In a letter by the Drug Controller General of India (DCGI), released on April 7, 2020, stated that oxygen therapy is a part of clinical management of COVID-19 patients and therefore, it is of vital importance to ensure the availability and supply of oxygen for medical use across the country.
According to the information published by WHO, patients suspected with COVID-19 or with severe acute respiratory infection (SARI) are recommended with supplemental oxygen therapy. In response to this, the All India Industrial Gases Manufacturers Association has proposed for manufacturing of medical oxygen by manufacturers of industrial oxygen. The Drug Controller General of India (DCGI) has decided to grant license to manufacturers of industrial oxygen to produce oxygen for medical use in public interest in the wake of the coronavirus outbreak.1
The DGCI has asked all state and union territory drug controllers to take action for granting license to manufacturers of industrial oxygen to make oxygen for medical use. To ensure proper availability of medical oxygen, the license will be granted to all the manufacturers having the facility to supply oxygen. The license should be supplied within 24 hours of receiving the application, fee etc. as per the Drugs & Cosmetic Act 1940 & Rules thereunder and an undertaking in writing to manufacture the medical oxygen in compliance with the standard prescribed in Indian Pharmacopoeia and labelling requirement as per the said act and rules.
Since WHO has already declared oxygen as important for clinical management in patients with COVID-19, Indian government has requested all manufacturers with the facility to manufacture oxygen required to manage to come forward COVID-19 patients. Moreover, the Government has also waived-off the time period for providing licenses to the manufacturers, which will help the manufacturers to initiate the production at immediately.
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