Pharmacy Practice Regulations 2015
Pharmacy Practice Regulations 2015
NOTIFICATION
No. 14-148/ 2012- PCI. — In exercise of the powers conferred by Section 10 and 18 of the Pharmacy Act, 1948
(8 of 1948), the Pharmacy Council of India, with the approval of the Central Government hereby makes the following
regulations; namely–
CHAPTER 1
(a) These regulations may be called the Pharmacy Practice Regulations, 2015.
(b) They shall come into force from the date of their publication in the official Gazette.
2. Definitions:
i. Interpretation, evaluation and implementation of medical orders; dispensing of prescriptions, drug orders ;
ii. Participation in drug and device selection, drug administration, drug regimen reviews and drug or drug-
related research,
28 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
iii. Provisions of patient counseling and the provision of those acts or services necessary to provide
pharmaceutical care in all areas of patient care including primary care ; and
iv. responsibility for Compounding and labeling of drugs and devices (except labeling by a manufacturer, re-
packer or distributor of non-prescription drugs and commercially packaged legend drugs and devices)
proper and safe storage of drugs and devices and maintenance of proper records for them.
(c) “Compounding” means the preparation, mixing, assembling, packing or labeling of a drug or device—
(i) as the result of a practitioner’s prescription drug order (or) initiative based on the
practitioner/patient/pharmacist relationship in the course of professional practice, or
(ii) for the purpose of, or as an incident to research, manufacturing, teaching, clinical trial or chemical analysis
including drug analysis and not for sale or dispensing.
Note — Compounding also includes the preparation of drugs or devices in anticipation of prescription, observed
prescribing patterns.
(d) “Dispensing” means the interpretation, evaluation, supply and implementation of a prescription, drug order,
including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container
appropriately labeled for subsequent administration to, or use by, a patient.
(e) “Distribute” means the delivery of a drug or device other than by administering or dispensing.
(f) “Patient counseling” means the oral communication by the pharmacist of information to the patient or caregiver,
in order to ensure proper use of drugs and devices.
(g) “Pharmaceutical care” means the provision of drug therapy and other patient care services intended to achieve
outcomes related to the care or prevention of a disease, elimination or reduction of a patient’s symptoms, or
arresting or slowing of a disease process, as defined by the Pharmacy Council of India.
(h) “Pharmacy Practitioner” means an individual (Community Pharmacist/ Hospital Pharmacist/ Clinical
Pharmacist/ Drug information Pharmacist) currently licensed, registered or otherwise authorized under the Act
to counsel or otherwise and administer drugs in the course of professional practice.
i. “Community pharmacist” means an individual currently registered and who works according to legal and
ethical guidelines to ensure the correct and safe supply of medical products to the general public. They are
involved in maintaining and improving people's health by providing advice and information as well as
supplying prescription medicines.
ii. “Hospital Pharmacist” means an individual currently registered and who works in a hospital pharmacy
service, primarily within the public / private sector. They are responsible for ensuring the safe, appropriate
and cost-effective use of medicines. Hospital pharmacists use their specialist knowledge to dispense drugs
and advise patients about the medicines which have been prescribed. They work collaboratively with other
health care professionals to devise the most appropriate drug treatment for patients. Some pharmacists are
also involved in manufacturing required drug treatments.
iii. “Drug Information Pharmacist” means an individual currently registered who works in a community
pharmacy/hospital Pharmacy/teaching hospital/ other health care settings and provides information and
advice regarding drug interactions, side effects, dosage and proper medication storage to
patients/physicians/dentists/other health care professionals.
iv. “Clinical Pharmacist” means an individual currently registered and who provides patient care that optimizes
the use of medication and promotes health, wellness and disease prevention. Clinical pharmacists care for
patients in all health care settings. Clinical pharmacists often collaborate with physicians and other
healthcare professionals.
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(i) “Registered Pharmacist” means a person whose name is for the time being entered in the register of the State in
which he is for the time being residing or carrying on his profession or business of pharmacy under the
Pharmacy Act, 1948.
(j) “Prescription” means a written or electronic direction from a Registered Medical Practitioner or other properly
licensed practitioners such as Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a specific
type and quantity of preparation or prefabricated drug to a patient.
Types of Prescription :
(i) Prescribers office information – [Name, qualification, address & Regn. No.]
