Vancomycin

Vancomycin antibiotic medicaments for therapeutic use

MEFCC CLEARANCE

HSN 3004 20 96 (Vancomycin) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory pre-import documentation uploaded in e-Sanchit before out-of-charge. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under pharmaceutical import policy controls, and an oxytocin-prohibition overlay under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to co-classified substances in the heading.

What this is

HSN code

3004 20 96

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence 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 drug registration certificate and import licence for Vancomycin from the Central Drugs Standard Control Organisation before the consignment departs the origin country. Both the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) must be uploaded in e-Sanchit at the bill of entry before customs out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for the drug (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of the Consignment (document code 0110dc) in e-Sanchit. The proper officer will verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CBIC e-Sanchit mandatory document verification requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is filing the bill of entry with the registration certificate but without a current, product-specific import licence — the two are distinct instruments and both are mandatory at out-of-charge. Vancomycin is an antibiotic in a heading that also covers oxytocin, which is prohibited for import under S.O. 2357(E); a misdescribed or broadly-worded invoice referencing the heading rather than the specific molecule can trigger the oxytocin-prohibition scrutiny and consignment detention pending CDSCO clarification.

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Frequently asked

Does HSN 3004 20 96 require BIS certification?

No. Vancomycin medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers antibiotic drug formulations. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT pharmaceutical import policy controls as the operative overlay.

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

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be uploaded before out-of-charge is granted.

Does the oxytocin import prohibition under S.O. 2357(E) affect Vancomycin imports?

No, the prohibition applies specifically to oxytocin, not to Vancomycin; however, invoices and packing lists must clearly identify the drug by its INN to avoid the consignment being flagged under the oxytocin-prohibition scrutiny applicable to co-classified products in this heading.

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