In India’s evolving pharmaceutical and drug research landscape, regulatory compliance remains central to innovation. Companies engaged in early-stage formulation development, analytical method validation, or preclinical evaluation often require access to Active Pharmaceutical Ingredients (APIs) that are not yet approved for commercial manufacture. This is where Form CT-15 becomes essential. It functions as the regulatory gateway that allows manufacturers to legally produce an unapproved API specifically for research, testing, or formulation development.
Understanding the purpose, scope, and compliance expectations of Form CT-15 is critical for pharmaceutical manufacturers, R&D organizations, CROs, and formulation development laboratories. This article breaks down the regulatory framework, eligibility criteria, documentation requirements, and compliance expectations associated with obtaining permission through Form CT-15.
To access the official regulatory service and guidance, refer to the authorized resource here:
Form CT-15 for Manufacturing an Unapproved API for Formulation Development
What Is Form CT-15?
Form CT-15 is a regulatory approval mechanism under the New Drugs and Clinical Trial Rules (NDCTR), 2019, governed by the Central Drugs Standard Control Organisation (CDSCO). It grants manufacturers authorization to produce an unapproved API for the limited purpose of research, development, testing, or analysis, and not for commercial sale.
This form is commonly used by:
- Formulation development labs
- Contract research organizations (CROs)
- API manufacturers engaged in R&D
- Companies developing new drug products
- Organizations preparing for clinical trial batches
The guidance ensures that even non-commercial manufacturing of APIs follows quality, safety, and traceability standards.
Why Is CT-15 Necessary?
Pharmaceutical research frequently requires experimental compounds or new variations of existing molecules. These are often not listed as approved APIs in standard regulatory databases. Without CT-15, manufacturing such materials—even in small quantities—would violate drug control regulations.
CDSCO introduced this form to:
- Ensure lawful and supervised productionof research-use APIs.
- Prevent misuse or diversionof unapproved substances.
- Maintain quality oversight, even for trial or analytical batches.
- Facilitate seamless R&D activitiesfor formulation development and analytical method creation.
- Support innovationwhile preserving patient and consumer safety.
Scope of Permissions Under Form CT-15
CDSCO issues CT-15 permission only for:
- Development of a new formulation
- Conducting non-clinical or analytical testing
- Creating exhibit batches
- Bioavailability (BA) or bioequivalence (BE) study samples
- Method development and validation
- Tests required for regulatory submissions
It does not allow:
- Commercial distribution
- Sale to third parties
- Full-scale API manufacturing
- Use in clinical trials without additional approvals
Every activity must strictly align with the R&D scope mentioned in the application.
Key Regulatory Requirements for CT-15
Applicants must demonstrate that they possess the technical capabilities, infrastructure, and laboratory controls to handle unapproved APIs safely. The core requirements include:
- Valid Manufacturing License
A valid API manufacturing license under the Drugs and Cosmetics Act is essential as the base authorization.
- Detailed R&D Protocol
The proposal must specify:
- Purpose of API manufacture
- Quantity required
- Formulation development objectives
- Stability studies, if applicable
- Analytical methods planned
- Safety and Quality Assurance Measures
CDSCO examines the applicant’s QA/QC processes, including:
- SOPs for handling unapproved substances
- Equipment qualification
- Environmental controls
- Waste disposal systems
- Documentation and Technical Dossiers
A comprehensive dossier strengthens the application and typically includes:
- API specifications
- Raw material details
- Manufacturing process outline
- Safety data
- Certificates and plant compliance documentation
Workflow for Obtaining CT-15 Permission
Manufacturers must apply through the SUGAM portal with a required set of documents. The typical process involves:
- Prepare technical documentationcovering process, safety, and quality.
- Submit Form CT-15 onlinealong with mandatory fees.
- Respond to CDSCO queries, if any.
- Receive approvalafter regulatory review.
- Begin controlled manufactureof the unapproved API strictly within approved limits.
This structured workflow ensures high transparency and compliance throughout the manufacturing cycle.
Compliance Obligations After Receiving CT-15
Once approved, the manufacturer must:
- Maintain batch manufacturing records
- Implement strict inventory controls
- Keep consumption and testing logs
- Restrict distribution to the approved internal R&D use
- Submit reports or records when requested by CDSCO
Any deviation can result in suspension or cancellation of the permission.
Importance of Expert Regulatory Guidance
Preparing a CT-15 application requires regulatory precision, technical clarity, and alignment with CDSCO expectations. Many organizations choose to partner with regulatory consultants to ensure:
- Accurate documentation
- Faster approval timelines
- Proper dossier preparation
- Compliance with NDCTR requirements
- Smooth coordination with regulatory authorities
Expert support minimizes delays and ensures that R&D teams can access required APIs without interruptions.
For detailed guidance, eligibility verification, and submission support, visit:
Form CT-15 for Manufacturing an Unapproved API for Formulation Development
Final Thoughts
Form CT-15 plays a vital role in enabling pharmaceutical innovation in India. By providing a controlled framework for manufacturing unapproved APIs strictly for research and formulation development, it balances scientific advancement with regulatory oversight. Manufacturers who understand the importance of compliance, documentation, and proper application procedures can streamline their R&D workflows and accelerate product development.
Organizations involved in formulation development or analytical testing should be fully aware of CT-15 requirements to benefit from faster project execution and uninterrupted R&D activities. Leveraging experienced regulatory partners further enhances the quality and efficiency of submissions.