(ii) Patient information – [Name & address, Age, Sex, Ref.No.]
(iii) Date
(iv) Rx Symbol or superscription
(v) Medication prescribed or inscription
(vi) Dispensing directions to Pharmacist (or) subscription
(vii) Directions for patient [to be placed on lable]
(viii) Refill, special labeling and /or other instructions
(ix) Prescriber’s signature and licence (or) Drug Enforcement Agency (DEA) number as required.
CHAPTER-2
3.1 Declaration:
Each applicant, at the time of making an application for registration under the provisions of the Act, shall be
provided a copy of the declaration as specified in Appendix I alongwith copies of Code of Pharmaceutical Ethics
and Pharmacist’s oath by the state pharmacy council, who shall submit it duly signed.
3.2 Privileges of persons registered as a pharmacist on the register of State Pharmacy Council:
Subject to the conditions and restrictions laid down in these Regulations regarding practice of profession of
pharmacy by persons possessing approved pharmacy qualifications, every person whose name is for the time
being entered in the register of the state in which he is for the time being residing or carrying on his profession or
business of pharmacy shall be entitled to practice as “Registered Pharmacist” and engage in the practice of
profession of pharmacy and to recover in due course of law in respect of such practice of pharmacy any expenses,
charges or any fee to which he/she is entitled in lieu of his/her discharging duties as defined by the PCI from time
to time.
(a) Name of the owner of pharmacy business shall be displayed at or near the main entrance of each premises in
which the business is carried on.
(b) Name of the registered pharmacist along with his registration number and qualification along with his/her
photograph shall be displayed adjacent to the area where dispensing is carried on in the pharmacy. Registered
pharmacist shall also comply with a dress code of being dressed formally and wearing clean white overall
(coat/apron)with a badge displaying the name and registration number.
30 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
(c) Registered pharmacists shall display as suffix to their names only recognized pharmacy qualification / degrees or
such certificates/diplomas and memberships / honours which confer professional knowledge or recognizes any
exemplary qualification/achievements.
(a) The owner of a pharmacy business to which this clause applies shall appoint a registered pharmacist to be
responsible for regulations 3.3. There must be such an appointment in force at all times; otherwise the owner of
the pharmacy business shall be deemed contravening the provisions of section 42 of the Act .
(b) To be effective the notice of appointment must be accompanied by a notice of acceptance of the appointment
signed by the appointed person.
(c) An appointment may be revoked by notice given either by the owner of the pharmacy business or by or on behalf
of the appointed person. The appointment shall be automatically revoked if the person appointed ceases to be a
registered pharmacist.
(a) The prime object of the pharmacy profession is to render service to humanity; reward or financial gain is a
subordinate consideration. Who- so-ever chooses his profession, assumes the obligation to conduct himself in
accordance with its ideals. A registered pharmacist should be an upright man, instructed in the art of medicines.
He shall keep himself pure in character and be diligent in caring for the sick; he should be modest, sober, patient,
prompt in discharging his duty without anxiety; conducting himself with propriety in his profession and in all the
actions of his life.
(b) A person having qualification in any other system of pharmacy is not allowed to practice modern system of
pharmacy in any form.
(c) A registered pharmacist shall uphold the dignity and honour of his profession.
For renewal of registration the pharmacist shall attend minimum 2 refresher courses in pharmacy of minimum one
day duration each in a span of 5 years organized by any one of the following body.
(a) The owner of the pharmacy shall seek prior approval of the PCI for approval of the pharmacy for the purpose of
imparting practical teaching to student of Diploma in Pharmacy. In the absence of approval from the PCI, the
student pharmacists shall not be treated to have completed their Diploma in Pharmacy (Part-III) to make them
eligible for registration as a pharmacist under the Act.
(b) The registered pharmacist shall impart practical training to student pharmacists as prescribed from time to time
under Education Regulations framed u/s 10 of the Act under intimation to the examining authority.
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(c) While imparting such practical training, the registered pharmacists shall comply with the prescribed norms relating
to number of students pharmacists to be trained, nature of practical training, duration of practical etc. as laid down
under the Education Regulations from time to time.
(a) The owner/registered pharmacist shall allow and co-operate with the inspectors appointed under the Drugs &
Cosmetics Act, 1940 and section 26A of the Pharmacy Act, 1948 by the State Pharmacy Council to inspect
premises where drugs are compounded or dispensed.
