Home » FDAs asked to quickly grant permissions to manufacture medical oxygen

FDAs asked to quickly grant permissions to manufacture medical oxygen

by Raju Vernekar
0 comment 3 minutes read

By IT Correspondent
Mumbai/Delhi, July 13:

The Drug Controller General (India) (DGCI) has directed all state licensing authorities (SLAs) to urgently grant permission to manufacturers of industrial oxygen to manufacture medical oxygen in the light of COVID-19 outbreak. 
DCGA has made it clear that the license to manufacture oxygen for medical use should be granted within 24 hours of the submission of application by the manufacturers after paying requisite fees as per the Drugs and Cosmetics (D&C) Act 1940. The manufacturers are required to furnish an undertaking in writing to manufacture medical oxygen in compliance with standards prescribed in Indian Pharmacopoeia (IP) and labelling requirement as per the D&C Act and Rules. 
Department for Promotion of Industry and Internal Trade (DPIIT) (under the union commerce ministry) has also asked the manufacturers to provide information concerning the daily stock position (in tons), daily installed capacity (in tons) and daily actual production (in tons), market share, along with their contact details and date of verification of the claim of venting. All this information is required to be furnished daily before 05.00 pm. 
A list of major medical oxygen manufacturers from the Union commerce ministry has been  received by DCGI, which includes the manufacturers from Tamil Nadu, Puducherry, Karnataka, Chhattisgarh, West Bengal, Jharkhand, Maharashtra, Orissa Gujarat, Assam, Andhra Pradesh, Uttar Pradesh, Jammu and Kashmir, Punjab and Uttarakhand. 
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 anaesthetics 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 also receive oxygen therapy during resuscitation. 
By a large a 200-bed hospital needs at least 180 oxygen cylinders a day. In a hospital, Jumbo sized cylinders are commonly used in manifold room, which are capable of holding 6800 litres of oxygen. 
Union ministry of commerce and industry and the Central Drug Standard Control Organization (CDSCO) regulate the medical gases in India. The Directorate General of Health Services (Government of India), enables manufacturers of industrial oxygen to obtain a license to sell the product for medical use. 
In the meanwhile Maharashtra, nearly 80 manufacturers have been permitted by DCGI, to  produce medical oxygen. The state produces nearly 3,000 tons of medical oxygen and accounts monthly sale of over 2,300 tons of medical oxygen. As of today, the state has over 65 tons of surplus medical gas. 
In Maharashtra major industrial oxygen manufacturers include “Lynde India”, “Taiyo Nippon Sanso India”, “Kolhapur Oxygen Acetylene” and “Inox India”. “Lynde India” has production capacity of 31.45 ton per day, “Kolhapur Oxygen Acetylene” has production capacity of 31 ton per day and “Inox India” has the capacity of 100 ton production per day.

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