PHARMACEUTICAL JURISPRUDENCE PPT ON PART 12B AND SCHEDULE F

1. TOPIC- DRUGS AND COSMETIC ACT(D AND
C ACT) . EXPLANATION OF PART 12B AND
SCHEDULE F
SAURABH PUNIA
PHARMACEUTICAL JURISPRUDENCE

2. WHAT IS D AND C ACT ?
The drug and cosmetics act 1940 is an act
of the parliament of india which
regulates the import, manufacture, and
distribution of drugs in india.
The main objective of the act is to ensure
that the drugs and cosmetics sold in
india are safe, effective and conform to
state quality standards.

3. PART 12B
It contains requirements for the premises, personnel,
equipments , organizations and operation of a blood
bank and/or for preparation of blood components. It’s a
part under schedule F.
1. Blood banks/ Blood components:
1. General
2. Accomodation for a blood bank
3. Personnel
4.Maintenance
5. Equipments and Instruments
(a) B.P apparatus
(b) Stethoscope

4. (c) Blood bags( single,double,triple)
(d) Donor questionnaire
(e) Weighing device for donors and blood bags
(f) Artery forceps, scissors
(g) Strippr for blood tubing
(h) Glass slides
(i) Test tube and test tube stand
(J) Anti-A, Anti- B,anti-AB, Antisera
(k) Emergency medical kit
(l) Insulated blood bags containers with provisions for
storing between 2degree to 10 degree.

5. 6. Supplies and reagents
7. Good manufacturing practices (Gmps)
8. Criteria for blood donation
9. Testing of whole blood
10. Record
11. Labels
2. Blood donation camps:
1. Premises, personnel etc.

6. 2. Personnel for out- door blood donation camp.
(a) 0ne medical officer and two nurses or
phlebotomists for managing 6-8 donor tables
(b) Two medico social workers
(c) Three blood bank technicians
(d) Two attendants
3. Equipments.

7. 3. Processing of blood components from
whole blood by a blood bank
1. Accomodation
2. Equiments
3. Personnel
4. Testing facilities
5. Categories of blood components
(a) conc. Human rbc
(b) platelets conc.

8. (c) Fresh frozen plasma
(d) Cryoprecipitate

9. SCHEDULE F
This contains regulations and standards for running a
blood bank.
Schedule f1
This contains regulations and standards for bacterial
vaccines,viral vaccines, antisera and diagonistic
agents.
Schedule f2
This contains regulations and standards for surgical
dressing.

10. Schedule F3
This contains regulations and standards for umbilical
tapes ( polyster and cotton tapes).
Schedule FF
This contains regulations and standards for
opthalamic preparation ( solutions, suspensions
and ointments). The label must bear:
1.. The statement “use the solution within one month
after opening the container”

11. 2..Name the concentration o the preservative used.
3..” Not for injection”
4.. Storage Instructions
5.. Warning
(a) If irritation persists or increases, discontinue the
use and consult physician
(b) Do not touch the dropper tip or the other
dispencing tip to any surface since this may
contaminate the solution.