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 provides CDSCO submission support, preparing the dossiers and shaping 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). A clinical trial application is submitted on Form CT-04, with permission granted in Form CT-06, while Form CT-04A covers the automatic-approval route in defined cases and Form CT-05 covers bioavailability and bioequivalence studies. To import or manufacture a new drug, applicants use Form CT-21 and the associated test-license forms. Alongside the central application, sponsors must secure Ethics Committee registration with the Department of Health Research through the Naitik portal, register the trial prospectively with the Clinical Trials Registry of India (CTRI) before the first participant is enrolled, and prepare for review by the Subject Expert Committee (SEC). A foreign sponsor must appoint an Indian authorized agent to fulfill local responsibilities.
- What we prepare
- CTD and eCTD dossiers for clinical trial and new drug applications
- Form CT-04, CT-06, CT-05, and CT-21 application packages and supporting documents
- Clinical trial protocols, Investigator’s Brochures, informed consent documents, and IMPDs
- Regulatory strategy: pathway selection, data-requirement gap analysis, and pre-submission planning
- Responses to CDSCO and SEC queries, and safety documents including DSURs and CSRs
- NDCTR 2019 alignment, including 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
What is the SUGAM portal?
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.
Do we need a local agent in India?
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.
Which rules govern new drug and trial approvals?
The New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, with the 2024 amendment adding clinical research organization registration requirements.