Captopril, enalapril, lisinopril, perindopril and ramipril

ACE inhibitor antihypertensive medicaments (captopril, enalapril, lisinopril, perindopril, ramipril)

MEFCC CLEARANCE

HSN 3004 90 71 (Captopril, enalapril, lisinopril, perindopril and ramipril) 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) administers the ITC (HS) import policy overlay, and note that import of oxytocin under this chapter is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, though that prohibition does not affect the ACE inhibitor molecules of this tariff line.

What this is

HSN code

3004 90 71

Chapter

30 · Pharmaceutical products

Primary regulator

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

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 and maintain a current drug registration certificate from the Central Drugs Standard Control Organisation (CDSCO) for each ACE inhibitor formulation to be imported. Upload the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) in e-Sanchit before filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · e-Sanchit mandatory upload requirement
2
Ensure the consignment is accompanied by a Certificate of Analysis for the drug (document code 0010dc), a Batch Release Certificate (document code 0030dc), and a Label of Consignment (document code 0110dc), all uploaded in e-Sanchit. The proper officer will verify these documents before granting out-of-charge.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc · CCR PGA-facilitated bill verification requirement

A word of counsel

The most common error on this tariff line is filing without the complete five-document set in e-Sanchit — the registration certificate (101dc1), import licence (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and label (0110dc) are each independently verified by the proper officer, and a missing document at any point triggers detention and demurrage regardless of whether the other four are present. Note also that the oxytocin prohibition under S.O. 2357(E) applies to a separate molecule and does not affect ACE inhibitors, but a misdescribed consignment that draws scrutiny under that prohibition will face seizure and CDSCO investigation.

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Frequently asked

Does HSN 3004 90 71 require BIS certification?

No, no BIS Quality Control Order covers this pharmaceutical tariff line. Import of captopril, enalapril, lisinopril, perindopril and ramipril formulations is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring drug registration and an import licence.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Five documents must be uploaded: 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 five are verified by the proper officer before out-of-charge is granted.

Does the oxytocin import prohibition under S.O. 2357(E) affect ACE inhibitor imports under this HSN?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin; captopril, enalapril, lisinopril, perindopril and ramipril are distinct molecules and are importable subject to CDSCO registration and the standard drug-import documentation.

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