Regulatory ยท CDSCO Consultant
CDSCO Registration
The starting point for any drug, device, or cosmetic regulatory pathway.
What is CDSCO Registration?
CDSCO Registration covers the initial regulatory approval needed before importing, manufacturing, or marketing a drug, medical device, or cosmetic in India, filed through the SUGAM online portal with the Central Drugs Standard Control Organisation (CDSCO) or the relevant State Licensing Authority under the Drugs and Cosmetics Act, 1940 and the Medical Device Rules, 2017.
CDSCO's regulatory framework exists to ensure every drug, device, and cosmetic sold in India is safe, effective, and manufactured to consistent quality standards โ protecting patients and consumers while giving legitimate manufacturers a clear, predictable approval pathway.
CDSCO oversight splits along two lines that determine which authority you deal with: the type of product (drug, cosmetic, or medical device, each governed by its own rules and risk-classification logic) and, for many categories, whether approval sits with CDSCO centrally or with the State Licensing Authority where your facility is located. Getting this classification right at the outset is the single biggest factor in how smoothly the rest of the approval moves, since every downstream form, fee, and inspection routes differently depending on it.
Most regulated health products in India are filed through the SUGAM portal, CDSCO's centralised online system for applications, queries, and approvals โ but SUGAM is the filing interface, not the decision-maker, so understanding which licence type and authority your specific product needs before you start filing avoids submitting to the wrong queue and losing processing time.
Who Needs It
Key Benefits
Documents Required
- Product classification and technical details
- Manufacturing site GMP/ISO certification
- Company incorporation and authorised signatory documents
- Product labelling and packaging artwork
- Test reports or quality data available for the product, if any
Our Process
Classification
We determine whether your product is a drug, cosmetic, or medical device (and its risk class).
Authority Mapping
We confirm whether the applicable licence sits with CDSCO centrally or the relevant State Licensing Authority.
Documentation Review
We compile and verify the manufacturing site, quality, and product documentation the identified pathway requires.
Portal Filing
The application is filed on SUGAM with the appropriate central/state authority.
Approval Tracking
We track queries and follow through to registration grant.
Penalty for Non-Compliance
Manufacturing, importing, or selling drugs, devices, or cosmetics without the applicable licence is an offence under the Drugs and Cosmetics Act, 1940 โ manufacture/sale without a valid drug licence under Section 18(c) is punishable under Section 27(b) with imprisonment of not less than three years (extendable to five) and a fine of not less than โน1,00,000 or three times the value of the drugs seized, whichever is more; unlicensed cosmetics manufacture/sale carries up to one year's imprisonment and a fine of up to โน20,000 under Section 27A, rising sharply where the product is spurious or adulterated; unlicensed medical device manufacture/import carries a similar three-to-five-year imprisonment band with a minimum โน1,00,000 fine under the Medical Device Rules โ alongside seizure of unlicensed stock in every case.
Frequently Asked Questions
Is CDSCO always the central authority?
No โ some categories are licensed by the State Drug Licensing Authority instead of CDSCO centrally; we confirm the correct authority during classification.
What is SUGAM?
SUGAM is CDSCO's online portal used to file most drug, device, and cosmetic applications and track them through to approval, regardless of whether the deciding authority is central or state.
Can one product need multiple registrations?
Yes โ a combination product (for example, a device with a drug-delivery component) can require classification and approval under more than one regulatory pathway; we identify this upfront to avoid a partial filing.
How do I know if my product is a drug, cosmetic, or device?
Classification depends on the product's intended use and claims โ a product marketed with a therapeutic claim, for instance, is typically treated as a drug even if it resembles a cosmetic; we assess this against the applicable definitions before filing.
Does registration guarantee approval of a specific import or manufacturing licence?
No โ CDSCO Registration confirms the pathway and classification; the actual import, manufacturing, or sale licence is a separate downstream filing built on that classification.
How severe are the penalties if I get the classification wrong and sell without the right licence?
Meaningfully severe โ unlicensed drug manufacture or sale carries a minimum three-year prison term under Section 27(b) of the Drugs and Cosmetics Act, not just a fine, which is why confirming classification and the correct licence before launch matters far more than it might for a lighter-touch regulatory regime.
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