Named-Patient Import in India: Step-by-Step Guide

How to Apply for a Named-Patient Import in India (Step-by-Step Guide)

Limited access to rare or life-saving disease therapies may happen when (a) Medicines are either not currently approved or available in India (b) Medicines have been removed/discontinued from the market in India. In these cases, hospitals and providers have relied on Named-Patient Import as an approved, regulated path for accessing unapproved therapies that are critically needed by patients.

In the following Guide you will find:

• When Named-Patient import may occur
• Forms & Documents required by the CDSCO
• Complete Processes for Hospitals and Clinicians
• Timelines for Approvals, Logistical Flow, and Cost Information
• Regulatory Compliance & Cold Chain Requirements (ensuring medicines are maintained at appropriate temperatures until administration)

What Is Named-Patient Import in India?

Under the CDSCO, a Named-Person Import in India is an exception to the typical regulatory process under which unapproved medicines are imported into India on a "special permission" basis for only one person/patient who will benefit from the treatment. To qualify for this process, the following criteria must be met:

• There is no other approved product available in India that can treat the condition of the individual
• The product has been approved for marketing in at least one other highly-regulated country
• There is written support from the Physician indicating that treatment is clinically necessary for that patient
• That drug or medicine can only be used by that particular person

The Named-Patient Import Process is used to access many different types of unapproved medications. Examples of the most common types of products imported via the Named-Patient Import Process would include:

• Treatments for rare diseases
• Immunotherapy and oncology/chemotherapy treatments
• Orphan drugs (drugs developed for rare diseases)
• Formulations that were manufactured and marketed previously, but are now no longer marketed
• Biologics that are still undergoing regulatory approval in India

Named-Patient Import cannot be used for wholesale or commercial importation, therefore every application submitted to the CDSCO must include medical documentation that supports the need for this product for a specific patient.

Regulatory Basis & Authorities Involved

Named-Patient import in India is regulated under:

• Drugs & Cosmetics Act, 1940
• Drugs & Cosmetics Rules, 1945 (Rule 36 & 37)
• Oversight by the Central Drugs Standard Control Organization (CDSCO)

Key authorities involved:

• CDSCO HQ or Zonal Office (approves special import permission)
• Customs authorities (verifies paperwork at entry port)
• Treating hospital and physician (responsible for justification and patient monitoring)

When Hospitals Should Consider Named-Patient Import

1. No Available Approved Alternatives in India

When there is no alternative option for a product currently being withdrawn

2. Rare/Orphan Disease Therapies

Patients with these types of diseases have no alternative to seek product via import from a country where the product has been approved.

3. Advanced Oncology & Immunotherapy

Biologics have long lead times between the time they are approved/marketed and when they will become available in India.

4. Temporary Shortages

Some manufacturers are unable to get adequate supplies to continue supplying the Indian hospitals so they used the NPI program to provide product for those patients who need it.

5. Compassionate or Emergency Situations

Compassionate use of a product can be warranted in the case of emergency, critical need. One example would be if an individual is in the IC unit for a particular reason and required a very high level of treatment that wouldn't have been available if they had to wait for the product to debut in India.

Required Documentation for Named-Patient Import

Hospitals will require the following documents in order to submit an NPI application:

1. Doctor’s Prescription & Clinical Justification

Physician issued prescriptions and a clinical justification (on Hospital Letterhead) that outlines the:

• Diagnosis
• An explanation of why there are no other acceptable options available
• Dosage amount and duration of treatment required
• Medical necessity for treatment

2. Patient Consent Letter

Signed written consent from the patient to acknowledge the following:

• That the product is subject to NPI
• The patient should be aware of the potential risk and benefit of the treatment
• The patient’s consent to treatment

3. Form 12 (Import Licence for Personal Use)

Form 12 (Request for Personal use of an Import) used by the labeling authority, CDSCO, to request a special import.

4. Product Regulatory Documents

Regulatory Documentation that will accompany the product as provided by the product manufacturer or authorized supplier and includes:

• Certificate of Analysis (COA)
• Summary of Product Characteristics (SmPC) or PI
• Manufacturer Declaration
• FDA/EMA approval proof (if applicable)

5. Purchase Order / Proforma Invoice

Required for import clearance and customs valuation.

6. Temperature-Control Plan (for biologics)

Cold-chain handling instructions and stability data.

Step-by-Step Process to Apply for Named-Patient Import in India

This is the core workflow most hospitals follow:

Step 1 — Physician Identifies the Treatment Need

The treating specialist determines that the patient requires a medicine unavailable in India. They prepare:

• Prescription
• Clinical justification
• Diagnostic reports

Tip: Use clear references (clinical guidelines, published evidence) to support necessity.

