Human blood

Human blood for diagnostic or therapeutic purposes

DGFT CLEARANCE

HSN 3002 90 10 (Human blood) is governed by the Directorate General of Foreign Trade (DGFT) import policy under ITC (HS) Policy Condition 1 to Chapter 30, which establishes a dual-track regime: import of blood and biological material for diagnostic or therapeutic purposes for individual cases is Free, while import of human biological material for bio-medical purposes is referred to the Indian Council of Medical Research (ICMR) and the Ministry of Health and Family Welfare. Six mandatory documents must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 90 10

Chapter

30 · Pharmaceutical products

Primary regulator

DGFT · ITC (HS) Policy Condition 1 to Chapter 30 (dual-track import regime)

Customs documentation

Import licence for drugs from DGFT
Registration certificate from CDSCO
Batch release certificate from manufacturer

Compliance steps

1
Determine which track applies before filing the bill of entry. If importing blood or biological material for diagnostic or therapeutic purposes for individual cases, the import is Free under ITC (HS) Policy Condition 1 to Chapter 30. If importing human biological material for bio-medical purposes, obtain prior referral clearance from ICMR and the Ministry of Health and Family Welfare before shipment.
ITC (HS) Policy Condition 1 to Chapter 30
2
Upload all six mandatory documents in e-Sanchit before filing the bill of entry: blood analysis report (document code 001003), certificate of analysis for drugs (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The customs proper officer will verify all six codes are present before granting out-of-charge.
ITC (HS) Policy Condition 1 to Chapter 30 · e-Sanchit document codes 001003, 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is conflating the Free track (individual diagnostic or therapeutic cases) with the bio-medical-purposes track, and filing the bill of entry under the Free category without the ICMR referral when the actual end-use is bio-medical research. Customs proper officers are instructed to verify the mandatory document set in e-Sanchit before out-of-charge; a missing registration certificate (101dc1) or import licence (9111dc) — even on a Free-track consignment — will result in consignment detention and accumulating demurrage and ground rent until the document is uploaded.

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Frequently asked

Does HSN 3002 90 10 require BIS certification?

No, human blood falls outside the BIS Quality Control Order regime entirely. Import is governed by the Directorate General of Foreign Trade under ITC (HS) Policy Condition 1 to Chapter 30, with a dual-track framework distinguishing individual diagnostic or therapeutic use (Free) from bio-medical-purpose imports (ICMR and Ministry of Health and Family Welfare referral required).

What are the six mandatory e-Sanchit documents for this tariff line?

The mandatory documents are: blood analysis report (001003), certificate of analysis for drugs (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be uploaded before customs out-of-charge.

When does the ICMR referral requirement trigger, and what happens if it is absent?

The ICMR and Ministry of Health and Family Welfare referral is triggered whenever the declared end-use is bio-medical rather than individual diagnostic or therapeutic treatment. An import shipped without prior referral clearance is liable to detention and potential confiscation as an unauthorised import under the ITC (HS) Restricted-category provisions.

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