Relaxations provided under Gas Cylinders Rules, 2016 for storage and transportation of medical oxygen



Quick Summary
The Indian government has relaxed rules under the Gas Cylinders Rules, 2016, to expedite the import of medical oxygen cylinders and pressure vessels. Physical inspections of global manufacturers' facilities by PESO will be waived for approvals, which will now be granted online. This aims to fast-track the supply of essential medical oxygen during the COVID-19 pandemic. While pre-shipment PESO certification is not mandatory, cylinders must meet Indian or international standards and undergo testing before use.

Relaxations provided under Gas Cylinders Rules, 2016, so as to fast track approvals for imported cylinders and pressure vessels for storage and transportation of medical oxygen

Government of India has reviewed the existing procedure for approval of global manufacturers for importing oxygen cylinders by Petroleum and Explosive Safety Organization (PESO). In view of the COVID pandemic, PESO shall not carry out physical inspection of global manufacturers' production facilities before grant of such approval. Now, such approvals shall be granted online without any delay on submission of manufacturer’s particulars; ISO certificate of manufacturer; List of Cylinders their specifications, drawings & batch number; Hydro test certificate and Third-Party inspection Certificate. Every foreign manufacturer/importer who wants to import oxygen cylinders is required to apply for import permission through PESO online system.

In view of emergent situation, procedures are relaxed and the following process is to be followed wherever due to unavoidable circumstances or urgencies, consignment of oxygen cylinders, ISO containers or PSA plants or its related equipment have already arrived in India, without taking import permission from PESO. The filling permission for these cylinders will be issued based on the following relaxation in the rules. Same procedure will apply for import of further such equipment in case the online approvals have not been taken.

Medical Oxygen Cylinder Import Rules Relaxed

As such, Certification of PESO will not be mandatory pre-shipment. However, the certification of PESO will be required before use of the oxygen cylinders which entails weight and hydro testing. The Indian Missions should however ensure that the oxygen cylinders should comply with India or International standards before shipment. In case of filled cylinders, the agency exporting to India shall certify that the oxygen filled in the cylinder is of such purity and concentration that is fit for medical use. The certification shall be attested by the Indian Mission in the exporting country. Further, soon upon receipt in India, such filled cylinders shall be inspected on sample basis by an empanelled agency of PESO and certified as fit for medical use.

Sr No

Description

Requirement of Rules

Acceptability criteria

Relaxation

Criteria not exempted

1

Design approval prior to import of oxygen cylinders

Rule 3(3) of the Gas Cylinders Rules, 2016

ISO 9809 Part I & II

IS 7285 with TPIA appraisal 

Cylinders manufactured with any international code without TPIA appraisal

1. Conformity of weight reduction not more than 5% of tare weight.

2. Shall pass hydro static test at a pressure of 225 Kg/Cm2 for 30 seconds

2

Import permission

Rule 50, 51 & 54 of the Gas Cylinders Rules, 2016

Manufacturer’s test and inspection report & fee

Manufacturer’s test and inspection report not required. Fee waived off.

3

Recognition of Original Equipment Manufacturer with 10 years experience

Rule 3(3) of the Gas Cylinders Rules, 2016

Prototype joint inspection of manufacturing and quality control with TPIA and site assessment

Exempted

4

Filling permission

Rule 43 & 45 of the Gas Cylinders Rules, 2016

Examination & test  as per Rule 35

Exempted except the test prescribed in next column.

5

PSA installations and other COVID centres installations with cylinder filling facilities

Rule 50, 51 & 54 of the Gas Cylinders Rules, 2016

Fulfill the requirement of E & F licenses

Exempted to obtain E&F license

Moderate guidelines prepared by PESO to be followed.

All the filled cylinders must be verified for quality of gas filled therein under the supervision of medical/ Food and Drugs Controllers and if quality of gas conforms to their requirement of medical oxygen, cylinder may be sent directly to hospitals for use.On emptying out the oxygen, cylinder shall be sent to filler and the process as given above shall be followed.

Guidelines for PSA installations at hospitals with filling facility or at COVID centers

A PSA plants where generated oxygen is directly supplied to hospital/ no filling of cylinder is taking place; does not need any permission or license under rules administered by PESO and can be allowed.

B. If PSA is attached with a compressor and filling of oxygen cylinder is to take place, hospital must notify it to PESO with following information:

  • Number of filling points.
  • Number of cylinders to be stored at site
  • An SRV shall be mandatorily installed in the pipeline outlet to compressor.
  • Well ventilated location with adequate illumination.
  • Before filling the cylinder, shall be examined/ cleaned for absence of any Carbonaceous grease and valid hydro test certificate (tested cylinder at 225 Kg/Cm2 hydrostatically)
  • Filling operation shall be carried out under supervision of a competent & experienced person.
  • The space for filling of cylinders to be isolated and maintain clearance of 1m from filling point on all the sides.

C. Any COVID centre may utilize liquid cylinders on board with vaporizer for supplying of gaseous medical oxygen through pipeline or for filling cylinders in open places are permitted subject to conditions stipulated under Sr No. (B) above for PSA and information be submitted to PESO.

These relaxations shall be valid for a period of 6 months or till further orders of Department for Promotion of Industry and Internal Trade, whichever is earlier.

FAQ :

Approvals for global manufacturers importing oxygen cylinders will be granted online without physical inspection of their facilities. Fee for import permission is also waived off.

PESO certification is not mandatory pre-shipment. However, it will be required before the oxygen cylinders are used in India, ensuring they pass weight and hydro testing.

In urgent situations where cylinders have arrived without prior permission, filling permission will be issued based on relaxed rules, provided they meet specific criteria and undergo testing.

Imported oxygen cylinders must comply with Indian or International standards. They need to pass a hydrostatic test at 225 Kg/Cm2 for 30 seconds and meet weight reduction criteria.

Yes, the exporting agency must certify that the oxygen purity is fit for medical use, attested by the Indian Mission. Upon arrival in India, filled cylinders will be inspected on a sample basis by a PESO-empanelled agency.

These relaxations are valid for a period of 6 months or until further orders from the Department for Promotion of Industry and Internal Trade, whichever is earlier.




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