Regulatory and Licensing Requirements for Setting up an Oxygen Manufacturing Plant in India

Introduction: 

Setting up an oxygen production facility became a major challenge given the increasing demand for medical oxygen in India. However, it is necessary to understand the legal and regulatory requirements governing the establishment and operation of these plants in a given country before entering this field. This article aims to provide an overview of the key considerations and procedures involved in setting up an oxygen manufacturing plant in India.

What is an oxygen manufacturing plant?

An oxygen manufacturing plant is a specialized industrial facility that produces oxygen gas for various applications. The main purpose of an oxygen manufacturing plant is to create a continuous supply of oxygen, usually by separating it from atmospheric air or other sources. There are various techniques used in oxygen manufacturing plants to generate oxygen, including cryogenic distillation, pressure swing adsorption (PSA), and membrane separation. 

Benefits of Setting up an Oxygen Manufacturing Plant

• It ensures a continuous and reliable supply of oxygen, which is crucial for various sectors, including healthcare, industries, and research facilities.
• It enables the production of medical-grade oxygen, supporting hospitals, clinics, and emergency services in treating patients.
• It enhances a region's preparedness for emergencies, such as natural disasters, pandemics, or unforeseen spikes in oxygen demand.
• It allows for the customization of oxygen production based on specific requirements, such as varying purity levels or flow rates.
• Having an on-site oxygen production facility ensures a readily available and consistent oxygen source for these applications.
• It can incorporate energy-efficient technologies and processes, contributing to sustainability goals and reducing environmental impact.
• It enhances self-reliance, reducing dependency on imports during times of global supply disruptions and bolstering national security.

Regulatory and Licensing Requirements for Setting up an Oxygen Manufacturing Plant

• Obtain Necessary Approvals: 

This typically includes obtaining a 'No Objection Certificate' (NOC) from the State Pollution Control Board (SPCB) or the Pollution Control Committee (PCC) in the respective state where the plant will be located. 

• Company Formation and Licensing: 

Must establish a legal entity such as a private limited company or a partnership firm. Once the company is registered, you must obtain the necessary licenses and permits, such as:
a. Industrial License: It is mandatory for large-scale oxygen manufacturing plants and obtained from the Department for Promotion of Industry and Internal Trade (DPIIT).
b. Factory License: It is required under the Factories Act, of 1948, and granted by the Chief Inspector of Factories in the respective state.
c. GST Registration: Obtain the Goods and Services Tax (GST) registration, as it is mandatory for any manufacturing unit in India.

• Infrastructure and Equipment: 

Ensure that the manufacturing facility meets the necessary specifications and adheres to safety standards. The plant should be equipped with:
a. Oxygen Generation Equipment: Select and install appropriate oxygen generation equipment such as pressure swing adsorption (PSA) units or cryogenic distillation plants, depending on the capacity and requirements of the plant.
b. Storage and Distribution Facilities: Adequate storage and distribution facilities for liquid oxygen or compressed oxygen cylinders must be established, considering safety protocols and storage regulations.

• Compliance with Drug Control Regulations: 

This includes obtaining necessary licenses from the Drug Controller General of India (DCGI) or the respective State Drug Licensing Authority. Compliance with quality control standards and Good Manufacturing Practices (GMP) is vital to ensure the production of safe and reliable oxygen.