Sedatives

Sedative medicaments in measured doses or retail packing

MEFCC CLEARANCE

HSN 3004 90 88 (Sedatives) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and drug registration under the Drugs and Cosmetics Act, 1940, with all five mandatory e-Sanchit documents verified at the bill of entry before out-of-charge. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy applies a critical prohibition: import of oxytocin is banned under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, though import of oxytocin reference standards for test and analysis is permitted against a test licence from DGCI/CDSCO.

What this is

HSN code

3004 90 88

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO import licensing and drug registration)

Customs documentation

Import licence for drugs from CDSCO
Registration certificate 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 import licence for drugs (document code 9111dc) and a current drug registration certificate (document code 101dc1) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted without them.
Drugs and Cosmetics Act, 1940 · CDSCO drug import licensing regime · document codes 9111dc and 101dc1
2
Upload the remaining three mandatory e-Sanchit documents before out-of-charge: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). A bill facilitated without PGA NOC routing requires the proper officer to verify all five documents are present in e-Sanchit.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin, the import of which is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. If importing oxytocin reference standards exclusively for test and analysis, obtain a test licence from DGCI/CDSCO before shipment.
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 — particularly the Batch Release Certificate (0030dc) and Certificate of Analysis (0010dc), which importers treat as supplementary rather than gate-keeping documents. Where a bill has not been routed through the PGA for NOC, the proper officer is specifically directed to verify each of the five codes before granting out-of-charge; a single missing upload results in consignment detention, with demurrage and ground rent accruing until the document deficiency is rectified.

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Frequently asked

Does HSN 3004 90 88 require BIS certification?

No, sedative medicaments under this tariff line are not covered by any BIS Quality Control Order. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, requiring an import licence, drug registration certificate, batch release certificate, certificate of analysis, and label compliance verified through e-Sanchit.

Is the oxytocin prohibition absolute, or are there exemptions for reference standards?

Import of oxytocin as a finished product is absolutely prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; however, oxytocin reference standards are permitted exclusively for test and analysis against a test licence issued by DGCI/CDSCO.

What happens if the drug registration certificate has expired at the time of filing the bill of entry?

An expired registration certificate (document code 101dc1) renders the import unlicensed under the Drugs and Cosmetics Act, 1940; the consignment is liable to detention and, pending regularisation, to re-export or confiscation.

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