Date: 11-Apr-2020

DCGI Directs SLAs To Urgently Grant Permission To Manufacture Industrial Oxygen For Therapeutic Use

To ensure availability and supply of industrial oxygen for medical use across the country, the Drugs Controller General of India (DCGI) has directed state licensing authorities (SLAs) to urgently grant permission to manufacturers of industrial oxygen to manufacture oxygen in the light of COVID-19 outbreak.

Supplemental oxygen therapy is a part of the clinical management of COVID-19. It is the use of oxygen as a medical treatment. This also includes supplementing oxygen for low blood oxygen, carbon monoxide toxicity, cluster headaches and to maintain enough oxygen while inhaled anesthetics are given.

All India Industrial Gases Manufacturers’ Association (AIIGMA) has been proposing for allowing manufacturers of industrial oxygen to manufacture oxygen for medical use. As per the DCGI directive, it has been decided in public interest that the premises which are having facility to manufacture industrial oxygen should be granted manufacturing license to manufacture oxygen for medical use within 24 hours of the submission of application and fees as per the Drugs and Cosmetics (D&C) Act. An undertaking need to be furnished in writing to manufacture medical oxygen in compliance with standards prescribed in Indian Pharmacopoeia and labeling requirement as per the D&C Act and Rules.

“SLAs are requested to take action in public interest to grant permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in light of COVID 19,” DCGI stated.

Oxygen therapy is likely to be the single most effective supportive measure in COVID-19 patients. Children with emergency signs (obstructed or absent breathing, severe respiratory distress, central cyanosis, shock, coma or convulsions) should receive oxygen therapy during resuscitation.

Amongst the key objectives, AIIGMA aims to propagate importance of safety in manufacturing and handling of industrial gases. It is also aimed at creating an institutional framework for policy planning and promoting trade and economic co-operation. It also aims in promotion and co-operation in the areas of research and development, meeting gas manufacturers’ various requirements and transfer of technology and foreign investment