When a medicine prescribed by a doctor is not approved or commercially available in India, patients and families may need to explore the applicable personal-use import process.
For certain medicines imported separately from a passenger's bona fide personal baggage, Rule 36 of the Drugs and Cosmetics Rules, 1945 provides a route involving Form 12A and Form 12B.
Understanding the difference between these forms is important. Form 12A is the application submitted to request permission to import a small quantity of medicine for personal use. Form 12B is the permit issued by the licensing authority when the application is approved.
This guide explains what the forms mean, what information and documents may be required, and how patients can prepare before applying.
Important disclaimer: This article is for general information only. It does not replace advice from CDSCO, Customs authorities, a treating physician or a qualified regulatory professional. The applicable requirements depend on the medicine, quantity and import circumstances.
What Are Form 12A and Form 12B?
Form 12A and Form 12B are prescribed under the second proviso to Rule 36 of the Drugs and Cosmetics Rules, 1945.
They relate to the import of small quantities of drugs for personal use when the medicine does not form part of bona fide personal baggage.
The two forms serve different purposes:
- Form 12A: The application submitted by the patient or applicant requesting permission to import the medicine.
- Form 12B: The permit issued by the licensing authority when the application is approved.
The licensing authority must be satisfied that the medicine is intended for bona fide personal use, that the quantity is reasonable and that it is covered by a prescription from a registered medical practitioner.
You can refer to the official Drugs and Cosmetics Rules, 1945 published by CDSCO.
When Is Form 12A and Form 12B Required?
The Form 12A and Form 12B process applies to certain medicines imported for personal use that do not form part of bona fide personal baggage.
Rule 36 describes two situations.
1. Medicine Carried as Bona Fide Personal Baggage
Small quantities of certain drugs may be imported as part of a passenger's bona fide baggage when they:
- Belong to the passenger.
- Are intended exclusively for the passenger's personal use.
- Are declared to Customs if the authorities direct.
- Do not exceed 100 average doses for any single drug, unless a larger quantity is sanctioned by the licensing authority in an exceptional case.
This baggage provision is distinct from the Form 12A and Form 12B process.
2. Medicine Imported Separately for Personal Use
If the medicine does not form part of bona fide personal baggage, it may be allowed to be imported under the second proviso to Rule 36, subject to the applicable conditions.
The process requires:
- An application in Form 12A.
- A prescription from a registered medical practitioner.
- A quantity considered reasonable by the licensing authority.
- Approval and issuance of the permit in Form 12B.
A prescription alone does not automatically authorize a separate international shipment. The applicable import permission should be confirmed before the medicine is dispatched.
What Documents Are Required for Form 12A?
The exact documents and information depend on the application and the requirements of the licensing authority.
The official CDSCO Form 12A application asks for information about the patient, medicine, quantity, country of import and prescribing doctor.
The preparation checklist below can help applicants organize the information.
1. Prescription From a Registered Medical Practitioner
A prescription is an important supporting document for a Form 12A application.
It should clearly identify:
- Patient details.
- Name of the prescribed medicine.
- Strength and dosage, where specified.
- Quantity required.
- Doctor's name.
- Doctor's registration number.
The prescription should establish the medical need for the medicine and support the quantity requested.
The official CDSCO application requires the prescription to be uploaded with the Form 12A application.
2. Form 12A Application
Form 12A is the application for permission to import small quantities of drugs for personal use.
The official application process requests details including:
- Applicant or patient information.
- Name of the medicine.
- Quantity of medicine.
- Dosage form.
- Pack-size description.
- Country from which the medicine will be imported.
- Prescribing doctor's name.
- Doctor's registration details.
- Prescription upload.
The applicant should ensure that the information matches the prescription and supporting documents.
You can access the official CDSCO Form 12A application.
3. Patient Information
The application requires patient details to establish who will use the medicine.
Applicants should prepare accurate patient information and ensure that the details are consistent across the application and prescription.
If someone is assisting the patient with the application, they should check the current CDSCO requirements for authorization and supporting documents.
CDSCO also provides a sample authorization letter from the patient through its personal-use import application section.
