Dicyclomine, metoclopramide and dexame thasone and ondansetron

Medicaments containing dicyclomine, metoclopramide, dexamethasone or ondansetron

MEFCC CLEARANCE

HSN 3004 90 35 (medicaments containing dicyclomine, metoclopramide, dexamethasone and ondansetron) is subject to Central Drugs Standard Control Organisation (CDSCO) import licence and registration requirements under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as subject to ITC (HS) policy conditions, with e-Sanchit documentation — including batch release certificate, registration certificate, and certificate of analysis — mandatory before customs out-of-charge.

What this is

HSN code

3004 90 35

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence from CDSCO
Registration certificate from CDSCO
Certificate of Analysis 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 import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; consignments on PGA-facilitated bills without these uploads will be held pending out-of-charge.
CDSCO import-licence and drug-registration requirements · e-Sanchit document codes 9111dc and 101dc1
2
Upload the batch release certificate (document code 0030dc), the label of the consignment (document code 0110dc), and the certificate of analysis for drugs (document code 0010dc) in e-Sanchit at the bill of entry stage. The customs proper officer must verify all five mandatory documents before granting out-of-charge.
CCR mandatory document checklist · e-Sanchit document codes 0030dc, 0110dc, 0010dc
3
Note the absolute prohibition on import of oxytocin; import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to submission of a test licence issued by DGCI/CDSCO. Confirm the consignment does not contain oxytocin as an active or excipient ingredient.
S.O. 2357(E) · DGFT Notification 09/2015-2020 both dated 23-05-2022

A word of counsel

The most frequent error on this tariff line is uploading an import licence without ensuring the registration certificate and certificate of analysis carry matching batch and product details — a mismatch causes the customs proper officer to withhold out-of-charge even where the licence is current. Separately, the ITC (HS) policy overlay linking this chapter to the oxytocin prohibition means that any consignment containing oxytocin — even as a minor component — is liable to confiscation; importers must obtain and retain explicit exclusion documentation from the manufacturer.

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Frequently asked

Does HSN 3004 90 35 require BIS certification?

No. No BIS Quality Control Order covers medicaments in this product family. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT ITC (HS) policy conditions and mandatory e-Sanchit documentation applying at the bill of entry.

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

Five documents are mandatory: batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), import licence for drugs (9111dc), and certificate of analysis for drugs (0010dc); all must be uploaded before the customs proper officer grants out-of-charge.

Is oxytocin import permitted under this tariff line?

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

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