Rifampicin

Rifampicin antibiotic medicaments in measured doses

CDSCO CLEARANCE · MEFCC CLEARANCE

HSN 3004 20 92 (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 (DGCI). The tariff line carries a concurrent prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, and all consignments require ITC (HS) policy compliance administered by the Directorate General of Foreign Trade (DGFT).

What this is

HSN code

3004 20 92

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
Certificate of Analysis from manufacturer

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 registration certificate for drugs (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO under the Drugs and Cosmetics Act before filing the bill of entry. Both documents must be uploaded in e-Sanchit, along with the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and label of consignment (document code 0110dc).
ITC (HS) import policy condition · Drugs and Cosmetics Act · CDSCO document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
Note that import of oxytocin under this CTI is prohibited; the sole permitted exception is oxytocin reference standards imported exclusively for test and analysis purposes, subject to a test licence issued by DCGI/CDSCO. Any consignment containing prohibited oxytocin formulations is liable to seizure.
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 arriving at the bill of entry with an expired or scope-limited drug registration certificate that does not cover Rifampicin specifically. CDSCO registration is product-specific, and a certificate covering a related antibiotic does not extend to Rifampicin formulations; customs out-of-charge will be withheld pending a corrective registration upload, accruing demurrage and ground rent at the designated port throughout the delay.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 20 92 require BIS certification?

No, pharmaceutical medicaments containing antibiotics such as Rifampicin are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, with registration, import licensing, and ITC (HS) policy compliance administered by the Drug Controller General of India and DGFT.

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

Five documents must be uploaded in e-Sanchit before out-of-charge: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc).

Can oxytocin reference standards be imported under this CTI?

Yes, but only for test and analysis purposes and exclusively upon submission of a test licence issued by DCGI/CDSCO; commercial import of oxytocin formulations under this CTI is prohibited per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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