How to Start Homeopathy Medicines Company in India?

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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.

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What are the Homoeopathic Medicines?

Homoeopathic medicines are the medicines which are herbal or animal in nature and made according to authorized books of homoeopathy.
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.
Homoeopathic medicines are covered under AYUSH department and regulated through Drug and Cosmetic Act & Rules.

Licenses and Registrations required:

Along with license required from drug authority, you may also require taking GST number, factory act or shop & establishment act registration that depend at your business eligibility for these licenses and registrations.

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:

Read Detail at link: How to start 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 Chemist’s qualification and experience required:

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

Area required and Machinery/ Equipment Recommended:

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 :