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GYANDEEP ACADEMY Mr. Arun Patidar (M.Pharm) Mob: 9826672215, 9644067667, 34 Prakash Nagar Navlakha, Indore Download study material (Notes) www.gyandeepacademy.in Key Notes: Pharmaceutical Jurisprudence (206) D Pharm II Year 1. Pharmaceutical legislation in India Origin : st - 1 chemist shop – 1811 – by Mr. Bathgate – Calcutta - Apothecary shop – 1821 – by Smith Stamstreet - Small chemical factory – 1901 – by Acharya Prafull Chandra Roy – Calcutta - Alembic chemical works – 1903 – by Prof. T.K. Gajjar – Parel, Mumbai Drug Enquiry Committee - D.E.C. – 1931 - Also known as Chopra committee - Chairman – Lt. Col. R.N. Chopra - Recommendations :- - To establish pharmacy councils. - To establish drug control departments. - To establish CDL - Import of drugs bill – 1937 Hathi committee Scope and objectives :- - The drug act – 1940 - The pharmacy act – 1948 - The drug and magic remedies act – 1954 - The medicinal and toilet preparation act – 1955 - The narcotic drug and psychotropic substance act – 1985 - The drug (price control) order – 1987 Emergency Regarding Blood Donner Please Contact – 9826672215, 9644067667 Page 1 GYANDEEP ACADEMY Mr. Arun Patidar (M.Pharm) Mob: 9826672215, 9644067667, 34 Prakash Nagar Navlakha, Indore Download study material (Notes) www.gyandeepacademy.in Key Notes: Pharmaceutical Jurisprudence (206) D Pharm II Year 2. Pharmacy act – 1948 Constitution of PCI - Elected members – 6 by UGC (out of 6, 1 from- Pharmachemistry, Phrmacology, Phrmacognosy & Pharmaceutics) - Nominated members – 6 by central govt. - Ex – officio members – 3 Drug controller of India (CDSCO) Head of CDL Director general of health services - One member each from MCI, UGC, AICTE Functions of PCI: - Education regulation - Minimum eligibility for admission in pharmacy course - Duration of course - Training period - Drafting of syllabus - Inspection of institute - Approval of institute - Extension of approval - Termination of approval - Maintenance of central register Constitution of SPCI - Elected members – 6 – by PCI - Nominated members – 6 by state govt - Ex – officio members – 3 Drug incharge Chief medical officer Drug analyst Emergency Regarding Blood Donner Please Contact – 9826672215, 9644067667 Page 2 GYANDEEP ACADEMY Mr. Arun Patidar (M.Pharm) Mob: 9826672215, 9644067667, 34 Prakash Nagar Navlakha, Indore Download study material (Notes) www.gyandeepacademy.in Key Notes: Pharmaceutical Jurisprudence (206) D Pharm II Year Functions of SPCI: - Verification of docs. - Registration of pharmacist - Renewal of registration - Termination of registration - Maintenance of first register - Inspection of drug store and any pharmaceutical premises 3. Drug and cosmetics Act – 1940 - Drug (Prevent /treat /diagnose disease including mosquito repelling sub, gelatine, WFI.) - Adulterated drugs (consists in whole or in part, of any filthy, putrid or decomposed substance) - Misbranded drugs (so coloured, coated, powdered or polished, not labelled in the prescribed manner) - Spurious drugs (If it is an imitation of, or is a substitute for, another drug or resembles another drug) Registered pharmacist - Min. qualification - Degree or diploma in pharmacy from PCI approved Institution - Training period (in case of D.Pharm) Not less than 500 hours., Not less than 3 months. Registration procedure : - Form - Fees – (3100/-)DD in favour of registrar SPCI - Copy of all mark sheets - Training certificate - ID proof Emergency Regarding Blood Donner Please Contact – 9826672215, 9644067667 Page 3 GYANDEEP ACADEMY Mr. Arun Patidar (M.Pharm) Mob: 9826672215, 9644067667, 34 Prakash Nagar Navlakha, Indore Download study material (Notes) www.gyandeepacademy.in Key Notes: Pharmaceutical Jurisprudence (206) D Pharm II Year - Domicile - Submission - Verification - Registration Schedules : - A – Form / proforma - B – price list of tests In CDL - C – biological parenterals - C1 – biological non-parenterals - E1 – List of Poisons - F- It includes requirements for the Functioning and operation of a blood bank - F (I) :- Give details of the standards of bacterial vaccines, antisera and diagnostic antigens. - F (II):- Standards for Surgical Dressings that include bandage cloth, absorbent gauze, rolled - bandage,etc. - F (III):- Standards For Umbilical Tapes like umbilical polyester tape, cotton tape, etc. - Schedule FF- It lays down Standards for Ophthalmic preparations. - G – list of drugs to be taken under RMP - H – prescription drugs - J – list of diseases for their advertisement Prohibited - L – GLP - M – GMP - M1 – GMP for homeopathic medicine - M2 – GMP for cosmetics - M3 – GMP for medical devices Emergency Regarding Blood Donner Please Contact – 9826672215, 9644067667 Page 4
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