in document notarization and declarations.
Quality Assurance: Reviews completeness and alignment with CDSCO expectations.

4. Accountability

The Head of Regulatory Affairs is accountable for ensuring proper submission of Form 44 and associated documents in compliance with Indian regulatory requirements.

5. Procedure

5.1 Determine Applicability of Form 44

Check if the study involves:
- New drug not approved in India
- BE study for export purposes
- Modified dosage form of an approved product
If applicable, initiate Form 44 submission process.

5.2 Compilation of Form 44 Application

Obtain the latest Form 44 format from CDSCO portal.
Fill all mandatory fields:
- Name and address of applicant
- Product details
- Type of application (BA/BE study)
- Justification and purpose
Sign and seal the form by the authorized signatory.

5.3 Supporting Documents Checklist

Prepare the following documents (refer Annexure-1):
- Cover letter
- Duly filled Form 44
- Prescribing Information / SmPC
- Study protocol
- Undertaking under Schedule Y
- Informed Consent Form (ICF)
- Ethics Committee approval (if available)
- Investigator CV and Site Details
- Payment receipt (Challan)

5.4 Payment of Government Fees

Pay the required fee as per Schedule A of Drugs and Cosmetics Rules via Bharatkosh.
Retain proof of payment and attach it to the application.

5.5 Submission to CDSCO

Submit physical copies to the CDSCO Zonal Office or Head Office, depending on jurisdiction.
Retain acknowledgement with stamped date and inward number.
Update the submission tracker (Annexure-2).

5.6 Post-Submission Follow-Up

Monitor status via SUGAM portal or direct communication.
Respond promptly to queries or deficiency letters, if issued.
Maintain query-response log in Annexure-3.

6. Abbreviations

CDSCO: Central Drugs Standard Control Organization
BE: Bioequivalence
BA: Bioavailability
SOP: Standard Operating Procedure
ICF: Informed Consent Form
CV: Curriculum Vitae

7. Documents

Form 44 Submission Checklist – Annexure-1
CDSCO Submission Tracker – Annexure-2
Regulatory Query Log – Annexure-3

8. References

Drugs and Cosmetics Act & Rules – Schedule Y
CDSCO Guidance on BE Study Applications
CDSCO SUGAM Portal: https://cdsco.gov.in

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Form 44 Submission Checklist

Document	Included (Yes/No)	Remarks
Cover Letter	Yes	Signed by Regulatory Head
Form 44	Yes	Filled and notarized
Protocol	Yes	Final version

Annexure-2: CDSCO Submission Tracker

Submission Date	CDSCO Location	Receipt No.	Status	Remarks
16/04/2025	Mumbai Zonal Office	INW-55234	Under Review	Awaiting queries

Annexure-3: Regulatory Query Log

Query Date	Query Description	Response Date	Status	Owner
22/04/2025	Clarify site PI registration	25/04/2025	Submitted	Sunita Reddy

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP	New Document	QA Head
17/04/2025	2.0	Inclusion of Bharatkosh, SUGAM tracking, and annexures	Regulatory Update	QA Head