How to get medical oxygen license in India

Medical oxygen is in high demand since the advent of the global pandemic known as COVID-19. Manufacturing and supplying medical oxygen requires medical oxygen license issued by the state where you are looking to set up an oxygen manufacturing plant.

Why medical license is needed

The license is required because oxygen is considered a drug and has been included in the WHO’s List of Essential medicines. The Central Drugs Standard Control Organization (CDSCO) stipulates the drug policy India and issues guidelines from to time for regulation of drugs and their sale which the state licensing authorities (SLA) must abide by for issuing licenses including manufacturing and supply of medical oxygen.

CDSCO discharges its functions through the powers bestowed to it under the Drugs & Cosmetics( D & C) Act, 1940.  Since drugs are unlike other commodities so require stringent law. Drugs are regulated right from the raw material stage through manufacture, sale, and distribution to the eventual sale to a patient by a pharmacist, hospital or a healthcare centre.

CDSCO is considered as the Indian equivalent of FDA in the US which is responsible regulation of pharmaceuticals and medical devices in India.  Supplemental oxygen therapy is essential for clinical management of COVID-19, which uses oxygen as a medical treatment. Numerous other health conditions that require use of oxygen as a drug including supplementing oxygen for low blood oxygen, cluster headaches, sleep apnea, low blood oxygen and for maintaining adequate oxygen during anesthesia.

Getting the medical oxygen license

Under the provisions of Drugs & Cosmetics Act, 1940, the government controls and regulates the manufacturing of pharmaceuticals and medical devices though its nodal agency Central Drugs Standard Control Organization (CDSCO).

Issuance of medical oxygen license

For getting the drug license for generating and supplying medical oxygen through an oxygen plant, you will have to visit the office of State Drug Controller. You will be required to fill the required forms and deposit the fees and the license will issued to you within the time frame mentioned at the time of submission of the form.

The government has issued directives to the state licensing authorities to issue licenses at the earliest. A directive has also been issued for granting manufacturing license to companies engaged in production of industrial oxygen for making oxygen for medical use within 24 hours after the submission of application and the requisite fees as per the Drugs and Cosmetics Act.  However, a written undertaking must be furnished to manufacture medical oxygen in complete compliance with the standards of Indian Pharmacopoeia and leveling specifications mandated under the provisions of D&C Act and Rules.

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.

Setting up oxygen manufacturing plant

Medical oxygen business is technology-driven so would require a basic level of knowledge of air separation processes. There are two processes used globally for generating oxygen for medical and industrial applications—pressure swing adsorption and fractional distillation.

Pressure swing adsorption (PSA)

This technique uses air separation through adsorption in which ambient air is filtered and compressed which is then passed through adsorbent containers filled with Zeolite molecular sieves (ZMS).  In the passage through ZMS, nitrogen molecules get stuck in the sieve allowing oxygen particles to pass through which are eventfully collected as a product gas.

Fractional distillation

This process starts with the intake of atmospheric air which is then filtered and compressed in the air compressor. Next the air is purified from impurities such as carbon dioxide, hydrocarbons and moisture.  Then the air is moved through a series of heat exchangers for achieving liquefaction. In this step, the air is separated into oxygen and nitrogen on the basis of their boiling points. It is distilled to meet required oxygen purity specifications.

Choose PSA or cryogenic distillation 

Depending upon your business requirements, you can either go for installing PSA or cryogenic based oxygen plant. PSA process is excellent for small industries and is extensively used in the industry for generating oxygen with medical and industrial specifications. It is suitable for hospitals or small businesses for captive consumption. For entering into medical oxygen business, you would require production of oxygen on a bigger scale.

One choose either of the processes but cryogenic oxygen plants are the most suited for generating oxygen for meeting the requirements of your medical oxygen business. Investment would require more capital but the reward that comes with the installation of the plant would be worth it. It can generate unlimited oxygen and have a life-cycle of over 25 years.

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