CHAPTER 08

PART 7
D and C Act 1940 Continued
SALE OF DRUGS:

Sale of Drugs is classified in to four types as follows:

1) Wholesale of Drugs
2) Wholesale of Drugs from Vehicles (vendor’s Licence)
3) Retail sale of Drugs
4) Restricted Sale of Drugs (Restricted licence)

I). Wholesale of Drugs :

It is the process of sale of Drugs by a licenced Manufacturer or Distributor or

Dealer to a licenced Retailer or Hospitals or Charitable Institutions or Research
organisationsor to Registered Medical Practioners.

The following types of Licences are issued for the purpose of wholesale of
Drugs.

a) Licence in form No 21-B for the wholesale of Schedule C and C1

Drugs.
b) Licence in form No 20-B for the wholesale of Drugs other than
Schedule C, C1 and ‘X’, Drugs.
c) Licence in form no 20-G for the wholesale of Schedule ‘X’ Drugs.
1) Any person who wishes to have a wholesale distribution or dealership
should obtain the above types of licences from the licensing authority on
submission of applications in prescribed forms along with the prescribed
fee and necessary documents including the information required for
obtaining the Licences.

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 2) If the licensing authority is satisfied of all the conditions being fulfilled by
the applicant shall issue such wholesale licences in the prescribed forms
to the applicant.
3) On obtaining the licences, the licencee can start the wholesale
distribution of Drugs from his licenced premises.
4) He should purchase the Drugs only from the licenced manufacturer or
licenced stockist and store them properly in an orderly manner.
5) He should neither purchase nor sell the Drugs which are prohibited to be
imported or manufactured or sold.
6) Drugs should be distributed /sold only under the supervision of a
“Competent person” (“Competent Person” is the one who has completed
at least an S.S.L.C. with a minimum of 3 years experience in wholesale
or retail sale of drugs).
7) He should sell the Drugs only to the licenced retailers, hospitals, nursing,
homes, Charitable Institutions and R.M.P’S
8) He should maintain all the records, invoices, bills and other related
documents at least for 3 years and produce them whenever demanded
by a Drugs inspector or licensing authority.
9) He should allow the Drugs inspector to inspect the premises, stock of
Drugs and the records maintained by him.

10) He should allow the Drugs inspector to take the samples of Drugs
to send them for analysis to a Govt. Analyst.

11) He should maintain separate storage facility, records, invoices and

related documents for Schedule ‘X’ Drugs ( to be explained).

12) He should also fulfill any other conditions mentioned in the licences
or mentioned under D and C act.

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 13) He should also maintain an inspection book in Form no. 35 issued
by the Licensing Authority in which the Drugs Inspector should enter his
observations during inspection

II) Wholesale of Drugs from vehicles ( Vendor’s Licence)

It is the process of distribution of Drugs through licenced vehicles to the

dealers, retailers, nursing homes and R.M.P’S.

The following types of Licences are issued for this type of Distribution of Drugs

a) Licence in form no 23-BB for the wholesale of Schedule ‘C’ and ‘C1’
Drugs.
Licence in form no 20-BB for the wholesale of Drugs other than Schedule ‘C’
‘C1’ and ‘X’.

All the conditions prescribed under wholesale of Drugs also apply for
wholesale of Drugs from vehicles under vendor’s licence. However
licence for the wholesale of Schedule ‘X’ Drugs is not issued under this
category.

III. Retail Sale of Drugs ( Chemist and Druggist)

It is the process of retail sale of Drugs by a licenced retailer to the

customers, Hospitals, nursing homes and R.M.P’S and require the
services of a “Registered Pharmacist”.

Following types of licences are issued for the retail sale of Drugs

a) Licence in form No 21 for the retail sale of Schedule ‘C’ and ‘C1’
Drugs.
b) Licence in form No 21 for the retail sale of Drugs other than Schedule
‘C’ ‘C1’ and ‘X’.
c) Licence in form no 20-F for the retail sale of Schedule ‘X’ Drugs.

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 Any person who wishes to start a retail sale business i.e. a Chemist and
Druggist store should fulfill the following conditions for obtaining the retail
licences:-

1) A premises with not less than 120 Sq. feet area should be provided
( either owned or leased).
2) It should be properly painted and furnished with Racks having
glass shutters and to be maintained cleanly.

3) It should be provided with a refrigerator for storing the Drugs which

are to be stored below 20° C.

d) Either the applicant should be a ‘Registered Pharmacist’ or he should

appoint a ‘Registered Pharmacist’ to supervise the sale of Drugs.
e) He should submit applications in the prescribed forms along with the
prescribed fee and necessary documents to the licensing authority at
least one month prior to the commencement of the business.
f) On receiving the applications and after the inspection of the premises
and verification of the documents submitted by the applicant, if the
licensing authority is satisfied, shall issue the licences in the
prescribed forms within one month of receiving the applications.

On obtaining the licences the licencee can commence the business of retail sale
of different categories of Drugs and fulfill the following conditions of retail
licences.

1) All the Licences should be prominently displayed in his premises.

2) He should purchase the Drugs only from the licenced Manufacturers or

distributors.

3) He should neither purchase nor sell the Drugs which are prohibited to be
sold.

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4) All the types of Drugs purchased should be stored properly and
systematically in an orderly manner.

5) He should not sell “physician samples” Drugs meant for “free of supply” at
Government Hospitals or charitable institutions and the Drugs which are
date expired.

6) A separate Rack should be provided for keeping the veterinary Drugs.

7) A separate rack with lock and key should be provided for storing Schedule
‘X’ Drugs.

8) All types of Drugs should be sold only under the supervision of “Registered
Pharmacist”.

