Drugs and Cosmetics Rules 1945
(e) Trays and scoops (stainless steel).
(f) Filling and sealing equipment provided with dust extractor.
(g) For compacts: -
(i) a separate mixer, (ii) compact pressing machine.
(h) Weighing and measuring devices
(i) Storage tanks.
An area of 15 square meters is recommended. The section is to be provided with adequate
exhaust fans.
B. Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade,
brilliantine, shaving creams and hair-oils etc.
(a) Mixing and storage tanks of suitable materials.
(b) Heating kettle – steam, gas or electrically heated.
(c) Suitable agitator.
(d) Colloidal mill or homogeniser (wherever necessary).
(e) Triple roller mill (wherever necessary).
(f) Filling and sealing equipment.
(g) Weighing and measuring devices.
An area of 25 square meters is recommended.
C. Nail Polishes and Nail lacquers.
1. Equipment:
(a) A suitable mixer.
(b) Storage tanks.
(c) Filling machine – hand operated or power driven.
(d) Weighing and Measuring devices.
An area of 15 square meters is recommended. The section shall be provided with flameproof
exhaust system.
2. Premises:–The following are the special requirements related to Nail
Polishes and Nail Lacquers: -
(a) It shall be situated in an industrial area.
(b) It shall be separate from other cosmetic-manufacturing areas by metal/brick partition
up to ceiling.
(c) Floors, walls, ceiling and doors shall be fireproof.
(d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be
brought in the premises.
(e) All electrical wiring and connections shall be concealed and main electric switch
shall be outside the manufacturing area.
(f) All equipment, furniture and light fittings in the section shall be flameproof.
(g) Fire extinguisher like foam and dry powder and sufficient number of buckets
containing sand shall be provided.
(h) All doors of the section shall open outwards.
3. Storage:
All explosive solvents and ingredients shall be stored in metal cupboards or in a
separate enclosed area.
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4. Manufacture:
(a) Manufacture of lacquer shall not be undertaken unless the above conditions are
complied with.
(b) Workers shall be asked to wear shoes with rubber soles in the section.
5. Other requirements:
No objection certificate from the local Fire Brigade Authorities shall be furnished.
D. Lipsticks and Lip-gloss, etc.
1. Equipment
(a) Vertical mixer.
(b) Jacketted kettle – steam, gas or electrically heated.
(c) Mixing vessel (stainless steel).
(d) Triple roller mill/Ball mill.
(e) Moulds with refrigeration facility.
(f) Weighing and measuring devices.
An area of 15 square meters is recommended.
E. Depilatories.
1. Equipment:
(a) Mixing tanks.
(b) Mixer
(c) Triple roller mill or homogeniser (where necessary).
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
(f) Moulds (where necessary).
An area of 10 square meters is recommended.
F. Preparations used for Eyes: - Such preparations shall be manufactured under strict
hygienic conditions to ensure that these are safe for use.
1. Eyebrows, Eyelashes, Eyeliners, etc.
1 Equipment:
(a) Mixing tanks.
(b) A suitable mixer.
(c) Homogeniser (where necessary)
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
An area of 10 square meters is recommended.
2. Kajal and Surma
1. Equipment:
(a) Base sterilizer.
(b) Powder sterilizer (dry heat oven).
(c) Stainless steel tanks.
(d) A suitable Mixer.
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(e) Stainless steel sieves.
(f) Filling and sealing arrangements.
(g) Weighing and measuring devices.
(h) Homogeniser (where necessary).
(i) Pestle and Mortar (for Surma).
An area of 10 square meters with a separate area of 5 square meters for base
sterilization is recommended.
Other requirements for 1 and 2:
(a) False ceiling shall be provided wherever required.
(b) Manufacturing area shall be made fly proof. An airlock or an aircurtain shall be
provided.
(c) Base used for Kajal shall be sterilized by heating the base at 150 degree C for
required time in a separate enclosed area.
(d) The vegetable carbon black powder shall be sterilized in a drying oven at 120 degree
C for required time.
(e) All utensils used for manufacture shall be of stainless steel and shall be washed with
detergent water, antiseptic liquid and again with distilled water.