(i) inspect any premises where drugs are compounded or dispensed and submit a written report to the
Registrar;
(ii) enquire whether a person who is engaged in compounding or dispensing of drugs is a registered pharmacist;
(iii) investigate any complaint made in writing in respect of any contravention of the Act and report to the
Registrar;
(iv) institute prosecution under the order of the Executive Committee of the State Pharmacy Council;
(v) exercise such other powers as may be necessary for carrying out the purposes of Chapters III, IV and V of
the Pharmacy Act or any rules made thereunder.
6.1 Membership in Association: For the advancement of his profession, a registered pharmacist shall affiliate with
associations and societies of allopathic pharmacy professions and involve actively in the functioning of such
bodies. A registered pharmacist shall participate in professional meetings as part of Continuing Pharmacy
Education programmes, organized by reputed professional academic bodies or any other authorized
associations/organisations. The compliance of this requirement shall be informed regularly to Pharmacy Council
of India or the State Pharmacy Councils as the case may be.
(a) Every registered pharmacist shall maintain the medical / prescription records pertaining to his / her patients for a
period of 5 years from the date of commencement of the treatment as laid down by the Pharmacy Council of India
in Appendix II.
(b) If any request is made for medical records either by the patients/authorised attendant or legal authorities involved,
the same may be duly acknowledged and documents shall be issued within the period of 72 hours.
(c) Efforts shall be made to computerize medical/prescription records for quick retrieval.
6.3 Highest Quality Assurance in patient care: Every registered pharmacist shall aid in safeguarding the profession
against admission to it of those who are deficient in moral character or education. Registered pharmacist shall not
employ in connection with his professional practice any attendant who is neither registered nor enlisted under the
Pharmacy Act in force and shall not permit such persons to attend, to patients wherever professional discretion or
skill is required.
6.4 Exposure of Unethical Conduct: A registered pharmacist should expose, without fear or favour, incompetent or
corrupt, dishonest or unethical conduct on the part of members of the profession.
6.5 Payment of Professional Services: The registered pharmacist, engaged in the practice of pharmacy profession
shall give priority to the interests of patients. The personal financial interests of a registered pharmacist shall not
conflict with the medical interests of patients. A registered pharmacist shall announce his fees before rendering
service and not after. Remuneration received for such services shall be in the form and amount specifically
32 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
announced to the patient at the time the service is rendered. It is unethical to enter into a contract of "no cure no
payment". Registered pharmacist rendering service on behalf of the state shall refrain from anticipating or
accepting any consideration.
7. Application of other laws not barred: The registered pharmacist shall observe the laws of the country in
regulating the practice of pharmacy and shall also not assist others to evade such laws. He shall be cooperative in
observance and enforcement of sanitary laws and regulations in the interest of public health. A registered
pharmacist shall have regard to the provisions of the acts like Drugs and Cosmetics Act, 1940; Indian Medical
Council Act, 1956; Narcotic Drugs and Psychotropic Substances Act, 1985; Drugs and Magic Remedies
(Objectionable Advertisement) Act, 1954.
CHAPTER-3
(a) Though a registered pharmacist is not bound to attend each and every person asking his services, he shall not only
be ever ready to respond to the calls of the sick and the injured, but shall be mindful of the high character of his
mission and the responsibility he discharges in the course of his professional duties. He shall never forget that the
health and the lives of those entrusted to his care depend on his skill and attention.
(b) Registered pharmacist having any incapacity detrimental to the patient or which can affect his performance vis-à-
vis the patient shall not be permitted to practice his profession.
(c) Pharmaceutical care (in addition to the provisions of Drugs and Cosmetics Rules 1945 and Schedule N of the said
Rules) the following provisions shall be included :-
- No person other than a Registered Pharmacist shall compound, prepare, mix, dispense or supply of any
medicine on the prescription of a Registered Medical Practitioner (Schedule H & X drugs);
- A Registered Pharmacist shall review the patient record and each prescription presented for supply for the
purpose of promoting therapeutic appropriateness by indentifying :
(i) Over utilization or under utilization
(ii) Therapeutic duplication
(iii) Drug-disease interactions
(iv) Drug-drug interactions
(v) Incorrect drug dosage or duration of drug treatment
(vi) Drug-allergy interactions
(vii) Correlation of availability of drugs (to avoid artificial shortage of drugs)
(viii) Clinical abuse/misuse
Note : upon recognizing any of the above, the Registered Pharmacist shall take appropriate steps to avoid or
resolve the problem that shall, if necessary, include consultation with the Registered Medical Practitioner.
