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Sale Of Drugs
Definitions:
Sale:
Sale includes the process of passage of articles from the
manufacturer to the consumers
Wholesale :
A dealer or his agent or a stockiest appointed by a
manufacturer or an Importer for sale of his drugs to a
retailer.
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Retailer:
A dealer carrying retail business of sale of drugs for
customers.

For the sale of drugs a license is required .

If drugs are sold or stocked for sale at different
places, a separate license is required for each place.
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Issuing the sales license of drugs are divided
into to 3 categories:
1) Drugs other than those specified in schedules C,C1
and X.
2) Drugs specified in schedule C and C1 but excluding-
schedule- X.
3) Drugs specified in schedule-X.

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License for wholesale / retail sale of
drugs
Application made together with prescribed fee to licensing
authority for wholesale / retail sale of drugs is as follows

The licensing authority issues license for wholesale / retail
sale of drugs in different forms for which applications are
made in different forms
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20B


21B

20G
1) Whole sale of drugs other
than those specified in
schedule C,C1 & X
2) Wholesale of drugs
specified in schedule C &
C1
3) Wholesale of drugs
specified in schedule X
No or form
for issue of
application
Type of license
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20


21

20F
1) Retail sale of drugs other
than those specified in
schedule C,C1 & X
2) Retail sale of drugs specified
in schedule C & C1
3) Retail sale of drugs specified
in schedule X
No or form
for issue
of
application
Type of license
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Conditions for sale of drugs
The licensed premises are adequate & equipped with
facilities of proper storage of drugs .

The pharmacy shall comply with requirements of
schedule-N.
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The license should be displayed in a prominent place
All the compounding &display of drugs shall be made
under personal supervision of qualified person i.e.
Registered Pharmacist
The supply of other than schedule-X drugs on prescription
shall be recorded either in prescription register or cash or
credit memo book
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The supply of schedule-C drugs shall be recorded
either in register or in a cash or credit memo book.
The drugs shall be purchased from licensed dealer or
a licensed manufacturer.
Purchase bills are numbered serially &maintained in
order.
All the registers & records shall be produced for
inspection by inspector, if required
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All the registers &records shall be preserved for a
period of two year from date of last entry.
Schedule-H & X drugs shall be sold on prescription of
registered medical practitioner.
The supply of schedule H & X drugs to the RMP
Hospitals &Nursing Homes, shall be made only
against the signed order in writing
Such order should be preserved for 2 years.
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The schedule H & X drugs shall not be supplied more than
once, unless it is stated by the prescriber .
Only prescribed schedule - H & X drugs shall be
dispensed, not the substitutes.
Schedule-X drugs shall be stored in cupboard under lock &
key separately under control of a responsible person.
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The description of chemist and druggist or pharmacy
shall be displayed
Inspection book in form-35 should be maintained
The physician sample drugs & drugs meant for Govt.
supply with a distinguishing mark, shall not be sold or
stocked
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The drugs for animal treatment shall be stored in
separate cupboard, with words Not for human use,
For animal treatment only on the cupboard

The supply of schedule-X drugs shall be recorded in
separate register & pages should be allotted for
other drugs
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Restricted license
Restricted licenses are issued for retail sale of drugs to:
Dealer or persons in respect of drugs whose sale does
not require the supervision of qualified person.
Where they do not have fixed premises
A vender who purchases drugs from licensed dealer for
distribution sparsely populated areas where other
channels of distribution of drugs are not available.
PH204.27 15
Restricted license is issued to traveling agent of firm for
special purpose of distribution to medical practitioner or
Dealer for supply of biological & other special products
in schedule -C.
Restricted licences for retail sale are issued for
Drugs other than those specified in schedule C / C1 &
X
For drugs specified in schedule C1
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This license is issued for drugs other than those
specified in schedule-C ,C1 and X in form -20-A on
application made in Form-19A.

