How to Start Homeopathy Medicines Company in India?

In this article we will cover Licenses required for selling, distribution, marketing and manufacturing of Homeopathic medicines along with Equipment and machinery required for manufacturing and processing.

Homeopathic Medicines work at theory of “similar treats similar”. Homeopathic medicines are derived from natural resources (herbal or animal) and prepared for use as safe medicines by diluting and potentized. Homeopathic medicines which are manufacture for sale or import for sale in India should be recorded in authoritative Homeopathic literature of India and aboard and is prepared according to the techniques of Homeopathic Pharmacy.

For Sale of Homeopathic Medicine in Retail:
Licence on form 20-C is issued for sale of Homeopathic medicines by retail. Application is to be submitted on Form-19-B at the office of licensing authority appointed by concern State Government.
For Sale of Homeopathic Medicine in Wholesale:
Licence on Form 20-D is issued for sale of Homeopathic Medicines by wholesale. Application is to be submitted on Form-19-B at the office of licensing authority appointed by concern State Government.
For Homeopathic Marketing Company: 

For Homeopathic Manufacturing Company:

Licence on Form 25-C is issued for manufacture for sale/distribution of Homeopathic Medicines (Form 24-C) by licensing authority appointed by state government.
Documents Required for applying for Homeopathic Medicines License:
  • Prescribed Fee Deposit Receipt
  • Manufacturing Premises Site Plan providing detail of layout with dimensions in  meters
  • Key-plan that provide accurate knowledge about location of the manufacturing unit including land marks and other specifications nearby manufacturing unit.
  • Proof of constitution of Firm e.g. Proprietor’ affidavit/partnership deed/Memorandum and Article of association which is applicable.
  • Power of Attorney in the name of one or more than one partner / Director / Manager/Secretary or any person who is competent to correspond with the Drugs Control Authorities with regard to grant/Renewal etc. of licence(s).
  • List of Equipment and Machinery installed for manufacturing and testing of drugs with complete detail.
  • Attested photo copies of qualified certificates, experience letter, letter of approval, Bio data, consent affidavit and joining report of the whole time technical staff employed for the manufacturing chemist and analytical chemist.
  • List of products intended to be manufactured with detailed formula, (including Pharmaceutical aids, excipients) in proforma prescribed by drug department duly signed by authorized signatory and manufacturing chemist.
  • Proof of ownership/Rent Agreement
  • An affidavit/undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940.
  • All the photocopies of documents should be self attached

Manufacturing Chemists:

The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee and who is—
(a) a graduate in Science with Chemistry as one of the subjects with three years‘ experience in manufacture of Homoeopathic Medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines

Equipment and Machinery required for manufacturing of Homeopathic medicines are as below:For Mother tinctures and mother solutions- 

The area and facilities for manufacture of mother tinctures and mother solutions shall be separate and shall be 55 square meters for each for basic installations.

  • Disintegrator;
  • Sieved separator;
  • Balances, weights and fluid measures, all in metric system;
  • Chopping table/board and knives;
  • Macerators with lids (all made of stainless steel of grade 304 or neutral glass);
  • Percolators (all made of stainless steel of grade 304);
  • Moisture determination apparatus;
  • Filter press/Sparkler filter (all metal parts shall be of stainless steel);
  • Mixing and Storage vessels.(Stainless steel of grade 304);
  • Portable stirrers (Rod, blades and screws shall be of stainless steel);
  • Water still/water purifier;
  • Macerators and percolators for preparing mother solutions of materials of chemical origin. These shall be of material, which will not react with the chemicals, used and which do not bleach; and
  • Filling and sealing machine.

For Potentization section – 

An area of 20 square meters shall be provided for basic installations.

  • Work benches with washable impervious tops;
  • Facilities for orderly storage of different potencies and back-potencies of various drugs;
  • Suitable devices for measuring and dispensing of potencies/back-potencies into the potentisation phials;
  • Potentiser with counter.

Note – (a) The requirement of potentiser is not mandatory. The process may be done manually also with proper SOPs. Potentiser, if used, shall be properly validated and shall be calibrated every time before commencement of work for proper performance.
(b) The manufacturer shall use back-potencies procured from Licensed manufacturer and the firm shall maintain proper records of purchase or shall prepare own back-potencies. Every container of potencies and back –potencies shall be kept properly labelled and there shall not be mix-up of different medicines and different potencies.

For Containers and Closures Section-
Area should be adequate for smooth storing, handling and processing all procedures.

