Clinical trials are a critical step in bringing new drugs, medical devices, and cosmetics to market. In India, these trials must be approved by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority. Getting approval from CDSCO ensures that your clinical trials are conducted ethically and scientifically.
This blog, brought to you by Corpbiz, explains the step-by-step process to get CDSCO approval for clinical trials in India. We also cover related registrations like CDSCO Registration Online, Medical Device Registration in India, Cosmetic Manufacturing License Registration, and Drug License Registration.
What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) is the regulatory body under the Ministry of Health and Family Welfare, Government of India. It oversees the approval of drugs, medical devices, and cosmetics and ensures their safety, efficacy, and quality.
CDSCO is also responsible for:
Granting clinical trial approvals
Issuing import licenses
Regulating drug standards
Granting Medical Device Registration in India
What Are Clinical Trials?
Clinical trials are research studies conducted on human volunteers to test new drugs, devices, or treatments. These trials determine:
Whether the new treatment is safe
How well it works
What dosage is best
Any possible side effects
If you want to introduce a new drug, device, or cosmetic in India, conducting a clinical trial and getting CDSCO approval is mandatory.
Step-by-Step Process to Get Clinical Trial Approval in India
Step 1: Understand the Requirement
Before applying, determine whether your product (drug, device, or cosmetic) requires a clinical trial under Indian regulations. Trials are required when:
You are launching a new drug
You are developing a new medical device
You are testing a cosmetic product for safety and efficacy
For any of the above, CDSCO approval is required under the Drugs and Cosmetics Act, 1940.
Step 2: CDSCO Registration Online
You must first register on the SUGAM portal, which is the official online platform of CDSCO.
Here’s how:
Go to https://cdsco.gov.in
Navigate to the SUGAM Portal
Create a user ID and password
Submit KYC documents like PAN, Aadhaar, company details, and authorizations
Corpbiz Tip: Getting expert help from Corpbiz can simplify your CDSCO Registration Online process.
Step 3: Prepare and Submit the Application
You must submit Form CT-04 for clinical trial approval, along with:
Protocol of the clinical trial
Investigator’s brochure
Informed consent form
Ethics Committee approval
Pre-clinical data (animal studies)
Previous human trial data (if any)
Details of the sponsor and principal investigator
If you're dealing with Medical Device Registration in India, similar trial protocols may need to be submitted for approval.
Step 4: Ethics Committee Approval
Before CDSCO approval, the clinical trial must be approved by a registered Ethics Committee (EC). The EC ensures the study complies with ethical guidelines and protects the rights and well-being of participants.
Step 5: Review and Query Handling
CDSCO may ask for clarification or additional documents. Prompt responses are essential to avoid delays. You may receive queries related to:
Protocol design
Dosage
Adverse events
Monitoring plans
Step 6: CDSCO Approval
Once all documents are verified and ethical clearance is granted, CDSCO will issue a No Objection Certificate (NOC) to conduct the trial.
Other Relevant Registrations
1. Medical Device Registration in India
If your trial involves medical devices, ensure you’ve applied for medical device registration under the Medical Device Rules, 2017. This registration is also managed by CDSCO.
2. Cosmetic Manufacturing License Registration
Planning to test or launch a cosmetic product? You'll need a Cosmetic Manufacturing License from CDSCO before conducting trials.
3. Drug License Registration
Before manufacturing or selling any drug in India, including clinical trial batches, a valid Drug License Registration is required from the State FDA and CDSCO.
Documents Required for Clinical Trial Approval
Cover letter
Form CT-04
Clinical trial protocol
Investigator’s brochure
Informed consent form
Ethics Committee approval letter
Details of sponsor and investigators
Undertaking of compliance with GCP (Good Clinical Practices)
Insurance for trial participants
Why Choose Corpbiz for CDSCO Clinical Trial Approval?
Getting clinical trial approval in India involves dealing with technical documents, regulations, and authorities. At Corpbiz, our experts assist with:
CDSCO Registration Online
Preparing and submitting trial documents
Coordinating with Ethics Committees
Obtaining Medical Device, Drug, or Cosmetic Licenses
Ensuring GCP compliance and fast approval
We guide you at every step to ensure smooth, hassle-free approval.
FAQs: Clinical Trial Approval in India
Q1. Is clinical trial approval mandatory for every new drug?
Yes, if you are introducing a new drug in India, clinical trial approval from CDSCO is mandatory.
Q2. How long does CDSCO take to approve a clinical trial?
It usually takes 3 to 6 months, depending on the nature of the drug and completeness of documents.
Q3. Can foreign companies apply for clinical trial approval in India?
Yes, but they must have an Indian representative or CRO registered with CDSCO.
Q4. Do medical devices also require clinical trials?
Yes, especially for high-risk (Class C and D) devices, trials are necessary under the Medical Device Rules, 2017.
Q5. Is an Ethics Committee approval compulsory?
Yes. Without EC approval, CDSCO will not consider your application for trial approval.
Author Profile
Atul Shukla
Regulatory Compliance Expert at Corpbiz
Atul has over 10 years of experience in legal metrology, CDSCO approvals, and business licensing in India. He simplifies complex regulatory pathways for startups and manufacturers. Through Corpbiz, he has helped 500+ clients get clinical trial approvals and other CDSCO-related services.
Final Thoughts
Clinical trial approval in India through CDSCO is a detailed process, but with the right guidance, it can be completed smoothly. Whether you’re working on a new drug, medical device, or cosmetic product, following CDSCO protocols is essential to ensure safety, quality, and compliance.
Corpbiz is here to support you with expert guidance, document preparation, and end-to-end regulatory assistance. Let us take the complexity out of compliance while you focus on innovation.
