Oral rehydration salts

Oral rehydration salts, medicaments for rehydration therapy

MEFCC CLEARANCE

HSN 3004 90 86 (Oral rehydration salts) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay that includes a prohibition on oxytocin imports, and mandatory e-Sanchit document uploads are required before customs out-of-charge.

What this is

HSN code

3004 90 86

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

Applicable Partner Government Agencies

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 an import licence for drugs from the Central Drugs Standard Control Organisation before shipment. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
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 before the bill of entry is processed. The customs proper officer is required to verify all five mandatory documents before granting out-of-charge.
CDSCO mandatory document upload requirement · document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin formulations — import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to a test licence issued by DGCI/CDSCO.
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 failing to upload all five mandatory e-Sanchit documents — registration certificate, import licence, Certificate of Analysis, Batch Release Certificate, and Label of Consignment — treating some as optional where the customs officer has discretion. All five must be present and verified before out-of-charge; a missing document code causes consignment detention with demurrage accruing at the port until the deficiency is remedied through a CDSCO-side correction.

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Frequently asked

Does HSN 3004 90 86 require BIS certification?

No, oral rehydration salts and medicaments under this tariff line fall outside the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT ITC (HS) policy controls as an additional overlay.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Five documents are mandatory: Certificate of Analysis (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 the customs proper officer grants out-of-charge.

Is oxytocin import prohibited even when classified under this tariff line?

Yes, import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the only permitted exception is oxytocin reference standards imported exclusively for test and analysis, subject to a test licence from DGCI/CDSCO.

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