A New Digital Backbone Is Coming for CDSCO
While most industry attention has been fixed on SUGAM portal tweaks, the Central Drugs Standard Control Organisation (CDSCO) has quietly initiated a far bigger project: a complete replacement of its underlying digital infrastructure. CDSCO has issued a Request for Proposal (RFP) inviting a Software Service Provider (SSP) for the Design, Development, Implementation, Operation & Maintenance of a “Digital Drugs Regulatory System” (DDRS), floated through the Government e-Marketplace (GeM) with Bid No. GEM/2026/B/7383439, dated 24-04-2026, with a corrigendum subsequently issued.
This is significant because DDRS signals that SUGAM — the portal that has processed drug, cosmetic, and medical device applications since 2015 — is heading toward a structural upgrade rather than incremental patchwork. For regulatory affairs teams, this means the application interfaces, document formats, and possibly even application numbering conventions could see changes over the coming 12–24 months as the new system is built out. Companies should treat this as an early-warning signal to keep digital archives of all past SUGAM correspondence, approvals, and query responses in an exportable format, since portal migrations historically create transition friction.
SUGAM Portal: What’s Actually Live in August 2026
The 30-Day Query Response Rule Has Teeth Now
Earlier in 2026, CDSCO communicated through a public notice dated 16 January 2026, issued under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare, that it would begin clearing its backlog of stalled applications. CDSCO announced that it will dispose of and reject long-pending applications submitted through the SUGAM portal if applicants fail to respond to regulatory queries within 30 days, since several applications had remained pending because responses were not submitted even after repeated reminders.
What makes this development newly urgent is the timeline: CDSCO’s own website listed “Last Date: 30 JUNE 2026” against the “Disposal / Rejection of Long-Pending Applications on Sugam Portal Awaiting Query Response” notice. That deadline has now passed. Any pharmaceutical, cosmetic, biologics, or medical device applicant that failed to respond to an outstanding CDSCO query by end-June should assume their application may already have been administratively closed. Re-filing — with fees and processing time reset to zero — is the likely consequence.
Action point: Businesses with any dormant SUGAM application should immediately log in, check the query/deficiency tab, and confirm status. If an application shows as “closed” or “rejected” post-30 June, a fresh submission with a complete response dossier is required rather than an appeal.
New Modules: Risk Classification, Export Codes, and Digital Certificates
Beyond enforcement, SUGAM has added functional capability through 2026. A new provision now allows applicants to submit Risk Classification applications for Medical Devices (w.e.f. November 2026) and for IVDs (w.e.f. February 2026) directly on the portal, while Market Standing Certificates and Non-Conviction Certificates can now be generated digitally for licensed entities. Separately, Class A Non-Sterile, Non-Measuring devices are now exempted from mandatory licensing under a 2026 CDSCO update.
Exporters have also gained a practical tool: a system-generated neutral code is now available for manufacturers exporting devices from India, simplifying the documentation trail for international shipments. Together, these updates reduce dependence on manual certificate issuance — historically one of the slowest parts of dealing with CDSCO’s regional and zonal offices — and push more of the compliance lifecycle onto the digital dashboard.
Practical implication: If your device falls under Class A NSNM, verify whether your existing license is now redundant or whether a formal de-registration/notification step is still needed to avoid confusion during future audits. If you regularly need MSC/NCC for tenders or export dossiers, route new requests through the upgraded digital workflow rather than the legacy manual process, which CDSCO is phasing out.
eCTD: Cutting Through the Hype vs. the Actual Status
There is considerable industry chatter — much of it from software vendors — suggesting eCTD (electronic Common Technical Document) is becoming mandatory in India in 2026. The reality on the ground is more measured. Independent 2026 industry analysis places India in a “watch and wait” category: Health Canada and CDSCO India are described as monitoring the FDA and EMA, with eCTD 3.2.2 remaining the active requirement rather than any newer version being mandated.
At the same time, the direction of travel is unmistakable. CDSCO has begun a phased shift toward mandatory eCTD (electronic Common Technical Document) submissions — a move aligned with global harmonization efforts in the US, EU, UK, Japan, and other mature markets. Broader technical commentary similarly notes that CDSCO began phasing in mandatory eCTD requirements in 2026, requiring eCTD format for new drug applications and clinical trial submissions through its SUGAM portal, and that Indian generic manufacturers already familiar with eCTD from US ANDA filings have adapted quickly, while smaller domestic-only firms have faced steeper learning curves.
Bottom line for sponsors: There is currently no blanket eCTD mandate for all CDSCO submissions as of August 2026 — the paper/CTD-on-CD route and the existing e-filing portal remain acceptable for most filings. However, companies filing New Drug Applications, biologics, or clinical trial dossiers should start building eCTD-capable publishing workflows now, since CDSCO’s stated direction — and the DDRS system overhaul described above — both point toward electronic-first submission becoming the default within the current regulatory cycle.
What Regulatory Teams Should Do Now
- Audit open SUGAM applications immediately for any unanswered CDSCO queries — the 30 June 2026 grace period has closed, and rejected files require full refiling.
- Switch to the digital certificate workflow for Market Standing Certificates and Non-Conviction Certificates instead of legacy manual applications.
- Reassess Class A NSNM device licensing status to determine if exemption applies and whether formal confirmation from CDSCO is advisable.
- Use the new neutral export code for outbound device shipments to simplify customs and buyer documentation.
- Begin eCTD readiness planning — even though not yet mandatory — for any NDA, biologic, or clinical trial dossier, given CDSCO’s stated 2026 direction and the pending DDRS infrastructure overhaul.
- Track the DDRS tender’s progress on GeM, as system migration could affect submission formats, credentials, and archived data access over the next two years.
ACPL’s regulatory experts can help you navigate CDSCO’s SUGAM portal transitions, digital certificate processes, and eCTD readiness. Contact us at info@acplgroupindia.co.in or call +91-9266665201 for a consultation.