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Pharmacy Practice38
The retail and wholesale licenses are granted with respect
to all the above three categories. Any person desirous of
getting a license to sell, stock, exhibit or offer to sale or
distribute the drugs should apply to the licensing
authorities appointed by the respective state governments
along with the following documents:
i. Application Form 19 (for drugs other than those specified
in schedule X) and/or Form 19 C (for drugs specified in
schedule X), duly filled in and in duplicate.
ii. A fee receipt of ` 40/- for each category of license
required, to be attached with the application form.
iii. The following documents as proof of age and qualifica-
tion of the applicant:
a. An attested copy of proof of passing the Diploma or
Degree course in pharmacy from a institute recognized
by the Pharmacy Council of India (PCI).
b. An attested copy of proof of undergoing 750 hours of
practical training in any hospital, dispensary or
chemist shop as recommended by PCI.
c. An attested copy of the registration certificate issued
by the state pharmacy council as proof of being
registered.
d. An attested copy of matriculation certificate as proof
of date of birth.
e. In case if proprietor of the drug store is not qualified,
then an affidavit from a qualified person is to be
attached with the application form.
f. In case the license is required for wholesale of drugs,
then a proof of passing the matriculation examination
or its equivalent with 4 years experiences in dealing
with drugs is to be attached with the application.
iv. A layout plan of the drug store duly signed by the
proprietor/partner of the firm.
v. In case two or more persons are partners for starting the
drug store, then a copy of the partnership deed is to be
attached with the application.
vi. If the applicant is the owners of the premises where the
drug store is to be started, then legal documents as a
proof of ownership or if the premises are on rent, then a
Community Pharmacy 39
copy of the rent receipt or rent deed is to be attached with
the application form.
vii. An affidavit of non-conviction under Drugs and
Cosmetics Act, by the proprietor or partners, on ` 3/-
non-judicial stamp paper, duly attested by a first class
magistrate is to be attached.
After scrutinizing the application form and all documents
and if all the requisitions are fulfilled, then the drug control
authority will personally visit the premises for which the
license is required. If the authorities are satisfied, then the
license for the sale of drugs may be issued on the following
forms as the case may be:
i. For retail sale:
a. Form 20 for drugs other than those specified in
schedule.
b. Form 21 for drugs specified in schedules X, C and C1
and excluding X.
c. Form 20 F for drugs specified in schedule X.
ii. For wholesale
a. Form 20 B for drugs other than those specified in
schedules C, C1 and X.
b. Form 21 B for drugs specified in schedules C and C1
and excluding X.
c. Form 20 G for drugs specified in schedule X.
4. Conditions of license: The licenses for the sale of drugs are
granted based on certain conditions including the following:
i. The license shall be displayed at a prominent place in a
part of the premises open to the public.
ii. The licensee shall comply with the provisions of the
Drugs and Cosmetics Act, 1900 and Rules there under for
the time being in force.
iii. No drug shall be sold unless such drug is purchased
under cash or credit memo from a duly licensed
manufacturer.
iv. No physician's samples (not for sale) or expired drugs
will be stocked on the sale premises. However, expired
drugs may be kept in separate packages or cartoon, the
top of which shows the words ‘Not for sale’.
Pharmacy Practice40
v. No drug belonging to ESI, CGHS, armed forces medical
store or a government hospital shall be present in the
licensed premises.
vi. In case of a pharmacy, the compounding of the
prescription would be done under the personal super-
vision of a qualified person.
vii. All registers and records required to be maintained under
the Act would be preserved for a period of at least 2 years
from the date of the last entry therein.
viii. The license will be renewed as and when required.
ix. Any change in ownership or a “qualified person” shell be
notified to the licensing authority within 3 months.
5. Duration of license: License for the sale of drugs becomes
valid up to 31st December of the year following the year of
is granting or renewal of the license.
6. Renewal of license: Application for the renewal of the
license may be put up before the expiry or within 6 months
of the date of its expiry, along with the late fees. The license
shall be deemed to have expired if the application for rene-
wal of the license is not made within 6 months after its expiry.
