CORTEX INSTITUTE
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DOC ID: LEG-001 | LAST UPDATED: 2025-12-27

Compliance Dashboard

Contents
1. Governance Structure 2. Clinical Safety (NABH) 3. Pharmacologics (CDSCO) 4. Data Privacy
DOC ID: LEG-001 | LAST UPDATED: 2025-12-27

Compliance Dashboard

Contents
1. Purpose & Scope 2. Regulatory Framework 3. Patient Obligations 4. Liability Limitations 5. Contact Officer

1. Governance Structure

The Cortex Institute is constituted as a private limited entity (Cortex Life Sciences Pvt Ltd) operating as a specialized Site Management Organization (SMO). Our governance model separates clinical decision-making from administrative operations to ensure patient safety remains paramount.

2. Clinical Safety & Accreditation

We strictly adhere to the accreditation standards set forth by the National Accreditation Board for Hospitals & Healthcare Providers (NABH). Our facility is designed to meet "Day Care Centre" requirements with extended observation capabilities.

  • View NABH Compliance Statement
  • Patient Rights & Responsibilities

3. Pharmacological Oversight

All investigation medicinal products (IMPs), specifically Ketamine Hydrochloride, are procured, stored, and administered in strict accordance with the Central Drugs Standard Control Organization (CDSCO) and the Narcotic Drugs and Psychotropic Substances (NDPS) Act.

  • View Drug License & Approvals

4. Data Privacy & Ethics

Our Independent Ethics Committee (IEC) oversees all N-of-1 protocols. Subject data is encrypted and handled according to HIPAA (USA) and DISHA (India) standards.

  • View IEC Registration
Disclaimer: The Cortex Institute acts as a Site Management Organization (SMO). All medical protocols are administered by independent licensed contractors under strict CDSCO oversight.
The Institute
Home Mission & Philosophy Clinical Board The Facility Admissions
Clinical Science
The Protocol Ketamine Infusion rTMS Therapy Hyperbaric Oxygen Efficacy Data
Indications
Executive Burnout Treatment Resistant Depression Complex PTSD Cognitive Optimization
Legal & Compliance
Compliance Dashboard NABH Accreditation CDSCO Approvals Patient Rights Clinician Portal

© 2025 The Cortex Institute. CDSCO Reg: ECR/123/Inst/MH/2025