How to Start Homeopathy Medicines Company

How to Start Homeopathy Medicines Company in India?

Last updated on March 8th, 2018 at 07:13 am

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
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

2 thoughts on “How to Start Homeopathy Medicines Company in India?

  1. What is approx. cost involved in setting up the Homeopathic Medicine company with the above equipment in place. Is there any back up support available.

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