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 |