The Education Regulations are Framed under Section 10 of the Act and Prescribe:
- Qualification for pharmacists. (Ref.: Regulation 2)
- Minimum qualification for admissions to Diploma Course in Pharmacy, Duration of the course, No. of hours to be covered for theory and practical, mode of examinations, eligibility for appearing in the examinations, minimum pass marks for passing examination etc. (Ref.: Chapter II)
- Period and other conditions for practical training etc.(Ref.: Chapter III)
- Detailed syllabus of Diploma in Pharmacy. (Ref.: Appendix A)
- Conditions to be fulfilled by the institutions for approval of course of study under section 12 of the Act. (Ref.: Appendix B). These conditions include details of infrastructural facilities which an institution seeking approval of the course of study has to create i.e. accommodation area, qualification, experience and No. of teaching staff, staff-student ratio, non teaching staff, equipments, museum, library etc.
- Conditions to be fulfilled by the examining authority conducting examinations of the students. (Ref.: Appendix C)
- Conditions to be fulfilled by the institutions to be recognised for giving practical training. (Ref.: Appendix D)
- Practical training contract form for pharmacists. (Ref.: Appendix E)
- Presently, the “Education Regulations 1991 For The Diploma Course In Pharmacy” (E.R.91) are in vogue.
Qualification for Registration as a Pharmacist:
- The minimum qualification for registration as a pharmacist is a pass in “Diploma course in Pharmacy” (D.Pharm) from an institution approved u/s 12 of the Act. D.Pharm is a two years course after 10+2 (science academic stream) followed by 500 hours of practical training spread over a period of 3 months.
- “Degree course in Pharmacy” (B.Pharm) from an institution approved by the PCI u/s 12 of the Act. B.Pharm is a 4 years course after 10+2 (science academic stream).
Regulation of Pharmacy Education under the Pharmacy Act:
- By prescribing minimum qualification for registration as a pharmacist.
- By prescribing norms to be fulfilled by the pharmacy institutions seeking approval for the purpose of registration as a pharmacist.
- Uniform implementation of prescribed norms all over the country.
- Verification of the prescribed norms by inspecting pharmacy institutions.
- Granting approval or otherwise (withdrawal of approval/rejection of application) depending on the merits of the case.
Regulation of Pharmacy Profession under the Pharmacy Act:
- Registration as a pharmacist is done by the State Pharmacy Council constituted under section 19 of the Pharmacy Act.
- Minimum Statutory requirements for registration as a pharmacist under the Pharmacy Act. (Ref. section 32(2) of the Pharmacy Act) –
a) Applicant should have attained the age of 18 years & pay the prescribed fee.
b) Applicant should reside or carry on the business or profession of Pharmacy, in the State.
c) Applicant should have passed an approved examination.
Should possess a qualification approved under section 14 of the Pharmacy Act.
Is a registered pharmacist in another state.
- An approved examination is “Diploma in Pharmacy” or “Degree in Pharmacy” from an institution approved under section 12 of the Pharmacy Act.
- Section 42 of the Pharmacy Act states that no person other than a Registered Pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner and whosoever contravenes it shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.
- Section 26A of the Pharmacy Act empowers the State Pharmacy Council, with the previous sanction of the State Govt. to appoint inspectors, who may –
a) Inspect any premises where drugs are compounded or dispensed;
b) Enquire whether a person who is engaged in compounding or dispensing of drugs is registered pharmacist;
c) Investigate any complaint made in writing in respect of any contravention of this Act;
d) Institute prosecution under the order of the Executive Committee of the State Council;
e) Exercise such other powers as may be necessary for carrying out the purposes of Chapters III, IV and V of this Act or any rules made thereunder.
The Procedure Following in Decision making Process:
- PCI grants approval to a pharmacy institution for the conduct of “Course of Study” and “Examination” for the purpose of registration as a pharmacist.
- Whenever any prospective institution applies, procedure for seeking approval is intimated.
On receipt of duly filled in application and complete documents, an inspection is arranged to verify the availability of prescribed norms.
- Inspection Report on receipt is forwarded to institution for rectification of the shortcomings, if any, within a stipulated time period.
- Inspection Report alongwith the compliance report if received from institution is placed before the Executive Committee of the Council for consideration.
- The recommendations of the Executive Committee are placed before the Central Council for approval.
- The decision of the Central Council is conveyed to the institution and all concerned like Examining Authority, State Pharmacy Council etc.
- Decision regarding approval and withdrawal is also notified in the Gazette of India.
The Norms set by the PCI for the Discharge of its Functions:
- The Education Regulations are prescribed and amended from time to time by the PCI with due approval of the Ministry of Health and Family Welfare, Govt. of India.
- Presently, Education Regulations, 1991 are in vogue which can be obtained from the office of the PCI-
– In person, by paying Rs. 40/-.
– By post, by submitting a Demand Draft of Rs. 90/- in favour of Pharmacy Council of India, payable at New Delhi.
The Rules, Regulations, Instructions, Manuals and Records Held by PCI:
- Pharmacy Act, 1948.
- Education Regulations, 1991.
- Regulations of the Pharmacy Council of India.
- Standing Orders of the Pharmacy Council of India.
- Pharmacist Oath.
- Procedure for seeking approval of the PCI under the Pharmacy Act
The Particulars of any Arrangement that exists for Consultation with or Representation by the members of the Public in Relation to the Formulation of its Policy or Implementation Thereof:
- The public can always represent to PCI and the suggestions received from members of Public are taken into account while formulating policy or its implementation.
Council, Committees of PCI and as to whether Meetings of Council, Committees are open to the Public, or The minutes of such Meeting are Accessible for Public:
- Detail of Council/Committees of the PCI.
It consists of representatives of :
a) Teachers u/s 3(a)
b) Central Govt. u/s 3(b)
c) Medical Council of India u/s 3(c)
d) Director-General, Health Services, ex-officio u/s 3(d)
e) Drugs Controller, India, ex-officio u/s 3(dd)
f) Director of the Central Drugs Laboratory, ex-officio u/s 3(e)
g) University Grants Commission & All India Council for Technical Education u/s 3(f)
h) State Pharmacy Council u/s 3(g)
i) State Govt. u/s 3 (h)
- Four representatives of the Press and other visitors, not exceeding four at a time may be admitted, at the discretion of the President, to the meetings on production of permits from the Secretary. The Press representatives shall be required to obtain the previous approval of the Secretary for the publication of their report of the proceedings. The President at any time may hold the meetings in camera in which case all visitors including Press representatives will be required to withdraw.
- As per regulation 34 of Regulation of PCI, the minutes of the Central Council are “Confidential”.