Clonidine, methyldopa

Antihypertensive medicaments containing clonidine or methyldopa

MEFCC CLEARANCE

HSN 3004 90 76 (Clonidine, methyldopa) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) classifies the tariff line under the broader pharmaceutical import policy, and an oxytocin-prohibition carve-out under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to related products at this subheading.

What this is

HSN code

3004 90 76

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

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 CDSCO import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) before filing the bill of entry. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until these are verified by the proper officer.
Drugs and Cosmetics Act, 1940 · CDSCO import licence (document code 9111dc) · Registration certificate (document code 101dc1)
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 at the bill of entry. These are mandatory PGA-facilitated documents verified before out-of-charge.
CDSCO e-Sanchit mandatory 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. Import of oxytocin reference standards is permitted 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 filing the bill of entry with the CDSCO import licence uploaded but the batch release certificate (0030dc) or Certificate of Analysis (0010dc) absent from e-Sanchit — a deficiency that triggers detention and demurrage even when the drug registration is current. Each batch of clonidine or methyldopa medicaments requires a fresh batch-specific Certificate of Analysis; a prior batch's certificate does not satisfy the per-consignment verification requirement.

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Frequently asked

Does HSN 3004 90 76 require BIS certification?

No. No BIS Quality Control Order covers this pharmaceutical tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls and a specific prohibition on oxytocin under S.O. 2357(E).

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

Five documents are mandatory: import licence for drugs (9111dc), registration certificate for drugs (101dc1), Certificate of Analysis (0010dc), batch release certificate (0030dc), and label of consignment (0110dc); 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 exclusively for test and analysis purposes and subject to submission of a test licence issued by DGCI/CDSCO; general commercial import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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