IN A NUTSHELL Author's NoteA cancer or rare disease medicine can be approved in the United States or Europe and still be unavailable in India for years. Sometimes the company never applies for approval here at all. When a patient's doctor believes that medicine is the right next step, this gap decides what treatment is possible. Indian law lets a patient import a small quantity of a medicine that is not approved in India for their own use, on a doctor's prescription, with a free permit from the national drug regulator. The permit is the easy part. Cost, paperwork, distance from a port city and the cold chain decide who can actually use the route. We are Team NPP-Named Patient Program (Ikris Pharma Network), and helping patients and doctors use this route is our daily work. That gives us an interest in the route working well, so we have tried to describe its limits as plainly as its strengths. Similar routes exist in many countries under names such as compassionate use, managed access or named patient supply, and the problems we describe are unlikely to be India's alone. Key points Rule 36 of India's Drugs and Cosmetics Rules,1945 allows a small quantity of an unapproved medicine to be imported for personal use, on a doctor's prescription. The CDSCO permit (Form 12B) carries no fee and, according to the regulator, is issued "preferably in a day or two". In practice, a complete prescription, genuine sourcing, an unbroken cold chain and safety reporting decide how well the route works. Cost, distance from a port city and long treatment still leave many patients out. Clear guidance, one online process, a link to public financing, open permit data and shared standards for importers could make it fairer.
By Team NPP
Named Patient Program (Ikris Pharma Network)
Noida, India
Approved Abroad, Out of Reach at Home
Who Can Use India’s Personal Import Route for Medicines?
Why do approved medicines reach India late?
A medicine reaches Indian pharmacies only after the manufacturer applies to India’s regulator and the product is approved here. The regulator has made part of this easier. Under Rule 101 of the New Drugs and Clinical Trials Rules, 2019, an order dated 7 August 2024 named six jurisdictions whose approvals can be considered when deciding whether to waive local clinical trials:
- the USA, the UK, Japan, Australia, Canada and the European Union.
The order covers specific categories, including:
- orphan drugs for rare diseases;
- gene and cellular therapies;
- new drugs with a significant therapeutic advance over current treatment.
The waiver can shorten the path, but the regulator decides each case, and it helps only when a company applies. Whether and when a medicine is launched in India remains the manufacturer’s decision. Until then, the patient has to look elsewhere.
How does the personal import route work on paper?
Rule 36 of the Drugs and Cosmetics Rules, 1945 allows small quantities of a drug that is otherwise not permitted in India to be imported for personal use. The Central Drugs Standard Control Organisation (CDSCO) sets out the procedure in a public notice:
- The applicant files Form 12A with a prescription from a registered medical practitioner.
- The prescription shows the doctor’s registration number, the drug, the quantity and the duration of treatment.
- If the licensing authority is satisfied that the quantity is reasonable, it grants a permit in Form 12B.
- The notice says this is done on priority, “preferably in a day or two”, and that no fee is charged.
For a regulatory process, that is simple, free and quick, and it was written with the patient in mind. The notice itself says such drugs are sometimes needed “to save their lives”.
What does it involve in practice?
Getting a medicine safely from a foreign supplier to a patient’s home takes several more steps after the permit, and a family can get stuck at any of them.
A complete prescription
The CDSCO notice lists the minimum. In our experience a request moves faster when the prescription is on the hospital or clinic letterhead and shows:
- the doctor’s full name, contact details and registration number;
- the patient’s full name, date of birth and diagnosis;
- the medicine’s name, strength and dosage form;
- the dose, the length of treatment and the total quantity;
- the date, and the doctor’s signature and stamp.
The doctor may be asked for a short clinical justification, and a medical summary with the treatment history often helps. If one of these details is missing, the request goes back to the doctor and the clock starts again. An oncologist at a large city hospital may have written such prescriptions many times. A doctor in a district hospital may never have seen one, and the family usually finds out about the gap only when the delay has already happened.
A genuine medicine
A medicine imported for one patient should come through authorised pharmaceutical channels, with documents that link the box in the patient’s hands to a known manufacturer and batch. Families searching online under pressure are sometimes offered stock from sources that cannot show this. A low price or a fast delivery promise says nothing about where a product came from, and a family has few ways to check that alone.
