Pharmaceutical Jurisprudence detailed study of act.

1. Drug and Cosmetic Act 1940
and
Rules 1945
Presented by,
Ms. Y. R. Deshmukh
Asst. Professor, GIPER, Limb, Satara

89. Conditions to be full filled :
1. Licensee must have adequate premises equipped
with facility for storage
2. Requirement prescribed to run pharmacy as per
schedule N
3. All register and records should be prevented for 2
years
4. Licensee must allow an inspector to enter and
inspect premises, register and records
5. If there’s any change in expert staff or major
technical change should inform to licensing
authority
6. The license should be displayed at prominent
place.
7. Maintain inspection book.

90. 9. Drug should be sold only to license holder.
10. Drugs should be purchased from license
manufacturer.
11. Do not stock and sell expired drug.
12. Veterinary products stored separately and labeled
“NOT FOR HUMAN USE”
13. If drug is dispensed after compounding it shall be
recorded in prescribed register.

91. Restricted license:
It is a license for the sale of drug or distribution
of drug whose sale does not require the
supervision of a qualified person.
Deal with such classes of drug whose sell can be
effected without qualified person and vendors
don’t have fixed premises.

92. separate license required for retail sale of drug:
1. Form 20 : retail sale of drug other than C, C1
and X
2. Form 21 : retail sale of drug specified in
schedule C, C1
3. Form 20F : retail sale of drug specified in
schedule X

93. 1. The license can deal only in such drug which can
be sold without supervision of a qualified person.
2. If licensee is vendor, he should buy drugs only
from fixed dealers which is specified in his license.
3. Licensee has to take adequate precautions for
preserving properties of the drugs.
4. The license should be displayed at prominent
place.
5. The drugs should be sold in their original
containers.
6. Drugs should be purchased only from a licensed
dealer or manufacturer.
Conditions to be full filled :