Tinidazole

Tinidazole medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 23 (Tinidazole) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory e-Sanchit documents — including a Registration Certificate for Drugs (101dc1), Import Licence for Drugs (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and consignment label (0110dc) — must be uploaded before out-of-charge. Directorate General of Foreign Trade (DGFT) policy controls apply as an additional overlay.

What this is

HSN code

3004 90 23

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Certificate of Analysis from manufacturer

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 from the Central Drugs Standard Control Organisation and an Import Licence for Drugs before filing the bill of entry. Both the Registration Certificate (document code 101dc1) and the Import Licence (document code 9111dc) must be uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
2
Upload the Certificate of Analysis for Drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is required to verify all five mandatory document codes before granting out-of-charge on PGA-facilitated bills.
Document codes 0010dc, 0030dc, 0110dc per CCR · e-Sanchit mandatory-document verification requirement

A word of counsel

The most frequent error on this tariff line is uploading a subset of the five mandatory e-Sanchit document codes and assuming the CDSCO NOC-routing covers the remainder. Each of the five codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — is independently verified by the proper officer on PGA-facilitated bills; a single missing code results in consignment detention and accruing demurrage until the document is uploaded and re-verified.

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Frequently asked

Does HSN 3004 90 23 require BIS certification?

No. No BIS Quality Control Order covers Tinidazole medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls as an additional overlay.

Are all five e-Sanchit document codes mandatory even when the bill has been routed through CDSCO?

Yes. The Registration Certificate (101dc1), Import Licence for Drugs (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and consignment label (0110dc) must all be uploaded in e-Sanchit before out-of-charge, regardless of PGA-routing status.

Does the oxytocin import prohibition or the used medical equipment restriction in the CCR apply to Tinidazole consignments?

No. The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, and the used or refurbished medical equipment conditions under the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023, pertain to entirely different product categories and do not affect Tinidazole imports.

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