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LEGAL
REQUIREMENTS
SUBMITTED BY
D.HEMA SARVANI
16AB1T0007
SUBMITTED TO
G.RAMESH [B. PHARM,PHARM. D(PH.D)]
INTRODUCTION
The layout of premises where the pharmacy is going to
b started ( the minimum area required to start a retail
to start pharmacy in 120 sq.mt.)
The rent agreement between the land lord & applicant.
Inconvience proof of purchases of the refrigerators for
stocking the schedule ‘C’ & ‘C1’ drugs.
The in charge person should be a qualified person who
is a registered pharmacist.
LEGAL REQUIREMENTS IN PURCHASING:
Law of contract, an agreement between to or
more persons during business transaction.
There must be lawful proposal by one party
and lawful acceptance by the other party.
So two parties can enter into agreement.
The form of agreement may be oral or in the
form of writing.
LEGAL REQUUIREMENTS INVOLVEDIN
PAYMENT OF PRICE:
There are three legal aspects involved in the payment of
price:
 TIME OF PAYMENT
 PLACE OF PAYMENT
 MODE OF PAYMENT
The buyer has to pay the due amount in time.
 If the buyer fails to inspect the goods within the
reasonable time and find out whether all the items are
in good condition and whether they confirm with their
terms and conditions.
LEGALREUIREMENTS IN PRICING OF BULK
DRUGS:
The drug price control, 1987 authorities the central
government to fix the maximum sale price of bulk
drugs.
While fixing prices of bulk drugs, the fallowing points
should be taken into consideration:
1. A past tax return of 14% on net worth.
2. A return o 22% on capital employed.
3. An internal return of 12%based on long term marginal
costing in respect of new plant.
LEGAL REQUIREMENTS IN PRICING DRUG
FORMULATION:
The drug price control order, 1987
authorized the central government to fix
the maximum sales price of drug
formulation.
LEGAL REUIREMENTS TO START A
COMMUNITY PHARMACY:
Sl.no Applicationform
number
Categoryof
drugsto be
sold
Personof
qualifiedperson
requirement
Formnumberin which
license issuedfor categoryof
drugs
1 19 Whole sale
or retail
drugsthan
specifiedin
schedule ‘X’
YES 20-For retailsale or category
A drugs
20B-Whichsaleof categoryA
drugs
21-Sale of category B drugs
21B-Whole sale of categoryB
drugs
21C-Renewable of license
20A&Band 21A&B
Sl.no Applicationform
numbers
Categoryof drugsto
be sold
Presence of
qualifiedperson
requirements
Formnumberin which license for
categoryof drugs
2 19A Restrictedlicense NO 20A-Retailsale of categoryA
drugs
21A-Retailsale of categoryB drugs
3 19AA Sale of drugsfrom
motor vehicles
YES 20BB-Whole saleof categoryA
drugs
21BB-Whole saleof categoryA
drugs
4 19B Whole sale or retail
sale of homeopatheic
medicine
YES 20C-Sale of retail
20D-Sale of whole sale
20E-Renewalsale of license
20C/20D
5 19C Wholesaleor retail
saleof drugsspecific
inschedule’X’
Yes 20F-Sale by retail
20G-Sale by whole sale
20C-Renewal of above
Sl.no Applicationform
numbers
Categoryof drugsto
be sold
Presence of
qualifiedperson
requirements
Formnumberin which license for
categoryof drugs

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Legal requirements

  • 2. INTRODUCTION The layout of premises where the pharmacy is going to b started ( the minimum area required to start a retail to start pharmacy in 120 sq.mt.) The rent agreement between the land lord & applicant. Inconvience proof of purchases of the refrigerators for stocking the schedule ‘C’ & ‘C1’ drugs. The in charge person should be a qualified person who is a registered pharmacist.
  • 3. LEGAL REQUIREMENTS IN PURCHASING: Law of contract, an agreement between to or more persons during business transaction. There must be lawful proposal by one party and lawful acceptance by the other party. So two parties can enter into agreement. The form of agreement may be oral or in the form of writing.
  • 4. LEGAL REQUUIREMENTS INVOLVEDIN PAYMENT OF PRICE: There are three legal aspects involved in the payment of price:  TIME OF PAYMENT  PLACE OF PAYMENT  MODE OF PAYMENT The buyer has to pay the due amount in time.  If the buyer fails to inspect the goods within the reasonable time and find out whether all the items are in good condition and whether they confirm with their terms and conditions.
  • 5. LEGALREUIREMENTS IN PRICING OF BULK DRUGS: The drug price control, 1987 authorities the central government to fix the maximum sale price of bulk drugs. While fixing prices of bulk drugs, the fallowing points should be taken into consideration: 1. A past tax return of 14% on net worth. 2. A return o 22% on capital employed. 3. An internal return of 12%based on long term marginal costing in respect of new plant.
  • 6. LEGAL REQUIREMENTS IN PRICING DRUG FORMULATION: The drug price control order, 1987 authorized the central government to fix the maximum sales price of drug formulation.
  • 7. LEGAL REUIREMENTS TO START A COMMUNITY PHARMACY: Sl.no Applicationform number Categoryof drugsto be sold Personof qualifiedperson requirement Formnumberin which license issuedfor categoryof drugs 1 19 Whole sale or retail drugsthan specifiedin schedule ‘X’ YES 20-For retailsale or category A drugs 20B-Whichsaleof categoryA drugs 21-Sale of category B drugs 21B-Whole sale of categoryB drugs 21C-Renewable of license 20A&Band 21A&B
  • 8. Sl.no Applicationform numbers Categoryof drugsto be sold Presence of qualifiedperson requirements Formnumberin which license for categoryof drugs 2 19A Restrictedlicense NO 20A-Retailsale of categoryA drugs 21A-Retailsale of categoryB drugs 3 19AA Sale of drugsfrom motor vehicles YES 20BB-Whole saleof categoryA drugs 21BB-Whole saleof categoryA drugs
  • 9. 4 19B Whole sale or retail sale of homeopatheic medicine YES 20C-Sale of retail 20D-Sale of whole sale 20E-Renewalsale of license 20C/20D 5 19C Wholesaleor retail saleof drugsspecific inschedule’X’ Yes 20F-Sale by retail 20G-Sale by whole sale 20C-Renewal of above Sl.no Applicationform numbers Categoryof drugsto be sold Presence of qualifiedperson requirements Formnumberin which license for categoryof drugs