Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives

Mixed medicaments containing penicillins or streptomycin derivatives

CDSCO CLEARANCE

HSN 3003 10 00 (medicaments containing penicillins or streptomycin derivatives, not in retail packs) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, as administered by the Drug Controller General of India (DCGI). The tariff line is Restricted under the ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT), with import permitted only upon satisfaction of CDSCO registration and all applicable drug-import requirements.

What this is

HSN code

3003 10 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act (DCGI registration and import licensing)

Customs documentation

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

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit; clearance will not be granted unless both are present and current.
ITC (HS) import policy, CTI 3003 10 00 · Drugs and Cosmetics Act (DCGI requirements)
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (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.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · ITC (HS) Restricted-import policy

A word of counsel

The error that most commonly delays consignments under this tariff line is submitting a registration certificate that covers the innovator formulation but not the specific multi-constituent bulk mixture being imported. Because HSN 3003 10 00 covers medicaments consisting of two or more mixed constituents not in retail packs, each distinct formulation must be independently registered with CDSCO; a registration for a downstream finished dosage form does not extend to the upstream bulk mixture, and a mismatched registration triggers detention and potential confiscation under the Drugs and Cosmetics Act.

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Frequently asked

Does HSN 3003 10 00 require BIS certification?

No, no BIS Quality Control Order covers pharmaceutical medicament formulations under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, with the ITC (HS) Restricted-import policy administered by DGFT as the concurrent overlay.

Which five documents must be uploaded in e-Sanchit before customs out-of-charge?

The mandatory document codes are: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all five must be present before the proper officer grants out-of-charge.

Does the ITC (HS) Restricted-import status mean a separate DGFT licence is required in addition to the CDSCO import licence?

No separate DGFT import licence is required; the Restricted status is satisfied by compliance with CDSCO registration and the import-licence regime administered by the Drug Controller General of India, which is the policy condition embedded in the ITC (HS) entry for this CTI.

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