-Named Patient Supply · Rule 36, D&C Rules
A medicine that doesn't exist in India yet can still reach one named patient, legally.
We handle the import licence, the customs clearance, and the last-mile delivery for medicines not registered in India — for a specific patient, under a doctor's prescription, start to finish.
1. AEO — Authorised Economic Operator, Indian Customs
2. ISO 9001 certified
3. 30 yrs founder-led pharma regulatory experience
Chain of custody — patient to prescription
01. Overseas manufacturer:- Supplier confirmed, proforma invoice raised
02. Form 12A → CDSCO:- Personal import licence application
03. Form 12B issued:- Typically within 4 working days
04. Customs & ADC clearance:- Port clearance, Assistant Drug Controller sign-off
✓ Delivered to patient:- Courier, door to door
-The legal basis
How an unregistered medicine becomes legal to import
India permits this through a specific, well-defined mechanism — not a grey area. Here's the framework that makes it work.
RULE 36
Drugs & Cosmetics Rules
CDSCO's notified route for import of small quantities of an unregistered drug, exclusively for one identified patient's personal use.
RX
A registered practitioner's prescription
Naming the patient, the drug, quantity, condition, and the doctor's MCI registration number.
100
Average-dose ceiling
The quantity imported under this route cannot exceed 100 average doses — it is scoped to one patient's course of treatment, not stock.
12A/B
Two forms, one licence
Form 12A is the application; CDSCO reviews it and issues a quantity-specific Form 12B licence in the patient's name.
-Cost relief that's easy to miss
Duty can be waived entirely for life-saving medicines
Under Customs Notification 045/2025 (Serial. 401, Condition 59), Basic Customs Duty is exempted when a government medical authority — DGHS, the State Directorate of Health Services, or the District Medical Officer/Civil Surgeon — certifies, case by case, that the imported medicine is life-saving.
10% + 10% + 18%
BCD + Social Welfare Surcharge + GST — the standard stack this exemption can remove.
-Two ways we deliver
Match the model to how urgently the medicine is needed
Some patients need a one-off import; others are on an ongoing therapy where every cycle counts. We run both models — the difference is where the medicine sits before it moves.
Direct Import
Medicine ships from the overseas manufacturer only after the patient's order — typical lead time 2–3 weeks.
1. Patient outreach:- On the doctor's reference, we contact the patient directly
2. Licence & payment:- Form 12B application; assistance with the overseas payment
3. ADC & customs:- Assistant Drug Controller clearance at port, full customs handling
✓ Door delivery:- Courier to the patient, coordinated end to end
FTWZ Stock & Forward
4–5 DAYS
The overseas principal pre-positions stock in our Free Trade Warehousing Zone, ready to move the moment a prescription clears.
1. Duty-deferred storage:- Stock held at Asian's FTWZ, no duty until it moves to a patient
2. Licence in parallel:- Form 12B processed while stock is already in-country
3. ADC & customs, out of FTWZ:- Clearance from zone to domestic market on demand
✓ Just-in-time delivery:- Cuts weeks of international transit off every cycle
-Paperwork, handled
What the file needs to look like
Two separate document sets — one to get the licence, one to clear the shipment. We assemble both; here's what goes into each.
For the Form 12A licence application
Prescription naming patient, drug, quantity & condition, doctor's MCI number
Patient's name, address and age
Aadhaar or passport copy with photo
Overseas supplier's name, address & country, ideally with proforma invoice
Authorisation letter if someone else is applying on the patient's behalf
To clear the shipment at customs
Overseas supplier's invoice
Certificate of analysis
Packing list & airwaybill
Prescription copy & the Form 12B licence itself
Patient's photo ID and clearance authorisation
-Who this is for
Three kinds of people call us about this
Patients & families
Searching for a medicine their own doctor has prescribed but that isn't sold in India yet — usually under real time pressure.
Hospitals
Managing a patient's treatment plan and needing a partner who won't be the reason a cycle gets delayed.
Pharma & biotech companies
Supporting compassionate-use or early-access requests for a named patient ahead of formal Indian registration.
-Why a regulatory background matters here
This isn't a courier service with a customs form attached
A named-patient shipment sits across two demands at once: strict CDSCO documentation and a patient who can't afford a week's delay. That combination is where most generalist logistics providers stumble — and where our clients tell us they need someone who's sat on the regulatory side of the table, not just the shipping side.
Ashok Bindumadhavan
Founder & Director, Asian Supply Chain
- Indian Customs F-Card holder
- Headed India / Sri Lanka / Nepal supply chain at Eli Lilly & Company
- Vice Chairman, OPPI Materials Management Committee (2008–2010)
- Led the industry team behind OPPI's Cold Chain Guidelines
- Nominated to DCGI's committee for Pharma Zones at Indian ports
- Supply chain consultant to the Government of Mauritius
-Questions people actually ask
Named Patient Supply, plainly explained
Named patient supply logistics in India involves coordinating the import, handling, storage, and delivery of medicines required for an individual patient when the product is not readily available through regular supply channels. The process is managed according to applicable regulatory and handling requirements.
A named patient program logistics partner coordinates logistics activities such as shipment planning, documentation, customs coordination, storage, and delivery. The partner helps ensure that medicines are handled appropriately throughout the supply chain.
Pharmaceutical companies, healthcare organizations, clinical teams, and other authorized stakeholders may require named patient program logistics when specific medicines need to be supplied to individual patients under applicable regulatory frameworks.
CDSCO import logistics in India involves coordinating the logistics and documentation processes associated with importing pharmaceutical, medical, or healthcare products subject to applicable CDSCO requirements. It may include shipment planning, documentation, customs coordination, and controlled handling.
A logistics partner can assist with shipment coordination, required documentation, customs processes, storage, and transportation while working with the relevant stakeholders to meet applicable CDSCO and import requirements.
Named patient supplies may involve time-sensitive medicines, specific handling conditions, and regulatory requirements. Specialized logistics support helps coordinate these requirements carefully and can reduce avoidable delays while maintaining appropriate product handling throughout the process.