An unbroken cold chain
Many of these medicines must stay within a fixed temperature range:
- room temperature: 15 to 25°C;
- refrigerated: 2 to 8°C;
- frozen: around -20°C.
A single shipment for one patient needs packaging chosen for that range and for the length of the journey, a temperature-monitoring device travelling with it, and a check of the temperature record on delivery. If the record shows the range was broken, the medicine may not be safe to use even when the box looks perfect. For a family that has already paid the full import price, finding this out at the bedside is the worst moment to find it out.
Someone responsible for side effects
A medicine imported for one person sits outside the usual commercial supply chain, but its side effects matter just as much. Someone has to record a suspected reaction with the medicine’s name, manufacturer, batch number and expiry date, and pass it to the manufacturer and the relevant safety authorities. Patients should tell their treating doctor first. When nobody is clearly responsible for this step, information about how a new medicine behaves in Indian patients can simply disappear.
One named patient, every time
The medicine is only for the personal treatment of the patient named in the prescription. It cannot be resold, shared or kept in stock by a hospital. The rule protects patients, but it also means every new patient starts from the beginning. A family member or carer can handle the paperwork with the patient’s consent, which matters when the patient is too unwell to do it.
Who does the route leave out?
People who cannot pay the import price
The permit is free. The medicine is not, and Rule 36 says nothing about who pays for it. Unless some scheme helps, the family pays the full import price. The main public support for this kind of cost is the National Policy for Rare Diseases, 2021. In a 2022 statement, the Health Ministry said the policy offers up to Rs 50 lakh to patients with rare diseases for treatment at one of its Centres of Excellence, of which eight had been identified at that time. That help is real, but it is tied to listed rare diseases and to specific centres. A patient whose doctor prescribes a new cancer medicine falls outside it, and so does a rare disease patient treated far from those centres. The legal route is open to everyone, but the medicine is affordable only for some.
People far from a port city
According to the CDSCO notice, permits come from the Drugs Controller General’s office in New Delhi and from CDSCO port offices at airports and seaports in Delhi, Mumbai, Navi Mumbai, Chennai, Kolkata, Hyderabad, Bengaluru, Ahmedabad and Kochi. A family in a smaller town has to work through one of these cities, and so does the shipment. For a refrigerated medicine, the road from the port city to the patient is one more stretch where the cold chain can fail.
People on long treatment
The rule talks about small quantities and allows larger amounts only in exceptional cases. Many patients who need these medicines are on treatment for months or years. For them, access becomes a cycle of repeat prescriptions, repeat applications and repeat shipments, and a delay in any one round can mean a gap in treatment.
What could make the route fairer?
Most of these ideas need better information and coordination between regulators, payers, manufacturers and importers rather than new law.
- A plain-language guide. A short guide from the regulator, in Indian languages, with a sample prescription that shows every detail needed, so doctors outside large centres get it right the first time.
- One online process. A single online way to file and track Form 12A that works the same at every port office, so that living near a major city stops mattering so much.
- A clear link to public financing. Families should know before they apply whether any central or state scheme can help pay for a medicine imported under Rule 36. The rare disease policy shows that targeted support is possible; the open question is how far it can reach.
- Published data on permits. Regular figures on how many Form 12B permits are issued, for which medicines and how long they take would show where unmet need is concentrated. Regulators could use them when weighing Rule 101 waivers, and manufacturers could see where an Indian launch is overdue.
- Shared minimum standards for importers. Authorised sourcing, a temperature record for every shipment and a named person for safety reporting, so that a family’s safety does not depend on which supplier they happened to find.
Personal import is meant for individual patients, and it should stay that way. It cannot replace timely approval and fair pricing. As long as the gap between global approval and Indian availability exists, though, the route should work as well for a family in a district town as it does for a family near a metro airport.
About the Author Team NPP is the patient access team at Named Patient Program (NPP), part of Ikris Pharma Network, based in Noida, India. The team helps patients and doctors in India obtain medicines that are approved abroad but not yet available in India, through the legal personal import route. namedpatientprogram.com