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CDSCO Dual Use NOC

No Objection Certificate from CDSCO for products classified as dual-use (drug-device or cosmetic-drug).

Import Requirements

Introduction

CDSCO Dual Use NOC is a No Objection Certificate issued by the Central Drugs Standard Control Organisation for products that have characteristics of both a drug and a device, or a cosmetic and a drug, or other dual-use classifications.

These products fall in a regulatory grey area and require CDSCO's determination of the primary regulatory classification before the appropriate licensing pathway can be followed.

This is relevant for importers and manufacturers of products such as medicated cosmetics, drug-device combinations, wound care products with drug claims, and similar borderline products.

Why This Service is Legally Required

Products with dual characteristics cannot be registered under a single regulatory category without CDSCO's classification determination.
The NOC clarifies the primary regulatory pathway, enabling the correct licensing process.
Without the NOC, customs may hold imported products and domestic marketing may be challenged.

Applicable Acts, Rules & Regulations

Primary Legislation

  • Drugs and Cosmetics Act, 1940
  • Medical Devices Rules, 2017
  • Cosmetics Rules, 2020

Supporting Guidelines & Standards

  • CDSCO guidance on drug-device combinations
  • CDSCO notifications on classification of borderline products

Governing Authorities and Departments

  • Central Drugs Standard Control Organisation (CDSCO).
  • Drugs Controller General of India (DCGI).

Scope of This Service / Registration

Drug-device combination products.
Cosmetic-drug borderline products.
Products with therapeutic claims that may be classified as drugs.
Any product requiring regulatory classification determination by CDSCO.

Import-Related Requirements

NOC application to CDSCO before initiating the import registration process.
Product details including composition, intended use, and claims.
Regulatory status in other countries.
Supporting technical documentation.

Licenses and Approvals Involved

  • CDSCO Dual Use NOC / Classification Determination Letter
  • Subsequent license/registration as per the classified pathway

Documents Required

1Application letter to CDSCO requesting classification determination
2Product description and composition details
3Intended use and product claims
4Regulatory status and classification in other countries
5Technical documentation supporting the product's mechanism of action
6Marketing materials and label copies

Step-by-Step Registration Process

1

Product Analysis

Analyse the product's characteristics, claims, and mechanism of action to prepare the classification rationale.

2

Application Preparation

Prepare a detailed application with supporting documentation for CDSCO.

3

Submission to CDSCO

Submit the NOC application to the relevant division at CDSCO.

4

CDSCO Review

CDSCO reviews the application and may consult the Medical Device or Drug Technical Advisory Committee.

5

NOC Issuance

CDSCO issues the classification determination or NOC specifying the regulatory pathway.

Regulatory Timelines

Indicative timelines: 1-3 months depending on product complexity and CDSCO review process.

ℹ️ Timelines are indicative and subject to change based on regulatory authority workload and documentation completeness.

Government Fees

  • Application fees as prescribed by CDSCO.
  • Additional fees may apply if the matter is referred to an expert committee.

ℹ️ Fees are subject to revision by the respective government authorities.

Common Challenges & Compliance Risks

Ambiguous product classification requiring strong regulatory justification.
Lengthy review times for complex combination products.
Changing regulatory positions on borderline products.
Need for robust technical documentation to support classification arguments.

How Globallex Compliance Helps

Product classification assessment and regulatory strategy.
Preparation of classification rationale and supporting documentation.
CDSCO application filing and follow-up.
Expert consultation for complex combination products.
Subsequent licensing support based on the classification outcome.
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Disclaimer: The information provided on this page is for general informational purposes only and does not constitute legal advice. Regulations, fees, and procedures are subject to change. Please consult with Globallex Compliance for the latest regulatory position and personalized guidance.