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The Pharmacy Act
DRUG REGULATIONS
DEPT OF REGULATORY AFFAIRS
NGSMIPS, NITTE UNIVERSITY
MANGALORE
- SWAPNIL D. FERNANDES
www.ngsmips.nitte.edu.in
CONTENTS
 INTRODUCTION
 HISTORY OF THE ACT
 PHARMACY COUNCIL OF INDIA
 STATE PHARMACY COUNCIL
 SPECIAL PROVISIONS OF THE ACT
 OFFENCES AND PENALTIES
 CONCLUSION
 REFERENCES
www.ngsmips.nitte.edu.in
INTRODUCTION
 “An Act to regulate the Profession of Pharmacy.”
 The Act was promulgated in the Year 1948.
 The Pharmacy Bill, 1947, having been passed by the
Legislature received its assent on 4th March, 1948. It
came on the Statute Book as THE PHARMACY ACT, 1948
(8 of 1948).
 Definitions –
Central Council
State Council
Central Register
Medical Practitioner
Registered Pharmacist
www.ngsmips.nitte.edu.in
HISTORY OF THE PHARMACY ACT
Great harm
to the
Health of
the People
Early twentieth
century – No
restriction to the
practice of
Pharmacy.
Poor quality of
service.
Absence of
recognized
curriculum
www.ngsmips.nitte.edu.in
 The following statement of objects and reasons of the
Pharmacy Bill was published in the Gazette of India, 1947,
Part V, Page 469:
“It is desirable that, as in most other countries, only persons who
have attained a minimum standard of professional education should
be permitted to practise the profession of Pharmacy. It is
accordingly proposed to establish a Central Council, which will
prescribe the minimum standards of education and approved
courses of study and examination for Pharmacists, and Provincial
Pharmacy Councils, which will be responsible for the maintenance
of provincial registers of Qualified Pharmacists. It is further
proposed to empower Provincial Governments to prohibit the
dispensing of medicines on the prescription pf a medical
practitioner otherwise than by, or under the direct and personal
supervision of, a Registered Pharmacist.”
www.ngsmips.nitte.edu.in
OBJECTIVES
Regulating and Raising the Status of the Profession
of Pharmacy in India.
Providing uniform education and training to the
persons willing to enter the profession of
Pharmacy.
Maintaining control over the persons entering the
profession of Pharmacy.
www.ngsmips.nitte.edu.in
PHARMACY COUNCIL OF INDIA
The PCI was first constituted in the year 1949.
Reconstituted every 5 years.
Composition:
Elected members
Nominated members
Ex-officio members
www.ngsmips.nitte.edu.in
 Elected members –
 Six members – Elected by UGC from Teaching profession.
 One member – Elected by MCI
 One member – Elected by State Pharmacy Council.
 Nominated members –
 Six members – Nominated by Central Govt.
 One representative each – UGC and AICTE
 One Registered Pharmacist – Each State/ Union Territory
 Ex – Officio members –
 The Director General of Health Services
 The Director of Central Drugs Laboratory.
 The Drugs Controller of India.
www.ngsmips.nitte.edu.in
EXECUTIVE COMMITTEE –
The President of the Council.
The Vice President of the Council.
Five other members elected by the Central Council from
amongst its members.
Apart from this, the council also appoints –
A Registrar
Other officers and servants for carrying out its statutory
functions.
www.ngsmips.nitte.edu.in
To frame an educational structure for the would be pharmacist and to keep
it tuned to the changing needs with passage of time .
Education Regulations
Recognise the qualification granted outside the territory to which the
Pharmacy Act extends.
Maintain the Central Register for Pharmacists.
Other functions for the furtherance of the Act.
FUNCTIONS OF THE PCI –
www.ngsmips.nitte.edu.in
 APPROVAL – Procedure to be followed for approval for an
institution providing course of study in Pharmacy:
 Application by institution to PCI
 Inspection
 Approval
 Declaration
 WITHDRAWAL –
Non compliance with Education Regulations
Notice issued to the Institution by the PCI.
3 month window for the Institute to make its representation.
Final Decision rests with the PCI.
APPROVAL/WITHDRAWAL OF INSTITUTIONS
www.ngsmips.nitte.edu.in
APPROVAL OF QUALIFICATION GRANTED OUTSIDE
INDIA
 Qualification in Pharmacy granted outside India
can be recognised by the PCI. This is applicable to
Indian Citizens.
