npp · 6 min read
Named Patient Programmes: A Step-by-Step Guide to Form 12A and 12B
How patients in India and abroad legally access medicines that are not approved in their country — the CDSCO pathway explained in plain language.
A Named Patient Programme (NPP) allows a specific patient, with a specific prescription, to legally import a medicine that is not approved or commercially available in their country.
Step 1 — Physician justification The treating doctor must document why no locally available alternative is suitable. This letter of justification is the foundation of the application.
Step 2 — Form 12A application Form 12A is submitted to the national drug authority (CDSCO in India) along with the prescription, patient identity proof and medical reports. It requests permission to import a specified quantity of a specified medicine for a named patient.
Step 3 — Form 12B permit If the authority is satisfied, it issues Form 12B — the actual import permit. Typical processing time is 24–72 hours for complete applications.
Step 4 — Sourcing and shipping With the permit in hand, the medicine is sourced from licensed suppliers and shipped with the permit copy, invoice and prescription in the documentation pouch.
Step 5 — Customs clearance and delivery The permit is presented at customs, and the consignment is released for delivery to the patient or their hospital.
Eviga's NPP team handles documentation, submission and sourcing as a single workflow — you can start an application from the Named Patient Programme page.