In the event of any change in constitution of licensed firm,
the license of such firm is deemed to be valid for a period of
3 months from the date of change unless in the mean time a
fresh license has been obtained.
MAINTENANCE OF RECORDS OF RETMAINTENANCE OF RECORDS OF RET
MAINTENANCE OF RECORDS OF RETMAINTENANCE OF RECORDS OF RET
MAINTENANCE OF RECORDS OF RET
AIL AND WHOLESALEAIL AND WHOLESALE
AIL AND WHOLESALEAIL AND WHOLESALE
AIL AND WHOLESALE
DRUG STORESDRUG STORES
DRUG STORESDRUG STORES
DRUG STORES
RR
RR
R
ecord of Purchase of Drugsecord of Purchase of Drugs
ecord of Purchase of Drugsecord of Purchase of Drugs
ecord of Purchase of Drugs
The records pertaining to the purchase of all drugs whether
intended to be sold in retail or by wholesale should be
maintained under the following heading:
i. Date of purchase
ii. Name and address of the licensee from whom purchased
and his license number
iii. Name and quantity of the drug and its batch number.
iv. Name of the manufacturer of the drug and its batch
number.
Purchase bills inhering cash or credit memos should be kept
as records.
Community Pharmacy 41
RR
RR
R
ecord of Sale of Drugsecord of Sale of Drugs
ecord of Sale of Drugsecord of Sale of Drugs
ecord of Sale of Drugs
Sale of Drugs other than those Specified in Schedule XSale of Drugs other than those Specified in Schedule X
Sale of Drugs other than those Specified in Schedule XSale of Drugs other than those Specified in Schedule X
Sale of Drugs other than those Specified in Schedule X
Sale of any drug other than those specified in schedule X is
required to be recorded at the time of supply in a prescribed
register maintained for the purpose or in a cash book or in a
cash or credit memo book. The following particulars are
required to be entered:
i. Serial number of the entry
ii. Date of supply.
iii. Name and address of the purchaser.
iv. Name and address of the patient or the name and address
of the owner of the animal, if the drug is supplied for
veterinary use.
v. Name along with the quantities of drug supplied.
vi. In case of schedules H and C drugs, the name of the
manufacturer, its batch number and the expiry date, if
any.
vii. Signature of the registered pharmacist under whose
supervision the medicine was made or supplied.
Sale of Drugs Specified in Schedule XSale of Drugs Specified in Schedule X
Sale of Drugs Specified in Schedule XSale of Drugs Specified in Schedule X
Sale of Drugs Specified in Schedule X
Supply of schedule X drugs should be recoded at the time of
supply in a bound and serially numbered register maintained
for this purpose and separate pages should be allotted for each
drugs. The following particulars should be mentioned in the
register:
i. Date of purchase
ii. Quantity recoiled, if any, the name and address of
supplier and the license number of the supplier.
iii. Name and quantity of the drug supplied.
iv. Manufacturer’s name, batch or lot number.
v. Name and address of the patient/purchaser.
vi. Reference number of the prescription against which
supplies were made.
vii. Bill number and date of receipt of purchase or supply
made by him.
Pharmacy Practice42
LL
LL
L
egal Regal R
egal Regal R
egal R
ecordsecords
ecordsecords
ecords
According to federal and state law the pharmacy owner or
manger is charged with maintaining accurate up-to-date
records of specific classes of drugs and poisons. Under the
provisions of the Federal Controlled Substances Act of 1970,
the pharmacist is charged for maintaining accurate records
related to the acquisition and disposal of certain drugs.
PP
PP
P
atient Ratient R
atient Ratient R
atient R
ecordsecords
ecordsecords
ecords
In recent years many pharmacists have broadened their record.
Keeping activities to include patient drug history. Although
the form of patient record varies, the basic idea is to establish a
record that follows the pharmacist to monitor the drugs usage
of each member of the family. It is increasingly important
because of the kinds and amount of drugs. To reduce the
problems associated with drug interactions and individual
drugs, the pharmacist has to maintain records.
