Date: 19-Jun-2020

Gujarat FDA Issues Licenses To 12 More Oxygen Manufacturers To Produce Medical Oxygen To Cater To COVID-19 Patients

The Gujarat Food and Drug Control Administration (FDCA) has issued licenses to 12 more oxygen manufacturers during the lockdown period to produce medical oxygen to cater to COVID-19 patients. As of today, the state has 45 medical oxygen manufacturers catering to over 66 hospitals in the state. It had 33 manufacturers before the outbreak of COVID-19.

According to official data, Gujarat state has a total capacity of 22,689 medical oxygen cylinders per day against the requirement of 7009 cylinders. The state has availability of 5,22,830 cubic metres oxygen against the requirement of 62,860 cubic metres oxygen. “As of today, Gujarat has surplus medical oxygen and is fully equipped to cater to emergency situations. Medical oxygen is life saver for COVID-19 patients and requirement also varies as per the medical condition of the patient,” explained Gujarat FDCA Commissioner Dr H G Koshia.

Dr Koshia has been appointed by the state government as the nodal officer to coordinate on the availability of medical oxygen with the hospitals, Union health ministry and medical oxygen manufacturers of the state. 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.

He further added that all healthcare institutions in the state of Gujarat are complying with essential commodities act and not charging anything on medical oxygen.

The Drugs Controller General of India (DCGI) had earlier directed state licensing authorities (SLAs) to urgently grant permission to manufacturers of industrial oxygen to manufacture medical oxygen in the light of COVID-19 outbreak.

All India Industrial Gases Manufacturers’ Association (AIIGMA) had proposed to the DCGI to allow manufacturers of industrial oxygen to manufacture oxygen for medical use. As per the DCGI directive to SLAs, 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 (IP) 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 had directed.

Oxygen therapy is 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.