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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.

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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.

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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.

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The above areas are recommended for the basic manufacturing of different categories of cosmetics. In addition to this separate adequate space for storage of raw materials, finished products, packing materials shall be provided in factory premises. The schedule M-II says that the walls of the room where the manufacturing is carried out shall be up to height of 6 feets from the floor be smooth water proof and capable of being kept clean. The schedule M-II also says that air-lock only in case of eye preparations. Manufacturer has to pay special attention to ingredients which is use for manufacture of cosmetic. Bureau of Indian standards, base on information available they have classified the raw materials into two parts:
a. Generally recognized as safe (GRAS).
b. Generally not recognized as safe (GNRAS).

Conditions of License: -
1. Manufacturer shall have to continue to provide and maintain the premises, equipment and staff as at the time of grant of license.
2. Manufacturer should test each batch of raw material before its use in the manufacture of cosmetic.
3. Manufacturer should have to test each batch of finished cosmetics.
4. Manufacturer should have to maintain records of raw materials, manufacturer of each batch of cosmetic and their testing.

Schedule U (I) Deals with particulars to be shown on the manufacturing records and records of raw materials: -

1. In case of manufacturing record:
a. Serial number.
b. Name of the product.
c. Batch No.
d. Batch size.
e. Date of commencement of manufacturing.
f. Name of all the ingredients and quantities required.
g. Control reference no for the raw materials.
h. Reference to analytical reports.
i. Date of release of batch for sale.
j. Signature of expert staff.

2. In case of raw materials:
a. Name of raw material.
b. Quantity received.
c. control reference number.
d. The quantity issued from time to time.
e. The batch name and number for which it issued.
f. Particulars for disposal of stock.

Regulatory Provisions on Sale of Cosmetics: - Sale of certain cosmetics is prohibited under the Act these 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.
  

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.

Loan License: Application for the loan license should be made in the form (31-A). along with a fee of RS.3500 along with the prescribe documents the licensing authority will examining the licensed manufacturer has spare capacity and has agreed to manufacture of cosmetic for applicant will grant loan license.

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Manner of Labeling: - On inner and outer labels:
1. Name of the cosmetic
2. Name of the manufacturer and complete address of the premises where the cosmetic is manufactured.

On outer label: A declaration of the net contents expressed in terms of weigh ofr solids, fluid measure for liquids weight for the semisolids.

On inner label where hazard exists: Adequate directions for safe use, any warning or caution required to be observed by the consumer, and statement for the name and quantities of ingredients that are hazardous. Along with this a distinctive batch no, manufacturing license no should be provide in both cases.

Special provision for toothpaste contains fluorides:
1.Fluoride content should not be more than 1000 ppm and the content of fluoride in ppm should be mentioned on tube and cartons.

2. Date of expiry should be mention on tube and cartons.
In case of cosmetic containing coal tar dyes: Hair dyes containing coal tar dyes should be well labeled with cautions and each package should also contains some instruction in English and local language.

Offences and Penalties: Here are some offences and penalties which are important aspect of regulatory provision for cosmetic in India.

CONCLUSION:
The Government of India has made Stringent Provision regarding manufacturing, Import, Sale and distribution of Cosmetics under the Drug and Cosmetic Act 1940. These Provisions must be strictly followed otherwise it is subjected to offence. The provisions regarding import have strictly included a system of licensing for the import of cosmetics in India which ultimately elicits the import of Misbranded and Spurious Cosmetics in India. There are 28 cosmetics which are placed in schedule S which are imported in India only after conformance to the Indian standards. The provisions for manufacturing have also included the system of licensing for the manufacturing of cosmetics which prevents the sale and distribution of spurious cosmetics in India. Also has included system of loan licensing. Such types of licenses are provided by the state drug regulatory agencies like FDA. Also it covers GMP on manufacturing of Cosmetics which are provided under schedule M of Drug and Cosmetic Rules 1945 which will allows the safe and clean manufacturing of Cosmetics. The provisions on the sale and distribution also have covered several lists of cosmetics which are banned on sale in India while it also has covered the definition of misbranded and spurious cosmetics.

REFERENCES:
1. Sharma P.P, Cosmetic formulation manufacturing and quality control, 3rd Edition, Nirali Prakashan: P.13-33.
2. vediclifesciences.com/pdfs/New Regulations in Cosmetics.pdf.
3. Drug and cosmetics Rules 1945.
4. en.wikipedia.org/wiki/Cosmetics.

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How to Practice GMP

The concept of GMP originated in early sixties in the United States of America. In the late sixties, World Health Assembly (WHA) recognized the need for international guidelines for the manufacture of drugs (medicines) and requested a committee of experts to draft GMP guidelines which were made an integral part of WHO Certification Scheme of Pharmaceutical Products. In the seventies, a group of experts published good practices in the manufacture of medicines, popularly known as orange guide. In India, GMP were introduced under Schedule M to the Drugs & Cosmetics Rules in 1988.
The first edition of this book was published in 1991 which contained Indian GMP and WHO GMP. From the publication of first edition of this book, GMPs world over have been revised several times. Accordingly, the book has been reviewed time to time. Pursuing this philosophy, seventh edition of this book has been published recently.
ICH published three inter-related documents, namely, ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) and recommended to three participating regions (US, EU and Japan) to incorporate these in the regulatory framework. The current edition of the book has information on all the contemporary GMPs and the concepts mentioned above. The book also has overview on important topics like validation, stability studies, AHU. In nutshell, the book is a treasure of information on GMP.

P P Sharma

P P Sharma Cosmetics Books Pdf Free

Shri. P.P. Sharma is B.Pharm (BITS, Pilani) and M.Pharm (Punjab University). He has been Rank Holder both at Graduate Level and Post Graduate Level and was awarded Gold Medal by Punjab University. After a short stint with Pharmaceutical Industry, he joined Drugs Control Dept. of Delhi Govt. where he worked in various capacities and retired as Dy. Drugs Controller and Licensing Authority. During his Professional career he had opportunities for training by Govt. of India and International Bodies like WHO and DANIDA. His approach to enforcement of law was ‘enforcement by education’ and this led him to write books. He has 06 books to his credit. He is faculty to various training programmes of Govt. of India and guest faculty to several pharmacy educational institutions. He is recipient of several National Awards notably, “Best Drugs Control Officer Award”, “K C Chatterjee Memorial Award”, “IPGA Lifetime Achievement Award”. Know him more by reading his books……….

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