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HomeHSNChapter 30HSN 3004 20 99

Other

Antibiotic medicaments in measured doses, retail packings

MOHFW CLEARANCE · MEFCC CLEARANCE

HSN 3004 20 99 (Other antibiotic-containing medicaments) is subject to Ministry of Health and Family Welfare (MOHFW) import licensing and drug registration under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as Restricted under the ITC (HS) import policy, and specific antibiotic formulations — including chloramphenicol, nitrofurans, and oxytocin — carry outright import prohibitions operative by MOHFW notification.

What this is
HSN code
3004 20 99
Chapter
30 · Pharmaceutical products
Primary regulator
MOHFW · Drugs and Cosmetics Act, 1940 (import licensing and drug registration)
Customs documentation
  • Registration certificate from CDSCO
  • Import licence for drugs from DGCI
  • Batch release certificate from manufacturer
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. 1
    Ensure the drug registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) are current and in the name of the importer before the bill of entry is filed. Both must be uploaded in e-Sanchit together with the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) prior to customs out-of-charge.
    e-Sanchit mandatory document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc · Drugs and Cosmetics Act, 1940
  2. 2
    Verify that the specific antibiotic formulation is not subject to an import prohibition before placing the purchase order. Import of chloramphenicol and its formulations, and nitrofurans and its formulations, for use in any food-producing animal rearing system is prohibited with immediate effect. Import of oxytocin is prohibited outright; oxytocin reference standards may be imported exclusively for test and analysis subject to a test licence issued by DGCI/CDSCO.
    S.O. 1158(E) dated 12-03-2025 (MOHFW) · S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
  3. 3
    If the consignment includes used or refurbished high-end, high-value medical equipment components, confirm compliance with the Ministry of Environment, Forest and Climate Change conditions for restricted import of such equipment. This overlay applies where the consignment falls within the scope of the O.M. dated 15-12-2023.
    O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
A word of counsel

The most common error on this tariff line is importing an antibiotic formulation that is prohibited for a specific end-use — particularly chloramphenicol and nitrofuran formulations intended for food-producing animal rearing — without recognising that the prohibition under S.O. 1158(E) is use-based and not dependent on the declared therapeutic category on the invoice. A consignment correctly registered as a drug under the Drugs and Cosmetics Act, 1940 may still face confiscation at the bill-of-entry stage if the end-use or the species label triggers the food-animal prohibition; importers must obtain explicit confirmation of end-use scope from MOHFW before shipment.

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Frequently asked
Does HSN 3004 20 99 require BIS certification?
No, antibiotic medicaments in retail packings are not within the BIS Quality Control Order regime. Import is governed by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940, with drug registration and import licensing as the operative requirements, and DGFT ITC (HS) Restricted-import policy as the policy overlay.
Which document codes must be uploaded in e-Sanchit for this tariff line?
Five documents are mandatory: Certificate of Analysis — Drug (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.
Is the prohibition on oxytocin import absolute, or are there carve-outs?
The import of oxytocin is prohibited as a general rule; however, oxytocin reference standards may be imported exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.
Last verified against gazette notifications: 2026-05-16. Source: MOHFW / MEFCC / DGFT / Indian Customs CUSDATA.
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