FDA: License issued to 7 more companies to manufacturers medical oxygen

The Maharashtra Food and Drug Administration (FDA) has issued licenses to seven manufacturers of industrial oxygen to produce medical oxygen for corona virus patients by increasing the total count to 80 manufacturers.

The state drug regulator recently had sent across a directive to all the industrial gas manufacturers in the state to produce medical grade oxygen to cater to the growing demand for treating critically ill COVID-19 patients in the country. Besides this, the Maharashtra FDA officials have maintained that there is adequate quantity of medical oxygen available in the state.

According to J B Mantri, joint commissioner (HQ), Maharashtra FDA and state drug controlling authority, “There are 20,084 oxygen cylinders available in the state with an estimated oxygen quantity of 140,589 cubic metres with oxygen available in bulk at 83,63,732 cubic metres.”

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

What is Oxygen Therapy ?
Oxygen therapy helps in 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. 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.

An undertaking is required to take the permission in thus regard. “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.

A recent meeting has been held by state regulatoy with the Union commerce ministry for discussing the availability of medical grade oxygen and cylinders and is in the process of collecting the data on the same besides the storage capacity of oxygen with the existing producers. Medical gases in India have been regulated by the Union ministry of commerce and industry and the Central Drug Standard Control Organization (CDSCO) regulate.

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