  • Washing tanks with suitable mechanical or hand operated brushes;
  • Rinsing tanks. Purified water shall be used for rinsing;
  • Closures washing/macerating tanks;
  • Driers;

For Trituration, Tableting, Pills and Globules making sections – 

An area of 55 square meters shall be provided for basic installations

  • Triturating Machine;
  • Disintegrator;
  • Mass Mixer;
  • Granulator;
  • Electrical oven;
  • Tablets punching Machine;
  • Kettle (steam or electrically heated) for preparing solutions;
  • Driers for drying granules and tablets;
  • Sieved separator (stainless steel);
  • Tablet counter;
  • Balances;
  • Coating Pan with spray-gun;
  • Multi-sifter;
  • Mill with perforations.

For Syrups and other oral liquids section.- 

An area of 20 square meters shall be provided for basic installations

  • Mixing and storage tanks. (stainless steel of grade 304);
  • Portable stirrer (rod. Blades and screws shall be of stainless steel);
  • Filter press/Sparkler filter (all metal parts shall be of stainless steel);
  • Filling and sealing machine;
  • pH meter
For Ointments and lotions section – 

A minimum area of 20 square meters shall be provided for basic installations.

  • Mixing tanks(Stainless steel)
  • Kettle (steam or electrically heated) for preparing solutions
  • Suitable powder/planetary Mixer
  • Ointment mill/colloidal Mill/Emulsifier
  • Filling and sealing machine/crimping machine
  • Filtering equipment.
  • Balance and weights.

For Ophthalmic preparations section –

Minimum area of 20 square meters shall be provided for basic installations

  • Hot air oven, electrically heated, with thermostatic control;
  • Laminar Air Flow bench;
  • Air Handling Unit with HEPA filters to provide filtered air and positive pressure to the section and air – locks;
  • Ointment mill/colloidal Mill
  • Mixing and storage tanks.(stainless steel of grade 304);
  • Pressure vessels, as may be needed;
  • Sintered glass funnels, Seitz Filter/Filter candle;
  • Vacuum pump;
  • Filling machines for liquids ointments etc.;
  • Autoclaves with pressure and temperature gauges;
  • Necessary workbenches, visual inspection bench, etc.;
  • Air Condition

Quality Control Equipment –

Area should be adequate for smooth storing, handling and processing all procedures.

  • Microscope of suitable magnification and photographic device;
  • Dissecting microscope
  • TLC apparatus;
  • UV lamp viewer;
  • Monopan Digital Electronic Balance;
  • Hot air oven;
  • Distillation apparatus;
  • Water Bath;
  • Polarimeter;
  • Refractometer;
  • Melting point apparatus;
  • PH meter;
  • Magnetic stirrer;
  • Table Centrifuge;
  • Muffle furnace/electric Bunsen;
  • Moisture determination apparatus;
  • U.V. Spectrophotometer;
  • Rotary microtome/Section cutting facilities;
  • Tablet Disintegration Machine.
Hope above information is useful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How Much Investment is Required to Start Pharmaceutical Company?

Most of person has issue of investment. 98 out of 100 person who think to start own business faces investment problem. Investment and money is most important prospect for starting any type of business. Here we are providing some basic calculations to calculate investment required to start pharmaceutical company.

Pharmaceutical Sector is one of the fastest growing sectors in world. As we have discussed in our Article: How to start Pharmaceutical Company? Pharmaceutical companies are of two types:

  • Pharmaceutical Marketing Company
  • Pharmaceutical Manufacturing Company

Investment required for both types of companies are also different. While preparing a Business Plan, investment is an important part of it. Pharmaceutical Marketing Company require less investment as compare to manufacturing company because manufacturing unit requires lot of machinery, a world class infrastructure, building and much more.

In this article we will try to calculate total investment required for starting marketing company and manufacturing company. Investment is of three types generally:

  • Fixed Capital Investment (One Time investment)
  • Working Capital Investment (Investment to run a company)
  • Inventory Investment (Stock, Raw Material, packaging material etc.)

Fixed Capital Investment:

We can say it also as One Time Investment. Fixed Capital Investment is the investment in fixed assets (like land, building, office, vehicle, machinery and equipment etc.). Fixed Capital Investment will be different for marketing company and manufacturing company.

Working(Operating) Capital Investment:

Working investment is liquid assets needed to run a company. Operative capital includes salary, wages, raw material cost, and marketing & promotional expenses etc. These are planned and unplanned investments (timely arise) require in daily basis to smoothly run an organization. Operating capital investment require till company start to earn adequate profit to handle its regular expense and wages.

Inventory Management:

Third type of Investment required for Stock and Product Availability (Inventory). Inventory investment depend at number of products you want to launch and manufacture in starting.

Investment Required for Pharmaceutical Manufacturing Company:

Pharmaceutical Manufacturing is a highly investment project. Major portion of investment will invest in purchasing a land, Building and infrastructure etc. This can be prevented if you start at rented premises and building. But location, area, plant and building infrastructure should meet with requirement of GMP certification (WHO: GMP and/or Schedule M).

