Apr 9, 2020

 

The Central Drugs Standard Control Organization, Government of India, has requested all State and Union Territory Drug Controllers to expedite the licensure procedure to manufacture oxygen for medical use. This is considered as a welcome move taken in public interest in the wake of outbreak of COVID-19 as supplemental oxygen therapy is part of clinical management of COVID-19 patient. Therefore, it is imperative to ensure the availability and supply of oxygen across the country.

This action has been taken on the proposal made by All India Industrial Gases Manufacturer’s Association (AIIGMA) wherein the association has proposed for allowing manufactures of industrial oxygen to produce oxygen for medical use.

As per the letter dated 07.04.2020, the Drugs Controller General (I) has requested all State and Union Territory Drug Controllers to grant manufacturing licence to manufacture oxygen for medical use to all the manufacturers of Industrial oxygen which are having the facility to manufacture industrial oxygen within 24 hours of receiving the application, fees, etc. as per the Drugs and Cosmetics Act, 1940 and Rules. However, the manufacturer has to submit an undertaking in writing to manufacture oxygen for medical use in compliance with the standards prescribed in Indian Pharmacopoeia and labelling requirement as per the said Act and Rules.