Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in regulating drugs and medical devices in India. To improve consistency and efficiency in regulatory approvals, CDSCO has introduced a structured dossier-based submission system. This approach ensures that applications are comprehensive, standardized, and easier for regulators to evaluate.
Objective of the Framework
The guidance aims to bring uniformity in regulatory submissions by requiring applicants to present information in a clearly defined format. It is designed to:
Structure of the Dossier
The dossier is organized into well-defined sections so that each aspect of the product can be assessed systematically.
This section provides a high-level description of the product, including its intended use, key features, and basic classification. It helps reviewers quickly understand the application.
Applicants must include detailed technical information such as design, specifications, components, and how the product functions. This section ensures transparency in product development.
This part focuses on how the product is manufactured and controlled. It includes process details, quality checks, validation data, and stability information to demonstrate consistency and reliability.
Evidence must be provided to show that the product is safe and performs as intended. This may include testing data, risk assessments, and, where required, clinical or performance studies.
This section includes certifications, labeling details, and declarations that confirm compliance with regulatory requirements.
Why This Approach Matters
Adopting a structured dossier system offers several advantages:
Impact on Industry
For manufacturers, this system emphasizes the importance of proper documentation and quality systems. While it may require more preparation initially, it ultimately helps in:
Submission of Dossier for grant/renewal of manufacturing licence w.r.t to administrative information (Part A)
Part A Firm/facility related details
1. Covering letter
2. Specific Power of Attorney in favour authorized signatory for submitting application on behalf of the company
3. Site Plan and layout of the building with the name, address, scale, measurements of the area as per Schedule M Requirement
4. Self-attested copies of documents pertaining to the possession of premises such as, Register ownership /rent /lease/allotment letter/Possession Letter, Tax Receipt, (Documents should be Registered with appropriate Authority )
5. Consent to establish from State pollution control Board.
6. List of Directors, Partners, Trustees, along with ROC Copy Registered Partnership deed, Trust deed
7. List of Competent Technical Staff with their qualification, Registration, Experience, previous FDA Approvals, Etc.
8. Appointment/Acceptance Letter of Competent Technical staff of manufacturing Section.
9. Appointment/Acceptance Letter of Competent Technical staff of Testing Section.
10. Section wise List of plant and Machineries
11. NOC of department of industrial safety & Health
12. HVAC installation and validation Certificate
13. Water System installation and validation Certificate
14. Site Master File
15. Constitution details of firms
16. List of SOPs/STPs
17. Self-declaration of technical person
18. Self-declaration of Director
If applicant is submitting, not applicable (NA) against any above mentioned documents, the same needs to be justified adequately.
Submission of Dossier for grant/renewal of manufacturing licence w.r.t to technical information (Part B)
Part B – Product specific details
1. Copy of valid Test license in Form 29
2. Source of bulk drugs along with current regulatory status with copy of Form 46A/ 45A/CT-19/CT-22 (if obtained)
3. Certificate of Analysis of the bulk drugs/drug substance
4. Master Manufacturing Formula
5. Manufacturing Procedure
6. Product Development report with Excipient compatibility and forced degradation study
7. Process validation report
8. Finished product specification including impurity profile
9. Finished Product Method of Analysis
10. Finished product Analytical method validation report
11. Finished Product Certificate of Analysis for three consecutive batches/three validation batches
12. Stability study data report as per requirements mentioning batch size. (should be presented in tabular form with details of Batch No, Batch size, Date of Manufacturing, Date of initiation, Packaging details)
13. Comparative Dissolution Release Profile with the Approved formulation (in case of oral dosage form)
14. Comparative evaluation of pharmaceutical equivalence with international brand(s) or approved Indian brands, if applicable
15. Draft specimen of the label and carton
16. Bio Equivalence protocol and report
17. Justification on Bio equivalence study waiver, if requested
18. Details of the approval of the New Drug in the country. In case of new drugs, copy of approval of new drug from CLAs in favour of the applicant in Form 46/CT-23
19. Form 10 Issued by CDSCO where required
20. Form 51 Undertaking
21. Challan of Fees Paid To Be Upload
22. Any Other Document
23. Application in prescribed legal form (e.g. Form 24, Form 27, Form 27-D, 27DA, etc.)
If applicant is submitting, not applicable (NA) against any above mentioned documents, the same needs to be justified adequately.
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