4. Medicine and Quantity Details
The medicine details in the application should match the prescription.
Applicants should prepare:
- Medicine name.
- Strength, where applicable.
- Dosage form, such as tablet, capsule or injection.
- Quantity requested.
- Pack-size description.
- Country of import.
The quantity must be reasonable in the opinion of the licensing authority and supported by the prescription.
Do not assume that the quantity prescribed will automatically be approved for import.
5. Prescribing Doctor's Details
The Form 12A application requests information about the prescribing doctor.
This includes:
- Doctor's name.
- Medical registration number.
- Prescription supporting the medicine requirement.
Applicants should check that the doctor's details are readable and consistent with the prescription.
How to Apply for Form 12A Through CDSCO
CDSCO provides an online facility for applications to import small quantities of drugs for personal use.
The general application process is as follows.
Step 1: Open the CDSCO Personal-Use Import Portal
Visit the official CDSCO Import of Small Quantity of Drugs for Personal Use portal.
Select the Form 12A application option.
Step 2: Enter Patient and Medicine Details
Provide the information requested in the application.
This includes patient details, medicine name, quantity, dosage form, pack-size description and country of import.
Review the entries carefully before proceeding.
Step 3: Enter the Prescribing Doctor's Details
Provide the doctor's name and medical registration details as requested.
Make sure the information matches the prescription.
Step 4: Upload the Prescription
Upload the prescription issued by the registered medical practitioner.
The prescription should clearly support the medicine and quantity requested.
Step 5: Generate, Sign and Upload Form 12A
The CDSCO application process provides a system-generated Form 12A.
Download the generated form, sign it and upload the signed copy in the relevant submission step.
Follow the instructions displayed on the portal.
Step 6: Submit the Application
Review the application and supporting documents before submission.
The portal provides an application-status facility. Applicants should retain the application details and monitor the status for any further instructions.
Important: Submitting Form 12A does not itself authorize the import. The applicant must wait for the licensing authority's decision and the applicable Form 12B permit before proceeding with a separate shipment under this route.
What Is Form 12B and When Is It Issued?
Form 12B is the permit for importing small quantities of drugs for personal use under Rule 36.
It is issued by the licensing authority after considering the Form 12A application and supporting information.
The permit identifies the medicine and the quantity allowed to be imported.
The 2024 version of the Drugs Rules published by CDSCO includes updated wording on the validity of Form 12B. It states that the permit remains in force, unless suspended or revoked, for as long as the patient requires the drug according to the prescription of a registered medical practitioner. The permit holder must submit details of medicines imported and utilised to the licensing authority annually.
Applicants should check the permit issued to them and follow its conditions.
You can refer to the CDSCO Drugs Rules publication for the applicable wording.
Form 12A vs Form 12B: What Is the Difference?
Detail
Form 12A
Form 12B
Purpose
Application for permission
Permit to import
Submitted or issued by
Applicant
Licensing authority
Main information
Patient, medicine, quantity, country and prescription
Medicine and permitted quantity
Role in the process
Requests approval
Records the permission granted
Import authorization
Does not itself authorize import
Provides the permit, subject to its conditions
The key difference: Form 12A is the application. Form 12B is the permit issued after approval.
Common Mistakes to Avoid When Preparing the Application
Incomplete or inconsistent information can lead to requests for clarification or delays.
Before submitting the application, check for these common issues:
1. Prescription Does Not Clearly Identify the Medicine
The medicine name, strength and quantity should be clear. Any mismatch between the prescription and application should be resolved before submission.
2. Missing Doctor Registration Details
The application requests the prescribing doctor's registration information. Check that the details are included and readable.
3. Incorrect Quantity
The quantity requested should be supported by the prescription and considered reasonable by the licensing authority.
4. Incomplete Medicine Details
Ensure the dosage form, pack-size description and country of import are entered accurately.
5. Unsigned Form 12A
The CDSCO online process instructs applicants to download the system-generated Form 12A, sign it and upload the signed document.
6. Arranging Shipment Before Permission
For a separate personal-use import under this route, submitting the application is not the same as receiving permission.
