JURISPRUDENCE PPT on Part 12B and schedule F
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The Drugs and Cosmetics Act of 1940 in India regulates the import, manufacture, and distribution of drugs and cosmetics to ensure they are safe and effective. Part 12B and Schedule F detail the requirements for blood banks, including premises, personnel, equipment, and operational standards for blood donation and processing. Regulations are also provided for various medical products, including vaccines and surgical dressings, mandating specific labeling and storage practices.
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.