 Citizens of Foreign nationality can be eligible for
registration when an Indian national holding the
same qualification is allowed to enter an practice
in that country.
www.ngsmips.nitte.edu.in
MAINTENANCE OF CENTRAL REGISTER
Under the provisions of the Pharmacy Act
(Amendment), 1976, the PCI is required to
maintain a Central Register.
The Register has to:
Maintained by the Registrar of the Council.
Has to be revised suitably from time to time.
Published in the Gazette of India.
www.ngsmips.nitte.edu.in
STATE PHARMACY COUNCIL
 Constitution of a State Pharmacy Council in each state.
 Composition –
Elected members-
Six members – Elected from amongst themselves by registered
pharmacist of the state.
One member elected by the Medical Council of State.
Nominated members –
Five members – nominated by the State Govt.
Ex-Officio members –
Chief Administrative Medical Officer
Officer in-charge of Drugs Control Administration of State.
Government Analyst.
www.ngsmips.nitte.edu.in
JOINT STATE PHARMACY COUNCIL
 Two or more states enter into an agreement to form a Joint
State Pharmacy Council.
 Elected Members –
 Registered pharmacist – 3 to 5 from each state instead of 6 in a
Single State Council.
 Medical Council – one from each State.
 Nominated Members –
Government Nominees – 2 to 4 from each State instead of 5.
 Ex-Officio Members –
 Chief Administrative Medical
 Officer in-charge of Drugs Control Administration
 Government Analyst
www.ngsmips.nitte.edu.in
 The President and Vice-President are elected by
the members from amongst themselves.
 Period of 5 years.
 Casual Vacancy is filled by nomination or election.
 Members are eligible for re-election.
 Possesses an Executive Committee similar to the
Central Government.
www.ngsmips.nitte.edu.in
FUNCTIONS OF SPC
1. Inspection by State Council:
The State Pharmacy Council appoints suitable
number of Inspectors.
Inspect premises where drugs are compounded or
dispensed.
Inquire regarding the Registration of a Person.
Investigate Complaints.
Institute Prosecution.
www.ngsmips.nitte.edu.in
2. Maintenance of Registers –
The first and subsequent Registers of Pharmacists in a State –
Prepared and maintained by the State Government.
The State Councils, before the end of June each year, are
required to pay to the PCI, a sum equivalent to one-fourth of
the fess realised by them during the period of 12 months ,
ending March 31st in that year.
Register of Pharmacists Particulars.
www.ngsmips.nitte.edu.in
3. ENTRY AND REMOVAL OF NAMES:
 Entry –
All applications for registration should be addressed to the
Registrar of the State Pharmacy Council.
If the applicant has the requisite qualifications for registration,
he shall direct his or her name to be entered in the register.
Upon entry, a Certificate of Registration is issued.
Person whose name has been removed from the Register of any
State shall not be entitled to registration unless the State
Council gives its consent.
Renewal Rules.
www.ngsmips.nitte.edu.in
Removal –
The name of a pharmacist may be removed from the
register on following counts-
If his name has been entered in register by error.
If he has been convicted of an offence in any professional
respect.
If a person employed by him is convicted of an offense or is
guilty of infamous conduct.
30 day period for Appealing.
Surrender of the Certificate of Registration and Published in
the Official Gazette.
www.ngsmips.nitte.edu.in
4. Printing of Registers-
Printing of the Registers – carried out on the first day of
April following the beginning of the Pharmacy
(Amendment) Act, 1959.
Thereafter, each year after the first of April, the
Registrar will arrange for the reprinting, showing
supplements to the Registers.
These Registers and supplements are deemed to be
proof that the persons, whose name are contained
therein, are registered pharmacist.
www.ngsmips.nitte.edu.in
SPECIAL PROVISIONS OF THE ACT
Pharmacy Act, 1959 (Amendment) –
Pertaining to Pharmacists affected by the Partition of
1947.
Also, the Reorganisation of States in 1956.
Provisions remained in effect for a period of 2 years.
State Governments were empowered to extend the
period of operation up to another 2 years.
www.ngsmips.nitte.edu.in
Pharmacy Act, 1976 (Amendment) –
Provided for Registration of Pharmacists by SPC’s who:
Were eligible for Registration between the closing of the First
register and the coming into effect of the Educational
Regulations.
