Other antileprotic drugs

Antileprotic medicaments, other antileprotic drugs

MEFCC CLEARANCE

HSN 3004 90 58 (Other antileprotic drugs) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document upload at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) designates this tariff line as carrying a specific prohibition on oxytocin imports — oxytocin reference standards are the sole exception, permitted exclusively for test and analysis against a DGCI/CDSCO test licence.

What this is

HSN code

3004 90 58

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Import licence for drugs from CDSCO
Registration certificate 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 current CDSCO import licence for drugs and ensure the drug registration certificate is valid before filing the bill of entry. Upload the import licence (document code 9111dc), registration certificate (document code 101dc1), certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) in e-Sanchit prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit mandatory document codes 9111dc, 101dc1, 0010dc, 0030dc, 0110dc
2
Verify that the consignment does not contain oxytocin in any formulation intended for therapeutic use — oxytocin import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. If importing oxytocin reference standards solely for test and analysis, a test licence issued by DGCI/CDSCO must accompany the bill of entry.
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 overlooking the oxytocin prohibition when the broader antileprotic formulation contains oxytocin as an ancillary active ingredient. The prohibition is absolute for therapeutic-use imports regardless of the primary therapeutic claim on the label; only a DGCI/CDSCO test licence permits entry, and solely for reference-standard quantities. A consignment detained on oxytocin grounds is liable to confiscation, not merely re-export, under the Drugs and Cosmetics Act, 1940.

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 90 58 require BIS certification?

No, antileprotic medicaments are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring an import licence, drug registration certificate, and batch release documentation uploaded in e-Sanchit.

Which document codes must be uploaded in e-Sanchit at the bill of entry for this HSN?

Five documents are mandatory: certificate of analysis (0010dc), batch release certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be present before customs grants out-of-charge.

Is any import of oxytocin permitted under this tariff line?

Only oxytocin reference standards imported exclusively for test and analysis are permitted, and solely against a test licence issued by DGCI/CDSCO; all other oxytocin imports are prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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