Drugs and Medicines

Drugs and medicines imported for personal use

DGFT CLEARANCE

HSN 9804 10 00 (Drugs and Medicines) is classified as Free under the ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT), subject to conditions specified by the Directorate General of Health Services (DGHS). Five mandatory documents — including a Drug Import Licence and Registration Certificate — must be uploaded in e-Sanchit before customs out-of-charge at the bill-of-entry stage.

What this is

HSN code

9804 10 00

Chapter

98 · Project imports; laboratory chemicals; passengers' baggage

Primary regulator

DGFT · ITC (HS) Free import policy subject to DGHS conditions, Chapter 98

Customs documentation

Import Licence for Drugs from DGHS
Registration Certificate from DGHS
Batch Release Certificate from supplier

Compliance steps

1
Confirm that the import satisfies the conditions specified by the Directorate General of Health Services applicable to personal-use drugs and medicines under this CTI. The Import Licence for Drugs (document code 9111DC) and the Registration Certificate for Drugs (document code 101DC1) must be current and valid at the time of filing the bill of entry.
ITC (HS) Import Policy, Chapter 98 — Free with DGHS conditions
2
Upload all five mandatory documents in e-Sanchit before the bill of entry is presented for out-of-charge: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Registration Certificate for Drugs (101DC1), and Import Licence for Drugs (9111DC). Absence of any single document will prevent out-of-charge clearance.
e-Sanchit mandatory document upload requirement · document codes 0010DC, 0030DC, 0110DC, 101DC1, 9111DC

A word of counsel

The most frequent error on this tariff line is uploading the Import Licence (9111DC) while omitting either the Batch Release Certificate (0030DC) or the Certificate of Analysis (0010DC), treating these as secondary documents. All five documents carry equal mandatory status in e-Sanchit, and customs out-of-charge is blocked if any one is absent — resulting in consignment detention, demurrage, and potential ground rent liability while documents are sourced retrospectively.

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Frequently asked

Does HSN 9804 10 00 require BIS certification?

No, personal-use drugs and medicines are not within the BIS Quality Control Order regime. Import is governed by the ITC (HS) Free policy subject to conditions specified by the Directorate General of Health Services, with five mandatory documents required in e-Sanchit at the bill-of-entry stage.

Are all five e-Sanchit documents required for every personal-use drugs consignment under this HSN?

Yes. Document codes 0010DC, 0030DC, 0110DC, 101DC1, and 9111DC are each listed as mandatory; the customs proper officer verifies their upload in e-Sanchit before granting out-of-charge, and no partial compliance is accepted.

Does the Free import status under ITC (HS) mean no conditions apply to personal-use drugs?

No. Free status indicates that no separate DGFT licence is needed for import, but the import remains subject to conditions specified by the Directorate General of Health Services; failure to satisfy those conditions or to produce the mandatory documents attracts detention and refusal of out-of-charge.

Last verified against gazette notifications: 2026-05-16. Source: DGFT / Indian Customs CUSDATA.