Step 2 — Hospital Gathers Documentation for CDSCO

The hospital or its pharmacy department compiles the full dossier:

• Form 12
• Patient consent
• Passport/ID copy
• Doctor’s justification
• Product documents (COA, PI, approval proof)
• Cold-chain logistics plan

Hospitals sometimes involve third-party regulatory support to ensure accuracy.

Step 3 — Submit Application to CDSCO (HQ or Zonal Office)

Submission can be done:

• Via email (in some zones)
• Through physical file submission
• Through an authorised representative

CDSCO reviews:

• Completeness of documentation
• Validity of medical justification
• Product regulatory status
• Safety data

If required, CDSCO may request additional details.

Step 4 — Approval Issued: “Special Permission” Letter

Once approved, CDSCO grants permission to import the specific quantity of drug for that specific patient.

Notes:

• Approval is usually product- and batch-specific
• Quantity is restricted to what is required for the prescribed duration
• Some cases require periodic renewal for repeat doses

Step 5 — Ordering, Shipping & Cold-Chain Logistics

The hospital or sourcing partner arranges:

• Order placement with the foreign manufacturer/distributor
• Airline-approved packaging
• Temperature-controlled shipment (if required)
• Insurance for high-value consignments

For biologics, continuous temperature monitoring is mandatory.

Step 6 — Customs Clearance in India

At the port of entry, customs requires:

• CDSCO permission letter
• Form 12
• Invoice & packing list
• COA
• Temperature logs (cold-chain goods)
• Identity proof of the patient

If documents match, customs releases the shipment.

Step 7 — Dispensing & Pharmacovigilance Monitoring

Post-import, the hospital must:

• Dispense the medicine strictly to the named patient
• Maintain treatment logs
• Report any adverse events
• Store remaining doses per specifications (biologics often require 2–8°C refrigeration)

Timelines for Named-Patient Import in India

Typical estimated timelines (may vary):

Emergency oncology cases may be prioritised.

Costs, Duties & Taxes

Cost Components:

• Drug cost (manufacturer/distributor pricing)
• International freight
• Temperature-controlled packaging
• Customs duty (often nil on lifesaving drugs, check HS code)
• Handling charges
• Repackaging/stability costs (if any)

GST Considerations

Medicines typically attract 5% GST, but vary by product category.

Common Challenges & How to Avoid Delays

1. Incomplete Documentation

Missing consent letters, wrong Form 12 details, or unclear medical justification are top reasons for delays.

2. Lack of Manufacturer Cooperation

Some companies require compliance checks or refuse supply without additional clinical justification.

3. Cold-Chain Failures

Biologics may be rejected if temperature logs show excursions.

4. Wrong Import Port Selection

Choose ports familiar with named-patient processing (Delhi, Mumbai, Bangalore).

5. Customs Queries / Valuation Issues

Ensure invoices match proforma and patient details exactly.

How Hospitals & Clinicians Benefit from Using a Professional Sourcing Partner

A global pharma sourcing platform or regulatory partner can streamline the process by providing:

• Verified manufacturers & authorised distributors
• Documentation support (Form 12, patient consent templates)
• Cold-chain packaging and logistics
• Real-time shipment tracking
• Faster customs clearance
• Regulatory compliance assistance
• Adverse event reporting support
• Lower procurement risk and guaranteed authenticity

This significantly reduces administrative burden on busy hospital teams.

Conclusion: Faster Access, Stronger Compliance

Named-Patient import is a critical pathway in India for patients who urgently need therapies unavailable locally. With the right documentation, a clear justification, and reliable sourcing support, hospitals can ensure:

• Faster access
• Safe and compliant procurement
• Authentic, traceable products
• Minimal delays in urgent scenarios

Frequently Asked Questions

Is Named-Patient import legal in India?

The Named Patient Importation process is legal in India as long as CDSCO approves it for an individual patient.

Can Individual Patients Apply Directly for the Named Patient Importation?

Applications for Named Patient Importations must come via a registered physician or medical institution.

Are Controlled Substance Imports Allowed?

Controlled Substance Imports are possible but need a separate narcotic license.

Is Any Country Eligible to Supply Drugs?

Any country can provide drugs to Named Patients but drugs should ideally come from regulated markets like: United States, European Union , Great Britain and Japan.

Can You Import Repeats for Multiple Doses?

You are allowed to import repeats for multiple doses. Each cycle or batch of drugs imported will likely need new approvals from CDSCO.