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DOC ID: LEG-CDSCO-RX | LAST UPDATED: 2025-12-27

CDSCO Approvals

Contents
1. Schedule X Drugs 2. Device Registration 3. Import Licenses
DOC ID: LEG-CDSCO-RX | LAST UPDATED: 2025-12-27

CDSCO Approvals

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

1. Management of Schedule X Drugs (Ketamine)

Ketamine Hydrochloride is a Schedule X drug under the Drugs and Cosmetics Rules, 1945. The Cortex Institute maintains strict custody:

  • Double Lock Storage: All vials are stored in a biometric-access double-lock safe.
  • Documentation: Every mg is accounted for in the Drug Register (Form 34), audited weekly.
  • Prescription: Administered only on prescription by a registered Anesthesiologist or Psychiatrist.

License No: MH/MZ/2025/X-0045

2. Medical Device Registration (rTMS)

Our Repetitive Transcranial Magnetic Stimulation (rTMS) equipment is classified as a Class B medical device.

  • Device: Cortex MagPro R30
  • CDSCO Reg: IMP/MD/2024/000123
  • Maintenance: Calibrated quarterly by OEM engineers.
Disclaimer: The Cortex Institute acts as a Site Management Organization (SMO). All medical protocols are administered by independent licensed contractors under strict CDSCO oversight.
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© 2025 The Cortex Institute. CDSCO Reg: ECR/123/Inst/MH/2025