ISOLISOL
ISOLISOL
ISOL
AA
AA
A
TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• Community pharmacy is the drug use, control and effective
application of knowledge of ethics, that assures optimal
drug safety in the distribution and use of medicines and
hence, it ensures maximum well-being of patients while
they are on drug therapy.
• In India, the minimum area of 10 sq.m is required to start a
medical shop for retail or wholesale.
• The store must have refrigerator and air conditioner in the
premises.
• For wholesale: The sale of drug by wholesale shall be made
either in the presence of registered pharmacist or in the
presence of a competent person who shall be a graduate
with 1 year experience in dealing in drugs or a person who
has passed SSLC with 4 years experience in dealing in
drugs, specially approved by the department of drug
control for the purpose.
• For retail: The sale of drug by retail must be made in the
presence of registered pharmacist approved by the
pharmacy council of concerned state.
Community Pharmacy 43
• Before opening a drug store (whether retail or wholesale),
specific laws are imposed such as:
i. Drugs and Cosmetics Act and Rules (1940 and 1945)
ii. Poison Act, 1919
iii. Dangerous Drug Act
iv. Prohibition and Excise Rules
v. Pharmacy Act, 1948
vi. Shops and Establishment Act.
• Following are certain legal requirements which must be
fulfilled for opening a medical store.
• A person who wishes to start a retailer drug should either
be a registered pharmacist.
• A minimum area of ‘10 sq.m is required for running a retail
or wholesale drug store.
• The licenses for the sale of drugs are required
• License for the sale of drugs becomes valid up to 31st
December of the year following the year of is granting or
renewal of the license.
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
VV
VV
V
erer
erer
er
y Shory Shor
y Shory Shor
y Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. What is Community Pharmacy?
2. Draw the layout of retail drug store.
3. Draw the layout of wholesale drug store.
4. What are patient records?
5. What are legal records?
6. What is the purpose of medical records in a hospital?
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Explain the legal documents for obtaining license to open a
drug store.
2. Write a note on sale of drugs specified in Schedule X.
3. Discuss about minimum space requirement for retail and
wholesale drug store.
4. What are the ideal characteristics of a drug store?
LL
LL
L
ong Answer Tong Answer T
ong Answer Tong Answer T
ong Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Define community pharmacy.What are its objectives and
functions?
Pharmacy Practice44
2. Write a detailed note on maintenance of records of retail and
wholesale drug stores.
3. What are the various conditions for grant of license for the
sale of drugs? What is the procedure for renewal of license?
4. Define community pharmacy. Explain the role of commu-
nity pharmacist.
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Minimum area required to start a wholesale or retail
medical shop is:
A. 10 sq.m B. 20 sq.m
C. 15 sq.m D. 40 sq.m
2. Thermolabile substances such as vaccines, enzymatic
preparations, antibiotics, vitamins are stored in refrigerator
at a temperature between
A. 0–5 degee celsius B. 2–8 degree Celsius
C. –5–0 degree celsius D. 5–10 degree Celsius
3. Drug and Cosmetics Act and Rules were made in which
year?
A. 1940 and 1945 B. 1961 and 1964
C. 1946 and 1948 D. 1970 and 1975
4. The medical store must have________ and air conditioner in
the premises.
5. Match the following Form no. with their respective
schedules
Form Schedule
a. 20 B i. X
b. 21 B ii. C & C1
c. 20 G iii. Other than C, C1 & X
AnswersAnswers
AnswersAnswers
Answers
1. A, 2. B, 3.A, 4. Refrigerator,
5. a. iii, b. ii, c. i
One of the basic services provided by hospital pharmacy
department is drug distribution system falls into three broad
categories:
1. Ward-controlled system.
2. Pharmacy-controlled imprest-based system.
3. Pharmacy-controlled patient issue system.
In the FIn the F
In the FIn the F
In the F
irst Categorirst Categor
irst Categorirst Categor
irst Categor
yy
yy
y
It may be “ward basket” system which occurs where the ward
writes an order to pharmacy for all drugs, it anticipates over a
particular time period for two or three days. The pharmacy
then assembles the order and sends it to the ward without
seeing the original inpatient medication orders written by
physician. Such systems are rarely seen in public hospitals with
a pharmacy department.