Area required and machinery detail for starting manufacturing unit, you can read at our article:  Area and machineries required for each section in Pharmaceutical Manufacturing Unit.

If you have own land and building that Good, but that is also an investment. We will consider it as investment. If you don’t have, you have two options: Either you purchase or you take a building at rent. In case of rented premises, rent and/or deposited money will be calculated as investment.

It’s not easy to calculate actual investment as cost of land, plant, cost to build a building, rent, machinery and equipment, staff salary, worker wages are not same at all locations, area’s, states and countries. Cost of any particular thing, we will replace with any alphabets. By replacing that alphabet with cost of that thing in you locality, you can calculate actual investment required to start pharmaceutical manufacturing company.

Requirements for Starting Pharmaceutical Manufacturing Unit:

Fixed assets:

  • Land (L)
  • Building (B)
  • HVAC (Heating, Ventilation and Air Conditioning) System (H)
  • Air Lock System (A)
  • Fitting, Finishing and Furnishing (F)
  • Machineries and Lab Equipments (M)
  • Electricity Supply (E)
  • Water Supply (W)
  • Compressed Air Supply (C)
  • Investment for completing Licenses and formalities (I)
  • Other Requirements (R)

Liquid Assets:

  • Skilled and Technical Staff Wages (S)
  • Non Skilled Worker Wages (N)
  • Repair and maintenance (H)
  • Rent if applicable (T)
  • Bank Loan installments and related expenses (I)
  • Promotional and Marketing (P)
  • Other expenses (J)

Inventory Investment:

  • Raw Material and Packaging Material Stock (R)

You need to calculate fixed capital investment and operating capital investment separately. This will help to establish and run manufacturing company smoothly. Fixed capital investment can be calculated by adding fixed assets cost where as operating capital investment can be calculated by adding liquid assets.

Fixed Capital Investment = L+ B + H + A + F + M + E + W + C + I + R

Operative Capital Investment = S + N + H + T + I + P + J

Other than these, a manufacturing company also needs to market its own product in market. So it also requires investment needed for marketing and promotion as needed by marketing company. We can also include investment that will require for starting pharmaceutical marketing company in below portion.

Investment Required for Pharmaceutical Marketing Company:

Investment for Pharmaceutical Marketing Company is relatively low as compare to manufacturing company. In marketing company there is less infrastructure and capital required. For marketing company, less space, small office and fewer requirements are needed but marketing and promotional budget could be higher side.

A pharmaceutical manufacturing company has few addition marketing tools other than conventional marketing tools and advantage in marketing like third party manufacturing, contract manufacturing, loan licensing, greater reputation and institutional supply etc. That is not available for pharmaceutical marketing companies. Marketing has to reliable at conventional marketing solutions like ethical, generic, pcd, franchise etc only.

In marketing company, office and premises can be at rented basis if not owned. If owned premises, we will add it in fixed capital investment. Otherwise rent will be considered as operating capital investment.

Fixed Assets:

  • Office Building (B)
  • Office Furniture and Accessories (A)
  • Computer and Electronic Equipments (C)
  • Fitting and Furnishing (F)
  • Investment at licenses and documents (L)
  • Other Requirements (X)

Liquid Assets:

  • Office Staff Wages (O)
  • Rent if applicable (R)
  • Bank Loan installments and related expenses (I)
  • Promotional and Marketing (P)
  • Other expenses (J)

Inventory Investment:

  • Stock Investment (S)

Fixed Capital Investment= B + A + C + F + L + X

Operation Capital Investment+ O + R + I + P +  J

Marketing Strategy and promotional methods are almost same for marketing and manufacturing companies. So there marketing and promotional expenses are almost same.

Above we have discussed about investment required to start pharmaceutical company. In short discuss about factors that affect investment for starting pharmaceutical company.

Factors:

Land Cost:

Cost of land is different at different localities. Possibilities is there if some where you can find land at cheap cost and some where cost of land is high.

Building and Premises Furnishings:

Building construction as per GMP certification is very essential for setting up manufacturing unit. A good architect is needed for it. Also building material cost varies place to place. That makes different in investment to construct a building at different places.

HVAC, Air Lock System and other machineries & equipments:

Some countries and localities are dependent at import for high quality systems and machineries for setting-up a plant. Also prices vary according to the manufacturers and quality of machineries and equipments.

Licenses and Documentation process and Fees:

Some regions and countries have relaxed policies in respect for licenses and documents to start pharmaceutical company. In some regions, it’s a difficult task to get any type of license even after completing all formalities. Bribe and unethical money distribution also affect the investment required.

