CDSCO Registration

The Central Drugs Standard Control Organisation (CDSCO) is the central drug authority for India under the Directorate General of Health Services, Ministry of Health and Family Welfare. It regulates the import, manufacture, sale and clinical evaluation of drugs, cosmetics, medical devices and vaccines under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, the Medical Devices Rules, 2017 and the Cosmetics Rules, 2020. For anyone importing a cosmetic product, a medical device or a drug into India, CDSCO registration is not just a compliance step — it is the gate through which the goods must pass before customs will clear them.

The Exim Roof runs a CDSCO practice that handles cosmetics import registration on the SUGAM portal, medical-device MD-14 / MD-15 import licences, drug import registration and marketing authorisation, clinical-trial approvals, retail and wholesale drug licences, and post-approval variations. Our team includes qualified regulatory professionals who have driven approvals for global cosmetic brands, medical-device manufacturers, generic pharma companies and clinical research organisations.

Medical devices — the Medical Devices Rules, 2017

India regulates medical devices under a risk-based classification — Class A (low risk), Class B (low-moderate), Class C (moderate-high) and Class D (high risk). Devices notified under the MDR 2017 need one of the following licences to be imported:

• MD-14 — application for import licence for a medical device.
• MD-15 — grant of import licence, valid for the life of the device (perpetual) subject to renewal of manufacturing certificate.
• MD-13 — registration certificate for licensed premises of the importer.
• MD-40 to MD-42 — clinical investigation approvals.
• MD-16 — permission for sale or distribution of new drug or investigational medical device.

Cosmetics import — the Cosmetics Rules, 2020

Every cosmetic imported into India must be registered with CDSCO before customs clearance. The registration process is entirely online on the SUGAM portal (also called the CDSCO Cosmetics Registration Portal) and requires a fee per brand plus a per-category (per-shade or per-variant) fee. The registration is granted in the form CDSCO-COS-1 (marketing authorisation) and is valid for three years, renewable. Every SKU must be linked to a brand registration, and any change of manufacturer, formulation or label requires a fresh application under the variation route.

Drug import registration

New drug and generic drug imports fall under the Drugs and Cosmetics Rules, 1945. The importer must hold a Form 10 licence (import) issued against a Form 8 application, with an RSN (Registration Certificate) in Form 41 for the manufacturer of the drug. For new drugs, additional approvals under CT Rules 2019 (clinical trial rules) may apply. Our regulatory team runs the entire process — Form 41 preparation, Form 8 filing, Form 10 grant and post-import compliance.

Timelines and validity

Cosmetics registration is typically granted in 6–8 months from a clean SUGAM application. Class A / B medical-device import licence (MD-14 → MD-15) takes 3–6 months. Class C / D takes 6–9 months. New-drug import is the longest — typically 12–18 months. We share a category-specific plan up front so there are no timeline surprises.

How The Exim Roof helps

• CDSCO cosmetics import registration on the SUGAM portal.
• MD-14 / MD-15 medical-device import licence — all four risk classes.
• Wholesale and retail drug licence — Form 20B / 21B.
• Drug import registration in Form 41 and Form 10.
• Clinical trial application and marketing authorisation for new drugs.
• Label declaration review and packing-line audit support.
• Post-approval changes and renewal filings.