This document discusses the requirements for manufacturing cosmetic products under Schedule MII in India. It provides an introduction to Schedule MII and its importance given the increasing popularity of cosmetics. The general requirements for factory premises, buildings, and equipment are outlined. Specific requirements for plant and equipment are defined for different types of cosmetic products based on the manufacturing area needed. The document also discusses labelling, packaging, and quality standards that must be followed. Offences and penalties for non-compliance with the act are mentioned.
2. CONTENTS
What is Schedule M?
Schedule MII
Introduction
General requirements
Location and surrounding
Buildings and permises
Plant and equipment
Sale
Labelling,packaging and standards
3. What exactly schedule M is?
It is requirement of factory and premises ,plant and
equipment for manufacturing drugs and pharmaceutical
product.
M-1: Requirement of factory premises for the manufacture
of Homeopathic preparations.
M-2: Requirement of factory premises for the manufacture
of cosmetics.
M-3: Requirement of factory premises for the manufacture
of medical devices.
4. SCHEDULE M II
It is requirement of factory and
permises ,plant and equipment for
manufacturing of cosmetic
products.
5. INTRODUCTION
Due to increasing popularity of the cosmetics the
government of india has shown its serious concern
in their manufacture as evident from the
introduction of the schedule M II in august 1992
laying down the requirements of factory
premises,plants and equipment for the
manufacture of cosmetics.
6. GENERAL REQUIREMENTS
1.Location and surroundings:
The factory building(s) for manufacture of drugs shall
be so situated that it avoid risk of contamination from
external environmental including open sewage, drain,
public lavatory.
2. Building and premises :
• Buildings shall be designed, constructed, adapted
and maintained to permit production of drugs under
hygienic conditions
• They shall conform to the conditions laid down in the
Factories Act, 1948
7. GENERAL REQUIREMENTS
The premises used for manufacturing, processing,
warehousing, packaging, labeling and testing purposes
shall be
a) compatible with other drug manufacturing
operations
b) adequate working space to avoid the risk of mix-up
between different materials & avoid the possibilities
of contamination and cross contamination
c) designed / constructed / maintained to prevent
entry of insects, pests, birds, and rodents
d)Well illuminated, effectively ventilated, with proper
Air Handling Units .
8. PLANT AND EQUIPMENT
Part II of schedule M II recommends the requirement of plant ,
equipment and area for the manufacture of cosmetics under the
following sections.( recommended area given in bracket)
A. Powders- Face powder,cake make-up,compacts,face
packs,masks,and rogues etc. (15 sq meters )
B. Creams,lotion,emulsion,pastes,cleansing milks, shampoo, pomade,
brilliantine, shaving creams and hair oils etc. (25 sq.meters)
C. Nail polishers and nail lacquers. (15 sq meters)
D. Lipsticks and lipgloss etc. (15 sq meters)
E. Depilatories ( 10 sq meters)
F. Preparations used for eye-
i) Eyebrows,eye lashes, eye liners etc. (10 sq meters)
ii) Kajal and surma ( 15 sq meters)
9. PLANT AND EQUIPMENT
G. Tiolet soaps ( 100 sq meters)
H. Aerosols (15 sq meters)
I. Alcoholic fragnance solutions (15 sq meters)
J. Hair dyes( 15 sq meters)
Tooth powders and tooth pastes-
i. Tooth powders in general (15 sq meters)
ii. Tooth pastes (15 sq meters)
iii. Tooth powder,black ( 15 sq meters)
10. OFFENCES AND PENALITIES
Adoption of the above good manufacturing practices to
the manufacture of cosmetics shall go a long way ensuring
better quality cosmetics to the consumers.
Manufacture of any cosmetic in contravention of this act
and the rules is punishable with imprisionment upto one
year or fine upto RS 2000 or with both on first convicton
and three years and with fine .The penality for subsequent
offences in both the cases is imprisionment upto 1 year or
fine upto Rs 2000 or with both.
11. SALE OF COSMETICS
Cosmetics which do not contravene the provision of the act
and the rules may be sold without a licence . Dealers are
bound to disclose on demand the name and other
particulars of the persons from whom they obtain
cosmetics . penality for the sale or distribution of cosmetics
contravening the provision of the Act and the rules as same
as applicable for their manufacture.
• Following classes of cosmetics are prohibited to be
stocked, sold or exhibited for sale:
12. SALE OF COSMETICS
1. Any cosmetic which is either misbranded,spurious or not
of standard quality.
2. Any cosmetic containing any ingredient which may
render it unsafe or harmful for use under the directions
indicated or recommended.
3. Any cosmetic which is imported or manufactured or
otherwise in contravention of the provision of the Act
and the rules.
13. LABELLING,PACKING AND STANDARDS
• Cosmetics whether imported or manufactured in india
must be labelled in accordance with the following
provisions:
• Labelling of cosmetics in general
On both the inner and outer labels
a) The name of the cosmetic.
b) The name and the principal place of business of the
manufacturer.
14. LABELLING,PACKING AND STANDARDS
On the outer label
a) A deceleration of the net contents expressed in terms of
weight for the solids, fluid measures for liquids,weights
for semi-solids,combined with numerical count if the is
sub-divided.
On the inner label where a hazards exists.
a) Adequate direction for safe use.
b) Any warning, caution or special direction required to be
observed by the consumer.
c) Batch number preceded by the letter “B”(not necessary if
the cosmetic is 10g or less; or 25 ml or less)
15. LABELLING,PACKING AND STANDARDS
d) A statement of the names and quanties of the poisions
ingredients.
e) Manufacturing licence number preceded by the letter
“M”. If the package has only one label all the information
required on the inner and outer label should appear on
such label only.
• Tooth paste containing fluoride
On tube and carton
a) Fluoride content in ppm (not more than 1000 ppm) and
the date of expiry.
