India’s cosmetics and personal care markets are expanding rapidly, and therefore, regulatory challenges. Such a challenge is the blurred line between drugs and cosmetics. Medicated shampoos, fluoride toothpastes, acne creams, and impartiality often fall into both categories based on their composition and claims.
To address this classification issue, the Central Drugs Standard Control Organisation (CDSCO) releases a dual-use no-objection certificate (NOC). It is not a license, but a clear certificate that confirms whether a product is regulated as a drug, a cosmetic, or both. It ensures compliance with the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020.
What is Dual Use NOC?
A dual-use NOC is released by CDSCO when a product overlap occurs between a medicine and the legal definitions of a cosmetic:
- Drugs (Section 3 (B), Drugs and Cosmetics Act, 1940): Products desired to treat, prevent, diagnose, or cure a disease.
- Cosmetic (Section 3 (AAA)): Products intended to change hygiene, beautify or appearance without medical effects.
Since 2020, cosmetics have been regulated under the Cosmetics Rules, 2020, which changed the earlier provisions under the Drugs and Cosmetics Rules, 1945.
Why is Dual Use NOC Needed?
- Regulatory clarity – confirms whether a product is a cosmetic, medicine, or dual-use.
- Smooth market entry – necessary before imports or manufacturing approval.
- Legal Safety – Customs prevents seizure, abortion, or punishment.
- Consumer safety – ensures labelling, safety and compliance with quality standards.
Examples of Dual Use Products
- Anti-dandruff shampoos → Cleanse hair (cosmetic) + treat dandruff (drug).
- Fluoride toothpastes → Clean teeth (cosmetic) + prevent cavities (drug).
- Acne creams/lotions → Improve appearance (cosmetic) + treat pimples (drug).
- Skin lightening creams with therapeutic claims → Beautification (cosmetic) + medical effect (drug).
Authority Responsible
The CDSCO, under the Ministry of Health & Family Welfare, is the competent authority.
Applications for Dual Use NOC are submitted via the SUGAM Portal (CDSCO’s official online system).
Process of Obtaining Dual Use NOC
- Register on the SUGAM Portal.
- File application with product details (formulation, intended use, claims).
- Upload documents – composition, labels, safety data.
- Evaluation by CDSCO – product is classified as a drug, a cosmetic, or a dual-use product.
- Issuance of NOC if applicable.
Typical Timeline: 3–6 weeks, depending on completeness of documents.
Documents Required
- Covering letter to CDSCO
- Full product composition/formula
- Label artwork showing claims
- Manufacturing license (for Indian companies)
- Import Export Code (IEC) (for importers)
- Toxicology/safety data (if applicable)
- Product testing reports (if available)
Post-NOC Compliance Requirements
- If classified as Cosmetic → Follow Cosmetics Rules, 2020 (Schedule II & IV, labelling, shelf-life rules).
- If you get drugs → get drug licenses and get drug licenses under Drugs and Cosmetics Rules, 1945 from CDSCO/SLA.
- EPR for packaging → If using plastic, follow plastic waste management rules, 2016 (revised 2022) and EPR obligations.
Common Challenges
- Ambiguous claims (e.g., “medicated,” “heals,” “prevents disease”).
- Incomplete documents or missing safety studies.
- CDSCO queries extend timelines.
- Regular updates in the CDSCO requirements.
How CosmeticsRegulatory.com Can Help
At CosmeticsRegulatory.com (ELT Corporate Pvt Ltd), we provide end-to-end support:
- Guidance on product classification under Indian law.
- Preparing and filing Dual Use NOC applications via the SUGAM Portal.
- Drafting compliant claims and labels.
- Responding to CDSCO queries.
- Ensuring compliance with Cosmetics Rules, Drugs & Cosmetics Act, and Plastic Waste EPR Rules.
With our expertise, you can confidently launch your products in India.
Conclusion
The Dual Use NOC is a critical compliance step for products that blur the line between drugs and cosmetics. It ensures proper classification, smooth regulatory approvals, and market acceptance in India.
For expert assistance obtaining a Dual Use NOC, contact us at CosmeticsRegulatory.com.
FAQs on Dual Use NOC in India
Is Dual Use NOC mandatory for all products?
No. It is only required when a product has both cosmetic and therapeutic functions.
How long does it take to get a Dual Use NOC from CDSCO?
Typically 3–6 weeks, depending on documentation and CDSCO review.
Can imported products also apply for a Dual Use NOC?
Yes. Importers must submit applications through the SUGAM portal along with the IEC code and product documents.
Does Dual Use NOC replace a license?
No. It is only a clarificatory certificate. If classified as a drug, you must still obtain a drug license.
