Hand Sanitizer Manufacturing License

Since the onset of COVID-19, hand sanitizers have become omnipresent and a medical weapon against the pandemic, shielding us from the effect of infections taking a toll on our health.

Hand sanitizers have become an essential part of our daily lives in today's rapidly changing world. The increasing demand for these hygiene products has opened up a lucrative opportunity for entrepreneurs to venture into the hand sanitizer manufacturing business. Nonetheless, obtaining a manufacturing license can be more complex, especially for individuals new to the industry. In this following guide, we will discuss the regulatory and legal requirements.

From educating oneself about the licenses and the registration involved to complying with the regulations, this guide will serve you with everything you need to begin a hand sanitizer manufacturing business.

What is Hand Sanitizer?

Hand sanitizers, or else known as hand antiseptics is an option to hand washing with soap and water. It can be prepared in different varieties such as gel, foam and liquid solution (e.g. sprays). The main component of all hand sanitizers is alcohol. The alcohol used may be ethanol-propanol, isopropyl alcohol (Isopropanol), or providence-iodine. Alcohol-based hand sanitizers are extra efficient in killing microorganisms.

An alcohol is any organic compound in which the hydroxyl functional group (OH) is bound to a saturated carbon atom. The primary alcohol usually forms the base of hand sanitizer which is about 60% in volume.

Hand sanitizer efficiency starts with its method and type of ingredients. The base of all hand sanitizers is alcohol, added to vitamin E, aloe Vera, etc. (for softening ingredients), and glycerine. The vital and germ-killing ingredient in hand sanitizers is alcohol.

The procedure of germ-killing starts by removing the oil on the skin, the bacteria present in the body from coming to the surface. Then the alcohol kills the bacteria once rubbed over the hands.

Moreover, Hand sanitizer consists of three categories, which include the following-

• Pharmaceutical Hand Sanitizer 
• Cosmetic Hand Sanitizer 
• Ayurvedic Hand Sanitizer 

Hand sanitizers are produced in various industries based on their types. It is important to note that the required license for manufacturing hand sanitizers differs depending on their classification. Furthermore, the type of hand sanitizer you intend to produce determines the specific drug manufacturing license you need. For example, you will require an Ayurvedic manufacturing license if you plan to manufacture a cosmetic-based hand sanitizer.

The materials required to manufacture hand sanitiser are as follows-

• Beaker
• Filter funnel
• Filter paper
• Foil paper
• Paper tape
• Packaging bottle
• Analytical weighing balance
• Lavender oil
• Glycerin
• Camphor
• Wild spinach
• Garlic
• Turmeric
• Ethanol
• Distilled water.

In addition, the principal raw materials required for the production of hand sanitizer are Ethanol or Isopropanol, Glycerol, Hydrogen Peroxide, distilled water and essential oils such as peppermint Lavender oil or lemon extract. All the enlisted raw materials can be procured locally.

Market of Hand Sanitizer Manufacturing

It is expected that the Indian Hand Sanitizer market will experience significant growth and is likely to exceed $43 million by 2025. This emerging market is a clear indication of the increasing awareness about wellness, hygiene, and consumer preferences for everyday healthcare. As a result, the hand sanitizer market in India is rapidly expanding, driven by the unprecedented outbreak or widespread use of hand sanitizers, which was never seen before. The hand sanitizer market is categorized into spray, liquid, foam, and gel. It is worth noting that the inception of hand sanitizers originated in West India and have since maintained its dominance in the Indian market.

The documents required for Hand Sanitizer manufacturing license is as follows-

• Area of the manufacturing unit should be not less than 600 sq. ft.
• DMR Act compliances must be followed by all manufacturers
• Technical Officer (BMS doctor)
• Incorporation / Proprietary / another form of business
• Technical Officer (BSC with Bio.)
• Product information (the composition of product)
• Directors (related to the herbal domain) will be more preferable

The facility requirements of hand sanitizer manufacturing are as follows-

• Requirements for Premises and Material

It is essential to acknowledge that the premises used for production should meet the requirements outlined in Schedule M of the Drugs and Cosmetic Rules about external preparations. Various conditions specified in Part-ID of the schedule specifically apply to hand sanitizers.

• Requirements of Plant & Equipment

The facility must comply with the requirements outlined in Schedule M Part-II 1. Specifically, for the production of hand sanitizers, the external preparations should meet the minimum equipment and area standards as recommended and deemed applicable.

Licenses and registration required for Hand Sanitizer Manufacturing

In establishing a hand sanitizer production unit, you will need to acquire several Licenses and registrations from different Government authorities. The licenses and registration needed for Hand Sanitizer manufacturing are as follows-

• UAM Registration (udyogaadhaar.gov.in)
• Company Registration with ROC
• Trade License
• Factory License
• Drugs & Cosmetics License
• BIS Certification
• Fire License (easybusiness.tn.gov.in)

The step-by-step procedure to avail of Hand Sanitizer Manufacturing License registration consists of the following steps, which are as outlined below-

Step 1:- Connect with the Corpseed team

Firstly, contact Corpseed as your one-stop solution provider. 

Step 2:- Meet Our Experts 

Secondly, Corpseed will align a dedicated professional to help you with the Hand Sanitizer Manufacturing License Registration. 

Step 2:- Documentation process  

Soon after, our experts will reach out to you and guide you in accordance with the necessary documentation that is required to establish your hand sanitiser manufacturing license application. With that, the documents might vary, depending upon the designated location of your company.

Step 3:- Submit application

In the next step, once you have gathered sufficient documentation, you will then be asked to submit an application for the hand sanitizer manufacturing license. To quicken this process, corpseed stands as your Watch Guard and assists you with filing an online form as per the requirements, stated.

Step 4:- Compliance Inspection 

Now, once you have submitted the application, the regulatory authorities will undergo a process, also known as the compliance inspection, being carried out at the manufacturing facility. This in turn would ensure that the facility is able to fulfil the safety standards while encouraging hand sanitizers.

Tip- Keep your facility prepared beforehand for inspection, without letting any loophole disturb the licensing process. 

Step 6:- License Issuance

If the manufacturing facility passes the compliance inspection, there is a good chance of obtaining the hand sanitizer license. This license is crucial for producing and distributing hand sanitizer according to the guidelines set by regulatory authorities. Once approval is confirmed, corpseed will inform you via email.

Therefore, such steps help you obtain a Hand Sanitizer manufacturing license.

At Corpseed, we place great emphasis on the registration of sanitizer manufacturing license and acknowledging its profound significance and the substantial impact it can have on businesses in India. We firmly believe that adhering to the regulations and requirements is essential for ensuring their seamless operations and long-term prosperity. We fully comprehend the intricate complexities and hurdles that entrepreneurs encounter when manoeuvring through the legal landscape. Our team of seasoned experts possesses extensive knowledge and expertise in obtaining Sanitizer manufacturing, enabling us to offer comprehensive guidance and unwavering support to our clients.