Lyophilisation apparatus, freeze drying units and spray dryers

PESO CLEARANCE

HSN 8419 33 00 (Lyophilisation apparatus, freeze drying units and spray dryers) is subject to Petroleum and Explosives Safety Organisation (PESO) approval under the Gas Cylinders Rules, 2016 where the equipment incorporates pressure vessels or cylinders. The Central Board of Indirect Taxes and Customs (CBIC) administers customs-level clearance, with PESO import permission obtained through the PESO online system prior to filing the bill of entry.

What this is

HSN code

8419 33 00

Chapter

84 · Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof

Primary regulator

PESO · Gas Cylinders Rules, 2016

Customs documentation

Import permission from PESO
Hydro test certificate from manufacturer
Third-party inspection certificate from manufacturer

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 permission through the PESO online system before the consignment departs. The application must include the manufacturer's particulars, ISO certificate of the manufacturer, list of cylinders with specifications, drawings and batch numbers, hydro test certificate, and third-party inspection certificate.
Gas Cylinders Rules, 2016 · DPIIT Press Release dated 15-05-2021 (Release ID 1718815)
2
Ensure the PESO approval is obtained and available at the bill of entry stage. Customs may give clearance only after PESO permission is in order; the COVID-era exemption permitting clearance without PESO approval under CBIC Instruction 12/2021-Cus dated 25-05-2021 was specific to medical oxygen cylinders for pandemic relief and is not a standing general exemption.
CBIC Instruction 12/2021-Cus dated 25-05-2021

A word of counsel

The most common error on this tariff line is assuming the COVID-era online-application relaxation announced vide the DPIIT Press Release dated 15 May 2021 constitutes a permanent waiver of physical inspection for all pressure vessels and cylinders under this HSN. That relaxation was granted expressly for cylinders and pressure vessels used in storage and transportation of medical oxygen during the pandemic, and consignees remain responsible for meeting all conditions in Para 3 of that press release before any oxygen filling at refiners or filling plants; importing general-purpose freeze-drying or lyophilisation equipment with integrated pressure vessels without a current PESO approval risks detention and ground rent at the port.

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Frequently asked

Does HSN 8419 33 00 require BIS certification?

No, lyophilisation apparatus and freeze drying units are not covered by a BIS Quality Control Order. Import is governed by Petroleum and Explosives Safety Organisation approval under the Gas Cylinders Rules, 2016 where the equipment incorporates cylinders or pressure vessels, with customs clearance administered by CBIC.

Is the COVID-era exemption from physical PESO inspection still available for importers of pressure vessels under this HSN?

The exemption under CBIC Instruction 12/2021-Cus dated 25-05-2021 was specific to cylinders and pressure vessels for storage and transportation of medical oxygen during the pandemic; importers of general freeze-drying or lyophilisation equipment must apply through the PESO online system and obtain approval in the ordinary course.

What documents must a foreign manufacturer submit to PESO for import approval of pressure vessels under this heading?

The required documents are: manufacturer's particulars, ISO certificate of the manufacturer, list of cylinders with specifications, drawings and batch numbers, hydro test certificate, and third-party inspection certificate, per the DPIIT Press Release dated 15-05-2021 (Release ID 1718815).

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