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How to Start a Nebulizer Manufacturing Unit in India?

calendar07 Dec, 2022
timeReading Time: 4 Minutes
How to Start a Nebulizer Manufacturing Unit in India?

Nebulization can relieve people of any age who are suffering from respiratory problems. A nebulizer is a portable device which turns liquid medicine to a mist that is inhaled through a mask. This makes it possible for the medicine to be absorbed into the lungs more rapidly and with less effort. It is commonly used for respiratory problems like chest congestion, asthma, and other similar conditions because it is easily adaptable, has a lower cost, and is less expensive. According to the MDR2017, nebulizers are considered medical devices with a low to moderate risk and must be registered. The Nebulizer Manufacturing Unit in India is subject to regulation by CDSCO.

Regulatory Authority for Nebulizer Manufacturing Unit in India

The Central Drugs Standard Control Organization will act as India’s central licencing authority and approve Nebulizer Manufacturing Unit applications. The manufacturer is the one who needs to apply for a manufacturing licence to CDSCO. The manufacturer of these goods must ensure that the safety and efficacy principle is adhered to under the provided guidelines. The individual who is interested in beginning the nebulizer manufacturing unit ought to have knowledge of the manufacturing process as well as the regulatory procedure. Nebulizers are typically available in electric and battery-operated variants, and they can either be portable (so that they can be brought along with you) or designed to be placed on a table and plugged into an electrical outlet.

Each nebulizer consists of the following components:

  • A base that houses an air compressor;
  • A small container for holding liquid medicine;
  • A tube that connects the air compressor to the medicine container; and a mouthpiece that inhales the medicine.

A mouthpiece or mask you put on before inhaling the mist is located directly above the medication container.

Nebulizers can be divided into the following three categories:

  • Jet Nebulizers: These devices take medications and turn them into an aerosol by using a compressed gas (like air). The most common type of nebulizer is one like this.
  • Ultrasonic nebulizers: These are typically reserved for use in medical facilities and are not available for purchase for individual use.
  • Mesh nebulizers: Mesh nebulizers have a mesh cap that has tiny holes in it, which allows the medication to be dispensed in a highly effective manner. These nebulizers are more advanced than jet nebulizers and frequently have greater power than the latter.

Technical Features of Nebulizer Manufacturing: 

  • Constructed from a clear aerosol mask that is ideal for extended use.
  • Made from a medical-grade material that is both comfortable and non-toxic.
  • Use a star lumen tube to prevent accidental blockage from occurring.
  • Constructed using a PVC tube that is resistant to kinking.
  • An integrated nasal clip that provides a secure and stable fixation over the patient’s nose.
  • The elastic strap or band ensures that the mask is in the correct position.
  • The length of the tube is two metres.

Procedures Used in the Production of Nebulizers

Injection Moulding Machine 

The process of forming known as injection moulding makes use of moulds. After being heated to melting, specific materials, like synthetic resins (plastics), are poured into moulds, remaining until they are cooled and solidified into the desired shape. Injection moulding is the name given to this system because of its striking similarity to the process of injecting fluids with the help of a syringe.

Mechanical

A device of this kind is utilized to toggle the machine to build up the tonnage on the side of the machine that does not open due to the injection pressure.

Hydraulic

Although these machines are not nearly as precise as they could be, the vast majority of the world still uses them.

Electric

The electric press, also known as electric machine technology, lowers the cost by reducing the energy consumed in the manufacturing process. The electric press is rumoured to be more stealthy, quicker, and accurate than its manual counterpart.

Sterilization Plant

Ethylene oxide is required in this process because it is intended for sterilization. Ethylene oxide, also known as ETO, is the gas utilised during the low-temperature sterilisation process. In most cases, it is used to sterilize items such as instruments or devices and everything else that needs to be sterilized but cannot be subjected to high temperatures.

Raw Material Used in Nebulizer Manufacturing Unit

  1. Polyvinyl chloride (PVC)
  2. Strap or band made of elastic
  3. Styrene acrylonitrile butadiene acrylonitrile (ABS)
  4. Polypropylene (PP)
  5. Polyethylene terephthalate of high density (HDPE)

How do nebulizers work?

A nebulizer[1] is a medical device disperses liquid medication into the body via pressurized air. Although people who have asthma typically make use of both nebulizers and inhalers, there are times when nebulizers are more straightforward to operate than inhalers. On the other hand, because setting up a nebulizer can take some time, an inhaler is typically recommended when the airways become constricted, such as during an asthma attack.

Nebulizers can be used to administer a variety of medications, including the following:

  • Bronchodilators are one type of medication that helps open up the airway.
  • Antibiotics are utilized in the process of treating infections.
  • Medical-grade saline solutions, also known as saltwater solutions, help break up mucus in the lungs.

Nebulizers are used for a various conditions, including but not limited to the following: chronic obstructive pulmonary disease ; asthma; bronchiectasis; cystic fibrosis; and pulmonary fibrosis.

Nebulizers are also helpful in administering medication to patients undergoing palliative care and very young children.

Reasons to start Nebulizer Manufacturing Unit

The production of nebulizers has seen expansion, and the data compiled from various sources indicates that the revenue generated by the industry is forecast to increase by 6.5% between the years 2020 and 2027.

Nebulizers are included in the home care services that are provided. One can take advantage of the opportunity in the nebulizer manufacturing market. The following are examples of driving factors that contribute to the manufacturing process of nebulizers:

  • An expanding market size due to the respiratory disease and the outbreak of Covid-19 has prompted an increase in the demand for nebulizers.
  • Home care service product – An increasing number of people, particularly among the elderly population, are deciding to purchase medical equipment for use in the comfort of their own homes.
  • The development of new technologies.
  • The government will launch new incentive programmes and update existing ones to modernize medical device manufacturing and reduce reliance on imported goods.

Conclusion

To summarise, we can say that the growing number of elderly patients around the world as well as technological advancements in healthcare devices contribute to the expansion of the market. These factors point to enormous opportunities in the nebulizer manufacturing unit, and precisely, these opportunities entice manufacturers and importers to begin the venture. Before they enter the market, these manufacturers and importers should consider all relevant regulations carefully.

Read Our Article: An Interplay between CDSCO Guidelines & Public Health Safety

Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

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