Other

Other medicaments for therapeutic or prophylactic use, retail packed

MOHFW CLEARANCE · MEFCC CLEARANCE

HSN 3004 39 90 (other retail-packed medicaments) is subject to Ministry of Health and Family Welfare (MOHFW) import controls under the Drugs and Cosmetics Act, 1940, including mandatory drug registration and import licensing administered through the Central Drugs Standard Control Organisation. The Ministry of Environment, Forest and Climate Change (MEFCC) conditions apply to used or refurbished medical equipment, and the Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy, which includes absolute prohibitions on chloramphenicol formulations, nitrofurans formulations, and oxytocin.

What this is

HSN code

3004 39 90

Chapter

30 · Pharmaceutical products

Primary regulator

MOHFW · Drugs and Cosmetics Act, 1940 (drug registration and import licensing regime)

Customs documentation

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

Applicable Partner Government Agencies

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate and import licence for drugs from the Central Drugs Standard Control Organisation before filing the bill of entry. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) before customs out-of-charge is granted.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · MOHFW
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer must verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills not routed through the PGA for NOC.
Document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · MOHFW import regime
3
Verify that the product is not a prohibited substance: import of chloramphenicol and its formulations and nitrofurans and its formulations for use in food-producing animal rearing systems is absolutely prohibited under S.O. 1158(E) dated 12-03-2025. Import of oxytocin is also prohibited; oxytocin reference standards are permitted solely for test and analysis on submission of a test licence from DGCI/CDSCO per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.
S.O. 1158(E) dated 12-03-2025 · S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is presenting a current drug registration certificate while omitting one or more of the four accompanying e-Sanchit documents — Certificate of Analysis, Batch Release Certificate, Label of Consignment, or Import Licence — which are each independently mandatory and verified by the proper officer before out-of-charge. A single missing document code detains the consignment regardless of the validity of the registration certificate, and demurrage accrues during the cure period. Importers of any formulation in the chloramphenicol, nitrofuran, or oxytocin families must establish at the purchase-order stage that the product does not fall within the S.O. 1158(E) or S.O. 2357(E) prohibitions.

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Frequently asked

Does HSN 3004 39 90 require BIS certification?

No. This tariff line is not covered by any BIS Quality Control Order. Import is governed by the Ministry of Health and Family Welfare through the Drugs and Cosmetics Act, 1940, with drug registration and import licensing administered by the Central Drugs Standard Control Organisation, and ITC (HS) policy conditions administered by DGFT.

Are all five e-Sanchit document codes mandatory for every consignment under this HSN?

Yes. The Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc) must all be uploaded in e-Sanchit; the proper officer verifies each before granting out-of-charge.

Can oxytocin reference standards be imported under this tariff line?

Yes, but exclusively for test and analysis, and only on submission of a test licence issued by DGCI/CDSCO; general commercial import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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