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A fully SUGAM-aligned rewrite of the import/registration playbook for bulk drugs and finished formulations — with a sharper Schedule D(I)/D(II) documentation ask and a formalised Post Approval Change fee structure.
The Central Drugs Standard Control Organization has released a revised Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India, effective 04.08.2026. It replaces the earlier version of the same document (IMP/REG/200711) and is built specifically around the reality that all Registration Certificate (RC) and Import Licence (IL) applications now move exclusively through the SUGAM portal (www.cdscoonline.gov.in). For foreign manufacturers, their Indian agents, and importers of APIs and finished formulations, this is the single reference document to work from for every fresh registration, renewal, endorsement, import licence, and post-approval amendment.
Key takeaway: The guidance is effective 04.08.2026 and formally embeds the SUGAM online workflow (RO Review → NO Review → DDA → Licensing Authority) as the standard review path for RC, IL, and PAC applications — with renewal applications still required 9 months before RC expiry.
Legal Backbone: Where This Sits in the D&C Act Framework
The guidance operates entirely within Chapter III of the Drugs and Cosmetics Act, 1940 and Part IV of the Drugs Rules, 1945. Registration Certificates are issued under Rule 27A in Form 41, following an application under Rule 24A. Import Licences are issued under Rule 24, either as Form 10 (for drugs outside Schedule X) or Form 10A (for Schedule X drugs). Where the product falls within the definition of a “new drug” under Rule 2(w) of the NDCT Rules, 2019, new drug approval is a mandatory precondition before an RC or IL application can even be filed.
Three Categories of Registration Certificate Applications
The document formally recognises three RC application types — Fresh, Re-registration (renewal), and Endorsement — each following the same document-review sequence: RO Review → NO Review → DDA, with a query loop back to the applicant before Licensing Authority approval. The same review architecture applies to Import Licence and Post Approval Change (PAC) applications, giving the entire submission ecosystem a consistent, predictable review path.
Documentation: Schedule D(I) and D(II) Get More Specific
The RC checklist retains the familiar Schedule D(I) (site/premises information) and Schedule D(II) (product-specific information) structure, but the supporting-document list under Schedule D(I) is notably granular. Beyond the notarized Plant Master File, applicants must now separately furnish:
- List of major equipment in Production and QC
- List of key personnel with qualifications, experience, and responsibilities
- Organizational chart and QA functional chart
- Plant layout, HVAC system drawing, and water system drawing
- Pressure differential drawing, personnel movement drawing, material movement drawing
- Distribution, complaints & product recall SOP
- List of contract manufacturing/analysis arrangements
Schedule D(II) continues to require the process flow chart, manufacturing process development report, control of critical steps, three-batch process validation report, impurity/residual solvent data, five-batch certificates of analysis, and — notably — details of PMS (post-marketing surveillance) studies, keeping the dossier squarely aligned with CTD-style product understanding rather than a bare administrative filing.
Labelling and Stability: Two Points Worth Flagging
Label submissions under Rule 96/97 must now carry a scannable/readable QR code wherever applicable, with storage conditions declared in line with IP general chapter requirements based on Climatic Zone IVb stability data. Stability data itself must be generated under Zone IVB conditions (30°C ± 2°C / 75% RH ± 5% RH), with annual data per Schedule M, and studies designed per ICH Q1A(R2) and WHO TRS No. 1010, Annex 10 — an explicit alignment of Indian import stability expectations with current international guidance.
Post Approval Changes: Now a Structured, Fee-Linked Framework
The document draws a clear line between Major Changes (manufacturing process/dosage form change, testing method change, shelf-life change, pharmacopoeia specification change, storage condition change, site addition/deletion, specification relaxation) and Minor Changes (specification tightening, editorial package insert updates, added warnings/precautions, excipient source change with no formulation impact). Each PAC category now carries a defined fee:
| Type of Amendment | Fee (USD) |
|---|---|
| Change in manufacturer/agent address (no location change) | 1,800 |
| Shelf-life change (extension/reduction) | 1,800 |
| Change of pharmacopoeia specification | 1,800 |
| Change in storage condition | 1,800 |
| Addition of pack size / pack presentation change | 1,800 |
| Deletion of manufacturing site | 1,800 |
| Addition of Co-marketer | 1,800 |
| Addition of manufacturing site | 10,000 |
| Major change in manufacturing/processing/testing/documentation | 5,000 |
Certain changes fall outside PAC entirely and require a fresh Registration Certificate — change of manufacturer/agent name with constitution change, change in constitution of the manufacturer, or any change in foreign manufacturer/Indian agent/registered manufacturer address with location change. Under Condition 6 of Form 41, an RC remains valid only for three months after such a change unless a new RC is obtained, and any change in constitution or address must be reported to CDSCO immediately in writing, with the formal application filed within 30 days for major changes.
Special NOC Pathways You Shouldn’t Overlook
Four distinct NOC/permission pathways are consolidated in the guidance, each with its own checklist:
| Rule | Purpose | Key Condition |
|---|---|---|
| Rule 31 | Import of drugs with residual shelf life <60% | Permitted only for specified exceptional circumstances (charity, national health programmes, orphan drugs, outbreak response, export-only manufacturing, etc.) with written justification to DCG(I) |
| Rule 104A | Overprinting/stickering/stamping of imported drug labels | Must not conceal the original label; requires dedicated QA/manufacturing personnel at the site |
| Rule 37 | Further packing of patent/proprietary medicines | Permission required at least 3 months before import; import window of 12 months from permission date |
| Rule 36A | Import by charitable hospitals, free of cost | Drug must not be import-prohibited and must carry ≥1 year residual shelf life |
Fee Structure at a Glance
- RC — Premises registration: USD 10,000
- RC — First drug: USD 5,000; each additional drug: USD 5,000
- Inspection/visit expenditure: USD 25,000
- RC amendment (general): USD 1,800
- Import Licence: ₹10,000 for one drug, ₹1,000 for each additional drug
All fees are payable online through the Bharatkosh portal, with the receipt uploaded against the SUGAM application — no offline challan route is contemplated in this revised guidance.
How Vaayath Can Help
Vaayath Consulting Services regularly supports foreign manufacturers and their Indian agents through the full RC/IL lifecycle — building compliant Schedule D(I)/D(II) dossiers (including the HVAC, water system, and pressure differential drawings CDSCO now expects), structuring PAC filings correctly as Major or Minor to avoid rejection at the RO/NO review stage, and managing SUGAM submissions end-to-end. Write to us at info@vaayath.com for a documentation gap-assessment against this revised guidance.
Bottom Line
This revised guidance doesn’t change the underlying legal framework — Rules 24, 24A, 27A and the associated Schedules remain the governing provisions — but it tightens the documentation expectations (particularly around plant systems drawings and PMS data), formalises the PAC fee matrix, and locks in SUGAM as the only submission channel. Companies with RCs due for renewal, or planning fresh registrations, should map their existing dossiers against this document now rather than at the point of a query from the Reviewing Officer.
Need Support Filing Under the Revised CDSCO Guidance?
Vaayath Consulting Services offers dedicated regulatory support for import registration, licensing, and post-approval change filings — get expert guidance before you submit.
Source: CDSCO Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India, Doc No. IMP/REG/200711, Version 1.0, effective 04.08.2026, issued by the Import & Registration Division, CDSCO, DGHS, MoHFW. This article is for general informational purposes and does not substitute for the original guidance document or professional regulatory advice.
