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CION Cancer Clinics
Compassionate use and named-patient access for liver cancer | CION Cancer Clinics
Compassionate use lets a seriously ill person receive a medicine that is not yet approved in India, when approved options are used up and no trial fits. It goes through your oncologist, the drug company and the national regulator. This page explains the routes, how a request works, who pays, and who it does not suit. At CION Cancer Clinics, a multidisciplinary tumour board weighs your liver function and your scans before recommending any treatment.
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Medically reviewed by Dr. Naresh GunduConsultant Medical Oncologist · MBBS, DNB (Internal Medicine), DM (Medical Oncology, AIIMS) · last reviewed October 2026, next review due October 2027
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On this page
- Can I get a liver cancer drug that is not yet approved in India?
- What are the ways to reach a medicine outside the usual route?
- How does a compassionate use request actually happen?
- What do these access terms mean in plain language?
- What do families often assume about new drugs?
- Who does compassionate use not suit, and what can this page not tell you?
- Common questions about compassionate use
The short answer
Can I get a liver cancer drug that is not yet approved in India?
Sometimes, but rarely, and only through a doctor. Compassionate use means giving a medicine that is still being tested, or not yet approved in India, to one seriously ill person who has run out of approved options and cannot join a trial. The request goes through the national drug regulator and the drug company. A family cannot arrange it alone.
Who this page is for
It is for people with primary liver cancer, usually hepatocellular carcinoma (HCC, cancer that starts in the liver cells), whose disease has kept growing through the standard medicines. If your cancer started in the bowel and spread to the liver, the options are different and are covered by your colon cancer team.
What it is not
Compassionate use is not a discount scheme and not a shortcut past a trial. Patient assistance programmes, which help pay for medicines that are already approved, are a separate thing. They are explained on our page about drug access and assistance programmes.
Most people who ask about compassionate use are better served by an approved medicine they have not yet tried, or by a trial.The three routes
What are the ways to reach a medicine outside the usual route?
People use the words loosely. Your oncologist will use them precisely, and each one works differently.
A clinical trial
The first route your doctor will look at. The drug is given under a written plan, with close checks, and the results help future patients. Trials have strict entry rules, often about liver function. Our guide on finding liver cancer trials in India explains where to look.
An expanded access programme
Run by the drug company, usually after a trial has shown promise and before approval. It covers a group of patients who meet set conditions. Few such programmes run in India for liver cancer at any one time.
Named-patient import
A doctor or hospital asks the national drug regulator for permission to import a small supply of an unapproved medicine for one named person. The company must agree to supply it.
The family may have to pay for the medicine itself on this route.What all three share
Each needs an oncologist to make the case, written consent from you, and a plan for checking side effects. None can be bought online or ordered by a relative abroad.
You will be asked for
- Every scan and blood report so far
- A list of medicines already tried
- Your current liver function results
Not sure whether this applies to you?
Ask an oncologistStep by step
How does a compassionate use request actually happen?
Your oncologist reviews every approved option
The first question is whether an approved medicine remains untried. The later lines of treatment are often still available, and a tumour board review checks this.
Trials are checked first
Your doctor searches trial registries for anything you might join. A request is only reasonable when no suitable trial is open to you.
The company is approached
The doctor writes to the drug company with your medical details. The company decides whether it will supply the drug at all. Many say no, often because supply is limited.
The regulator gives permission
An application goes to the national drug regulator. Paperwork takes time, so this route rarely suits someone whose illness is moving fast.
You consent, and checks begin
You sign a consent form that explains the medicine is unproven. Blood tests and scans are planned so side effects are caught early.
Words you will hear
What do these access terms mean in plain language?
- Compassionate use
- Giving an unapproved medicine to a seriously ill person outside a trial, because nothing approved is left to try.
- Named-patient supply
- A supply of medicine requested for one specific person, by name, rather than for a group of patients.
- Expanded access
- A company programme that opens an unapproved medicine to a group of patients who meet set conditions, usually before approval.
- Unapproved medicine
- A drug the Indian regulator has not yet cleared for this use. It may be approved abroad, or still in testing everywhere.
- Off-label use
- An approved medicine used for a cancer or a situation it was not approved for. This is different from compassionate use and is decided by your oncologist.
- Informed consent
- Your written agreement after the risks, the unknowns and the alternatives have been explained in a language you understand.
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Commonly believed
What do families often assume about new drugs?
"If a drug is approved in America, it must work better than what we have here."
Approval abroad means the drug helped some people in a trial. It does not mean it beats the medicines already approved in India, or that it suits your liver function.
"Compassionate use means the drug costs nothing."
Sometimes the company supplies it without charge. Sometimes the family pays for the imported medicine. Scans, blood tests and hospital visits usually cost money either way. Ask before you agree.
"A relative abroad can just post the medicine to us."
