What Exporters Should Know About CDSCO Certificate Requirements?

The exporters play an instrumental role in increasing international trade. Furthermore, they facilitate the movement of goods and services across the borders. Meanwhile, many exporters are entering the booming Indian market for the exportation of drugs, medical devices, and cosmetics. However, there is a barrier for exporters that they should know before making a presentation in Indian markets. Whether you are an importer, exporter, or manufacturer, you need to align with the legal requirements by securing a CDSCO certificate. The governing authority, CDSCO, sets the bar under which it regulates the activities of drugs, medical devices, and cosmetics. For the startup, establishing the export business without guidance and with a complex documentation procedure can feel overwhelming. 

 Let’s delve into this blog to understand which requirements the exporters must follow and how they can increase international trade. 

Why is the CDSCO Registration Crucial for Exporters? 

There is a structure outlining legal compliance. For the exporters, the CDSCO registration certificate serves as a golden ticket. To legally export medical devices, cosmetics, or pharmaceuticals, they need to register with the Central Drugs Standard Control Organization. CDSCO, governed by the Drugs and Cosmetics Act, 1940, ensures your products meet legal compliance. Overall, exporters required for the CDSCO license apply online. Through the registration, they get the certificate that acts as an identifier.

However, without the certification, the drug or cosmetic can suffer from multiple challenges. The hurdles start from the hefty fines imposed by the governing authority against businesses. Without the CDSCO license, the issues raised are the possible product ban, block from the market, or imprisonment for non-compliance. Acquiring the CDSCO certificate for cosmetic products serves as the entry point to accessing the largest and rapidly growing make-up sector in the world. But there is a catch: the registration procedure for CDSCO must be complex for startups. 

What are the Requirements of CDSCO Certification in India?

Before dealing with the activities of medical devices and cosmetics for exportation, the operators must know the requirements of the CDSCO. Under the Drugs and Cosmetics Act, it is a mandatory requirement that ensures product standardization. Here are the key aspects for exporters:

CDSCO License Registration

Registration for the CDSCO certificate is a mandatory step for all importers, manufacturers, and exporters dealing with cosmetics and drugs. To export the business of medical devices or cosmetics, the operators are required to be registered with the Central Drugs Standard Control Organization. The registration procedure involves the submission of an application form including the required documents. 

The Mandatory Compliance

It is crucial for all exporters to comply with Good Manufacturing Practices (GMP). It is a mandatory requirement that comes out during the product manufacturing. As well as their manufacturing procedure, they must also adhere to the Good Distribution Practices (GDP). 

Certificate of Free Sale

In many cases, the exporters are required to secure the free sale certificate. This certificate has been issued by the governing authority, CDSCO. In the realm of medical device exports, securing the free sale license becomes increasingly crucial. Register now for a free sale license through the official CDSCO portal.  

Necessary required Documents

To complete the registration procedure for the CDSCO license, the applicants need to provide the specific documents. The documents are needed for the application procedure, which acts as evidence for exporters and their businesses. Provide the documents like a manufacturing certificate, an import permit from the importing country, and the packaging material type. 

Packaging and Labelling

The authority has also established requirements for the wrapping and marking of products. To meet the compliance, the labeling and the packaging procedure of the product must adhere to the importing country’s requirements. Every country has its own rules and regulations, which must be followed by exporters to ensure a seamless working procedure. 

The Import Regulations 

Every country has regulations for imports. In short, it is necessary for all exporters to align with the import rules and regulations in the destination country. Beyond the CDSCO NOC, these requirements add additional compliances. 

User Query: How CDSCO Certification Builds International Partnerships?

What are the CDSCO New Export NOC Rules 2025?

The Central Drugs Standard Control Organization, every year, introduces new guidelines to make the exportation procedure more transparent. Well, you are aware of the new export NOC rules, which were introduced in 2025 by CDSCO. If not, let us inform you that the authority has implemented new rules related to the export. The CDSCO certificate for export NOC rules has been developed to streamline the steps for exporting unverified and verified new drugs. In these rules, the authority made the key changes from consignment-specific to blanket NOCs. The breakdown of new export NOC rules (2025): 

1. One-year Blanket NOCs: In the previous rules, the exporters needed to apply for a separate NOC for each consignment. Nevertheless, under the new regulation, exporters are permitted to apply for a blanket NOC. The validity of the blanket NOC is for one year. 
2. One-Time Registration: An Integrated Registration Form (IRF) is important for exporters to fulfill. It is complete with respect to their regional offices. This certificate is valid for a duration of one year.
3. Focus on Digital System: The new export NOC rules transform the state-level clearances. This has been replaced by the digital system, which can be done through the SUGAM portal. 

The benefits of the new rules (2025) introduced by CDSCO

• Due to the new rules, there are no more requirements for the applications and documents. The multiple procedures are replaced with a one-time registration and blanket NOCs. 
• Now delay can be faced by the exporters, and they can start business in a short time. The new guidelines of CDSCO grant the NOCs in only seven working days. It eliminated the long registration procedure.
• For the export NOC process, the digital system is introduced as a game-changing tool. The online procedure enhances the overall efficiency of the export NOC route. 
• The major aim is to establish these rules to enhance compliance for exporters. Such measures alleviate the challenges and facilitate a smoother exportation process.

The advantages of the CDSCO Certificate for Exporters

Final Thoughts

In essence, securing the CDSCO certificate for export helps to be aware of the legal regulations. The registration with the Central Drugs Standard Cosmetic Organization follows a rigorous testing procedure to ensure their products meet legal standards. Aligning with the import regulations of the destination country to facilitate smooth export procedures. Attempting CDSCO registration for a drug business alone, you need to take expert guidance. Reach your destination with the knowledgeable consultants at LegalRaasta Private Limited.

User Query: Common CDSCO Registration Challenges And Solutions

FAQ | CDSCO registration for Export

1. Can I export products without a CDSCO certificate?

Regulating the business of medical devices or drugs without a license is illegal. You cannot export without a CDSCO registration certificate, which can lead to hefty penalties.

2. Who is eligible to register with CDSCO?

The manufacturers, importers, and distributors who operate in the business of medical devices, drugs, or cosmetics in India. 

3. Which documents are required for CDSCO registration? 

For the registration, the applicants need to submit the export NOC, a valid export order or purchase order, a manufacturing license, an import permit certificate from the relevant country, and prototype packing material.

4. Is the working process of CDSCO and BIS the same?

No, both are regulating bodies, but CDSCO is responsible for regulating the activities of healthcare-related products, while BIS acts as a product identifier to regulate quality standards. 

5. What are Forms 20B and 21B for export?

The forms 20B and 21B serve as a type of drug license. These are for the wholesale of drugs in India.