End-to-End CDSCO Compliance,
Handled for You
Dossier Preparation · Sugam Portal Filing · Query Response · License Issuance
Regulatory approvals for pharmaceutical drugs, cosmetics, and medical devices under CDSCO / DCGI. We manage the complete licensing journey — from product classification to final approval.
Our CDSCO specialists handle technical dossier preparation, Sugam portal filing, query response management, and liaison with the Drug Controller — so you can focus on bringing your products to market.
Which CDSCO Approval Do You Need?
Different products require different CDSCO pathways. Here's what applies to your product.
Drug License
Manufacturing or import license for pharmaceutical drugs and formulations under Drugs & Cosmetics Act.
Cosmetic License
Import or manufacturing license for cosmetic products sold in India under CDSCO regulations.
Medical Device Registration
Registration for medical devices including Class A, B, C & D devices under MDR 2017.
CDSCO Import License
Import license for drugs, cosmetics and medical devices under Form 10 / Form 8 procedures.
DCGI Approval
Approval from Drug Controller General of India for new drugs, biologicals and clinical trials.
Clinical Trial Approval
CDSCO approval for conducting clinical trials in India for new drugs and medical devices.
Importance & Benefits of CDSCO Licensing
CDSCO approval is a legal mandate under the Drugs & Cosmetics Act — not a voluntary exercise. It directly governs market access, customs clearance, and commercial viability of every drug, device, and cosmetic in India.
Legal Mandatory Requirement for Market Access
CDSCO approval is mandatory under the Drugs & Cosmetics Act for all drugs, cosmetics, and medical devices sold, imported, or manufactured in India. No product in scope can legally reach the Indian market without valid CDSCO registration or license.
Avoid Customs Detention & Import Rejection
Customs authorities actively verify CDSCO registration for drug and device imports. Shipments without valid CDSCO documentation are detained, returned at importer cost, or destroyed. CDSCO licensing is a prerequisite for customs clearance of all regulated healthcare products.
Medical Device Market Entry
India's medical device market is among the fastest growing in Asia. CDSCO registration under MDR 2017 is the mandatory gateway for Class A, B, C, and D devices — from diagnostics and surgical instruments to implants and in-vitro diagnostics.
Pharmaceutical Drug Approvals
All new drugs, generics, biosimilars, and combination products require DCGI approval before they can be manufactured or imported in India. We manage the complete CTD dossier preparation, Sugam portal filing, and DCGI liaison for drug approvals of all categories.
Government & Institutional Procurement
Government hospital tenders, CGHS empanelment, and institutional procurement of drugs and medical devices mandatorily require valid CDSCO registration as an eligibility criterion. Enterprise healthcare buyers also require CDSCO proof before vendor onboarding.
IAA Services for Foreign Manufacturers
Foreign manufacturers must appoint an Indian Authorized Agent (IAA) to apply for CDSCO approvals. We provide full IAA services — acting as your legal representative for dossier filing, query responses, DCGI liaison, and certificate management.
Cosmetic Import Compliance
All cosmetics imported into India require a CDSCO import license. Certain products — hair dyes, sunscreens, anti-dandruff shampoos — are classified as drugs and require drug-level approval. We identify the correct classification and manage the complete licensing process.
Structured Renewal & Lifecycle Management
CDSCO licenses and registrations have defined validity periods and renewal cycles. Expired licenses result in loss of market access and customs clearance rights. We manage renewal timelines proactively across your entire product portfolio to ensure uninterrupted compliance.
The Drugs & Cosmetics Act prescribes imprisonment of up to 3 years and fines for manufacturing, importing, or selling drugs or devices without valid CDSCO approval. Customs authorities reject shipments of unapproved products at Indian ports. CDSCO enforcement has intensified significantly since 2020, with increasing scrutiny of medical device imports and cosmetics classified as drugs. Non-compliance risks not just regulatory penalties but irreversible reputational damage in the Indian market.
Step-by-Step CDSCO Licensing Process
A clear, expert-guided roadmap from product classification to CDSCO license — timeline varies by product category and regulatory pathway.
Product Classification & Regulatory Pathway
We classify your product under the appropriate CDSCO regulatory category — drug, cosmetic, or medical device — and identify the correct application type, applicable rules, and CDSCO department handling your approval. This determines whether your application goes to CDSCO Central Licensing Authority, State Licensing Authority, or DCGI directly.
Technical Dossier Preparation
We prepare your complete regulatory dossier as per CDSCO requirements — in CTD format for drugs, and as per MDR 2017 format for medical devices. This includes clinical/safety data compilation, GMP certificates, stability data, manufacturing process documentation, and all supporting technical evidence required for your product category.
Sugam Portal / Physical Application Filing
We file the complete CDSCO application on the Sugam portal (for most drug and device applications) or physically with the appropriate licensing authority for categories not yet on the portal. Application filing includes correct form selection, fee payment, document upload, and verification of all portal entry fields against the dossier.
CDSCO Technical Review & Query Response
CDSCO technical reviewers examine the dossier for completeness and scientific adequacy. If additional information or clarification is needed, CDSCO raises formal queries on the Sugam portal or via official communication. Prompt, accurate, and complete query responses are critical — delayed responses directly extend the approval timeline.
DCGI Review / Expert Committee (for New Drugs)
New drugs and certain biological products require review by the Subject Expert Committee (SEC) or Technical Expert Committee (TEC) convened by DCGI. We prepare the SEC presentation package, coordinate the pre-submission meeting where available, and manage all DCGI correspondence through this review phase.
License Issuance & Renewal Management
CDSCO issues the drug license, device registration certificate, or import license with a unique registration number. We provide the certificate, advise on correct usage in commercial documentation, and manage proactive renewal reminders. Any product specification change — formulation, indication, manufacturing site — may require a variation application, which we handle.
Official CDSCO Portal for All Applications
All CDSCO drug, device, and cosmetic applications are filed on the Sugam portal. The portal has separate application flows for new drugs, medical devices (by class), import licenses, and clinical trials — each with distinct document requirements. Our team handles all Sugam portal navigation, form selection, and submission for every product category.
Timelines, Costs, Validity & Renewal
Plan your product launch and compliance calendar with a clear picture of what CDSCO licensing involves from start to finish.
Key Rules to Know
Import licenses for drugs are typically valid for 3 years and must be renewed before expiry to maintain uninterrupted customs clearance rights.
Medical device registrations under MDR 2017 are valid for 5 years. Renewal requires a fresh application if any technical specification has changed.
State-level drug manufacturing licenses require annual renewal. Lapsed manufacturing licenses result in immediate halt of production and export activities.
Each drug formulation, strength, and dosage form requires separate CDSCO registration. Device variants with different intended uses may also require separate registration.
CDSCO renewal and variation filing require careful management. Common challenges our clients face:
Navigate CDSCO with Confidence
Our regulatory experts will guide you through every step of the CDSCO approval process.
Free consultation. Transparent pricing. Error-free dossiers.