Rent:

In case, you are in rented premises and/or building, rent at that particular locality affect the investment. In prime location rent may be high, in non prime locality rent would be relaxed.

Staff and Workers wages:

Easy availability of skilled and technical staff, Non availability of skilled staff directly or indirectly affects operation investment. If available then investment will be lesser otherwise skilled staff recruitment from outside locality may increase operation investment.

Investment required for Stock and Product Availability (Inventory Investment):

Stock may be in both assets fixed and liquid depend at situations. Stock is moving thing and will be in rotation as per demand and supply. Stock investment will be covered under Inventory management but here we will also cover important aspects regarding stock because it is an important part of Operative Capital Investment.

We can divide stock investment in three parts.

  • Initial Investment
  • Second investment in second batch to prevent shortage of products
  • Emergency money

You could need double of your initial investment as reserve money for smooth flow of stock at initial stage. You have to invest in market, doctors and products. You have to invest at stock irrespective of marketing and/or manufacturing type. You also have to invest at market by providing credit to chemist and stockiest.

Monthly Expenses:

Monthly expenses like Rent of Premises, Electricity bill, office expenses and other miscellaneous expenses depend at location and area. Some expenses like accountant/CA fee, quarterly sale tax return etc also will be added in your expenses.

Promotional Inputs:

Design of logo, company profile, product card, reminder card, catch cover, writing pads, visuals etc. Designing charges may vary printer to printer but most of printers do designing free of cost if you are printing all material from them.

Hope this article is helpful for you to calculate investment required for starting pharmaceutical company.

You can also read here about- how much you have to invest in third party manufacturing of your products?

You must read : Investment at Packing material of Each Dosage form also to prepare your complete budget.

We are also mentioning few queries related to Investment here for more elaboration. Hope you will get some help for these queries:

Query 1: I am a Doctor working in a reputed medical college. My wife is a gynecologist and she is in private sector. We want to start a pharma business of our own. What we want is that to have product packaging from reputed company and sell at our company name. Please guide us in following points. .
1. Starting budget is 12 to 15 lacs. Is it adequate?
2. Do we have to form a company to do that?
3. Where do we get quality manufacturer because we don’t want to comprise quality.
Please advice.

Response 1: You want to start pharma business and sell products from your name and thinking about starting your own Pharma marketing company.

  1. Starting budget is 12 to 15 lac. Is it adequate?

Starting budget depend upon number and type of products you want to get manufactured. Few products are costlier and few are cheaper in rates. The molecules and/or salts you want in your product list will affect your budget. For example, you are starting with 26 products and products are A, B, C etc. Your budget is depend upon rates of A to Z products.

If your products are costlier like Cefixime, Cefpodoxime, Cefuroxime , levofloxacin, Azithromycin etc then chances are you have to invest big amount. If you start with vitamins, ferrous combinations, nimusulide, paracetamol, ofloxacin etc then budget will be less. Above molecules are example purpose only, costing of products can depend upon circumstances.

12 to 15 lakhs is sufficient amount if you invest it wisely. We have seen person to start their own marketing company with amount as less as 1 Lakh.

You can start your company from 1 product or you can start with above 100 products or as number you want. We will recommend to start with lesser number of products and add new products gradually.

  1. Do we have to form a company to do that?

To work with your company name, you have to start your own marketing company. Read Procedure by clicking following link: How to start your own pharma marketing company

  1. Where do we get quality manufacturer because we don’t want to comprise quality?

Searching for Quality manufacturer is difficult task but you can find good quality manufacturer easily. You are doctor and prescribe medicines. You better know which product is good in quality and efficacy. Products which you are prescribing will have manufacturer address. Even multinational companies like pfizer, lupin, cadila, sun pharma, unichem, cipla are also get manufactured their products at third party or loan license basis. See the address of manufacturer on strip or box, you trust the most. You can easily find quality manufacturer address. Search for that manufacturer at internet and will get contact number easily. Contact them and ask them to manufacture your products.

Query 2:Estimate Budget for Pharmaceutical Marketing Company!!!

Query 3:How much cost required to set-up pharma marketing company office?

Query 4:I want to start my own pharma company with multivitamin, iron and calcium. Please send me the budget.

Query 5:How much cost required to set-up pharma marketing company office?

Query 6:What will be budget for pharma company, please guide us !!!

Query 7:I want to start a pharma company with two products

Query 8:I want to start pharma marketing company. I want to know of budget of starting business

If you want to know about estimated budget for your new marketing pharma company read here…

You will also need to find out price to retailer/price to stockist read here…

Hope you have found it useful…..

For any query and suggestion mail us at pharmafranchiseehelp@gmail.com