8.2 Patience, Delicacy and Secrecy: Patience and delicacy shall characterize the registered pharmacist. Confidences
concerning individual or domestic life entrusted by patients to a registered pharmacist and defects in the
disposition or character of patients observed during medical attendance shall never be revealed unless their
revelation is required by the laws of the State. Sometimes, however, a registered pharmacist shall determine
whether his duty to society requires him to employ knowledge, obtained through confidence as a registered
pharmacist, to protect a healthy person against a communicable disease to which he is about to be exposed. In such
instance, the registered pharmacist shall act as he would wish another to act toward one of his own family in like
circumstances.
8.3 Prognosis: The registered pharmacist shall neither exaggerate nor minimize the gravity of a patient’s condition.
He shall ensure himself that the patient, his relatives or his responsible friends have such knowledge of the
patient’s condition as will serve the best interests of the patient and the family.
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8.4 The Patient must not be neglected: A registered pharmacist is free to choose whom he will serve. However, he
shall respond to any request for his assistance in an emergency. Registered pharmacist shall not willfully commit
an act of negligence that may deprive his patient or patients from necessary medical care.
CHAPTER-4
(a) The various activities of dispensing (prescription assembly) like removal of drugs from the packing, filling the
prescription etc. may be performed under the super-vision of a registered pharmacist by any person who has been
trained to perform these activities. However, the actual dispensing of drugs to patients shall only be performed by
the Registered pharmacist after due verification of the prescription filled by others.
(b) A Registered pharmacist shall undertake a pharmaceutical assessment of every prescription presented for
dispensing. For the purpose of the act, pharmaceutical assessment is defined as the point at which Registered
pharmacist applies his knowledge to establish the safety, quality, efficacy and rational use of drugs treatments
specified by a prescriber.
(d) Appropriate information shall be provided to the patient or the care giver and, where possible, understanding of
this information should be checked.
(f) Assessment of the prescription should include but not be limited to assessment of whether :
(ii) The prescription includes an appropriate dosage form and appropriate route of administration.
(v) Prescription is appropriate according to patient’s para-meters (age, weight etc.) and previous medication.
(ix) Contra-indicated.
(x) Potential for misuse and inappropriate use of the medicines in prescription by patient exists.
(g) Compounding, dispensing and labeling of required drug products should ensure that
34 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
(iii) The drug product is appropriately compounded (if necessary), packed and labeled appropriately.
(h) Delivery of the drug product to the patient/carer is done in such a way as to ensure that:
(i) The Registered pharmacist hands over the drug to the patient/carer.
To promote rational use of drugs, the pharmacist shall involve himself in activities such as:
(i) Preparation of formularies both at the hospital level and at state/ national levels.
(iv) Updating the knowledge of drugs through continuing education programmmes and also to organize
educational programmes for health professionals.
Note : The pharmacist shall not be required to counsel a patient or caregiver when the patient or
caregiver refuses such consultations.
(b) The pharmacist shall maintain the records pertaining to drugs administered to the patients (drug
card) that may be utilized for the evaluation of the drug therapy
(c) The pharmacist is authorized (as a Health care professional) to undertake process and outcome
research, health promotion and education and provide health information. Also to undertake the
Pharmacoepidemiological studies.
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(a) Pharmacies providing patient counseling shall have regard to the following:
i. Only Registered pharmacists are involved in counseling.
ii. Facilities are provided for confidential conversation and patient confidentiality is maintained.
iii. Patient information leaflets are provided.
iv. Proper documentation is made.
v. Unnecessary counselling should be avoided.
vi. Counselling for Patient’s Benefit: In every consultation, the benefit to the patient is of foremost
importance. All registered pharmacists engaged in the case should be frank with the patient and his
attendants.
vii. Punctuality in counselling: Utmost punctuality should be observed by a registered pharmacist in
making themselves available for counselling.
CHAPTER-5
10. RESPONSIBILITIES OF REGISTERED PHARMACISTS TO EACH OTHER.
A registered pharmacist shall consider it as a pleasure and privilege to render gratuitous service to all registered
pharmacists and their immediate family dependants.
