Pharmaceutical Jurisprudence (BP505T) Unit-2 Schedules and DMR.pptx

This PPT covers the topics Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)

1. Drugs and Cosmetics Act 1940 and its rules 1945 Unit-2

2. Schedules Schedule/Form Description Schedule G Hormonal preparations Schedule H Rx and Narcotic Drugs and Psychotropic Substances Act, 1985 Schedule M Good Manufacturing Practices for Allopathic Medicines Schedule N Facilities and equipment for the efficient running of a Pharmacy. Schedule P The life period of drugs in months Schedule T Regulations and requirements for the manufacture of Ayurvedic, Siddha and Unani products Schedule U Manufacturing record, records of raw materials and analytical drugs Schedule V Standards for patent or proprietary medicines Schedule X Habit forming, psychotropic and other drugs likely to be misused for addictive purposes Schedule Y Requirements and guidelines on Clinical trials for the import and manufacture of new drugs Part XII B Operation of a Blood Bank and/or for preparation of Blood components Schedule F Regulations and standards for running a blood bank DMR (OA) Drug and Magic Remedies (Objectionable Advertisements)

3. Mnemonics

4. Schedule G Drugs - Hormonal Preparations

5. Cautionary Statement Drug label prominently displays: "Caution: It is dangerous to take this preparation except under medical supervision."

6. Examples

7. Importance of Hormonal Preparations

8. Schedule H Drugs - Prescription Medications

9. Label Requirements

10. Supply and Sale Restrictions

11. Prescription Information The time and date of the prescription must be noted.

12. Examples of Schedule H Drugs

13. Schedule H and Narcotic Drugs If a Schedule H drug falls under the Narcotic Drugs and Psychotropic Substances Act 1985, it requires additional labeling.

14. Dual Classification Labeling "NRx" displayed in red on the left top corner of the label. "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only." prominently placed.

15. Importance of Regulation Schedule H drugs require stricter control due to their potential risks. Ensures patient safety and proper usage

16. Introduction to Schedule M (GMP - Good Manufacturing Practices)

17. Requirements for Premises and Materials 1. Locations and Surroundings: - Avoid contamination from odors , dust, and drainage. 2. Buildings and Premises: - Hygienic conditions, insect-free, proper lighting, ventilation. - Adequate space, compatible operations, smooth surfaces. - Proper drainage, fire safety, and drying space. 3. Water Supply: - Potable water, adequate supply. 4. Waste Disposal: - Follow environmental regulations and handle hazardous waste. 5. Stores: - Separate storage for raw and packaging materials. 6. Working Space: - Adequate space for equipment and materials to prevent mix-ups. 7. Sterile Products: - Separate enclosed areas, HEPA-filtered air, and routine microbial counts.

18. Requirements for Premises and Materials (Contd.) 8. Container Cleaning: - Separate washing and cleaning section. 9. Machinery: - Adequate machinery, maintenance, and calibration. 10. Raw Materials: - Inventory, identification, testing, quality control. 11. Equipment: - Constructed, designed, cleaned, and prevented contamination. 12. Batch Manufacturing Record: - Detailed records of the manufacturing process. - Testing, approval, quality verification, and sale clearance.

19. Requirements for Premises and Materials (Contd.) 13. Worker Hygiene: - Healthy workers, proper uniforms, sanitation facilities. 14. Medical Services: - First aid facilities, medical check-ups. 15. Distribution Record: - Batch distribution records for prompt recalls. 16. Market Complaints: - Register for market complaints and investigations. 17. Quality Control: - Establish own QC section or use approved labs.

20. Requirements for Plant and Equipment 1. Area: - Basic and ancillary installation requirements. 2. Equipment: - Various equipment for manufacturing processes.

21. Parts of Schedule M 1. Part 1: General GMP for Premises and Material. 2. Part 1A: Sterile Products - Parenteral and Ophthalmic. 3. Part 1B: Oral Solid Forms - Tablets and Capsules. 4. Part 1C: Oral Liquids - Syrups, Emulsions, Suspensions. 5. Part 1D: Topical Products - Creams, Ointments, Lotions, etc. 6. Part 1E: Metered Dose Inhalers (MDI).

