Task force to monitor availability of medical oxygen: Maha FDA

A task force comprising of drug inspectors has been constituted to monitor availability of medical oxygen in the state- Maha FDA

FDA Regulators DCO
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2 min. read

In order to address the growing demand of medical grade oxygen, the Maharashtra Food and Drug Administration (FDA) has formed a task force comprising of drug inspectors to monitor its availability and ensure its optimal production.

Maharashtra has been producing 3,000 tons of medical oxygen and accounts for a monthly sale of 2,311 tons of medical oxygen based on official data available with the Union commerce ministry. Union commerce ministry oversees regulation of medical oxygen in the country.

“A task force comprising of drug inspectors has been constituted to monitor availability of medical oxygen in the state. There are 80 manufacturers in Maharashtra which have been licensed to produce medical oxygen and in order to ensure that adequate oxygen is sustainably produced, Drugs Controller General of India (DCGI) and Union commerce ministry has issued directives towards maintaining adequate stock of medical oxygen,” according to a senior official associated with the development.

Department for Promotion of Industry and Internal Trade (DPIIT) under the union commerce ministry had earlier shared with DCGI a list of major medical oxygen manufacturers which are based in Tamil Nadu, Puducherry, Karnataka, Chhattisgarh, West Bengal, Jharkhand, Maharashtra, Orissa Gujarat, Assam, Andhra Pradesh, Uttar Pradesh, Jammu and Kashmir, Punjab and Uttarakhand to discuss preparedness for availability of medical oxygen in the country.

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According to official sources, Maharashtra today has surplus oxygen supply as almost all major industrial oxygen manufacturers have their footprint in Maharashtra like Lynde India, Taiyo Nippon Sanso India, Kolhapur Oxygen Acetylene and Inox India. Taiyo Nippon Sanso India alone has a production capacity of 3,000 ton per month with Kolhapur Oxygen Acetylene having production capacity of 31 ton per day. Lynde India has production capacity of 31.45 ton per day with Inox India having 100 ton production capacity per day, as per official records.

DPIIT has directed state licensing authorities (SLAs) to furnish details about stock of medical oxygen on an urgent basis. It had also requested to provide information concerning the daily stock position (in tons), daily installed capacity (in tons) and daily actual production (in tons), market share, name and address of the manufacturers along with their contact details and date of verification of the claim of venting. All this information needed to be furnished daily before 05.00 pm.

DCGI had earlier directed SLAs to urgently grant permission to manufacturers of industrial oxygen to manufacture medical oxygen. . 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.

Following this, Maharashtra FDA had also sent across a directive to all the industrial gas manufacturers in the state to produce medical grade oxygen to cater to the growing demand.

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 needs to be furnished in writing to manufacture medical oxygen in compliance with standards prescribed in Indian Pharmacopoeia (IP) and labeling requirements as per the D&C Act and Rules.

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