Theophylline and salts thereof

Theophylline and salts medicaments, retail dosage forms

MEFCC CLEARANCE

HSN 3004 49 70 (Theophylline and salts thereof) is subject to drug-import controls under the Ministry of Environment, Forest and Climate Change (MEFCC) overlay and mandatory Central Drugs Control Organisation (CDSCO) registration, with an Import Licence for drugs required at the bill of entry. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy condition, and all mandatory documents — including the Registration Certificate and Import Licence — must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 49 70

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Ministry of Environment, Forest and Climate Change (legacy code) · Drugs import controls with CDSCO registration overlay

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 is registered with the Central Drugs Control Organisation and obtain the Import Licence for drugs before filing the bill of entry. Upload the Registration Certificate (document code 101dc1) and Import Licence (document code 9111dc) in e-Sanchit; out-of-charge will not be granted without these documents.
e-Sanchit mandatory document codes 101dc1 and 9111dc · CCR PGA-facilitated-bills instruction
2
Upload the Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry. The proper officer is required to verify all five mandatory documents before granting out-of-charge.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc · CCR PGA-facilitated-bills instruction
3
Note that import of oxytocin is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to submission of a test licence issued by the DGCI/CDSCO. Confirm the consignment does not fall within the prohibited oxytocin category before shipment.
S.O. 2357(E) · DGFT Notification 09/2015-2020 both dated 23-05-2022

A word of counsel

The most common error on this tariff line is uploading only the Import Licence and Registration Certificate while omitting one or more of the three product-level documents — Certificate of Analysis, Batch Release Certificate, and Label of Consignment. All five document codes (101dc1, 9111dc, 0010dc, 0030dc, 0110dc) are independently mandatory; a single missing upload causes detention at the port and accruing demurrage until the e-Sanchit record is complete, even when the drug itself is fully registered.

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Frequently asked

Does HSN 3004 49 70 require BIS certification?

No, theophylline medicaments in retail dosage form are not covered by any BIS Quality Control Order. Import is governed by drug-registration and licensing controls administered through CDSCO and the MEFCC overlay, with DGFT administering the ITC (HS) policy condition.

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 present before the proper officer grants out-of-charge.

Is import of oxytocin under this chapter affected by the prohibition notified under S.O. 2357(E)?

Yes. Import of oxytocin is prohibited; only oxytocin reference standards for test and analysis are permitted, subject to a test licence issued by the DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Theophylline consignments are unaffected but must not be co-shipped with prohibited oxytocin formulations.

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