Chloropheniramine maleate, with or without other compounds (excluding steriods and alkaloids)

Chloropheniramine maleate medicaments, antihistamine formulations

MEFCC CLEARANCE

HSN 3004 90 93 (Chloropheniramine maleate, with or without other compounds) 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) classifies this tariff line under Restricted ITC (HS) import policy, and mandatory e-Sanchit document uploads — including registration certificate, import licence, Certificate of Analysis, and batch release certificate — are verified by the proper officer before out-of-charge.

What this is

HSN code

3004 90 93

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Certificate of Analysis 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
Obtain a valid drug registration certificate and an import licence for drugs from CDSCO before filing the bill of entry. Both documents must be current and uploaded in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit. The proper officer verifies all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CCR e-Sanchit mandatory document list · document codes 0010dc, 0030dc, 0110dc
3
Note the product-scope restriction: import of oxytocin is prohibited on this chapter; import of oxytocin reference standards is allowed exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO. Ensure the consignment does not contain prohibited substances.
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 filing the bill of entry with the registration certificate and import licence in hand but omitting one or more of the three batch-level documents — Certificate of Analysis (0010dc), batch release certificate (0030dc), or label of consignment (0110dc). All five document codes must be present in e-Sanchit simultaneously; a missing batch-level upload causes detention and demurrage even when the principal drug-registration credentials are current.

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Frequently asked

Does HSN 3004 90 93 require BIS certification?

No. No BIS Quality Control Order covers this pharmaceutical tariff line. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with an ITC (HS) Restricted-import policy overlay administered by DGFT.

Which five documents must be uploaded in e-Sanchit before out-of-charge for this HSN?

The mandatory uploads are: Certificate of Analysis for drugs (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all verified by the proper officer before out-of-charge is granted.

Is oxytocin importable under HSN 3004 90 93?

No. 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 from DGCI/CDSCO.

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