Clindamycin

Clindamycin antibiotic medicaments, retail-packed dosage forms

MEFCC CLEARANCE

HSN 3004 20 95 (Clindamycin) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the applicable ITC (HS) import policy overlay as an additional clearance requirement.

What this is

HSN code

3004 20 95

Chapter

30 · Pharmaceutical products

Primary regulator

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

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 an import licence for drugs from CDSCO before filing the bill of entry. Both documents — registration certificate (document code 101dc1) and import licence for drugs (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
2
Upload all five mandatory documents in e-Sanchit at the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Out-of-charge will not be granted until all five are verified.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is uploading only the registration certificate and import licence while overlooking the Batch Release Certificate (0030dc) and the Certificate of Analysis (0010dc) as separately required uploads. All five document codes must be present in e-Sanchit before the proper officer can grant out-of-charge; a single missing document code results in consignment detention and accruing demurrage regardless of the validity status of the drug licence.

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Frequently asked

Does HSN 3004 20 95 require BIS certification?

No. No BIS Quality Control Order covers antibiotic medicaments under this tariff line. Import of Clindamycin dosage forms is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with ITC (HS) policy oversight by DGFT.

Which e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Five document codes are mandatory: 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.

Does the oxytocin import prohibition under S.O. 2357(E) affect Clindamycin imports?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies exclusively to oxytocin; Clindamycin is a structurally unrelated antibiotic and is not subject to that prohibition, provided full CDSCO registration and licensing requirements are met.

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