Actinomycin D Dactinomycin and doxorubicin

Actinomycin D, dactinomycin and doxorubicin medicaments

MEFCC CLEARANCE

HSN 3004 90 46 (Actinomycin D, Dactinomycin and doxorubicin) 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 an ITC (HS) Restricted-import overlay, and mandatory e-Sanchit document uploads — including a registration certificate, import licence, batch release certificate, and certificate of analysis — are verified before customs out-of-charge.

What this is

HSN code

3004 90 46

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 drugs from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit. The proper officer must verify all five mandatory documents are present before granting out-of-charge.
CBIC CCR mandatory-document requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
Note that import of oxytocin is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO. Confirm that the consignment does not fall within the oxytocin prohibition before filing.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most frequent error on this tariff line is presenting an expired or scope-mismatched drug registration certificate at the bill of entry — doxorubicin and dactinomycin are high-value oncology agents, and CDSCO registrations are product-specific and manufacturer-specific. A registration covering one strength or formulation does not automatically cover another; mismatched documents result in consignment detention and ground rent accrual while corrective submissions are processed through the CDSCO import-licensing system.

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Frequently asked

Does HSN 3004 90 46 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 an ITC (HS) Restricted-import overlay administered by the Directorate General of Foreign Trade.

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

Five documents are mandatory: Certificate of Analysis — Drug (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 affect consignments of dactinomycin or doxorubicin?

No, the prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 applies specifically to oxytocin, not to dactinomycin or doxorubicin; however, if an oxytocin reference standard is included for testing purposes, a separate test licence from DGCI/CDSCO is required.

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