Confirm the applicable requirements and obtain the Form 12B permit before arranging the shipment.
What Happens After Form 12B Is Issued?
Once the permit is issued, the applicant should review its details and conditions before proceeding.
Check that:
- The patient details are correct.
- The medicine name matches the prescription.
- The permitted quantity is correct.
- The source country and other details are accurate.
- Any conditions stated in the permit are understood.
- The annual reporting requirement, where applicable, is followed.
The permit should be retained with the relevant prescription and import documentation.
The importer must also comply with applicable Customs requirements. A Form 12B permit does not remove the need to complete customs clearance or meet other applicable import conditions.
How Sowaka Health Can Help
Sowaka Health coordinates access to medicines prescribed by treating physicians that are not approved or commercially available in India, subject to the applicable regulatory pathway.
For a patient or family, the process can involve several connected steps:
- Understanding the medicine and physician-led request.
- Assessing the applicable import pathway.
- Coordinating required regulatory documentation.
- Supporting the sourcing process through authorized suppliers.
- Coordinating import and customs requirements.
- Arranging temperature-controlled logistics, where required.
- Coordinating delivery to the hospital or patient.
Sowaka Health does not prescribe medicines or replace the treating physician. The physician remains responsible for treatment decisions, while Sowaka Health coordinates the applicable access, regulatory and supply-chain process.
Learn more about Sowaka Health.
Checklist: Documents and Details to Prepare
Before starting a Form 12A application, prepare the following:
- Prescription from a registered medical practitioner.
- Patient details.
- Medicine name and strength.
- Dosage form.
- Quantity required.
- Pack-size description.
- Country from which the medicine will be imported.
- Prescribing doctor's name.
- Doctor's medical registration number.
- Any additional information or authorization requested by CDSCO.
Use the official CDSCO personal-use import portal to check the current application requirements.
Frequently Asked Questions
What is Form 12A in medicine import?
Form 12A is an application for permission to import small quantities of drugs for personal use under the second proviso to Rule 36 of the Drugs and Cosmetics Rules, 1945.
What is Form 12B?
Form 12B is the permit issued by the licensing authority when the application for importing small quantities of drugs for personal use is approved.
Is Form 12A enough to import medicine into India?
No. Form 12A is an application, not the import permit. For a separate personal-use import under this route, the applicant must obtain the applicable Form 12B permit before proceeding.
Is a doctor's prescription mandatory for Form 12A?
Rule 36 requires the requested quantity to be covered by a prescription from a registered medical practitioner. The CDSCO application also requires the prescription to be uploaded.
Can a family member apply on behalf of a patient?
A family member may assist with the application process. CDSCO provides a sample patient authorization letter through its personal-use import portal. Applicants should check the current requirements for authorization and supporting documents.
How long is Form 12B valid?
The 2024 Drugs Rules publication states that Form 12B remains in force, unless suspended or revoked, for as long as the patient requires the drug according to the prescription of a registered medical practitioner. It also requires the permit holder to submit details of drugs imported and utilised to the licensing authority annually.
Always check the conditions stated on the permit actually issued.
Can I import medicine after submitting Form 12A?
Submitting Form 12A does not itself grant permission. For a separate personal-use import under this route, wait for the licensing authority to issue Form 12B and check the permit conditions before arranging the shipment.
Does Form 12B remove customs requirements?
No. Form 12B is a drug import permit under Rule 36. The importer must still comply with applicable Customs procedures, documentation and assessment requirements.
Final Thoughts
Form 12A and Form 12B are important parts of the personal-use import process for certain medicines that do not form part of bona fide personal baggage.
Form 12A is the application submitted by the applicant, supported by a prescription from a registered medical practitioner. Form 12B is the permit issued by the licensing authority when the applicable conditions are satisfied.
Before arranging an international shipment, patients and families should confirm the applicable import route, prepare accurate documents and wait for the required permission.
For medicines that are not commercially available in India, coordinating the physician, regulatory documentation, authorized sourcing and logistics requirements can help make the access process clearer.