For drugs specified in schedule C1 in Form-21 A on
application made in 19A

Itinerant vendors in exceptional cases for bonafide
traveling agents of firms dealing in drugs
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Conditions
The license should be displayed in prominent place in a
part of premises open to public place or kept on the
person of vendor
Shall produce the same on demand by inspector or other
officer authorized by state Govt.
Drugs should be purchased only from a duly licensed
dealer or manufacturer.
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The licensee can deal only in such drugs as can be sold
without a supervision of a qualified person
Drugs should be sold in original container.
If the Licensee be a vendor having no fixed place of
business
He should buy drugs only from such dealers as may be
specified in his license
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Distribution Of Drugs From Motor
Vehicles
Licenses are issued for sale of drugs from motor vehicles
Separate license are issued for
Drugs other than schedule C & C1
Drugs specified in schedule C& C1.
License issued in form 20BB for drugs other than
schedule C and C1 where application is made in form
19AA
License issued in form 21BB for drugs specified in
schedule C and C1 where application is made in form
19AA
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Conditions:
The drugs can be distributed to only such persons who
hold license for retail sale of drugs.

The license should be displayed in a prominent place in
the vehicle.

Any change in ownership of vehicle or constitution of the
firm should be informed to licensing authority with in
week of change.

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In case of change in constitution of the firm fresh license
should be requested to be issued with in 3 months of the
change.

For distribution of schedule C & C1 drugs the licensee
should provide proper facilities for storage of drugs.

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Cancellation & Suspension of Licenses
The licensing authority may cancel or suspend the
license either wholly or in respect of substances to which
it relates.

If the licensee fails to comply with the conditions of
license or with any provisions of Act.
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He or his employee had not guilty of any similar act or
omission with in 12 months before the date on which
act or omission in question took place or
If the offence was committed and licensee could not
reasonably have had knowledge of previous offence

Cancellation & Suspension of Licenses:
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Licensee whose license has been cancelled /
suspended may appeal with in 3 months from date of
cancellation or suspension of license to the state
Govt.
Procedure for disposal of drugs if the licence is
cancelled
The licensee should apply to the licensing authority
giving the particulars
Name & address of the person to whom the drugs
are proposed to be sold and his licence number.
Cancellation & Suspension of Licenses:
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Procedure For Disposal Of Drugs If
License In Cancelled
Names of drugs together with quantities, batch number,
name and address of the manufacturer & date of expiry,
and person to whom proposed to be sold.
The licensing authority after examination of the particulars
furnished
If necessary, after inspection by inspector of the premises,
where the drugs are stocked, grant required permission for
disposal.
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Mfg, sale,
distribution &
stocking
I
st
conviction:

II
nd
conviction
a) Any adulterated
or spurious drug
not of standard
quality
Imprisonment for
minimum 5yrs
extending up to
life imprisonment
&fine not less than
Rs:10,000
Imprisonment
up to 10yrs or
fine up to Rs.
:20,000 or both
Offences and penalties
Offences penalties
PH204.28 27


c) Spurious drugs
but not mfg under
name of any other
drugs.
Imprisonment for NLT 3 to
5 yrs & fine NLT
Rs:5,000.The court many
award Imprisonment for
lesser time but not less
than 1year.
Imprisonment for
NLT 6to 10
years & fine NLT
Rs. :10,000.
b) Adulterated drugs
but not containing
any toxic or harmful
substances which
may be injurious to
health
Imprisonment
from 1to 3
years. And fine<
Rs 5,000
Imprisonmen
t from 2 to 4
years & fine
not less than
Rs:10,000
PH204.28 28
2) Not disclosing
the name of Mfg. of
the place where
the manufacture
drugs kept.
Imprisonment up
to 3 years or fine
up to Rs:1,000
or both.
same as the I
st

conviction.
3) Not keeping
records of
manufacturer or
sale of drugs in
specified manner.
Imprisonment up
to 3years or fine up
to Rs:1,000or both.
Same as I
st

conviction
4) Using the report of
Govt. analyst for
advertising any
drug
Fine up to
Rs. 5,000
Imprisonment up
to 10 yrs or with
fine or both