Medicinal grade

Medicinal grade oxygen for pharmaceutical use

PESO CLEARANCE

HSN 2804 40 10 (Medicinal grade oxygen) is subject to Petroleum and Explosives Safety Organisation (PESO) import approval for cylinders and pressure vessels under the Gas Cylinders Rules, 2016, with drug-registration and import-licence requirements enforced at the bill of entry. Mandatory additional qualifiers for Chapter 28 commodities under CBIC Circular 23/2023-Cus dated 30-09-2023 apply as a customs overlay.

What this is

HSN code

2804 40 10

Chapter

28 · Inorganic chemicals; organic or inorganic compounds of precious metals

Primary regulator

PESO · Gas Cylinders Rules, 2016

Customs documentation

Import approval from PESO
Import licence for drugs from CDSCO
Registration certificate from CDSCO

Applicable Partner Government Agencies

PESOPESO·Petroleum and Explosives Safety Organisation

Procedural directions for customs clearance are issued by: Central Board of Indirect Taxes and Customs.

Compliance steps

1
Apply for PESO import approval through the PESO online system, submitting the manufacturer's particulars, ISO certificate, cylinder specifications and drawings with batch numbers, hydro-test certificate, and third-party inspection certificate. Every foreign manufacturer or importer of oxygen cylinders must hold this approval before import.
Gas Cylinders Rules, 2016 · PESO press release dated 15-05-2021 (Release ID 1718815) · CBIC Instruction 12/2021-Cus dated 25-05-2021
2
Upload all mandatory drug-related documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify these prior to granting out-of-charge.
CBIC Instruction 12/2021-Cus dated 25-05-2021 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Ensure the import declaration includes mandatory additional qualifiers for Chapter 28 commodities as stipulated in Para 4.1 and 4.2 of CBIC Circular 23/2023-Cus. These qualifiers are mandatory with effect from 15 October 2023 and must appear in the import declaration before out-of-charge is granted.
CBIC Circular 23/2023-Cus dated 30-09-2023, Para 4.1 and 4.2

A word of counsel

The most common error on this tariff line is treating the PESO cylinder-import approval as the only clearance required and overlooking the full suite of drug-regime documents — particularly the drug registration certificate (101dc1) and the import licence for drugs (9111dc) — which are independently verified in e-Sanchit before out-of-charge. A consignment arriving with PESO approval but missing any one of the five document codes will be detained at port, accumulating demurrage and ground rent, until the deficiency is remedied.

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Frequently asked

Does HSN 2804 40 10 require BIS certification?

No, medicinal grade oxygen is not within the BIS Quality Control Order regime. Import is governed by Petroleum and Explosives Safety Organisation approval under the Gas Cylinders Rules, 2016, with drug-registration and import-licence requirements enforced at the bill of entry under the e-Sanchit framework.

Were any exemptions granted from the PESO physical-inspection requirement for oxygen cylinders?

Yes. Via the DPIIT press release dated 15 May 2021 (Release ID 1718815) and CBIC Instruction 12/2021-Cus dated 25-05-2021, PESO was directed to grant approvals online without physical inspection of overseas facilities for COVID-relief purposes; however, the consignee remains responsible for complying with the relaxed-condition procedure in Para 3 of that press release before filling medical oxygen at refillers or filling plants.

What are the Chapter 28 mandatory qualifiers and when did they take effect?

CBIC Circular 23/2023-Cus dated 30-09-2023 requires importers to include mandatory additional qualifiers in import declarations for commodities under Chapters 28, 29, 32, 39 and CTH 3808, as detailed in Para 4.1 and 4.2, with effect from 15 October 2023.

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