REVIEW: REGULATORY PROVISIONS REGARDING COSMETICS IN INDIA

 

ABOUT AUTHOR:
Abhijeet Welankiwar
Govt. college of Pharmacy,
kathora naka,
Amravati (Maharashtra), 444604.
abhi123welankiwar@gmail.com

ABSTRACT:
The Government of India through the Drug and Cosmetic act 1940 and rules 1945 has made stringent provisions regarding import, Manufacturing, Sale and Distribution of Cosmetics. These provisions mainly cover the licensing for the import, manufacturing of cosmetics and also the GMPs for the manufacturing of cosmetics. Also these guidelines have covered certain categories of cosmetics whose import and sale is prohibited by the Law. These guidelines have also listed the 28 cosmetics whose import is allowed only on to the conformance to the Indian standards. These guidelines have also covered the offences and penalties in case of contravention of the provisions of the Drug and Cosmetic Act 1940.


REFERENCE ID: PHARMATUTOR-ART-1876

INTRODUCTION:
Under the Drug and Cosmetic Act Cosmetic has been defined as “Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic”.

Regulatory Provisions on Import of Cosmetics in India: Chapter III of Drug and Cosmetic Act deals with import of Drug and Cosmetic. Now import of certain cosmetic is prohibited under section 10 of the Act and rules 134A, 135, 135A of Drug and Cosmetic Rules 1945 they are:

  • Any cosmetic this is not of Standard Quality.
  • Any cosmetic this is misbranded or spurious.
  • A cosmetic containing ingredient which render it injurious or harmful or unsafe to use.
  • A cosmetic whose import is prohibited by rule.
  • Any cosmetic containing hexachlorophene.
  • Any cosmetic in which lead or arsenic compound used for coloring purpose.
  • Any cosmetic which contains mercury compounds.


The Government of India In Fed 2007, the Ministry of Health and Family Welfare has bring amendment in Drug and Cosmetic Rule, 1945 according to which a cosmetic to be imported into the India has to be get registered under Rule 129D by licensing authority appointed by Central Government under Rule 21. Usually Drug controller General of India is the Licensing Authority. There should be a single Application made for one or more cosmetic which are manufactured by same manufacturer. And the registration Certificate which is provided is valid for 3 years if it is not cancelled. And the application for the registration should be made either by manufacturer or his agent or importer in India. Cosmetic can be imported in India only through following ports as per the rule 43A.

1. Firozpur Cantonment and Amritsar Railway Stations.
2. Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla by Sea route.
3. Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai by Air.
4. Raxaul by Road/Railway lines connecting in India.

Now there are 28 Cosmetic which are Placed under Schedule S to the rule which are imported in India only after compliance with the Indian standards. They are:
1. Skin Powder.
2. Skin Powder for infants.
3. Tooth powders.
4. Toothpastes.
5. Skin Creams.
6. Hair oils.
7. Shampoos soap based.
8. Shampoos synthetic detergent based.
9. Hair creams.
10. Oxidation hair dyes, liquid.
11. Cologne.
12. Nail Polish.
13. Aftershave Lotion.
14. Pomades and Brilliantine’s.
15. Depilatories.
16. Shaving Creams
17. Cosmetic Pencils.
18. Lipstick.
19. Toilet soap.
20. Liquid Toilet soap.
21. Baby Toilet soap.
22. Transparent toilet soap
23. Shaving soap.
24. Lipslave.
25. Powder Hair dye.
26. Bindi.
27. Kumkum Powder.
28. Henna Powder.

Misbranded Cosmetic: - A cosmetic is deemed to be misbranded if:
A. If it contains a color which is not prescribed; or
B. If it is not labeled in the prescribed manner; or
C. If the label or container bears any statement which is false or misleading in any particular.

Spurious cosmetic: - A cosmetic is deemed to be spurious if:
A. If it is imported under a name which belong to another cosmetic; or

B. if the label or containers bears the made of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

C. if it purports to be the product of a manufacturer of whom it is not truly a product.

Rule 134A also prescribes that no cosmetic shall be imported which contains a coal tar color other than one  prescribed in schedule Q and Indian standards (IS: 4707 Part I) to the above rules and coal tar color used in cosmetic should not contain more than –
1. 2 ppm of arsenic as arsenic trioxide.
2. 20 ppm of Lead.
3. 100 ppm of heavy metals other than lead calculated as total of the respective metals.

Regulatory Provisions for the Manufacturing of Cosmetics: - A license is required for the manufacture of cosmetic for sale/distribution. This license is issued by the state regulatory authorities (State Food and drugs administration).

How to obtain license: - Application is required to made in form no 31. The application should accompanied by a fee of Rs.2500 and inspection fee of Rs. 1000 additional fee will be deposited, if no of items in any category exceeds ten. The application is accompanied with following documents.

1. Layout plan of the factory premises
2. A list of equipment and machinery to be installed.
3. A document showing the constitution of the firm.
4. A document showing the possession of applicant on the proposed premises for factory e.g. rent receipt.

Apart from the following documents state drug control departments also required some affidavits or some other relevant information. Before granting the license (which is issued in form no 32) the factory premises is inspected by the officer of the state regulatory agency. During inspection the officer finds out weather:
1. The applicant has provided adequate space for manufacturing, quality control and storage of raw materials, packaging materials and finished products.

2. The applicant has provided adequate Equipment and machinery for manufacture of cosmetics which he intends to manufacture.

3. The applicant has provided adequate testing facilities for raw materials and finished form of cosmetics.

4. The applicant has whole time services of a person who has either of the qualifications Diploma in pharmacy, registered pharmacist, intermediate in science with chemistry as one of the subjects. Schedule M (II) of Drug and Cosmetic rule 1945 Deals with Requirements for the factory premises for manufacture of cosmetics. It covers:

I. General requirements:
A. Location and Surroundings.
B. Buildings.
C. Water supply.
D. Disposal of water.
E. Health clothing and sanitary requirements of the staff
F. Medical devices.
G. Working benches for the operation of cosmetics.

II. Requirements of Plant and Equipments:
The following equipments, area, and other requirements are recommended for manufacturing of-

1. Lipstick and lipgloss: Equipments –
a. Vertical mixer.
b. Jacketed kettle.
c. Mixing vessel.
d. Triple roller mill.
e. Moulds with refrigeration facility.
f. Weighing and measuring devices.

= An area of 15 square meters is recommended.

2. Hair dyes: Equipments-
a. Stainless steel tanks.
b. Mixer.
c. Filling unit.
d. WEIGHING and measuring devices.
e. Masks, Gloves, goggles.

= An area of 15 square meters with proper exhaust is recommended.

3. Toothpowders:
Equipments-
a. Weighing and measuring devices.
b. Dry mixer.
c. Stainless steel tanks.
d. Powder filling and sealing equipments.

= An area of 15 square meters with proper exhaust is recommended.

4. Tooth Pastes:
Equipments-
a. Weighing and measuring devices.
b. Jacketed kettle.
c. Planetary mixer.
d. Stainless steel tanks.
e. Tube filling equipments.
f. Crimping Machine.

= An area of 15 square meters with proper exhaust is recommended.

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to Pharmatutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE


Pages

FIND MORE ARTICLES