Pharmaceutical companies typically use a variety of factors to determine the price of their drugs, including: Development and production costs: Pharmaceutical companies invest significant amounts of money into the research, development, and production of new drugs. The cost of these activities, including clinical trials and obtaining regulatory approval, is factored into the price of the drug. Marketing and Distribution Cost: Marketing and distribution costs may also be considered by pharmaceutical companies when determining drug prices. These costs include expenses related to advertising, sales representatives, and distribution networks. Drug Uniqueness: If a drug is the first of its kind or represents a significant improvement over existing treatments, the pharmaceutical company may set a higher price for it. If a drug has many competitors or is like existing treatments, the company may have to set a lower price to remain competitive. Market demand: Companies also consider the dem
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
For more detail refer Drug and Cosmetic Act
Schedule M-II (Rule 139):
Schedule M-II describes the requirements of factory premises
for manufacture of cosmetics.
1.
General Requirements
·
Location and surroundings
·
Buildings
·
Water Supply
·
Disposal of water
·
Health, clothing and sanitary requirements of
the staff
·
Medical Services
·
Worker Benches
·
Adequate Facilities
2.
Requirements of Plant and Equipments
The following equipment, area and other
requirements are recommended for the manufacture of:
A. Powders:− Face powder, cake make-up,
compacts, face packs, masks and rouges, etc.
Equipment:
(a)Powder mixer of suitable type provided
with a dust collector
(b)Perfume and colour blender
(c)Sifter with sieves of suitable mesh size
(d)Ball mill or suitable grinder
(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.
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.
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
Equipment:
(a) Base sterilizer
(b)Powder sterilizer (dry heat oven)
(c) Stainless steel tanks
(d) A suitable Mixer
(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.
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.
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
(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.
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
For more detail refer Drug and Cosmetic Act
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