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 
        
        
        
        
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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 
        
           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