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

Last updated: 18 May 2021

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.

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

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.