Approved Qualified Persons, before 31st December 1969,
under the Drugs and Cosmetics Act, 1940 and Rules.
Displaced persons from Bangladesh, after 14th April, 1957 but
before 25th March, 1971.
Repatriates from Burma, Sri Lanka, Uganda or any other
country.
www.ngsmips.nitte.edu.in
OFFENCES PENALTIES
1. Falsely Claims to be a Registered
Pharmacist
 Fine up to Rs 500.00 on first
conviction.
 Fine up to Rs 1000.00 and/or 6
months imprisonment of any
subsequent conviction.
2. Dispensing by an Unregistered
Person (Exception – Medical
Practitioner)
 6 months of imprisonment or a fine of
up to Rs 1000 or both.
3. Failure to Surrender the Certificate
of Registration
 Fine of Rs 50.
4. Obstruction of State Pharmacy
Council Inspectors
 Imprisonment of up to 6 months or a
fine of up to Rs 1000 or both.
www.ngsmips.nitte.edu.in
CONCLUSION
 The Pharmacy Act provided the Profession of
Pharmacy in India with a framework.
 It Regulated and Raised the status of the
Profession of Pharmacy in the country.
 Education imparted to Individuals willing to
enter into this Profession was standardised
and made uniform.
 It helped the Government achieve a certain
level of control of the professionals engaged in
this field.
www.ngsmips.nitte.edu.in
REFERENCES
 Indian Pharmaceutical Association. The Pharmacy Act, 1948.
http://www.ipapharma.org/pdf/Pharmacy_act_1948.pdf
(accessed 05 November 2017).
 Dr S.P. Agarwal. The Pharmacy Act, 1948. (ed). Pharmaceutical
Jurisprudence and Ethics, Fifth ed. New Delhi: Birla Publications;
2000. pp. 24-35.
 K.K. Singh. The Pharmacy Act, 1948. (ed). Law of Drugs, Medicines
and Cosmetics, 3rd ed. Allahabad: Law Book Company; 1984. pp.
135-155.
 Pharmacy Act, 1948. Amending Act II - Bare Act.
https://www.legalcrystal.com/act/40731/pharmacy-act-1948-
amending-act-ii (accessed 06 November 2017).

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The Pharmacy act, 1948

  • 1. www.ngsmips.nitte.edu.in The Pharmacy Act DRUG REGULATIONS DEPT OF REGULATORY AFFAIRS NGSMIPS, NITTE UNIVERSITY MANGALORE - SWAPNIL D. FERNANDES
  • 2. www.ngsmips.nitte.edu.in CONTENTS  INTRODUCTION  HISTORY OF THE ACT  PHARMACY COUNCIL OF INDIA  STATE PHARMACY COUNCIL  SPECIAL PROVISIONS OF THE ACT  OFFENCES AND PENALTIES  CONCLUSION  REFERENCES
  • 3. www.ngsmips.nitte.edu.in INTRODUCTION  “An Act to regulate the Profession of Pharmacy.”  The Act was promulgated in the Year 1948.  The Pharmacy Bill, 1947, having been passed by the Legislature received its assent on 4th March, 1948. It came on the Statute Book as THE PHARMACY ACT, 1948 (8 of 1948).  Definitions – Central Council State Council Central Register Medical Practitioner Registered Pharmacist
  • 4. www.ngsmips.nitte.edu.in HISTORY OF THE PHARMACY ACT Great harm to the Health of the People Early twentieth century – No restriction to the practice of Pharmacy. Poor quality of service. Absence of recognized curriculum
  • 5. www.ngsmips.nitte.edu.in  The following statement of objects and reasons of the Pharmacy Bill was published in the Gazette of India, 1947, Part V, Page 469: “It is desirable that, as in most other countries, only persons who have attained a minimum standard of professional education should be permitted to practise the profession of Pharmacy. It is accordingly proposed to establish a Central Council, which will prescribe the minimum standards of education and approved courses of study and examination for Pharmacists, and Provincial Pharmacy Councils, which will be responsible for the maintenance of provincial registers of Qualified Pharmacists. It is further proposed to empower Provincial Governments to prohibit the dispensing of medicines on the prescription pf a medical practitioner otherwise than by, or under the direct and personal supervision of, a Registered Pharmacist.”