10.1 Conduct in Counselling: In counselling, no insincerity, rivalry or envy shall be indulged in. All due respect shall
be observed towards the registered pharmacist in-charge of the case and no statement or remark be made, which
would impair the confidence reposed in him. For this purpose no discussion shall be carried on in the presence of
the patient or his representatives.
10.2 Appointment of Substitute: Whenever a registered pharmacist requests another registered pharmacist to attend
his patients during his temporary absence from his practice, professional courtesy requires the acceptance of such
appointment only when he has the capacity to discharge the additional responsibility along with his other duties.
The registered pharmacist acting under such an appointment shall give the utmost consideration to the interests
and reputation of the absent registered pharmacist and all such patients shall be restored to the care of the latter
upon his return.
CHAPTER-6
11.1 Registered pharmacists as Citizens: Registered pharmacists, as good citizens, possessed of special training shall
disseminate advice on public health issues. They should play their part in enforcing the laws of the community and
in sustaining the institutions that advance the interests of humanity. They shall particularly co-operate with the
authorities in the administration of sanitary/public health laws and regulations.
11.2 Public and Community Health: Registered pharmacists, especially those engaged in public health work, shall
enlighten the public concerning quarantine regulations and measures for the prevention of epidemic and
communicable diseases. At all times the registered pharmacist shall notify the constituted public health authorities
of every case of communicable disease under his care, in accordance with the laws, rules and regulations of the
health authorities. When an epidemic occurs a registered pharmacist shall not abandon his duty for fear of
contracting the disease himself.
11.3 Physician/Nurses: Registered pharmacists shall seek cooperation from physicians, dentists and nurses wherever
required.
CHAPTER-7
A registered pharmacist shall not aid or abet or commit any of the following acts which shall be construed as
unethical –
36 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
12.1 Advertising:
(a) Soliciting of patients directly or indirectly, by a registered pharmacist, by a group of registered pharmacists or by
institutions or organisations is unethical. A registered pharmacist shall not make use of him (or his name) as
subject of any form or manner of advertising or publicity through any mode either alone or in conjunction with
others which is of such a character as to invite attention to him or to his professional position, skill, qualification,
achievements, attainments, specialities, appointments, associations, affiliations or honours and/or of such character
as would ordinarily result in his self aggrandizement. A registered pharmacist shall not give to any person,
whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report or
statement with respect of any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or
appliance or any commercial product or article with respect of any property, quality or use thereof or any test,
demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or
manner of advertising through any mode nor shall he boast of cases, cures or remedies or permit the publication of
report thereof through any mode. A registered pharmacist, however, shall be permitted to make a formal
announcement in press regarding the following:
i on starting practice;
ii on changing address.
(b) Printing of self photograph, or any such material of publicity in the letter head or on sign board of the Pharmacy or
any such establishment shall be regarded as acts of self advertisement and unethical conduct on the part of the
registered pharmacist. However, printing of sketches, diagrams, picture of medicines shall not be treated as
unethical.
A registered pharmacist / Pharmacy shall not give, solicit, or receive nor shall he offer to give solicit or receive,
any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring
of any patient for sale/dispensing of medicines . A registered pharmacist shall not directly or indirectly, participate
in or be a party to act of division, transference, assignment, subordination, rebating, splitting or refunding of any
fee for dispensing/sale of medicines.
12.3 Secret Remedies: The prescribing or dispensing by a registered pharmacist of secret remedial agents of which he
does not know the composition, or the manufacture or promotion of their use is unethical and as such prohibited.
All the drugs dispensed by a registered pharmacist shall carry a proprietary formula and clear name.
12.4 Human Rights: The registered pharmacist shall not aid or abet torture nor shall he be a party to either infliction of
mental or physical trauma or concealment of torture inflicted by some other person or agency in clear violation of
human rights.
CHAPTER-8
13. MISCONDUCT:
The following acts of commission or omission on the part of a registered pharmacist shall constitute professional
misconduct rendering him/her liable for disciplinary action.
(b) Dispensing medicines without the prescription of the Registered Medical Practitioner which are required to be
dispensed on prescription only.
(c) Substitution of the prescription without approval/consent of the Registered Medical Practitioner.
(d) Allowing the owner of the pharmacy to use his pharmacist registration certificate without attending the pharmacy.
