Chenodiol and ursodiol

Chenodiol and ursodiol bile acid medicaments

MEFCC CLEARANCE

HSN 3004 90 36 (Chenodiol and ursodiol) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill of entry. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under the ITC (HS) Restricted-import policy, and the Ministry of Environment, Forest and Climate Change applies an overlay governing high-value used or refurbished medical equipment where relevant.

What this is

HSN code

3004 90 36

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO import licensing regime)

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 valid CDSCO import licence for drugs and ensure the foreign manufacturing facility is registered under the Drugs and Cosmetics Act, 1940. Upload the Registration Certificate (document code 101dc1) and the Import Licence for Drugs (document code 9111dc) in e-Sanchit before filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload all remaining mandatory documents in e-Sanchit prior to out-of-charge: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer must verify these uploads on PGA-facilitated bills before granting out-of-charge.
E-Sanchit mandatory document requirements · document codes 0010dc, 0030dc, 0110dc
3
Note that import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020, both dated 23-05-2022; however, oxytocin reference standards are permitted exclusively for test and analysis purposes subject to a test licence issued by DGCI/CDSCO. Confirm the consignment does not contain prohibited formulations.
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 uploading an incomplete document set in e-Sanchit — importers frequently upload the import licence and registration certificate but omit the Batch Release Certificate (0030dc) or the Label of Consignment (0110dc). On PGA-facilitated bills that bypass the NOC routing, customs proper officers are explicitly instructed to hold out-of-charge until all five document codes are verified; a single missing code results in consignment detention, accumulating demurrage and ground rent until the deficiency is remedied.

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Frequently asked

Does HSN 3004 90 36 require BIS certification?

No, pharmaceutical medicaments such as chenodiol and ursodiol are not covered by any BIS Quality Control Order. Import is governed by CDSCO import licensing and registration under the Drugs and Cosmetics Act, 1940, with an ITC (HS) Restricted-import policy overlay administered by DGFT.

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

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

Is any substance in this tariff chapter subject to a complete import prohibition?

Yes. Oxytocin formulations are prohibited for import under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23 May 2022; the sole carve-out permits import of oxytocin reference standards exclusively for test and analysis, subject to a DGCI/CDSCO test licence.

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