Rifampicin

Rifampicin medicaments in measured doses for retail sale

CDSCO CLEARANCE · MEFCC CLEARANCE

HSN 3004 90 52 (Rifampicin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act administered by the Drug Controller General of India (DCGI). The ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT) permits import subject to those registration requirements, and note that import of oxytocin under this CTI is prohibited, with a narrow carve-out permitting oxytocin reference standards exclusively for test and analysis under a DCGI-issued test licence.

What this is

HSN code

3004 90 52

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act (DCGI registration and import licensing)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

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 (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Drug Controller General of India 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 · ITC (HS) import policy, CTI 3004 90 52 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is required to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CDSCO mandatory document set · e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If the consignment contains oxytocin, note that import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole permitted exception is oxytocin reference standards imported exclusively for test and analysis against a test licence issued by the DCGI/CDSCO.
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 filing the bill of entry with the registration certificate and import licence in place but omitting one of the three product-specific documents — Certificate of Analysis, Batch Release Certificate, or Label of Consignment — from the e-Sanchit upload. All five mandatory document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) must be live in e-Sanchit before the bill is presented; a single missing code triggers consignment detention, accumulating demurrage and ground rent while the proper officer awaits the outstanding upload.

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Frequently asked

Does HSN 3004 90 52 require BIS certification?

No. No BIS Quality Control Order covers this product family. Import of Rifampicin medicaments is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, with registration and import licensing administered by the Drug Controller General of India as the operative requirement at the bill of entry.

Which five documents must be uploaded in e-Sanchit for Rifampicin imports?

The mandatory set is: 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.

Is oxytocin import permitted under CTI 3004 90 52?

Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the only permitted exception is oxytocin reference standards imported exclusively for test and analysis, subject to a test licence issued by the DCGI/CDSCO.

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