Manufacture Unapproved New Drug for Treatment of Life-Threatening Disease: Approval Procedure in India

Aryan Panwar

Aryan Panwar

Published on: Jun 19, 2026

Shatakshi Sharma

Updated on: Jun 19, 2026

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Introduction

This procedure outlines the legal framework and compliance steps for obtaining approval to Manufacture Unapproved New Drug for the treatment of Patient of Life Threatening Disease in India. It defines the mandatory documentation, fee structures and application forms required by regulatory authorities to verify safety and quality standards.

Applicable Provisions

Process for Grant of Approval

Manufacturers who intend to manufacture an unapproved new drug under clinical trial for a patient with a serious or life-threatening illness that lacks other local treatments shall:

1. Obtain written consent from the patient or their legal heirs
2. Submit an application to obtain recommendations for the manufacture of such an unapproved new drug to the Ethics Committee of the Government hospital or medical institution, as the case may be
3. Submit an application in Form CT-26 to obtain approval for the manufacture of such an unapproved new drug to the Central Licensing Authority, along with the following fees:

   Particulars	Fees
   Application for permission to manufacture an unapproved new drug, but under clinical trial, for the treatment of patient of life threatening disease	5,000

The manufacturer shall ensure that the quantity of a single new drug produced does not exceed one hundred average dosages per patient, unless exceptional circumstances, a medical officer’s prescription, and an Ethics Committee recommendation prompt the Central Licensing Authority to permit a larger amount.

Approval

The Central Licensing Authority, if satisfied after scrutiny of the information and documents furnished with the application, grant the Approval in Form CT-07.

Validity of Approval

The Approval granted remains valid for a period of one year from the date it has been issued.

Condition of Approval

The permission granted by the Central Licensing Authority in Form CT-27 shall be subject to following conditions, namely:

• Patients must use the unapproved drug under medical supervision at the location authorized by the Central Licensing Authority.
• Manufacturers must use the drug solely for the permitted purpose and never sell or supply it to others
• Manufacturers must record all production, storage, and patient supply details in the Form CT-27 annexure register
• Manufacturers must submit a half-yearly report to the Central Licensing Authority tracking drug production and patient supply
• Drug must follow label storage conditions and be delivered by a supervising medical officer or authorized pharmacist
• Authorized pharmacists must maintain countersigned patient and dosage logs for inspection by the Central Licensing Authority
• Unused, damaged, expired, or substandard drugs must be destroyed by the manufacturer and the action formally recorded
• Permission holders must report serious adverse events and any drug recalls to the Central Licensing Authority within 15 days.

Cancellation or Suspension

Where the Permission Holder fails to comply with any provision of the Act and these Rules, the Central Licensing Authority may, after giving a show cause notice and an opportunity of being heard, by an order in writing, suspend or cancel the permission.

Frequently Asked Questions (FAQS)