  • 6. www.ngsmips.nitte.edu.in OBJECTIVES Regulating and Raising the Status of the Profession of Pharmacy in India. Providing uniform education and training to the persons willing to enter the profession of Pharmacy. Maintaining control over the persons entering the profession of Pharmacy.
  • 7. www.ngsmips.nitte.edu.in PHARMACY COUNCIL OF INDIA The PCI was first constituted in the year 1949. Reconstituted every 5 years. Composition: Elected members Nominated members Ex-officio members
  • 8. www.ngsmips.nitte.edu.in  Elected members –  Six members – Elected by UGC from Teaching profession.  One member – Elected by MCI  One member – Elected by State Pharmacy Council.  Nominated members –  Six members – Nominated by Central Govt.  One representative each – UGC and AICTE  One Registered Pharmacist – Each State/ Union Territory  Ex – Officio members –  The Director General of Health Services  The Director of Central Drugs Laboratory.  The Drugs Controller of India.
  • 9. www.ngsmips.nitte.edu.in EXECUTIVE COMMITTEE – The President of the Council. The Vice President of the Council. Five other members elected by the Central Council from amongst its members. Apart from this, the council also appoints – A Registrar Other officers and servants for carrying out its statutory functions.
  • 10. www.ngsmips.nitte.edu.in To frame an educational structure for the would be pharmacist and to keep it tuned to the changing needs with passage of time . Education Regulations Recognise the qualification granted outside the territory to which the Pharmacy Act extends. Maintain the Central Register for Pharmacists. Other functions for the furtherance of the Act. FUNCTIONS OF THE PCI –
  • 11. www.ngsmips.nitte.edu.in  APPROVAL – Procedure to be followed for approval for an institution providing course of study in Pharmacy:  Application by institution to PCI  Inspection  Approval  Declaration  WITHDRAWAL – Non compliance with Education Regulations Notice issued to the Institution by the PCI. 3 month window for the Institute to make its representation. Final Decision rests with the PCI. APPROVAL/WITHDRAWAL OF INSTITUTIONS
  • 12. www.ngsmips.nitte.edu.in APPROVAL OF QUALIFICATION GRANTED OUTSIDE INDIA  Qualification in Pharmacy granted outside India can be recognised by the PCI. This is applicable to Indian Citizens.  Citizens of Foreign nationality can be eligible for registration when an Indian national holding the same qualification is allowed to enter an practice in that country.
  • 13. www.ngsmips.nitte.edu.in MAINTENANCE OF CENTRAL REGISTER Under the provisions of the Pharmacy Act (Amendment), 1976, the PCI is required to maintain a Central Register. The Register has to: Maintained by the Registrar of the Council. Has to be revised suitably from time to time. Published in the Gazette of India.
  • 14. www.ngsmips.nitte.edu.in STATE PHARMACY COUNCIL  Constitution of a State Pharmacy Council in each state.  Composition – Elected members- Six members – Elected from amongst themselves by registered pharmacist of the state. One member elected by the Medical Council of State. Nominated members – Five members – nominated by the State Govt. Ex-Officio members – Chief Administrative Medical Officer Officer in-charge of Drugs Control Administration of State. Government Analyst.
  • 15. www.ngsmips.nitte.edu.in JOINT STATE PHARMACY COUNCIL  Two or more states enter into an agreement to form a Joint State Pharmacy Council.  Elected Members –  Registered pharmacist – 3 to 5 from each state instead of 6 in a Single State Council.  Medical Council – one from each State.  Nominated Members – Government Nominees – 2 to 4 from each State instead of 5.  Ex-Officio Members –  Chief Administrative Medical  Officer in-charge of Drugs Control Administration  Government Analyst
  • 16. www.ngsmips.nitte.edu.in  The President and Vice-President are elected by the members from amongst themselves.  Period of 5 years.  Casual Vacancy is filled by nomination or election.  Members are eligible for re-election.  Possesses an Executive Committee similar to the Central Government.
  • 17. www.ngsmips.nitte.edu.in FUNCTIONS OF SPC 1. Inspection by State Council: The State Pharmacy Council appoints suitable number of Inspectors. Inspect premises where drugs are compounded or dispensed. Inquire regarding the Registration of a Person. Investigate Complaints. Institute Prosecution.
