Other

Other medicaments for therapeutic or prophylactic use, retail pack

MOHFW CLEARANCE · MEFCC CLEARANCE · +1 OTHER PGAS

HSN 3004 90 99 covers residual medicaments for therapeutic or prophylactic use and is subject to Ministry of Health and Family Welfare (MOHFW) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Where the consignment contains a psychotropic substance such as tramadol, Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate controls apply concurrently under Rule 53 of the NDPS Rules. DGFT policy conditions and MEFCC restrictions on used medical equipment provide additional import-policy overlays.

What this is

HSN code

3004 90 99

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from manufacturer

Applicable Partner Government Agencies

MOHFWMOHFW·Ministry of Health and Family Welfare

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
Ensure the drug product holds a valid registration certificate (document code 101dc1) and import licence (document code 9111dc) issued by the Central Drugs Standard Control Organisation before filing the bill of entry. Upload both documents in e-Sanchit along with the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) before out-of-charge.
CCR e-Sanchit mandatory document list · document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
Verify that the product is not within any prohibited category before shipment. Import of chloramphenicol, its formulations, nitrofurans, and their formulations for use in any food-producing animal rearing system is prohibited under S.O. 1158(E) dated 12-03-2025. Import of oxytocin (other than reference standards for test and analysis under a DGCI/CDSCO test licence) is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.
S.O. 1158(E) dated 12-03-2025 (MOHFW) · S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022
3
Where the medicament contains tramadol or any other psychotropic substance listed under the NDPS regime, obtain an import certificate from the Narcotics Commissioner before dispatch. Import without this certificate is prohibited under Rule 53 of the NDPS Rules, as notified by S.O. 1761(E) dated 26-04-2018 issued by the Department of Revenue.
Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018, Department of Revenue

A word of counsel

The most frequent error on this residual tariff line is treating the drug registration certificate and import licence as the entire compliance checklist while missing a product-specific prohibition. Chloramphenicol and nitrofuran formulations destined for veterinary or aquaculture use, oxytocin outside the reference-standard carve-out, and tramadol without a Narcotics Commissioner import certificate each trigger an independent prohibition that renders the consignment liable to seizure and confiscation regardless of whether all standard CDSCO documents are in order.

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Frequently asked

Does HSN 3004 90 99 require BIS certification?

No, this residual medicaments tariff line is not subject to any BIS Quality Control Order. Import is governed by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940, with CDSCO drug registration and import licensing as the primary clearance requirements, and NDPS controls where the product contains a scheduled psychotropic substance.

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

Five documents must be uploaded: Certificate of Analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Out-of-charge will not be granted until all five are verified in e-Sanchit.

Is oxytocin import entirely prohibited under this tariff line?

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

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