Drug and cosmetics Act 1940 and rules 1945 PDF Notes

 Drug and cosmetics Act 1940 and rules 1945

of Drug and cosmetics Act 1940 and rules 1945:-

The main aim of the drug and cosmetics Act 1940 and rules
1945 is to be maintained the import manufacture, distribution and sales of
drugs and cosmetics.

Continuous use of cosmetics in luxury item prove to be
harmful as they may be contain harmful ingredients. Therefore there is need to
control the cosmetics.

This act varifies that the drug and cosmetics should be
manufactured, distributed and sold only by qualified person having the licence
for this purpose. The central and state drugs control authority are also
recognised to control these action.

of Drug and cosmetics Act 1940 and rules 1945:-

What is

All medicines for internal and external use of human being
or animals and all substance intended to be used for in the diagnosis,
treatment or prevention of any disease or disorders.

Including preparation applied on the human body for the
purpose of repelling inserts like mosquitoes. Such substance (Other than food)
intended to effect the structure or any function of the human body or intended
to be used for the destruction of insects which causes disease in human beings
or animals as may be specified from time to time by the central government by
notification in the official gazette.

Patent medicine / Brand: – Patent medicine refer to a
remidies whose formula is on by the manufacturer and which is marketed usually
under a name register as a trademark.

In relation to ayurvedic, sidha, Unani system of the
medicine all formulation containing only such ingredients mention in the
formally described in the authoritative books of Ayurvedic, Sidha, Unani system
of medicines specified in the first schedule but does not include a medicines
which is administered by parenteral routes.


A drug is deemed to be Mis-branded.

It is so coloured, coated, powdered or polished that
damaged. If it is made to appear of better or therapeutic value then it is

If it is not labeled in the prescribe manner.

If it is label or container the drug bears any statement,
design or device which makes any false claim for the drugs or which is false or
mis-leading in any particular.

cosmetics Or Mis-branded Cosmetics:-

If it contain a colour which is not prescribed.

If it is not labeled in the prescribed manner.

If the label or container bears any statement which is




If it is consist any filthy, decompose substance.

If it has been prepared, packed or store under insanitary
condition where by it may have be injurious to health.


Same as adultered drugs.

Sale is the process passing of drug from the manufacturer to
the consumer. The different kinds of licence issuable for wholesale and retail
of drug.

There are
two types of salling:-

1.   Wholesale

2.   Retail

• The process of passing drugs from manufacture to consumer
is termed sale. In india saling of drugs was an open trade till 1940 hence, anyone
can sale, compound or dispense drugs without any restriction but after
implementation of the drugs and cosmetics Act 1940, selling of drugs become
restricted practice and only the licence individual can involve in the
wholesale, retail, compounding, dispensing of drugs.

• Licence are required for wholesale or distribution from a
motar vehicle retail sale of drugs and a separate licence needed for each
promise where drug are sold.

distribution of drug: –
Retailing of drug is done through shops or by
vendors certain important and basics for retailing selling of drugs or as

Retail sale
from shops: –
There are following rules for the retail sale from

     Facilities as
per schedule N.

     Purchase only
from license wholesaler.

     No sales of
specified drugs (Schedule H and Schedule X) without prescription.

     Separate licence
for Schedule C, C1 and X.

     Sale under
qualified supervisions.



    Sale of specified
house hold drugs from drug stores but schedule N and sale under qualified
supervision not applicable.

Retail sale of drug can be done from the following shops:-

1. Chemist and druggist (Followed by registered Pharmacist
but do not compound drugs)

2. Pharmacies (Followed by registered Pharmacist and engaged
in compounding of drugs)

3. Drug store (Drug store which do not have a registered
Pharmacist and sale drugs specified as household remedies)

Retail sale from Vendors:- Sometimes drugs are sold buy
vendors who do not have a fix place of business but have been granted licence
by the licensing authority to conduct business in a particular area. Persons
who distribute drugs in sparsely populated area with no others agencies for
drug distribution or to travelling agents of firms dealing in drug are issues
licence to sale drugs. The licence to sale drugs are issues only for drugs
other than those specified in Schedule C and C1.

distribution of drugs:-

A wholesaler with a valid trade license can approach the
drug manufacturer for supplying medicines for salling to the retailers.

Followings are the conditions of granting the licence for
wholesale of the drug.

1.   Adequate
infrastructural facilities

2.   Records

3.   Sale only to
licensed retailers

4.   Inspection

for fix premises:-

Wholesale of drugs can be done from fix premises or by motor
vehicle. Separate licence is needed for wholesale of drugs under schedule C
& C1.

Wholesale of Schedule C and C1 Drugs:- there are following
conditions –

• The licence must have adequate premises not less than 10m2
in area, equipped with adequate facilities for storage of drugs in order to
preserve their potency.

• The drug should be sold to person with licence to retail

• If the licence desired to self any other categories of
drugs be should seek permission from the licensing authority.

Records of all
purchases and sales of schedule C drugs by wholesale dealing should be
maintained under following-

The date of purchase and sale

Name and address

Name and quantities of drugs and there batch

Name of the manufacturer of the drugs.

for sale, Purchase and Storage of drugs:-

In different kinds of stablisment for the sale of drug there
are following:-

     Dispensing and
compounding of drugs

     Sale of schedule
X and Schedule H drugs

     Supply/Sale of
schedule C drugs.

     Supply Sale of
other drugs.

     Records of
purchase of drugs

     Storage of
Schedule X drugs with expiry dates.

     Storage of
veterinary medicine

     Drug stores.

Labeling of
the drugs

Class & Nature of Medicine in which


Particulars which should appear on label

Schedule C In Original form

1.   Proper name of the
substance along with the name of any patent.

2.   License number under which
manufactured or imported.

3.   Batch number

4.   Statement of potency in

5.   Name and address of the
manufacture of finical products.

6.   The expiry date

7.   The manufacture date

8.   Name and percentage of
added antiseptics

Schedule – C1 and their preparation including combination with other

1.   The Manufacture date

2.   The expiry date

3.   Import license number

Schedule F & F1

The prescribed name

Schedule G


Medicine made up ready for internal use in the treatment of human

The word caution it is dangerous to take this preparation expert
under medical supervisions should be Cleary printed and surrounded by a line
with in which there should be no other words.

Schedule H Medicine for internal use of

human beings  

1.   Simple should be clearly
displayed on the left top corner of the label.

2.   Schedule H drug warning to
be sold by retain on the prescription of a registered medical practitioner

Schedule X Medicine for internal use of

human beings

1.   Schedule X drugs/ Warning
to be sold by retail on the prescription of the RMP.

2.   Symbol X given conspicuously
in red

Schedule P  any drug

1.   The manufactured date

2.   Expiry date

Schedule W Single ingredient.

1.   Proper name (No trade

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