CDSCO Submission Support for India
The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), is India's national regulatory authority for drugs, clinical trials, and medical devices. EvySaif prepares the dossiers and shapes the regulatory strategy that move applications through cleanly, grounded in the New Drugs and Clinical Trials Rules, 2019 (NDCTR) and the Drugs and Cosmetics Act.
Understanding the CDSCO pathway
Applications to CDSCO follow the Common Technical Document (CTD) structure and are filed through the SUGAM portal, with certain applications routed via the National Single Window System (NSWS). Alongside the central application, sponsors carry parallel obligations that trip up first submissions more often than the dossier itself does.
Prepare the dossier and application forms
A clinical trial application is submitted on Form CT-04, while Form CT-04A covers the automatic-approval route in defined cases, Form CT-05 covers bioavailability and bioequivalence studies, and Form CT-21 with its associated test-license forms covers import or manufacture of a new drug.
File through SUGAM
Most drug and clinical trial applications are filed and tracked through CDSCO's SUGAM portal, with some routed via the National Single Window System.
Complete the parallel registrations
Sponsors must secure Ethics Committee registration with the Department of Health Research through the Naitik portal, and register the trial prospectively with the Clinical Trials Registry of India (CTRI) before the first participant is enrolled.
Clear expert review
Applications are reviewed by the Subject Expert Committee (SEC), whose questions decide how quickly the file moves. Permission is granted in Form CT-06.
Foreign sponsors: the NDCTR requires an Indian authorized agent to fulfill local responsibilities and file. EvySaif prepares the dossier and strategy and works alongside that agent, not as it.
What we prepare
CTD and eCTD dossiersFor clinical trial and new drug applications, structured for SUGAM.
Application packagesForm CT-04, CT-06, CT-05, and CT-21 packages and supporting documents.
Trial documentsClinical trial protocols, Investigator's Brochures, informed consent documents, and IMPDs.
Regulatory strategyPathway selection, data-requirement gap analysis, and pre-submission planning.
Query responses and safety documentsResponses to CDSCO and SEC queries, plus DSURs and CSRs.
NDCTR 2019 alignmentIncluding SAE reporting timelines and compensation provisions.
How EvySaif helps
We are your scientific and strategic regulatory partner for India. We author the dossier, advise on the right pathway and data package, and prepare you for the SEC and DCGI's questions. Because the NDCTR requires a foreign sponsor to have an Indian authorized agent for filing, we work alongside yours rather than acting as it, so your submission is both well prepared and correctly routed.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and CDSCO is our home regulator. Our submissions are clinician-led, built to the NDCTR the first time, and shaped by direct familiarity with how CDSCO and its expert committees actually review. For sponsors entering India, that local fluency shortens the path.
Frequently asked questions
SUGAM is CDSCO's online portal for applications, licenses, permissions, and tracking. Most drug and clinical trial applications are filed and followed through it, with some routed via the National Single Window System.
A foreign sponsor must appoint an Indian authorized agent to handle local filing and responsibilities. EvySaif prepares the dossier and strategy and works alongside that agent.
The New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, with the 2024 amendment adding clinical research organization registration requirements.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
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Planning a CDSCO submission?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
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