Regulatory Analysis

Objective

To conduct an in-depth regulatory analysis and evaluate national regulatory guidelines in India, enabling the client to understand the complete approval pathway for their dermatology therapy. The objective included identifying documentation requirements, assessing clinical trial obligations, and outlining post-approval regulatory procedures to ensure full compliance with CDSCO (Central Drugs Standard Control Organization) standards.

Problem Statement

A leading European pharmaceutical company in the Dermatology market sought clarity on the India regulatory landscape to successfully file their market-ready product with CDSCO. To ensure a smooth and timely approval, the client required a detailed understanding of:

• Regulatory guidelines and documentation required for product registration
• The CDSCO clinical trial approval process and whether local trials were mandatory
• Procedures for manufacturing and import licensing in India
• Post-marketing surveillance (PMS) and safety reporting obligations
• The latest review protocols, approval timelines, and regulatory expectations
  
  

To navigate India’s evolving drug regulatory framework, the client engaged DelveInsight for expert guidance, detailed regulatory intelligence, and end-to-end assessment of the CDSCO approval pathway.

Our Methodology

• Regulatory Guideline Assessment: Detailed study of CDSCO norms, Schedule Y guidelines, NDCT rules, and current regulatory notifications.
• Regulatory Analysis: Evaluation of submission pathways, risk classifications, approval routes, and data requirements.
• Clinical Trial Application Approval Assessment: Analysis of clinical trial prerequisites, waiver possibilities, and ethics committee requirements.
• Manufacturing & Import Licensing Process Mapping: Step-by-step review of Form 44, Form CT-applications, import licensing protocols, and GMP compliance expectations.
• Post-Approval Compliance Framework: Assessment of PMS guidelines, safety updates, periodic safety reports, and renewal procedures.
  
  

Results

• A comprehensive, end-to-end regulatory roadmap detailing the complete Regulatory Analysis and Drug Approval Process in India.
• A fully structured list of CDSCO-required documents for clinical trial approval, import/manufacturing licensing, and product registration.
• A simplified workflow with updated approval timelines, helping the client forecast regulatory milestones and plan market entry effectively.
• Clear identification of all regulatory prerequisites, ensuring the client’s therapy aligned with CDSCO’s compliance expectations.
  
  

Through DelveInsight’s regulatory expertise, the client gained a complete understanding of India’s regulatory framework—empowering them to prepare a compliant and strategically positioned regulatory submission.