The second category of pharmacy-controlled imprest-based
system is commonly used. In such systems, a defined range of
drugs available in each ward and is managed by pharmacy
staff. Traditionally, such systems have accounted for the
distribution of 75–80% if inpatient drugs, the balance being
supplied directly to the patient.
The third category is the systems that are based on direct
patient issue. In these systems, the drugs are issued to the
patient rather than the ward can be classed as unit dose systems.
In the unit dose system is where each dose is delivered by the
pharmacy.
Drug Distribution
System in Hospital
5
Pharmacy Practice46
DRUG DISTRIBUTIONDRUG DISTRIBUTION
DRUG DISTRIBUTIONDRUG DISTRIBUTION
DRUG DISTRIBUTION
Outpatient SerOutpatient Ser
Outpatient SerOutpatient Ser
Outpatient Ser
vicesvices
vicesvices
vices
Outpatient refers to patients not occupying beds in a hospital
or in clinics, health centers and other places where outpatients
usually go for health care. In short from the outpatient
department is known as OPD. The patient with minor and
common illness go for the OPD for consultation to the physician
feels that there is no need of admitting the patient to the
hospital, ward, he prescribes the medicines and the patient is
required to get the prescribed medicines from the hospital
pharmacy and take home these medicines.
The prescription written by the physician is brought to the
pharmacist for compounding and dispensing, after careful
examination of the prescription the pharmacist carries out the
compounding. The compounded medicaments are filled into
suitable containers which are labeled properly. The pharmacist
also calculates the price of the filled prescription which are
handed over to the patient.
Hospitals generally break down their outpatient load into
three categories:
1. Emergency
2. Referral or tertiary care
3. Primary care, and
4. Ambulatory
Emergency OutpatientEmergency Outpatient
Emergency OutpatientEmergency Outpatient
Emergency Outpatient
A patient gave emergency or accidental care for conditions,
which require immediate medical attention.
RR
RR
R
eferred Outpatienteferred Outpatient
eferred Outpatienteferred Outpatient
eferred Outpatient
He is referred directly to outpatient department by his
attending medical/dental practitioner for specific treatment,
other than an emergency treatment.
PP
PP
P
rimarrimar
rimarrimar
rimar
y Carey Care
y Carey Care
y Care
Primary care is majority care. It describes a range of services
adequate for meeting the great majority of daily personal health
needs. This majority includes the need for prevention, health
Drug Distribution System in Hospital 47
maintenance and for evaluation and management of various
symptoms, problems and chronic aspects of disease.
AmbulatorAmbulator
AmbulatorAmbulator
Ambulator
y Py P
y Py P
y P
atientatient
atientatient
atient
An ambulatory patient is able to walk and since outpatients,
receive primary health care and walk off, they are wrongly
called ambulatory patients. However, majority of the outpatient
are ambulatory.
LL
LL
L
ocation of Outpatient Dispensingocation of Outpatient Dispensing
ocation of Outpatient Dispensingocation of Outpatient Dispensing
ocation of Outpatient Dispensing
There is no set rule regarding the location of outpatient
dispensing area, preferably it should be located on the ground
floor of the building and near to the entrance of the building
for easy access by the patients. It should be close to the central
registration and outpatient departments so that the patients
do not find any difficulty in its location.
The outpatient dispensing area should be provided with
proper seating arrangement so that if long time is needed for
filling the prescription, the patient can wait till the prescription
is filled (Fig. 5.1).
Dispensing of Drugs to InpatientDispensing of Drugs to Inpatient
Dispensing of Drugs to InpatientDispensing of Drugs to Inpatient
Dispensing of Drugs to Inpatient
The drug distribution to the inpatient department can be carried
out from the outpatient dispensing area. The staff handling the
distribution of drugs to outpatient can carry out the distribution
of drugs in the inpatient departments. If the workload is too
Fig. 5.1: Location of outpatient dispensing