The Government has allowed makers of industrial oxygen to manufacture oxygen for medical use to help combat the scourge of Covid-19.
Subsequently, 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 provided they meet certain parameters.
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.
According to the World Health Organisation (WHO), although the majority of people with COVID-19 have uncomplicated or mild illness (81%), some will develop severe illness requiring oxygen therapy (14%) and approximately 5% will require intensive care unit treatment. Of those critically ill, most will require mechanical ventilation. The most common diagnosis in severe COVID-19 patients is svere pneumonia.
The move to give nod for oxygen manufacture for therapeutic purpose followed after the All India Industrial Gases Manufacturers’ Association (AIIGMA) proposed such a request.
As per the DCGI directive issued recently, “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 needs 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.
According to health experts, oxygen therapy is likely to be the single most effective supportive measure in COVID-19 patients in critical stage. Children with emergency signs (obstructed or absent breathing, severe respiratory distress, central cyanosis, shock, coma or convulsions) should receive oxygen therapy during resuscitation.
The expert said that during the ongoing COVID19 pandemic, ventilator support will be required for about 5-8 per cent of patients with symptoms whereas a large number would require Oxygen support. The existing facilities are not adequate to cater for such large requirements.