22. Conclusion for Schedule M

23. Schedule N - Facilities and Equipment for Efficient Pharmacy Operations

24. Entrance and Premises 1. Entrance: - "Pharmacy" inscription at the front. 2. Premises: - Separated, well-built, well-lit, and ventilated. - Proper storage for poisons. - Adequate space for the dispensing department. - Minimum height of 2.5 meters. - Smooth, washable floor and walls. - Barrier to the separate dispensing area from the public. - Ample supply of good quality water.

25. Furniture and Apparatus - Suitable furniture, drawers, containers, and glasses. - Labeled containers for medicaments. - Dispensing bench with washable top. - Separate lockable cupboards for poisons. - Labeling for concentrated solutions. - Apparatus and books for official preparations.

26. Equipment and Apparatus - Balance - Beakers, bottles, funnels - Filter and litmus papers - Mortar and pestle, glassware - Spatula, scissors, stands - Spirit lamp, thermometer - Water bath, distillation apparatus - Pill machines, suppository molds - Essential reference books.

27. General Provisions - Pharmacist Requirements: - Clean white overalls. - Record Keeping: - Maintain records and registers as per regulations. - Medicament Labeling : - All medicaments must bear labels as per regulations.

28. Conclusion - Schedule N outlines pharmacy requirements. - Ensures safe and efficient pharmacy operations. - Adherence to guidelines leads to quality and compliance.

29. Schedule P Schedule P describes the life period of drugs in months (unless otherwise specified) between the date of manufacture and date of expiry, which the labeled potency period of the drug shall not exceed under the conditions of storage specified.

30. Schedule P

31. Schedule P1

32. Schedule T: Regulations and Requirements for Ayurvedic, Siddha, and Unani Product Manufacturing

33. Part 1 - Good Manufacturing Practice (GMP) Adequate Space for Daily Activities Receiving and Storage Production Area Quality Control Section Finished Goods Store Office and Administration Rejected Products Store Location and Surroundings Avoiding Contamination Building Requirements Hygienic Conditions Insect/Rodent-Free Proper Light and Ventilation Water Supply and Waste Disposal

34. Part 1 - Good Manufacturing Practice (Contd.) Container Cleaning and Stores Working Space and Health Hygiene Worker Health and Clothing Lavatories and Changing Rooms Medical Services and Machinery/Equipment Batch Manufacturing Record Manufacturing Process Details Testing and Signatures Distribution Record and Market Complaints

35. Part 2 - Recommended Machinery and Equipment Anjana/ Pisti , Churna / Nasya / Manjan /Lepa End Runner/Ball-Mill, Sieves/Shifter Pills/ Vati / Gutika Matirai and Tablets Ball Mill, Mass Mixer, Granulator, Drier, Tablet Compressing Machine

36. Part 2 - Recommended Machinery and Equipment (Contd.) Kupi Pakava / Ksara / Parpati / Lavana /Bhasma/ Satva Bhatti, Flask, Multani Matti/Plaster of Paris, Copper Rod Kajal and Capsules Filling/Packing Room Setup, Triple Roller Mill, Capsule Filling Machine Ointment/Marham Pasai and Pak/ Avaleh /Khand/ Modak / Lakayam Tube Filling Machine, End Runner/Mill, Iron Kadahi

37. Part 2 - Recommended Machinery and Equipment (Contd.) Panak , Syrup/ Pravahi Kwath Manapaku Tincture Press, Bhatti Section, Filter Press, Liquid Filling Machine Asava-Aristha and Sura Fermentation Tanks, Distillation Plant Ark Tinir and Tail/ Ghrit Ney Maceration Tank, Distillation Plant, Filling Tank

38. Part 2 - Recommended Machinery and Equipment (Contd.) Aschyotan /Netra Malham Panir / Karn Bindu/Nasa- bindu Hot Air Oven, Kettle, Tube Filling Equipment, Autoclave Separate Areas for Bhatti, Furnace, Puta

