Form 12A and Form 12B: How to Import a Prescribed Medicine for Personal Use in India
Form 12A and Form 12B at a glance
| Point | Detail |
|---|---|
| Law | Rule 36 (second proviso), Drugs and Cosmetics Rules, 1945 |
| Form 12A | Application for a permit to import small quantities of drugs for personal use |
| Form 12B | The permit, which names the drug and the quantity allowed |
| Who it is for | One named patient who needs a medicine that is not available in India |
| Quantity limit | Up to 100 average doses of any single drug (more only in an exceptional case) |
| Time to issue | On priority, preferably within one or two days |
| Validity | Six months from the date of issue |
| Where it is filed | Online at cdscoonline.gov.in, or with CDSCO HQ in New Delhi or a CDSCO port office |
What is Form 12A?
Form 12A is the request that starts a personal import. It tells CDSCO who the patient is, which medicine the doctor has prescribed, and how much of it is needed. The application is in the patient's name, even when a family member or a service like NPP prepares the paperwork.
On the online version, the applicant fills in the patient's name, address and occupation; the medicine's name, dosage form, pack size and quantity; the prescribing doctor's name and medical council registration number; and the CDSCO airport or seaport office where the medicine will arrive. The form is verified by email and mobile OTP, and the signed, system-generated Form 12A is uploaded with the other documents.
What is Form 12B?
Form 12B is the import permit. CDSCO issues it once it is satisfied of three things: the medicine is for the patient's own use, the quantity is reasonable, and a registered doctor has prescribed it. The permit lists the drug and the exact quantity that can come in. If the prescription says six vials, the shipment cannot carry eight.
The permit stays valid for six months, unless CDSCO suspends or cancels it earlier. A patient on a longer treatment plan needs a fresh application when the permit runs out or the quantity is used up.
Who needs a Form 12B permit?
You need one when the medicine is not approved or not sold in India, a registered doctor has prescribed it for a specific patient, and it is coming by courier or cargo rather than in the patient's own luggage. This is the legal base of a named patient program: the medicine is brought in for one person, against one prescription, and is never sold as open stock.
Step-by-step: from prescription to permit
Prescription
Medicine, dose, quantity, duration and the doctor's registration number.
Form 12A
Patient and medicine details, documents uploaded, arrival port chosen.
Form 12B
CDSCO review on priority, usually one or two days.
Import & delivery
Shipped under label storage, cleared through customs, delivered.
Not sure your prescription has everything? Our prescription guidelines show what a usable prescription looks like. At collection, the original application and prescription are shown to the port office.
Documents checklist
- Prescription from a registered medical practitioner (medicine, quantity, duration, registration number)
- Patient's ID proof
- ID proof of the person collecting the consignment
- Signed Form 12A
- Diagnosis and treatment history (not mandatory for CDSCO, but NPP asks for it because it helps the review)
How much medicine can be imported on one permit?
CDSCO's rule is that a single drug should not go above 100 average doses. In an exceptional case, the licensing authority can allow more. The quantity must also match the prescription.
What "100 doses" means changes from drug to drug. For a once-daily tablet, it is a little over three months of treatment. For a drug dosed by body weight, such as Trodelvy, the prescription has to show the weight and the dose so the number of vials can be worked out.
Where are applications handled?
CDSCO headquarters at FDA Bhawan, New Delhi, and its port offices at New Delhi, Mumbai, Navi Mumbai (Nava Sheva), Chennai, Kolkata, Hyderabad, Bengaluru, Ahmedabad and Cochin.
Common reasons for delay
- The prescription does not state the quantity or the length of treatment.
- The doctor's registration number is missing.
- The quantity asked for is more than the prescription supports.
- The ID of the person collecting the consignment is not uploaded.
Almost every delay we see comes from paperwork, not from CDSCO. That is why the documents are checked before anything is filed.
How NPP helps with Form 12A and Form 12B
A registered pharmacist at NPP reviews the prescription and reports first, prepares the Form 12A application in the patient's name, and flags anything missing on day one. Once the Form 12B permit is issued, we buy the medicine from authorised channels and ship it under its label conditions. For refrigerated medicines that means 2°C to 8°C with a temperature logger, as described on our temperature-controlled shipping page, and it goes to the treating hospital, as explained in our guide to hospital delivery across India. For the wider legal picture, read our guide to Indian import regulations.
The permit settles the legal side, not the cost. If paying for the medicine is the harder part, our patient support and access programs guide explains the government funds and charities that families apply to alongside the import.
Need a medicine that is not available in India?
Share the prescription and we will tell you what the Form 12A application needs.
Form 12A and 12B: questions patients ask
Is Form 12A the same as Form 12B?
No. Form 12A is the application the patient files. Form 12B is the permit CDSCO issues in reply.
How long does a Form 12B permit take?
CDSCO's notice says it is issued on priority, preferably within one or two days, once the documents are complete.
Is there a government fee for Form 12A?
No fee is prescribed under Rule 36. Customs duty and GST on the medicine itself are separate.
Can a family member apply for the patient?
The application is in the patient's name. A family member can help fill it in and can collect the consignment, but their ID proof must be uploaded with the form.
Can one permit cover a whole year of treatment?
Not usually. The permit lasts six months and covers up to 100 average doses of a drug. A longer treatment needs a new application.
Do I need Form 12B if the medicine is already sold in India?
No. Form 12A and 12B are for medicines that are not approved or not available in India.
References
- CDSCO. Procedure for permission to import small quantities of drugs for personal use. cdsco.gov.in
- CDSCO. Form 12A. cdsco.gov.in
- CDSCO. Form 12B. cdsco.gov.in
- CDSCO online portal, Form 12A. cdscoonline.gov.in
This page gives general information only and does not replace legal or medical advice. Rules can change; check CDSCO's latest notice before you apply.