How to Apply for CRO Registration under CDSCO in India?

The pharmaceutical, biotechnology, and medical device companies manage the clinical trials with the help of a CRO (Clinical Research Organization). A CRO, also recognized as a contract research organization, acts as a company whose expertise is an expert in clinical trial services. The drug, medical device, and cosmetics manufacturers’ approaches to CRO to test their products to ensure safety and quality before obtaining the license. This signals that a clinical research organization plays a big role for the pharmaceutical, biotechnology, and medical device companies. 

Not only the manufacturers but also the individuals who are building a clinical research organization in India need to register with the CDSCO (Central Drugs Standard Control Organization). This comprehensive guide will explain why CRO registration is important, the licensing procedure with CDSCO, and how it benefits manufacturers. Apply for CRO licensing now to build a strong organization for product clinical trials. 

What is meant by CRO (Clinical Research Organization)?

A registered clinical research organization acts as a contract researcher that provides services related to CDSCO-certified products. Such organizations are a game-changer for the pharmaceutical, biotechnology, and medical device companies. In India, the Central Drugs Standard Control Organization mandates the necessary use of a license for medical devices, drugs, and cosmetics. Meanwhile, in the same cases, CRO registration under CDSCO is required. The CRO certification ensures that the organization is legally connected to the CDSCO guidelines. Such organizations get access to conduct the clinical trial to ensure compliance. In India, CRO licensing under CDSCO is mandatory. 

Also Check: Drug License in India

What are the Steps for CRO Registration under CDSCO?

Thinking of building your own successful clinical research organization in India? No need to worry, as the CDSCO registration online procedure makes it seamless. For the CRO licensing, you must first register on CDSCO’s official online portal. The breakdown for CRO certification in India:

Prepare Documentation

Gathering the necessary documentation is the primary step for the CRO registration in India. Collect the important paperwork like organization identification proof, address information, permission from the governing authority, and many more.

CRO Online Application

Make an account on the CDSCO official portal (SUGAM Portal). Select the GCT Division and then fill out the application form—Form CT-07 B. 

Submit Form CT-07 B.

Mention all details in the application form, including CRO proof, infrastructure, and personnel. Submit the application form on the SUGAM portal.

Fee Submission

Pay the mandatory government registration fee online (Rs 5 lakh)

Application Review

The official of CDSCO will review the form to ensure compliance with regulatory requirements. If any query is raised by the authority, the applicant needs to respond promptly. 

Inspection and approval

If required, the inspection may be conducted by the governing authority to ensure compliance. The facilities and infrastructure are analyzed by the CDSCO inspectors. 

Certificate  Issuance

After the successful inspection and application review, CDSCO will issue the CRO registration certificate.

Note: Stay updated with CDSCO’s new rules and regulations changes and understand their legal requirements. 

The Mandatory Documents for CRO Certification in India

The CRO operators are required to submit several documents to register with the CDSCO authority. The paperwork you need to provide is

1. Application Form: It is the primary document, which is known as Form CT-07 B.  Mention the CRO details and other major information. 
2. Legal Entity Evidence: Must have the clear CRO’s legal status. With the application form attached, important certificates like registration certificates, partnership deeds, or company incorporation documents. 
3. Organization plan layout: Create a strategic layout of your business and further mention the services you provide, with financial projections.
4. Clinical Trial Details: Mentioned the past clinical trial details, care report forms, and study protocols.
5. Facility Information: This section refers to the infrastructure and the resources used for clinical trials. 
6. Ethical Committee Approval: Must have the approval from the ethical committee, which outlines that CRO aligns with legal compliances and follows the ethical guidelines. 
7. Relevant Certification: If needed, provide the manufacturing, wholesaling, or importing license of drugs or medical devices.
8. Power of Attorney: Appointing a power of attorney helps solve legal matters. A POA acts on behalf of the CRO. 
9. Application Fee/Challan: The fee receipt is mandatory after the required registration fee.
10. Site Registration: The site documents or proves where the clinical trials will be held. 

Renewal of CRO (Clinical Research Organization) License

Any license is valid for a specific period. In the same way, the CRO registration certificate is also valid for a period after which the operator is required to renew it. The CRO license works for only 5 years. The renewal of the certificate demonstrates that the organization aligns with the latest standards of CDSCO and the Drugs and Cosmetics Act, 1940. Well, before the date of its expiry, you must apply for renewal. The renewal requirements are

Form CT-07 B:- This form is valid for both new application registration and registered license renewal. Complete the form online for CRO certification.

Renewal Fee: For the renewal, the government fee is mandatory, which must be paid by every applicant. For the CRO licensing renewal, pay Rs 100,000 online.

Validity: The CRO registration certificate works only for 5 years in the market, and it is important to submit it before expiry.

Compliance: It is crucial to meet the regulatory requirements. Comply with their rules and guidelines mentioned by CDSCO. 

Final Thoughts | Clinical Research Organization Registration

In essence, navigating the complex registration process for CRO registration is the gateway to connecting legally with CDSCO. By understanding the compliance with CDSCO requirements, one can obtain access to operate a business related to clinical trials. After the registration for CRO, manage the license by renewing it after expiry. By renewing the present license, the operator is eligible to maintain ongoing regulatory compliance, ensure ethical conduct, and protect the patients in clinical trials. For a more streamlined CRO licensing process in India, take tailored advice from Legal Raasta professionals. 

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