9) All the Drugs specified under Schedule ‘H’ and ‘ X ‘should be sold only on
the prescription of a ‘Registered medical practitioner’.

10) No prescription should be dispensed repeatedly unless required to do so by

the prescriber.

11) The Drugs prescribed by R.M.P should not be substituted or altered or

changed with an alternative Drug unless approved by the prescriber.

12) All the Drugs should be sold only with a invoice or a bill in which name of
the patient, name of the prescriber, names and quantities of Drugs, their
Batch Nos, Date of expiry and name of the of the Manufacturer, cost of the
Drug, total amount etc. should be entered, signed by the “Registered
Pharmacist” and issued to the customer.

13) All the purchase invoices, sales bills and other related documents should
be maintained by the licencee for at least 3 years and produced whenever
demanded by the Drugs Inspector or licensing authority.

14) All date expired Drugs should be removed from the stock, entered in a
separate register and returned to the distributor for replacement.

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15) Separate stock register, purchase invoices, and sales bills should be
maintained for Schedule ‘X ‘Drugs.

16) Inspection Book in form No 35 should be maintained by the licencee.

17) Drugs Inspector or any authorized officers of the Drugs Control Department
should be allowed to Inspect the premises.

18) If the Drugs inspector wishes to collect the samples of Drugs to send them
for analysis and assay, should be allowed to collect such samples for which
he can collect the cost and issue a Bill.

19) If the Drugs inspector orders to stop the sale of a certain batch of drug he
should do so until the officer allows him to sell that particular Batch of Drug

20) Drugs inspector should enter all observations he has made during
inspection in “Inspection Book No. 35” maintained by the licencee

21) Licencee should inform any change in the name of ‘Registered Pharmacist’
with in one month of such a change and get the new name entered in his
licences.

22) Licencee should get the licences renewed within the due date ( at least one
month before the date of expiry.

23) He should also follow any other conditions of his licences or the conditions
mentioned under D and C act

24) Licences are liable to be suspended or canceled if the licencee has

committed any offence under the retail licence

IV). Restricted Sale of Drugs (Restricted licence):

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It is a type of licence issued for the retail sale of only certain categories of drugs
and does not require the services of a ‘Registered Pharmacist’.

Following types of Licences are issued under ‘Restricted Licence’

a) Licence in from No 21-A for the sale of Schedule ‘C’ and ‘C1’ Drugs
b) Licence in from No 20-A for the sale of Drugs other than Schedule ‘C’,
‘C1’ and ‘X’

Any person who wishes to sell the drugs under ‘Restricted Licence’ should
obtain the above mentioned licences from the Licensing Authority on
submission of an Application in prescribed form and the prescribed fee.

Only certain types of Drugs namely general Drugs and household remedies like
Vicks, Amurtanjan and certain OTC drugs are permitted to be sold under this
licence.

All the conditions mentioned under the licences should be followed by the
licencee.

SCHEDULE ‘N’ OF DRUGS AND COSMETICS ACT:

Requirements to be fulfilled for the efficient Running of a ‘Dispensing

Pharmacy’:-

1). Entrance: The front portion of the pharmacy shall bear the signboard as
“Dispensing pharmacy” which should be clearly visible to the public

2). Premises: The premises meant for pharmacy should have at least 200 Sq
of total area with a separated section of at least 80 Sqft. for dispensing room. It
should be at least 9 feet height, well built, property ventilated, well painted clean
and hygienic. Walls and floors should be smooth without any cracks or fissures.

3). Dispensing Section: This section with at least 80 sqft. area should be
provided with separate racks for keeping Chemicals, apparatus, poisons, Books
and journals. separate working benches should be provided for each
pharmacist to dispense the Drugs.

4) Apparatus: The following apparatus should be provided in a Dispensing

Pharmacy. Dispensing Balances, Chemical Balances, Electronic or Digital

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Balances, Beakers, funnels, Measuring Cylinders, Pipettes (1 ml, 2ml, 5ml,
10ml etc.) Tripod stands, Corks, Cork extractors, filter papers , Mortar and
pestles ( both glass and porcelain) Ointment slabs , Ointment pots, Scissors,
Spatulas, spirit lamps, gas connections, Thermometers, Distillation still, Pill
making machines, Suppository moulds etc.

5) Books and Journals: The following Books and Journals should be

provided in the Dispensing Pharmacy

a) Indian Pharmacopoeia (I.P) (latest edition)

b) National formulary of India (latest edition)

c) Drugs and Cosmetics act 1940 and its rules 1945 (including latest
amendments)

d) Pharmacy act 1948

e) NDPS act 1985

f) Other related Acts

g) Various Pharmaceutical Journals

6) General Conditions

a) Dispensing of Drugs should be carried out only by the ‘Registered

Pharmacist’ and his registration certificate should be prominently displayed
in the premises.

b) He should always wear a clean and white Apron with a Name Plate and his
Registration number.

c) He should store all the chemicals and apparatus properly and separately.

d) Poisons should be stored separately under lock and key and that Rack
should be labeled clearly as “POISONS” in Red Colour.

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e) He should always dispense the drugs with correct weighing, measuring,
dispensing, filling, packing and labeling.

f) The label should bear the name of the Patient, Age, Sex, Name of the
prescriber , Name and quantity of the Drug, date of dispensing, dose and
directions for use.

g) He should dispense the drugs only on the prescription of an R.M.P.

h) He should maintain a record of all transactions including purchase invoices,

Sales Bills, Stock Register etc.

i) He should update himself with modern technologies of Dispensing.

j) He should follow any other conditions mentioned in the licence or under D

and C Act 1940.

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