Introduction: Why Named Patient Import Matters in India
Rare diseases affect about 300 million people worldwide. In India alone, an estimated 70 million people live with rare genetic conditions, many of which are difficult to diagnose or treat due to limited awareness, testing facilities, and available therapies. With over 4,000 rare diseases already identified by the Indian Council of Medical Research, including conditions like thalassemia, haemophilia, and spinal muscular atrophy, the need for timely access to specialized medicines has never been greater.
This is where access pathways like named patient import become vital. Since many orphan drugs, those meant to treat rare diseases, are not yet approved or marketed in India, patients often rely on special permissions to access life-saving medicines approved abroad. In a country where regulatory approvals take time and local availability remains patchy, such systems can make the difference between having treatment options and having none at all.1-3
What Is a Named Patient Import?
A Named Patient Import allows individuals in India to bring in medicines for their own personal treatment when those medicines may not be easily available in the country. Under Rule 36 of the Drugs & Cosmetics Rules, patients can legally import small quantities of such medicines, either in their baggage or with special approval, strictly for personal use.
The process is simple and regulated: patients need a valid prescription from a registered medical practitioner (with their MCI number) and must submit Form 12A to the Central Drugs Standard Control Organization (CDSCO). Once reviewed and approved, permission is granted through Form 12B, often within a couple of days. This system ensures patients can access essential or life-saving medicines safely and legally, without facing unnecessary delays or costs.4
Who Can Apply: Eligibility Criteria for Patients and Doctors
Patients in India can apply for named patient import if the medicine they need is not available in the country and is required for their personal treatment. The import must be strictly for personal use and limited to small quantities.
To be eligible, the patient must have a valid prescription from a registered medical practitioner that clearly mentions the medicine’s name, quantity, duration of use, and includes the doctor’s MCI number. The prescribing doctor should be recognized by the Medical Council of India (MCI) and must confirm that the medicine is essential for the patient’s treatment.4
Named Patient Import: Step-by-Step
This step-by-step process ensures that patients in India can legally access life-saving or essential medicines for personal use, even if those medicines are not yet available in the Indian market.3,4
Step 1: Doctor’s Prescription and Medical Justification
The process begins with a valid prescription from a registered medical practitioner. The prescription must include the doctor’s MCI number and clearly mention the drug’s name, quantity, and duration of use to justify why the medicine is needed for the patient’s treatment.
Step 2: Identifying the Unapproved or Unavailable Medicine
This route applies when the required medicine is not available or marketed in India. The medicine may be approved by authorities in other countries but not yet listed or accessible locally.
Step 3: Submitting the Application to CDSCO (Central Drugs Standard Control Organization)
The patient or their representative must submit an application in Form 12A to the CDSCO port office, along with the doctor’s prescription and other supporting details.
Step 4: Required Documentation and Patient Consent
The submission must include the completed Form 12A, the valid medical prescription, and any relevant documents confirming that the medicine is for the patient’s personal use only.
Step 5: Review and Approval Process by CDSCO
Once received, CDSCO reviews the application. If all details are in order, permission to import the medicine is issued in Form 12B—often within one or two days.
Step 6: Import License and Customs Clearance
The approval under Form 12B serves as official authorization to import the medicine. The medicine can then be brought into India, either carried personally in baggage or cleared through customs under the approved quantity limit (usually up to 100 average doses).
Step 7: Dispensing the Medicine to the Patient
After clearance, the medicine is handed over for the patient’s personal treatment use. This streamlined process ensures that patients can legally and safely access essential medicines not otherwise available in India.
Responsibilities of Doctors
The physicians have an obligation not only to initiate the named patient application but also to ensure ongoing safety monitoring and transparent reporting to regulatory authorities as part of their ethical and regulatory duties in named patient cases.
Challenges and Limitations of Named Patient Import in India
The Named Patient Import route in India provides a crucial lifeline for patients with rare diseases who need access to orphan drugs not yet approved in the country. However, it also comes with several challenges and limitations. Since India does not have national legislation or a comprehensive rare disease policy, patients relying on this route often have to bear the full cost of these high-priced medicines themselves. Unlike developed countries that offer structured reimbursement systems or government-backed support, the cost in India is largely out-of-pocket, with only limited help from NGOs or patient groups.
Another major challenge lies in how access decisions are made. India’s Health Technology Assessment (HTA) framework evaluates both the clinical effectiveness and cost-effectiveness of treatments. As a result, the process of approval, pricing, and access through the NPI route becomes complex.5
Conclusion
The Named Patient Import route plays a vital role in bridging the treatment gap for rare disease patients in India, offering access to life-saving medicines that are otherwise unavailable in the country. However, while it provides hope, it also highlights the urgent need for stronger national policies, financial support systems, and faster regulatory pathways to make orphan drugs more accessible and affordable.1-5
Note:
The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment.
Disclaimer:
Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import.
References:
- Sheth J, Nair A, Sheth F, et al. Burden of rare genetic disorders in India: twenty-two years' experience of a tertiary centre. Orphanet J Rare Dis. 2024;19(1):295. Published 2024 Aug 13. doi:10.1186/s13023-024-03300-z
- Gahilod RS, Veeranna B, Thakre S. Orphan drug development policies in India and the United States: a comparison. Indian J Pharm Educ Res. 2023;57(2):329-336. doi:10.5530/ijper.57.2.42
- Rajueni K, Chakraborty Choudhury M. Assessment of the availability of repurposed orphan drugs in India. PLOS Glob Public Health. 2023;3(9):e0001498. Published 2023 Sep 27. doi:10.1371/journal.pgph.0001498
- Central Drugs Standard Control Organisation. Procedures To Import Small Quantities of Drugs for Personal Use: Notice. Ministry of Health & Family Welfare, Government of India. February 19, 2015. Accessed August 25, 2025. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadConsumer/ProcedureforpermissiontoImportSmallQuantitiesofDrugsForPersonalUse_link.pdf
- Gammie T, Lu CY, Babar ZU. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries. PLoS One. 2015;10(10):e0140002. Published 2015 Oct 9. doi:10.1371/journal.pone.0140002
