FDA issues lic to 7 more cos to produce medical oxygen
The Maharashtra Food and Drug Administration (FDA) has issued licenses to seven more manufacturers of industrial oxygen to produce medical oxygen for COVID-19 patients taking 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.
Stock of medical oxygen
“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,” according to J B Mantri, joint commissioner (HQ), Maharashtra FDA and state drug controlling authority. More licenses are likely to be issued as Maharashtra FDA has outlined a plan to help manufacturers take up production of medical oxygen on war footing.
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. 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.
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DCGI’s directive
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 to the 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 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 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.
The state drug regulator had recently met with the Union commerce ministry to discuss 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. Union ministry of commerce and industry and the Central Drug Standard Control Organization (CDSCO) regulate the medical gases in India.
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