Named Patient Supply Program

Form 12A is the application a patient (or their authorised representative) submits to the CDSCO licensing authority to obtain permission to import a specific unregistered medicine for personal use.

Form 12A is the application; Form 12B is the licence itself. Once CDSCO reviews and accepts the Form 12A application, it issues a quantity-specific import licence under Form 12B, in the name of the patient.

Once a complete application is submitted, CDSCO typically issues the licence within 4 working days.

A complete application includes: a prescription from a registered medical practitioner (stating the patient's name, the drug prescribed, quantity, purpose, and the condition it's prescribed for, along with the doctor's stamp and MCI registration number); the patient's name, address, and age; an Aadhaar or passport copy with photo as identity and address proof; the overseas supplier's name, address, and country (ideally with a proforma invoice); and an authorisation letter if someone other than the patient is applying on their behalf.

Three components typically apply: Basic Customs Duty of 10%, a Social Welfare Surcharge of 10% on the basic customs duty, and GST of 18% calculated on the landed cost plus the basic customs duty and social welfare surcharge combined.

Yes, in specific circumstances. Under Customs Notification 45/2025 (Serial 401, Condition 59), basic customs duty can be exempted if: the goods are imported by an individual for personal use; a qualified government medical authority — the Director General, Deputy Director General, or Assistant Director General of Health Services (New Delhi), the Director of Health Services of the State Government, or the District Medical Officer/Civil Surgeon of the district — certifies, in that specific case, that the goods are life-saving drugs or medicines; and this certificate is produced to the Deputy/Assistant Commissioner of Customs at the time of clearance.

It must come from a government health authority — either the Directorate General of Health Services (DGHS) in New Delhi, the State Directorate of Health Services, or the District Medical Officer/Civil Surgeon of the relevant district — certifying, case by case, that the specific medicine qualifies as life-saving.

It depends on the arrangement. Individual patients or families typically pay directly for the medicine and the service fee. Where a pharmaceutical or biotech company is supporting a named-patient case (for example, ahead of formal Indian registration), the overseas company may instead cover the medicine cost and/or the service charges directly.

A complete shipment file typically includes: the invoice from the overseas supplier, a certificate of analysis, the packing list, the airwaybill, a copy of the prescription, the personal import licence (Form 12B), the patient's Aadhaar or other photo identification, and an authorisation to clear the shipment on the patient's behalf.

Personal import shipments under this route are typically small in quantity and time-sensitive given the patient's medical need, which is why they are almost always moved by air freight and cleared against an airwaybill rather than shipped by sea.

Many named-patient medicines — particularly biologics and oncology therapies — require continuous temperature control from origin to the patient. This is handled through validated cold-chain packaging and monitored transport, with the same GDP-aligned handling standards applied whether the shipment is a one-off import or moving through pre-positioned stock.

Broadly, two models are used, and which one applies depends on how the case is set up. In a Direct Import model, the medicine ships from the overseas manufacturer only after a specific patient's order and licence are in place — typical lead time is around 2–3 weeks. In a Stock & Forward model (typically used where an overseas pharma company is supporting an ongoing or recurring need), product is pre-positioned in a bonded/duty-deferred facility in India, such as a Free Trade Warehousing Zone (FTWZ), so it can move to a patient within days of a prescription and licence clearing — typically 4–5 days.

It matters most for ongoing therapies where a patient needs repeat doses over time — waiting 2–3 weeks for every cycle isn't practical. Pre-positioning stock in India removes the international transit time from each individual shipment, so once a patient's licence and paperwork are ready, delivery is a matter of days rather than weeks.

No import duty is payable while the medicine sits in the FTWZ — duty and other charges apply only when a specific quantity is released against a patient's own Form 12B licence, at which point the same customs and regulatory process applies as with a direct import.

All three. Individual patients and their families use this route directly, but hospitals managing a patient's treatment, and pharmaceutical or healthcare companies supporting compassionate-use or early-access situations for a specific patient, also rely on an experienced logistics and regulatory partner to execute this correctly and quickly.

For a one-off direct import, plan for roughly 2–3 weeks from a complete application to delivery, though this depends on the specific product's availability from the overseas supplier and how quickly documentation (particularly the prescription) is finalised. Where a case is set up under a Stock & Forward arrangement, delivery can be as fast as 4–5 days once the licence is in hand.

Incomplete or incorrect documentation is the most common cause of delay in this process — particularly a prescription missing required details like the doctor's MCI registration number, or quantity/purpose not clearly stated. Having the file checked by someone experienced with these applications before submission is the single biggest lever for avoiding an avoidable delay.

We support the full process end to end: procuring the personal import licence under Form 12B, pursuing duty exemption from DGHS based on a life-saving drug certificate from the government District Medical Officer, customs clearance of the shipment, arranging courier delivery to the patient, and coordinating directly between the patient (or hospital) and the overseas supplier throughout — across both the Direct Import and Stock & Forward delivery models.

This process sits across two demanding requirements at once — strict CDSCO regulatory compliance (correct Form 12A documentation, prescription details, licensing timelines) and time-critical, often temperature-sensitive shipment handling. Asian Supply Chain's founder has direct regulatory-side experience, including work with CDSCO/DCGI on pharma import matters and OPPI's Cold Chain Guidelines, and the company holds AEO (Authorised Economic Operator) status with Indian Customs and ISO 9001 certification — credentials that matter when a shipment cannot afford documentation errors or clearance delays.

Yes. End-to-end coordination between the patient (or the hospital managing their care) and the overseas supplier is part of the service, so the patient's family isn't left managing international logistics and customs paperwork on their own during an already difficult time.

Yes. This is one of Asian's core capabilities — FTWZ warehousing combined with the same regulatory and customs services used for direct imports, so an overseas pharma or biotech company can pre-position stock and have it ready to move to a named patient within days of a licence clearing.