(f) Containers employed for ‗Kajal‘ shall be cleaned properly with bactericidal solution
and dried.
(g) Workers shall put on clean overalls and use hand gloves wherever necessary.
G. Aerosol.
1. Equipment: -
(a) Air-compressor (wherever necessary).
(b) Mixing tanks.
(c) Suitable propellant filling and crimping equipments.
(d) Liquid filling unit.
(e) Leak testing equipment.
(f) Fire extinguisher (wherever necessary)
(g) Suitable filtration equipment.
(h) Weighing and measuring devices.
An area of 15 square meters is recommended.
2. Other requirements: - No objection certificate from the Local Fire Brigade
Authorities shall be furnished.
H. Alcoholic Fragrance Solutions.
Equipment: -
(a) Mixing tanks with stirrer
(b) Filtering equipment.
(c) Filling and sealing equipment.
(d) Weighing and measuring devices.
An area of 15 square meters is recommended.
I. Hair Dyes.
Equipment:
(a) Stainless steel tanks.
(b) Mixer.
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Drugs and Cosmetics Rules 1945
(c) Filling Unit.
(d) Weighing and measuring devices.
(e) Masks, gloves and goggles.
An area of 15 square meters with proper exhaust is recommended.
J. Tooth powders and toothpastes, etc.:
1. Tooth-powder in General.
Equipment:
(a) Weighing and measuring devices.
(b) Dry mixer (powder blender).
(c) Stainless steel sieves.
(d) Powder filling and sealing equipments.
An area of 15 square meters with proper exhaust is recommended.
2. Toothpastes.
Equipment:
(a) Weighing and measuring devices.
(b) Kettle – steam, gas or electrically heated (where necessary).
(c) Planetary mixer with de-aerator system.
(d) Stainless steel tanks.
(e) Tube filling equipment.
(f) Crimping machine.
An additional area of 15 square meters with proper exhaust is recommended.
3. Tooth-powder (Black)
Equipment:
(a) Weighing and measuring devices.
(b) Dry mixer powder blender.
(c) Stainless steel sieves.
(d) Powder filling arrangements.
An area of 15 square meters with proper exhaust is recommended. Areas for
manufacturing ―Black‖ and ―White‖ tooth powders should be separate.
K. Toilet Soaps:
Equipment: -
(a) Kettles/pans for saponification.
(b) Boiler or any other suitable heating arrangement.
(c) Suitable stirring arrangement.
(d) Storage tanks or trays.
(e) Driers.
(f) Amalgamator/chipping machine.
(g) Mixer.
(h) Triple roller mill.
(i) Granulator.
(j) Plodder.
(k) Cutter.
(l) Pressing, stamping and embossing machine.
(m) Weighing and measuring devices.
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Drugs and Cosmetics Rules 1945
A minimum area of 100 square meters is recommended for the small-scale
manufacture of toilet soaps.
The areas recommended above are for basic manufacturing of different categories of
cosmetics. In addition to that separate adequate space for storage of raw materials, finished
products, packing materials shall be provided in factory premises.1[***]
Note No. I−The above requirements of the Schedule are made subject to modification at
the discretion of the Licensing Authority, if he is of the opinion that having regard to the
nature and extent of the manufacturing operations it is necessary to relax or alter them in the
circumstances of a particular case.
Note No. II.−The above requirements do not include requirements of machinery,
equipments and premises required for preparation of containers and clousers of different
categories of cosmetics. The Licensing Authority shall have the discretion to examine the
suitability and adequacy of the machinery, equipments and premises for the purpose of taking
into consideration of the requirements of the licensee.
Note No. III.−Schedule M-II specifies equipments and space required for certain
categories of cosmetics only. There are other cosmetics items, viz. Attars, perfumes, etc.,
which are not covered in the above categories. The Licensing Authority shall, in respect of
such items or categories of cosmetics have the discretion to examine the adequacy of factory
premises, space, plant and machinery and other requisites having regard to the nature and
extent of the manufacturing operations involved and direct the licensee to carry on necessary
modification in them.
1. The words ―A testing laboratory shall also be provided‖ omitted by G.S.R.285 (E) , dt. 16.7.1996.
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