Regulatory Support for
Medicinal Products in India
End-to-end CDSCO regulatory expertise for pharmaceutical companies seeking new drug approval, generic drug registration, clinical trial permissions, and import/export compliance in India’s fast-growing pharmaceutical market.
🔍 CDSCO Regulatory Pathways
Form CT-04 → Form 46
Abbreviated Pathway
Registration Certificate
NDCT Rules, 2019
CDSCO Medicinal Product Registration
Every medicinal product sold in India — new drug, generic, biologic, or imported formulation — must be registered with the CDSCO before it can be marketed.
✅ Generic Drugs
✅ Fixed-Dose Combinations
✅ Biologics
✅ Imported Products
Key Requirement: Applications are classified into four risk-based categories with processing fees ranging from US$1,000 to US$3,000. Clinical trials must comply with Indian Council of Medical Research (ICMR) ethical guidelines and require Institutional Ethics Committee approval before enrolment begins.
What Is CDSCO Medicinal Product Registration?
India’s medicinal products market is one of the fastest-growing in the world, driven by an aging population, rising chronic disease burden, growing disposable income, and an expanding pharmaceutical manufacturing base — with the market projected to grow at a CAGR of around 8.4% through 2026.
The Central Drugs Standard Control Organisation (CDSCO), under India’s Ministry of Health and Family Welfare, is the national authority responsible for approving and regulating drugs — including new drugs, investigational drugs, and generics — as well as authorising clinical trials, under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019.
RABT Global helps pharmaceutical sponsors navigate CDSCO’s dossier requirements, clinical trial permissions, marketing authorisation, import/export compliance, and pharmacovigilance obligations — reducing the risk of delays caused by incomplete or non-compliant applications.
Overview of the CDSCO New Drug & Generic Approval Process
A structured pathway to Indian market entry for new drugs, generics, and imported medicinal products — from clinical trial permission through post-market pharmacovigilance.
Pre-Submission Classification
Determine whether the product is a New Drug, generic, fixed-dose combination, or biologic, and confirm whether clinical trial data or a waiver applies under the New Drugs and Clinical Trials Rules, 2019.
New Drug / Generic / FDC / Biologic
Clinical Trial Permission (Form CT-04)
For new drugs, the sponsor or its authorised Indian representative files Form CT-04 through the SUGAM portal along with the protocol, investigator’s brochure, and informed consent documents.
SUGAM / 90 Working-Day Timeline
Ethics Committee & CTRI Registration
Obtain Institutional Ethics Committee approval per ICMR guidelines and register the trial with the Indian Clinical Trials Registry (CTRI) before enrolling the first participant.
IEC Approval / CTRI
Conduct Clinical Trials
Trials are conducted under GCP and Schedule Y requirements, with adverse events reported promptly to CDSCO and data compiled to CTD/eCTD standards.
GCP / Schedule Y
CDSCO & Subject Expert Committee (SEC) Review
CDSCO screens the dossier for completeness and refers it to the relevant Subject Expert Committee for technical evaluation of quality, safety, and efficacy data.
SEC Technical Review
Manufacturing Facility Inspection
CDSCO or state authorities may inspect manufacturing sites to verify Good Manufacturing Practices (GMP) compliance ahead of marketing approval.
GMP Verification
Marketing Approval (Form 46)
On successful review, CDSCO grants marketing authorisation via Form 46 (or the applicable registration certificate for imports), allowing the product to be lawfully sold in India.
Form 46 / Registration Certificate
Import / Export Compliance
Imported medicinal products must be registered with CDSCO before marketing; export requires a no-objection certificate (NOC) from CDSCO.
NOC / Import Registration
Pharmacovigilance & Post-Market Surveillance
Ongoing monitoring of adverse drug reactions, risk management plan implementation, and reporting to the Pharmacovigilance Programme of India (PvPI) are mandatory throughout the product lifecycle.
PvPI / Ongoing Obligation
New Drug vs. Generic Drug — Which Pathway Applies?
Understanding the right submission pathway is critical to a successful CDSCO regulatory strategy.
New Drug — Full Clinical Development Pathway
Required for new chemical entities and products not previously approved in India
Clinical trial permission via Form CT-04 through SUGAM
Full Phase I–III clinical trial data generally required
Subject Expert Committee (SEC) technical review of safety and efficacy
Marketing approval granted via Form 46 following successful review
Priority review available for oncology, rare disease, and public health emergency products
Generic Drug — Abbreviated Pathway
For products relying on the safety and efficacy of a previously approved reference drug
Bioequivalence (BA/BE) study data typically substitutes for full clinical trials
Application processed through State or Central Licensing Authority depending on category
Application processing fees range from US$1,000 to US$3,000 based on risk classification
GMP compliance and stability data required for manufacturing site approval
Faster route to market than full New Drug applications
CDSCO Pharma Regulatory Services We Provide
Comprehensive support across every stage of India’s medicinal product regulatory lifecycle.
Classification Strategy
New drug, generic, and fixed-dose combination classification strategy.
Clinical Trial Applications
Clinical trial permission dossiers and Form CT-04 submissions via SUGAM.
Ethics & CTRI Registration
Institutional Ethics Committee liaison and CTRI registration support.
Dossier Compilation
Dossier compilation in CTD/eCTD format for CDSCO submission.
Marketing Authorisation
Marketing authorisation support through Form 46 and import registration certificates.
Import / Export Compliance
Import and export compliance, including CDSCO no-objection certificates.
GMP Compliance
GMP facility readiness and manufacturing site inspection support.
Regulatory Liaison
Liaison with CDSCO, Subject Expert Committees, and State Licensing Authorities.
Pharmacovigilance
Pharmacovigilance programme design, ADR monitoring, and risk management plans.
Lifecycle Management
Post-approval lifecycle management, labelling, and regulatory change support.