39. Schedule U: manufacturing records, raw materials, and analytical drugs

40. Manufacturing Records (Substances other than Parenteral Preparation)

41. Manufacturing Records (Parenteral Preparations)

42. Records of Raw Materials

43. Analytical Records (Tablets, Capsules, Other Drugs)

44. Analytical Records (Parenteral Preparations)

45. Analytical Records (Raw Materials)

46. Analytical Records (Container and Packing Material)

47. Schedule UI - Manufacturing Record for Cosmetics Similar to Schedule U Manufacturing Records for cosmetics

48. Schedule V: Standards for Patent/ Proprietary Medicines

49. Schedule V - Standards for Patent/ Proprietary Medicines

50. Schedule X - Regulation of Habit-Forming and Psychotropic Drugs

51. Schedule Y - Clinical Trials Requirements Clinical trials permission process (Form 12) Responsibilities of Sponsor/Investigator

52. Schedule Y - Data Required for New Drug Approval Clinical and Pharmaceutical Information Animal toxicology: Acute, chronic, reproduction studies, mutagenicity, carcinogenicity Animal pharmacology, Phase 1, 2, 3 trials, Special studies

53. Clinical Trials Phase 1 Clinical Trials Determining maximum tolerated dose in humans Pharmacodynamics effects, adverse effects   Phase 2 Clinical Trials Determining therapeutic doses, effective dose range Safety and pharmacokinetics   Phase 3 Clinical Trials Obtaining evidence of efficacy and safety Submission of trial reports

54. Schedule F This contains regulations and standards for running a blood bank.

55. Schedule F1 This contains regulations and standards for bacterial vaccines, viral vaccines, antisera and diagnostic agents.

56. Schedule F2 This contains regulations and standards for surgical dressing

57. Schedule F3 This contains regulations and standards for umbilical tapes (polyester and cotton tapes)

58. Schedule FF This contains regulations and standards for ophthalmic preparations (solutions, suspensions, and ointments). The label must bear the following: ( i ) The statement “use the solution within one month after opening the container”. (ii) Name and concentration of the preservative used. (iii) ‘’Not for Injection’’. (iv) Storage instructions. (v) Warning (a) If irritation persists or increases, discontinue the use and consult a physician. (b) Do not touch the dropper or dispensing tip to any surface since this may contaminate the solution.

59. Part XII-B: Requirements for Blood Banks and Blood Components

60. Blood Banks/Blood Components

61. Equipments and Instruments (a) BP Apparatus (b) Stethoscope (c) Blood Bags (single, double, triple, quadrapole ) (d) Donor Questionnaire (e) Weighing Device for Donors (f) Weighing Device for Blood Bags (g) Artery Forceps, Scissors (h) Stripper for Blood Tubing ( i ) Bed Sheets, Blankets

62. Equipments and Instruments (Cont.) (j) Lancets, Swab Stick/Toothpicks (k) Glass Slides (l) Portable Hb Meter/Copper Sulphate (m) Test Tube (big) and 12×100 mm (small) (n) Test Tube Stand (o) Anti-A, Anti-B and Anti-AB, Antisera and Anti-D (p) Medicated Adhesive Tape (q) Plastic Waste Basket

63. Equipments and Instruments (Cont.) (r) Donor Cards and Refreshments for Donors (s) Emergency Medical Kit (t) Insulated Blood Bag Containers (2°C to 10°C) (u) Dielectric Sealer or Portable Tube Sealer (v) Needle Destroyer (wherever necessary) (vi) Supplies and Reagents (vii) Good Manufacturing Practices (GMPs)/Standard Operating Procedures (SOPs)

64. Blood Donation Camps ( i ) Premises, Personnel, etc. (ii) Personnel for Out-door Blood Donation Camp (iii) Equipments (iv) Testing Facilities (v) Categories of Blood Components (a) Concentrated Human Red Blood Corpuscles (b) Platelets Concentration (c) Granulocyte Concentration (v) Categories of Blood Components (Cont.) (d) Fresh Frozen Plasma (e) Cryoprecipitate

65. Drug and Magic Remedies

66. Definition

67. Prohibited Advertising of Drugs and Remedies The law prohibits the advertising of drugs and remedies for ( i ) Inducing miscarriage or preventing conception in women. (ii) Improving or maintaining the capacity for sexual pleasure. (iii) Correction of menstrual disorders. (iv) Curing, diagnosing or preventing any disease or condition mentioned in an included schedule.