Other

Other medicaments for therapeutic or prophylactic use, retail-packed

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 90 49 (Other medicaments in measured doses or retail packs) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Narcotic Drugs and Psychotropic Substances (NDPS) regime imposes an import-certificate requirement for scheduled psychotropic substances such as tramadol, and the Directorate General of Foreign Trade (DGFT) Restricted-import policy and a Ministry of Environment, Forest and Climate Change (MoEFCC) condition apply as additional overlays.

What this is

HSN code

3004 90 49

Chapter

30 · Pharmaceutical products

Primary regulator

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

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

NDPSNDPS·Narcotics Control Bureau

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 CDSCO before the bill of entry is filed. Upload both documents in e-Sanchit, together with the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc), prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
If the consignment contains tramadol or any other scheduled psychotropic substance, produce an import certificate issued by the Narcotics Commissioner before clearance. Import of tramadol without such a certificate is prohibited under Rule 53 of the NDPS Rules.
Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018, Department of Revenue
3
Note that import of oxytocin is prohibited outright; import of oxytocin reference standards is permitted exclusively for test and analysis purposes on production of a test licence issued by DGCI/CDSCO. If the consignment contains used or refurbished high-end medical equipment, verify compliance with the conditions under the MoEFCC Office Memorandum dated 15-12-2023.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022 · MoEFCC O.M. dated 15-12-2023

A word of counsel

The most common error on this tariff line is filing under the general CDSCO drug-import pathway without first screening the product for scheduled-substance status. Tramadol is separately prohibited under Rule 53 of the NDPS Rules unless accompanied by an import certificate from the Narcotics Commissioner — a CDSCO import licence does not substitute for that certificate. Consignments detained for an absent NDPS import certificate attract demurrage and ground rent while the certificate is obtained retrospectively, a process that can take weeks.

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Frequently asked

Does HSN 3004 90 49 require BIS certification?

No, this tariff line falls entirely outside the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with NDPS import-certificate requirements for scheduled psychotropic substances and a DGFT Restricted-import overlay for certain product categories.

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

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc) — all must be uploaded in e-Sanchit before customs out-of-charge.

Is the import of oxytocin under this tariff line completely prohibited?

Import of oxytocin as a finished product is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; however, import of oxytocin reference standards is permitted exclusively for test and analysis purposes on production of a test licence issued by DGCI/CDSCO.

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