Launching Your Homeopathy Medicines Company in India: A Step-by-Step Guide
Friends, the demand for homeopathy medicines has been increasing for the last several years in a big country like India. According to recent data, a large population of India is adopting natural, side-effects-free treatments for overall health wellness. This growing trend is presenting a golden opportunity for entrepreneurs to start a homeopathy medicine business and establish a promising business. Apart from this, the government is also showing its support to increase awareness about alternative medicine and AYUSH initiatives.
So friends, today in this blog article, we will try to give you the ultimate roadmap from legal requirements and financial planning to understanding the setup process and operational essentials if you are thinking of starting a homeopathy medicine company in India and in this blog article, whether you are a budding entrepreneur or an industry enthusiast, this step-by-step guide will help you gain the knowledge to turn your vision into a successful venture.
Why Start a Homeopathy Medicines Company in India?
So friends, now the question arises that why should an entrepreneur start a homeopathy pharmaceutical company in India, well there can be many reasons for this. If we talk according to our experience, India is a country with a large population where many people are looking for safe and effective treatment, due to which the sector has expanded a lot, which is supported by the increasing demand and support of healthcare professionals. This trust, coupled with the growth trajectory of the industry makes homeopathy an attractive and sustainable business opportunity.
Types of Homeopathy Businesses You Can Start
So friends, whenever you think of starting a homeopathy business, the first question that comes to your mind is what kind of business should I do? Should I start a business in the field of homeopathy medicine manufacturing or should I open a marketing company or should I sell homeopathy medicines through retail or online sales. So if we talk about starting a homeopathy medicine business, then you have to be very clear in your mind according to the need of your business that what kind of homeopathy business you want to start.
License and Registration Required for Homeopathic Medicines?
First of all you have to understand the eligibility of your business and accordingly apply to the drug authority of your state with the required documents to get the required license. Apart from this, you have to get GST number and get your Homeopathy Factory Act or Shop and Establishment Act registration done etc.
If you want to sell homeopathic medicine in retail, what license will be required for that?
The license will be issued by the State Drugs Department on Form 20-C but you have to fill the application form in Form 19-B and submit it to the office of the licensing authority appointed by your respective state.
What licenses will be required to start a homeopathic marketing company?
If you want to start a Homeopathic marketing company and want to know about it in detail then click on the given link. How to start Homeopathic marketing company in india?
License requirement for starting a Homeopathic Manufacturing Company.
Friends, to obtain license to manufacture, sell/distribute Homeopathic medicines in India you have to submit the form (Form 24-C) to the State Licensing Authority.
If you want to apply for a homeopathic medicine license, you need to keep these essential documents ready.
- Receipt will be required for depositing prescribed fee
- Whichever manufacturing premises you have selected, you are required to prepare a site plan of the manufacturing premises which must include the layout details with dimensions in metres.
- Prepare a key plan that provides accurate information regarding the location of the manufacturing unit.
- Certificate of formation of the firm would be required which may include affidavit of the proprietor/partnership deed/memorandum etc.
- You have to prepare a list of all the installed equipment and machinery used during the manufacturing and testing of the medicines and submit the same with complete details.
- To maintain safety and efficacy related to drug manufacturing, qualification certificate of all the manufacturing chemist and analytical chemist technical staff appointed by you, experience letter of full-time technical staff, biodata approval letter, consent affidavit and joining report will have to be prepared and submitted along with attested photo copies.
- The form prescribed by the Department of Pharmaceuticals should be read carefully and should contain the list of health products to be manufactured along with the detailed formula list, duly signed by the authorized signatory and the manufacturing chemist.
- Proof of ownership/rent agreement as documents
Area required and recommended machinery/equipment for manufacture the homeopathic medicine.
Friends, we have prepared a list of essential equipment and machinery used for manufacturing homeopathic medicines which you can see below.
Machinery and equipment required for mother tinctures and mother solutions.
Partner, you are required to create separate manufacturing facilities for manufacturing Mother Tinctures and Mother Solutions in the manufacturing area and each should have a minimum area of 55 square meters to ensure basic installations.
- Sieved separator
- Disintegrator
- Weights, scales and liquid measures must all be in the metric system.
