Pharmaceutical Jurisprudence .

1. PHARMACY ACT (1948)

2. HISTORY OF PHARMACY ACT
 Drug Enquiry Committee, Health survey and Development Committee
recommend that the persons practicing Pharmacy should have a proper
educational background.
 To Regulate the practice of Pharmacy in India.
 The Pharmacy Act came into force in March 1948.

3. PHARMACY ACT (1948)
Objectives:
 To regulate the profession and practice of Pharmacy and to raise the status of
profession of pharmacy in India.
 Divided into 5 chapters and 46 sections.
Significant features
 The constitution of the PCI and State pharmacy councils.
 The prescribing of the minimum standard of education required for qualifying as a
pharmacist.
 Registration of the pharmacists by the state pharmacy councils.
 Maintenance of disciplinary control over the profession of Pharmacy.
 Dispensing of prescription of registered medicinal practitioners only by registered
pharmacists.

4. THE PHARMACY COUNCIL OF INDIA ( CENTRAL COUNCIL)
 The PCI was first constituted by the Central Govt. in 1949.
 Reconstituted every 5 years.
 Headquarter  New Delhi
Composition
1) Elected members
 6 members  Elected by UGC from teaching profession
 1 member  Elected Medical council of India
 1 member  Elected by state pharmacy council from registered pharmacists to represent each
state.
2) Nominated members
 6 members atleast 4 persons possessing Diploma or Degree in pharmacy  nominated by
central govt.
 1 representative each UGC & AICTE.
 1 registered pharmacists from each state  nominated by State Govt./ Union territory.
3) Ex-Officio Member
 The director general of Health Services
 The director of Central Drugs Laboratory.
 The Drugs controller of India.

5.  The members of PCI elects a President and Vice President amongst
themselves.
 Elected member hold office for 5 Years, and are eligible for re-election.
 The council also appoints a Registrar and if needed its treasurer.
 It can appoint officers and servants necessary to carry put its function.
 The PCI has to constitute an executive committee
 Executive committee
 The president (Chairman of the committee)
 Vice president
 5 members elected by the PCI amongst its member.

6. FUNCTIONS OF PCI
 The PCI makes the Education Regulations
 Approves the courses of study and examinations, after the enquiry and to the
satisfaction of the council.
 Maintains the central register of pharmacists in the prescribe manner.
 The Executive committee appoints the Inspectors.
 To inspect any institution which provides an approved courses of study
 To attend any approved examination and to report about the standard of the examination
 To inspect the institutions and report on the facilities available and decides whether the
institutes should be recognized or not.
 To recognize qualifications granted outside the territories to which Pharmacy Act
extends.

9. APPROVAL/ WITHDRAWAL OF INSTITUTION
 APPROVAL : Procedures to be followed for Approval for Institution
providing course of study in Pharmacy
 Application by institution to PCI for approval of the course or examination.
 Inspection by inspectors from PCI
 Approval
 Declaration
 WITHDRAWAL
 Not compliance with Educational regulations
 Notice issued to the Institution by PCI
 Within 3 months, Institution should make representation from the receipt of
notice
 Final decision rests with the PCI.

10. Approval of Qualification granted outside India
 Qualification in pharmacy granted by an institute outside India can be recognize
by PCI, this is applicable to Indian citizen.
 Citizen of foreign nationality can be eligible for registration when an Indian
national holding the same qualification is allowed to enter and practice in that
country.
Maintenance of Central Register
 Maintain by the Registrar/ Secretary of the council.
 After 1st
day of April every year, every state council has to supply 5 copies of a
register for a state to the central council
 Has to be revised suitably from time to time.
 Publish it in the Gazette of India.

11. STATE PHARMACY COUNCIL
 The state government constitute a state pharmacy council under section 19 of the Pharmacy Act.
 Composition
1) Elected members
 6 registered pharmacists elected from amongst themselves.
 1 member elected by the medical council of the state
2) Nominated members
 5 members  nominated by State Govt.
3) Ex-Officio members
 Chief Administrative medical officer of the state.
 Office-in-charge of Drugs and Cosmetic Act 1940.
 Govt. Analyst under Drugs and Cosmetic Act
 President and vice president is elected amongst themselves and Elected member hold office for 5
Years.
 The council also appoints a Registrar and if needed its treasurer.
 It can appoint officers and servants necessary to carry put its function.

12. JOINT STATE PHARMACY COUNCIL
 Two or more states enter into an agreement to form a Joint State Pharmacy Council.
Composition
1) Elected members
 Registered pharmacist  3 to 5 from each participating states.
 Medical council  One from each state.
2) Nominated Members
 2 to 4 members  nominated by each State Govt.
3) Ex-Officio members
 Chief Administrative medical officer of each participating state.
 Office-in-charge of Drug control organization of each participating state
 Govt. Analyst under Drugs and Cosmetic Act
 President and vice president is elected amongst themselves and Elected member hold office for 5
Years.
 Casual vacancy is filled by nomination or election. Members are eligible for re-election.
 Possess an Executive Committee similar to the Central Government.

14. .

15. 3. Registration And Removal of Names
o Registration
The pharmacy act provides for the registration of pharmacist.
 There are two types of register,
1) First register
2) Subsequent register
1) First Register
 The state govt. is responsible for the preparation of first register.
 Constitutes a registration Tribunal by notification in Official gazette.
 The Tribunal consists of 3 persons, The registrar is also appointed who acts as its secretary
 Tribunal fixes the date on or before which all applications for registration with prescribe fees
are accepted.
 All applications are examined
 If tribunal is satisfied, it directs the entry of the name of the applicant on the register.

16. QUALIFICATION REQUIRED FOR MAKING AN
ENTRY IN THE FIRST REGISTER
 A person must have attained the age of 18 years.
 Holds a degree or diploma in pharmacy
 Holds a degree of an Indian University other than degree or diploma in
pharmacy
 Has passed an examination recognized as adequate by the state govt. for
compounders or dispensers, or
 Has been engaged in the compounding of drugs in a hospital or dispensary or
other places in which drugs are regularly dispensed
 After the entry of names in the first register, it is publish in a manner
prescribed by the state government.

17. Subsequent Register
1) After the preparation of the first register and before the implementation of E.R.
 A person who has attained 18 years and resides or carry the profession of the
pharmacy in the concerned state is entitled to have his name entered in the register on
payment of prescribe fee if he,
i) Satisfies the conditions prescribe by PCI, OR
ii) A registered pharmacist in another state, OR
iii) Possess a qualification for registration granted outside the states and are atleast
matriculates.
2) After the ER take effect;
i. Those who have passed an approved examination, OR
ii. Those who possess a qualification granted by authority outside India and recognize
by PCI, OR
iii. Those who are Registered Pharmacist in another State.

18. Removal of names from Register
 The name of Pharmacist may be removed from register.
i) If the name has been entered into the register by error.
ii) If he has been convicted of any offence in any professional
respect which renders him unfit to be kept in the register. OR
iii) If the employed person is registered pharmacist, his name may be
removed from register. if,
 Convicted of offence or held guilty of infamous conduct.
 Offence was investigated by registered pharmacist himself.
 If the repetition of similar offence or conduct during the period of
12 month.
 Pharmacist may go to the appeal to the state Government within 3
Months.
 A person whose name has been removed from the register is
required to surrender his certificate or registration to the register.