Easy Process to Get CDSCO Import License in India

To import drugs, medical devices, and cosmetics into India, the manufacturers need to obtain a valid license. To obtain the CDSCO import license, the businesses need to register with the national authority. In India, the Central Drugs Standard Control Organization (CDSCO) acts as the national authority for drugs, medical devices, and cosmetic businesses. It signifies you cannot import the product until you obtain a license.

However, navigating the CDSCO registration process can be overwhelming for startups. In this comprehensive guide, we will explore the steps to secure the CDSCO certificate for import in India, including license benefits, fees, and many more.

Why do manufacturers need a CDSCO certificate for Import? 

The license of import acts as proof that ensures the products meet the safety and quality standards. Here is why you need to obtain a CDSCO certificate for import:

Regulatory Compliance: To import products like medical devices, cosmetics, or drugs from India, the CDSCO online registration is a legal formality. The registration ensures that the manufacturer aligns with the regulatory legal structure proposed by the CDSCO. The step eliminates the non-compliance risks. 

Market Access: To gain the Indian market, obtaining the CDSCO certificate becomes important. The license allows for operating in Indian markets, which also facilitates the route for government tenders. 

Ensure Safety and Quality: The major purpose was to encourage the manufacturers to obtain the license to evaluate the safety, quality, and efficacy standards. Before importing the products from India, the products need to meet the regulatory requirements. 

CDSCO Registration Certificate Steps for Import Business

To get a CDSCO certificate for import in India, the operator needs to complete multiple steps. Breakdown of registration steps:

Register on the CDSCO online portal

Navigate to create an account on the CDSCO online portal. The official registration website of CDSCO is “SUGAM”.

Complete Application

According to your business type (e.g., medical devices, drugs, or cosmetics), complete the relevant form. The information includes your organization and the things you intend to import. Must ensure the mistakes are corrected before submission.

Prepare Documents

The documents that act as proof of the authority gather the necessary documents like registration proof, manufacturing licenses, and other important certificates. Attach them with the license. 

Pay the Fees

Pay the prescribed fees for the application registration. 

Application review and inspection 

To ensure the documents and application’s accuracy, the CDSCO official will review them. The inspection of premises might be conducted to ensure compliance with site standards. 

CDSCO import license issuance

If the application meets the specific requirements, the certificate will be issued by the CDSCO. 

The supported documents for the CDSCO Certificate Registration

• Company  Registration certificate as proof
• Identity proof, like a passport, an Aadhar card, or a driving license
• Applicant’s address proof, like a utility bill or lease agreement
• Manufacturing or wholesale license if involved in relevant operations
• Undertaking from the government authority
• Copy of BA/ BE sire registration
• Other documents as specified by CDSCO. 

Conclusion | CDSCO Import License in India

Navigating the CDSCO registration process needs a proper plan and accurate documentation. To adhere to requirements, focus on rules and authority guidelines. As the CDSCO import license process takes 4-8 months, start preparation early. Before dealing, one must ensure that the products are regulated under the Drugs and Cosmetics Act. It is necessary to align with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). If an international company wants a CDSCO certificate to import into India, it needs to build a legal entity in India. To streamline registration steps, appoint a CDSCO consultancy service. Register your import business now with the CDSCO to avoid legal penalties.