  • 18. www.ngsmips.nitte.edu.in 2. Maintenance of Registers – The first and subsequent Registers of Pharmacists in a State – Prepared and maintained by the State Government. The State Councils, before the end of June each year, are required to pay to the PCI, a sum equivalent to one-fourth of the fess realised by them during the period of 12 months , ending March 31st in that year. Register of Pharmacists Particulars.
  • 19. www.ngsmips.nitte.edu.in 3. ENTRY AND REMOVAL OF NAMES:  Entry – All applications for registration should be addressed to the Registrar of the State Pharmacy Council. If the applicant has the requisite qualifications for registration, he shall direct his or her name to be entered in the register. Upon entry, a Certificate of Registration is issued. Person whose name has been removed from the Register of any State shall not be entitled to registration unless the State Council gives its consent. Renewal Rules.
  • 20. www.ngsmips.nitte.edu.in Removal – The name of a pharmacist may be removed from the register on following counts- If his name has been entered in register by error. If he has been convicted of an offence in any professional respect. If a person employed by him is convicted of an offense or is guilty of infamous conduct. 30 day period for Appealing. Surrender of the Certificate of Registration and Published in the Official Gazette.
  • 21. www.ngsmips.nitte.edu.in 4. Printing of Registers- Printing of the Registers – carried out on the first day of April following the beginning of the Pharmacy (Amendment) Act, 1959. Thereafter, each year after the first of April, the Registrar will arrange for the reprinting, showing supplements to the Registers. These Registers and supplements are deemed to be proof that the persons, whose name are contained therein, are registered pharmacist.
  • 22. www.ngsmips.nitte.edu.in SPECIAL PROVISIONS OF THE ACT Pharmacy Act, 1959 (Amendment) – Pertaining to Pharmacists affected by the Partition of 1947. Also, the Reorganisation of States in 1956. Provisions remained in effect for a period of 2 years. State Governments were empowered to extend the period of operation up to another 2 years.
  • 23. www.ngsmips.nitte.edu.in Pharmacy Act, 1976 (Amendment) – Provided for Registration of Pharmacists by SPC’s who: Were eligible for Registration between the closing of the First register and the coming into effect of the Educational Regulations. Approved Qualified Persons, before 31st December 1969, under the Drugs and Cosmetics Act, 1940 and Rules. Displaced persons from Bangladesh, after 14th April, 1957 but before 25th March, 1971. Repatriates from Burma, Sri Lanka, Uganda or any other country.
  • 24. www.ngsmips.nitte.edu.in OFFENCES PENALTIES 1. Falsely Claims to be a Registered Pharmacist  Fine up to Rs 500.00 on first conviction.  Fine up to Rs 1000.00 and/or 6 months imprisonment of any subsequent conviction. 2. Dispensing by an Unregistered Person (Exception – Medical Practitioner)  6 months of imprisonment or a fine of up to Rs 1000 or both. 3. Failure to Surrender the Certificate of Registration  Fine of Rs 50. 4. Obstruction of State Pharmacy Council Inspectors  Imprisonment of up to 6 months or a fine of up to Rs 1000 or both.
  • 25. www.ngsmips.nitte.edu.in CONCLUSION  The Pharmacy Act provided the Profession of Pharmacy in India with a framework.  It Regulated and Raised the status of the Profession of Pharmacy in the country.  Education imparted to Individuals willing to enter into this Profession was standardised and made uniform.  It helped the Government achieve a certain level of control of the professionals engaged in this field.
  • 26. www.ngsmips.nitte.edu.in REFERENCES  Indian Pharmaceutical Association. The Pharmacy Act, 1948. http://www.ipapharma.org/pdf/Pharmacy_act_1948.pdf (accessed 05 November 2017).  Dr S.P. Agarwal. The Pharmacy Act, 1948. (ed). Pharmaceutical Jurisprudence and Ethics, Fifth ed. New Delhi: Birla Publications; 2000. pp. 24-35.  K.K. Singh. The Pharmacy Act, 1948. (ed). Law of Drugs, Medicines and Cosmetics, 3rd ed. Allahabad: Law Book Company; 1984. pp. 135-155.  Pharmacy Act, 1948. Amending Act II - Bare Act. https://www.legalcrystal.com/act/40731/pharmacy-act-1948- amending-act-ii (accessed 06 November 2017).