The document discusses regulations around the manufacture and sale of cosmetics in India according to the Drugs and Cosmetics Act of 1940. It outlines several prohibited categories of cosmetics including those that are misbranded, adulterated, below standard quality, or contain unsafe ingredients. It also describes the different types of licenses required for manufacturing, wholesale, and retail sale of drugs and cosmetics and the conditions that license holders must satisfy. Record keeping requirements are also specified. Certain drugs and cosmetics are prohibited from import or wholesale based on quality, labeling, or disease treatment claims.

1. Prohibition of manufacture and sale of certain
cosmetics
Submitted by:-
RICHA TIBREWAL
M.PHARM 1ST YEAR
Submitted to:-
Dr.Manjula
Department of pharmaceutics

2. introduction :-
•As per Section 3(a) of the Drugs and Cosmetics Act 1940 and
Rules 1945, Cosmetic
means 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 cosmetics.
•Imports of cosmetic products are regulated in India under the
provisions of the Drugs
& Cosmetic Act 1940 & Rules 1945 vide Gazette notification G.S.R
426(E)

3. MANUFACTURE OF DRUGS & cosmetics
• Manufacture in relation to any drug or cosmetic, includes any process or
part of process for making, altering, ornamenting, finishing, packing, labeling,
braking up or otherwise treating any drug or cosmetic with a view to its sale
& distribution but does not include the compounding or dispensing of any
drug or packing of any drug in ordinary course of retail business.
Sale of Drugs
Sale may be defined as the process of passage of articles from the
manufacturer to the consumer.
There are two general types of sale
• Retail sale
• Wholesale
• Retail Sale: It means a sale whether to a hospital or a dispensary or medical,
educational, or research institute or to any other person other than a sale by
way of wholesale dealing.
•Wholesale: (sale by way of wholesale dealing) It means a sale to a person for
the purpose of selling again & also includes a sale to hospital or a dispensary
or medical, educational, or research institute

4. Kinds of manufacturing licence
1. Drugs other than those specified in Schedule C, C1 & X
2. Drugs specified in Schedule C, C1 but not specified in
Schedule X
3. Drugs specified in Schedule C, & C1
4. Drugs specific in Schedule X but not in Schedule C & C1
5. Drugs specified in Schedule C, C1 and X
6. Drugs for the purpose of examination, test or analysis
7. Loan Licenses
8. Repacking Licenses
9. Blood products

5. Kinds of licence for wholesale

6. Kinds of licence for retail sale

7. Prohibition for the manufacture & sale of Certain Drugs
A. From the date notified by the State Government, no person shall himself
manufacture for sale or distribution or sell or distribute.
1. Any cosmetic which not of standard quality or is misbranded, adulterated
or spurious;
2. Any patent or proprietary medicine whose formulae is not disclosed on
label or the container;
3. Any drug which purports to cure, mitigate or prevent any disease specified
in Schedule J;
4. Any cosmetic containing any ingredient which may render it unsafe or
harmful for use;
5. Any drug or cosmetic in contravention of this act or rules thereunder;
6. Any drug or cosmetic which has been imported or manufactured in
contravention of the provisions of this Act or Rules thereunder or in
contravention of the conditions of a license.

8. B. Every person not being manufacturer of a drug or cosmetic or his agent for the
distribution shall if so required disclose to the inspector the name address and
other particulars of the person from whom he procured the drug or cosmetic.
C. A drug or cosmetic shall not be rendered to be misbranded, adulterated or
spurious or below standard quality, if
o There has been added there to some ingredient required for its manufacture or
preparation as an article of commerce in state fit for carriage or consumption,
& not to increase the bulk, or weight or measure of the drug or cosmetic or to
conceal its inferior quality or other defect.
o In process of manufacture, preparation or conveyance some extraneous
substance has been unavoidably become inter-mixed with it, however this
does not apply in relation to any sale or distribution of the drug or cosmetic
occurring after the vendor or distributor becomes aware of such intermixture.

9. • There are two types of conditions for all manufacturing
licenses
o Conditions which are to be satisfied before a license is granted
o Conditions which are to be satisfied after the license is granted.
Disclosure of the name of the manufacturer
Every person, not being the manufacturer of a drug or cosmetic or his agent for
the distribution thereof, shall, if so required, disclose to the Inspector the name,
address and other particulars of the person from whom he acquired the drug or
cosmetic

10. Maintenance of records and furnishing of information.
Every person holding a licence under clause (c) of
section 18 shall keep and maintain such records,
registers and other documents as may be prescribed
and shall furnish to any officer or authority
exercising any power or discharging any function
under this Act such information as is required by
such officer or authority for carrying out the
purposes of this Act.

11. Classes of cometics prohibited to Import
Any drug which is not of standard quality.
Any misbranded, spurious or adulterated drug
Any misbranded or spurious cosmetic
Any drug or cosmetics which require import license & if imported
without such license.
Any patent or proprietary medicine, the true formula or list of
active ingredients with their true quantities, is not displayed on the
label or container in a prescribed manner.
Any cosmetics containing any such ingredient which may render it
unsafe or harmful for use.
 Any drug which claim to cure or prevent any disease or ailment
described in schedule
 Any drug or cosmetic the import of which is prohibited by rules

12. classes of drugs prohibited for wholesale
 Misbranded, spurious & adulterated drugs & drugs not of
standard quality
 Any patent or proprietary medicine
 Any drug which claims to cure or prevent any disease or ailments
as described in sch J.
 Any drug manufactured or imported in contravention to the act.
Drugs whose date of expiry has expired.
Drugs intended for supply to central govt. health scheme or govt
hospital or institution. Physician samples.
 Drugs not intended for sale.

13. References:
 www.cdsco.nic.in
 Forensic pharmacy,” kolate CK and Gokhle SB, Pharma book
Syndicate; 152
 Dr. D.R Lohar’s book of Legal status of Ayurvedic, Siddha and
Unani Medicines.”