In India, some patients may need medicines that are not normally available in the country. Rule 36 of the Drugs and Cosmetics Rules, 1945 allows a small quantity of such medicine to be imported for personal treatment.
If the application is accepted, the licensing authority issues Form 12B as the permit to import the approved quantity for personal use.
This article looks at the Form 12A/Form 12B route used when medicine is sent separately for one patient. It covers who can apply, what documents are needed, how the request is submitted and the main conditions that apply.
What Is the Named Patient Program in India?
The Drugs and Cosmetics Rules do not formally call Rule 36 a “Named Patient Program.” CDSCO instead covers this route under Drugs for Personal Use. When a medicine is imported separately for a patient and is not part of a passenger’s bona fide baggage, the application is made in Form 12A, and the import permit is issued in Form 12B.
Here, Named Patient Program (NPP) is used for the Form 12A/Form 12B route where a medicine is brought into India for one patient. The request must be backed by a prescription from a Registered Medical Practitioner, and the licensing authority considers whether the medicine is for bona fide personal use and whether the quantity requested is reasonable.
A traveller carrying their own medicine in personal baggage is also covered by Rule 36, but that is a separate baggage provision. The usual limit is 100 average doses of any single drug, unless a larger quantity is specially permitted in an exceptional individual case.
Who Can Use the Form 12A/Form 12B Route?
The Form 12A/Form 12B route applies when a drug is being imported for an individual patient’s bona fide personal use and is not being carried as part of the passenger’s baggage. The quantity must be considered reasonable by the licensing authority and must be supported by a prescription from a Registered Medical Practitioner.
Documents Required for Form 12A
To apply, the patient submits Form 12A along with a prescription from a Registered Medical Practitioner. The prescription should state the medicine name, quantity required and duration of medication. The doctor’s registration number should also be given.
Applications for import of small quantities of drugs for personal use are submitted online through the SUGAM portal. CDSCO provides this facility directly to the general public, and a separate SUGAM account is not required to submit the Form 12A application.
Form 12B Validity and Reporting Requirements
Once Form 12B is issued, the permit does not expire after a fixed six-month period. Under the current rule, it remains valid for as long as the patient needs the medicine according to the prescription of a Registered Medical Practitioner.
The permit holder must also submit details of the drugs imported and used to the licensing authority on a yearly basis. This requirement was added through the 2018 amendment to Rule 36 and is reflected in the current consolidated Drugs Rules.
How to Apply for Form 12A and Obtain Form 12B
The process generally involves:
- Open the SUGAM personal-use import service.
- Select the Form 12A application option.
- Enter the patient and medicine details.
- Upload the prescription and any other information or supporting documents requested through the SUGAM application.
- Submit the application for CDSCO review.
- If the request is accepted, Form 12B is issued as the permit for import.
CDSCO’s official procedure says these applications are handled on a priority basis, preferably within one or two days. No fee is prescribed under Rule 36 for this permission.
Named Patient Access vs Compassionate Use in India
Named patient access under the Rule 36 personal-use import route should not be confused with compassionate use of an unapproved new drug.
Rule 36 deals with importing a small quantity of a medicine for an individual patient’s personal use. The Form 12A/Form 12B route is used when the medicine is being imported separately rather than carried in personal baggage.
Compassionate use is a broader term generally used for access to unapproved medicines in serious or life-threatening situations. It should not be treated as the same regulatory route as the personal-use import mechanism established under Rule 36.
Conclusion
Rule 36 allows a patient in India to import a small quantity of medicine for personal treatment. If the medicine is shipped separately rather than carried in the patient’s luggage, the request is made in Form 12A with a prescription from a Registered Medical Practitioner. The licensing authority issues Form 12B when the request is approved.
The permission is meant for the individual patient’s personal use and does not amount to a general approval to market or commercially distribute the medicine in India. Patients should also make sure that the quantity requested, prescription details and annual reporting requirements are met throughout the period covered by the Form 12B permit.
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FAQs
1. What is the Named Patient Program in India?
“Named Patient Program” is not the formal name used in the Drugs and Cosmetics Rules. In this article, it refers to the patient-specific import route under Rule 36 where a medicine is imported separately for an individual patient using Form 12A and Form 12B.
2. What is Form 12A?
Form 12A is the application used when a patient wants permission to import a small quantity of a drug for personal use and the medicine is not being carried as part of the passenger’s personal baggage.
3. What is Form 12B?
Form 12B is the permit issued by the licensing authority after the Form 12A request is accepted. It allows the approved quantity of the medicine to be imported for that patient’s personal use.
4. How long does CDSCO take to issue Form 12B?
CDSCO states that permission is handled on a priority basis and is preferably issued within one or two days.
5. Is there a fee for Form 12A or Form 12B?
No fee is prescribed under Rule 36 for this personal-use import permission.
6. How long is Form 12B valid?
Form 12B stays valid for the period the medicine is needed, based on the prescription from the Registered Medical Practitioner. The permit holder must also report the quantity imported and used to the licensing authority once each year.
7. Can a traveller carry medicine into India without Form 12A?
Yes. Rule 36 separately allows a traveller to carry medicine as part of bona fide personal baggage for their own use. The usual limit is 100 average doses of any single drug, unless a larger quantity is specially permitted.
8. Is named patient access the same as compassionate use in India?
No. The Rule 36 route is a personal-use import mechanism. Compassionate use is a broader concept used for access to unapproved medicines in serious or life-threatening situations and should not be treated as the same regulatory route.
