CDSCO Import License for Clinical Trial Drugs in India: Step-by-Step Guide
Importing clinical trial drugs into India requires authorization from the Central Drugs Standard Control Organization (CDSCO) under the New Drugs and Clinical Trials (NDCT) Rules, 2019. Sponsors, CROs, or importers must apply for an import license to legally bring investigational products (IPs), new chemical entities (NCEs), biologics, or comparator drugs into the country for clinical research. This guide provides a comprehensive walkthrough of the CDSCO import licensing process for clinical trial drugs in India.
Regulatory Basis and Governing Law:
- NDCT Rules, 2019, Chapter VII – Manufacturing or Import of New Drugs for Clinical Trials
- GSR 227(E), March 19, 2019
- Form CT-16 and CT-17 (as per CDSCO requirements)
- Guidance on SUGAM portal submission and import regulations
When is an Import License Required?
- Import of investigational products for approved clinical trials
- Import of placebo or comparator drugs
- Import of reference standards, kits, or auxiliary materials used in the trial
- Import of modified dosage forms for BA/BE studies
Types of Applicants Eligible to Apply:
- Sponsor (Indian or multinational company)
- Contract Research Organization (CRO) authorized by sponsor
- Importer or distributor with valid drug licenses
- Authorized Indian legal representative (in case sponsor is
Key Forms and Documentation:
- Form CT-16: Application form for import license
- Form CT-17: License issued by CDSCO for approved import
- Copy of Clinical Trial Approval Letter from CDSCO (Form CT-06)
- Details of protocol, product label, and trial design
- Free Sale Certificate (FSC) from the exporting country
- Drug Master File (DMF) or equivalent technical dossier
- Letter of Authorization from sponsor (if applicable)
- Batch release certificate and Certificate of Analysis (CoA)
- Storage and handling SOPs
Online Application Procedure via SUGAM Portal:
- Visit the CDSCO website and log into the SUGAM portal.
- Register as an Importer or Sponsor with complete organizational details.
- Navigate to the “Import of Investigational Drugs” section.
- Fill out Form CT-16 with drug, sponsor, clinical trial, and shipment information.
- Upload supporting documents (PDF format, digitally signed).
- Pay applicable government fees through Bharatkosh portal and upload receipt.
- Submit the application and track status using reference number.
Processing Timeline and Review:
- CDSCO typically reviews the application within 30 working days.
- Queries, if any, are raised via the portal and must be addressed promptly.
- Upon approval, Form CT-17 is issued to the applicant for each drug and batch.
Import and Customs Clearance:
After obtaining Form CT-17, the sponsor/importer must submit the following to Indian customs:
- Copy of Form CT-17 and clinical trial approval
- Shipping invoice, air waybill, and packing list
- Batch-specific CoA and temperature logs (if applicable)
- Letter of Authorization to customs broker
Common Challenges and Mitigation:
- Challenge: Incomplete documentation or unclear labeling
- Solution: Use SOP checklists from Pharma SOPs for import readiness
- Challenge: Delay in payment verification or form upload errors
- Solution: Perform trial runs on the SUGAM portal before official submission
- Challenge: Customs clearance bottlenecks for temperature-sensitive drugs
- Solution: Coordinate with a GMP-compliant cold chain logistics provider and ensure GMP quality control in packaging
Compliance Obligations Post-Import:
- Maintain import register with batch details, expiry, and usage
- Submit utilization report to CDSCO post-trial
- Ensure trial site documentation for storage and dispensing is GCP-compliant
- Include imported drugs in trial master file (TMF)
Inspections and Enforcement:
CDSCO or Drug Inspectors may audit sponsor offices or trial sites for verifying import compliance, drug accountability, and storage conditions. Violations may result in import license suspension or clinical trial halt.
Integration with International Practices:
India’s regulatory requirements for investigational drug imports align with EMA and USFDA standards. However, the CDSCO process mandates local sponsor or importer accountability and SUGAM digital workflow adherence.
Conclusion:
Securing an import license from CDSCO is a critical compliance milestone for conducting clinical trials in India. Sponsors must carefully plan documentation, timelines, and logistics in alignment with NDCT rules. Leveraging regulatory platforms such as Stability Studies can further streamline import-readiness and ensure smooth execution of clinical trials with full regulatory compliance.