Theophylline, aminophylline and other broncho dilators

Theophylline, aminophylline and other bronchodilator medicaments

MEFCC CLEARANCE

HSN 3004 90 94 (Theophylline, aminophylline and other broncho dilators) is subject to drug registration and import licensing under the Central Drugs Standard Control Organisation (CDSCO) framework, with mandatory e-Sanchit documentation at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay including a prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 94

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · CDSCO drug registration and import licensing framework

Customs documentation

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

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
Ensure the drug product holds a valid CDSCO registration certificate (document code 101dc1) and a current import licence for drugs (document code 9111dc) before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to customs out-of-charge.
CDSCO drug registration and import licensing framework · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), the batch release certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit. The proper officer must verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills not routed through PGA for NOC.
CCR e-Sanchit mandatory document list · document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. The sole exception is oxytocin reference standards imported exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is conflating the oxytocin prohibition with the general bronchodilator import regime: importers sometimes misread the S.O. 2357(E) prohibition as applying only to finished-form oxytocin and attempt to import oxytocin-containing combination products. Any consignment containing oxytocin — other than reference standards with a DGCI/CDSCO test licence — is liable to confiscation and customs detention regardless of the CDSCO registration status of the accompanying bronchodilator products.

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Frequently asked

Does HSN 3004 90 94 require BIS certification?

No, bronchodilator medicaments fall outside the BIS Quality Control Order regime. Import is governed by the CDSCO drug registration and import licensing framework, with an ITC (HS) policy overlay administered by the Directorate General of Foreign Trade, including the oxytocin prohibition under S.O. 2357(E).

Which document codes must be uploaded in e-Sanchit before out-of-charge is granted?

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 present in e-Sanchit before the proper officer grants out-of-charge.

Can oxytocin reference standards be imported under this tariff line?

Yes, but only for test and analysis purposes, and exclusively on submission of a test licence issued by DGCI/CDSCO; commercial import of oxytocin in any other form remains prohibited under DGFT Notification 09/2015-2020 dated 23-05-2022.

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