- Note the macerator, including the lid (all should be made of grade 304 neutral glass or stainless).
- Board and knives/Cutting
- All percolator components should be made of 304 stainless steel.
- Keep in mind that all metal parts associated with the sparkler filter or filter press must be made of stainless steel.
- Moisture determination device
- Both mixing and storage vessels (made of Grade 304 stainless steel)
- Water purifier/water still
- Keep in mind that the portable stirrer screw should be made of stainless steel and the rod and blade should be made of steel
- Sealing machine and Filling
Equipment and machines required for Potentisation section.
Need for Containers & Closures section.
To ensure the safety and efficacy of the medicines you need to ensure the availability of adequate area for storage, handling and processing for the smooth functioning of all the processes.
- You can wash the tanks in two ways, either by using suitable mechanical means or by using a manual brush.
- Keep in mind that pure water will be used to wash the tank
- Closures washing/macerating tanks
- Driers
Special machinery and equipment for tableting, trituration, tablets and globules preparation sections.
- You should have an area of 55 square metres available for the basic setup required.
- Disintegrator
- Granulator
- Mass Mixer
- Electrical oven
- Tablets punching Machine
- A kettle for preparing the solution (heated by steam or electricity)
- Sieved separator (stainless steel)
- Balances
- Tablet counter
- Multi-sifter
- Coating Pan with spray-gun
- Mill with perforations
Machinery and equipment required for syrup and other oral liquids section
Friends, remember that you must have 20 square meters of area available for the basic installations required here.
- Portable stirrer (screw, rod and blade must be made of stainless steel)
- Mixing and storage tanks shall be made of grade 304 stainless steel.
- Sealing and Filling Machine
- All metal parts attached to the sparkler filter/filter press must be made of stainless steel.
- pH meter
Machinery and equipment required for ointments and lotions section
Keep in mind that even for its basic installation you must have a minimum area of 20 square meters available.
- The kettle used for preparing the solution must be electrically automated
- Mixing tanks(Stainless steel)
- Emulsifier/Ointment mill/colloidal Mill
- Planetary Mixer/suitable powder
- There will be a crimping machine that will help with filling and sealing.
- Balance and weights
The equipment and machines required for the ophthalmic preparation section may be as follows.
For all these basic setups you should have at least 20 square meters minimum area.
- Laminar air flow benches should have
- Must be electrically powered, hot air oven and with thermostatic control.
- Colloidal Mill/ointment mill
- As equipment you must have a handling unit with a HEPA filter that provides filtered air and positive pressure to the air-lock.
- Mixing and storage tanks should be made of stainless steel and should be grade 304
- Seitz Filter,Sintered Glass Funnel/Filter Candle
- Vacuum pump
- Must have an autoclave with pressure and temperature gauges
- Machines required for filling ointments, liquids etc.
- Necessary workbenches, visual inspection bench, etc.
- Air Condition
List of equipment required for quality control.
It is more important to have adequate area to run all types of processes smoothly, which will prove useful for storage, handling and processing.
- Dissecting microscope
- UV lamp viewer
- There should be photographic equipment and microscope equipment with proper magnification.
- TLC apparatus
- Hot air oven
- Monopan Digital Electronic Balance
- Water Bath
- Distillation apparatus
- Refractometer
- Polarimeter
- PH meter
- Melting point apparatus
- Magnetic stirrer
- Electric bunsen/Muffle furnace
- Table Centrifuge
- Moisture determination apparatus
- Section cutting facilities/Rotary microtome
- U.V. Spectrophotometer
- Tablet Disintegration Machine
Conclusion:
Overall friends, starting a homeopathy manufacturing company in a big country like India can be a promising and profitable business but to get a manufacturing license, you have to prepare the list of required documents and equipment and machinery and apply to the AYUSH licensing authority of your state by following all the rules given by the licensing authority appointed by the state government. Then the AYUSH officer will inspect your premises and if all things are found correct, then the license will be provided to your manufacturing firm.
Read related article:
A Comprehensive Guidelines on How To Start a small Ayurvedic Manufacturing Unit
A Beginner's Guide to Starting an Ayurvedic Marketing Company.