Bringing in an unapproved cancer medicine without permission is not legal, and your oncologist cannot safely give a drug with no supply chain, storage record or monitoring plan.
"Asking for it means the doctors have given up on standard care."
A good request sits alongside symptom care and palliative care, never instead of them. Comfort and control of symptoms matter whichever medicine you take.
Being straight with you
Who does compassionate use not suit, and what can this page not tell you?
It does not suit someone who still has an approved medicine to try. It rarely suits someone whose liver is failing, with deep jaundice, fluid building up in the abdomen or new confusion, because most new liver cancer drugs were only tested in people whose liver still worked well. It does not suit someone who is too unwell to travel for the checks the medicine needs.
The evidence is thin by definition
A drug reached through this route has not finished testing. Nobody can tell you how well it will work for you, and the side effects may not be fully known. That is the honest trade.
What this page cannot do
It cannot tell you whether a particular drug is available, which companies currently supply on request, or how long permission takes. Those answers change and belong to your oncologist. This is general information, not legal advice on import rules. At CION, the tumour board can review your records and say plainly whether any access route is realistic.
If you are unsure, call the helpline and describe what has been tried so far.Questions we are asked
Common questions about compassionate use
Is compassionate use legal in India?
Yes. Indian drug rules allow a hospital or doctor to apply to the national regulator to import an unapproved medicine for a seriously ill patient with no other option. It needs permission each time, and the company must agree to supply. Families cannot apply on their own.
Can I ask the drug company directly?
You can write to them, but most companies only respond to a treating doctor, because they need medical details and a named person responsible for giving the drug safely. It is quicker and more useful to ask your oncologist to make the approach.
How long does it take?
It varies widely and cannot be promised. Company approval, regulator permission and import all take time. For someone whose illness is changing quickly, that delay matters, which is why approved medicines and open trials are checked first.
Who pays for the medicine?
Sometimes the company supplies it at no charge, and sometimes the family pays for the import. Tests, scans and visits are usually charged separately. Ask for the costs in writing before you sign anything, and ask what happens if the supply stops.
Is it the same as a clinical trial?
No. A trial follows a set plan and collects results to answer a question. Compassionate use is for one person, to treat them, and does not aim to prove anything. Trials usually offer closer checks, which is one reason doctors look at them first.
What if the company says no?
That is common and usually about supply or safety, not about you. Your oncologist can look again at approved medicines, trials elsewhere in India, or focus on controlling symptoms well. A refusal does not mean nothing more can be done.
Can I stop if it is not helping?
Yes, at any time. Consent is not a lifelong contract. If the medicine causes harm or the scans show it is not working, your oncologist will recommend stopping, and you are free to stop for your own reasons too.
Can CION arrange compassionate use?
CION oncologists can review whether a request is realistic, explain the alternatives, and support the paperwork where a route genuinely exists. Whether a medicine is supplied is decided by the company and the regulator, not by any hospital.
Your Specialists
Meet CION's liver cancer specialists. Bring your scan reports and liver blood tests.
Our medical and surgical oncologists plan liver cancer care together, weighing the tumour and how well your liver works before choosing surgery, a liver-directed procedure or medicines.
Medical Oncologist
Dr. C. Raghavendra Reddy
MBBS(Gold Medal), DNB(General Medicine), DM(Medical Oncology)(Gold Medal)
Medical Oncologist
Dr. Bharati Devi Gorantla
MBBS, MD(General Medicine), DM(Medical Oncology)(Adyar,Chennai), ECMO, MRCP SCE(UK)
Medical Oncologist
Dr. Owais Mohammed
MBBS, MD (General Medicine), DrNB (Medical Oncology), ECMO, MRCP SCE (Medical Oncology) (UK)
Medical Oncologist
Medical Oncologist
Surgical Oncologist
Dr. Muralidhar Muddusetty
MBBS (AIIMS), MS (Surgery) (AIIMS), DNB (Surgical Oncology), MRCS (Edinburgh)
Surgical Oncologist
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Sources
- American Cancer Society — Clinical Trials
- National Cancer Institute — What Are Clinical Trials?
- Clinical Trials Registry - India — Clinical Trials Registry - India
- American Cancer Society — What's New in Liver Cancer Research?
This page is general information, not a prescription. Do not change or stop any treatment based on what you read here. If anything is worrying you, contact your own treating team — or call our helpline and we will help you reach the right specialist.
Keep reading
Related pages
Patient assistance and drug access programmesHelp paying for medicines that are already approvedHow to find liver cancer trials in IndiaThe route your doctor will check firstThird-line treatment and beyondApproved options that may still be untriedShould I join a liver cancer trial?Weighing a trial honestly before you decide
Talk to us
Wondering whether any option is left to try?
Send us the reports and the list of medicines already tried, and an oncologist will tell you honestly whether an approved drug, a trial or an access request is realistic. One helpline serves every CION centre.