(e) Giving his pharmacist registration certificate at more than one pharmacies.
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(f) Not maintaining the prescription/dispensing records of his patients for a period of five years as per regulation
6.2 a and refuses to provide the same within 72 hours when the patient or his authorised representative makes a
request for it
(g) Not displaying the registration certificate accorded to him by the State Pharmacy Council in his pharmacy.
(h) Willfully obstructing an inspector appointed under the Drugs & Cosmetics Act, 1940 and/or Pharmacy Act, 1948
for inspecting/enquiring/investigating.
(i) Committing adultery or improper conduct with a patient or by maintaining an improper association with a patient
abusing his professional position. This will render a Registered pharmacist liable for disciplinary action as
provided u/s 36 of the Pharmacy Act, 1948.
(j) Conviction by a Court of Law for offences involving moral turpitude/Criminal acts.
(k) Signing Professional Certificates, Reports and other Documents: Registered pharmacist may be in certain cases
bound by law to give, or may from time to time be called upon or requested to give certificates, notification,
reports and other documents of similar character signed by them in their professional capacity for subsequent use
in the courts or for administrative purposes etc. Any registered pharmacist who is shown to have signed or given
under his name and authority any such certificate, notification, report or document of a similar character which is
untrue, misleading or improper.
(Note: The foregoing does not restrict the proper training and instruction of bonafide student pharmacists under
the personal supervision of registered pharmacists.)
(m) Contributing to the lay press articles and giving interviews regarding diseases and treatments which may have the
effect of advertising himself or soliciting practices; but is open to write to the lay press under his own name on
matters of public health, hygienic living or to deliver public lectures, give talks on the radio/TV/internet chat for
the same purpose and send announcement of the same to lay press.
(n) Disclosing the secrets of a patient that have been learnt in the exercise of his profession except –
(ii) in circumstances where there is a serious and identified risk to a specific person and /or community; and
(o) Refusing on religious grounds alone to dispense medicines on the prescription of Registered Medical Practitioner.
(p) Publishing photographs or case reports of his patients without their permission, in any medical or other journal in a
manner by which their identity could be made out. However, if the identity is not to be disclosed, the consent is
not needed.
(q) In the case of running of pharmacy by a registered pharmacist and employing Registered Pharmacists to help him,
the ultimate responsibility rests on the registered pharmacist.
(t) If a registered pharmacist posted in rural area is found absent on more than two occasions during inspection by the
Head of the District Health Authority or the Chairman, Zila Parishad without information, the same shall be
construed as a misconduct .
38 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
(u) If a registered pharmacist working in Pharmacy is also found working in another pharmacy/pharmacy
college/institution/industry/any other organization as a teaching faculty or otherwise, shall be construed as
misconduct.
CHAPTER-9
(a) It must be clearly understood that the instances of offences and of Professional misconduct which are given above
do not constitute and are not intended to constitute a complete list of the infamous acts which calls for disciplinary
action, and that by issuing this notice the Pharmacy Council of India and or State Pharmacy Councils are in no
way precluded from considering and dealing with any other form of professional misconduct on the part of a
registered pharmacist. Circumstances may and do arise from time to time in relation to which there may occur
questions of professional misconduct which do not come within any of these categories. Every care should be
taken that the code is not violated in letter or spirit. In such instances as in all others, the Pharmacy Council of
India and/or State Pharmacy Councils have to consider and decide upon the facts brought before the Pharmacy
Council of India and/or State Pharmacy Councils.
b) Any complaint with regard to professional misconduct can be brought before the Pharmacy Council of
India/concerned State Pharmacy Council for disciplinary action. Upon receipt of any complaint of professional
misconduct, the Pharmacy Council of India/concerned State Pharmacy Council would hold an enquiry and give
opportunity to the registered pharmacist to be heard in person or by pleader. If the registered pharmacist is found
to be guilty of committing professional misconduct, the Pharmacy Council of India/concerned State Pharmacy
Council may award such punishment as deemed necessary or may direct the removal altogether or for a specified
period, from the register of the name of the delinquent registered practitioner. Deletion from the Register shall be
widely publicized in local press as well as in the publications of different Pharmacy Associations/
Societies/Bodies.
c) In case the punishment of removal from the register is for a limited period, the concerned State Pharmacy Council
may also direct that the name so removed shall be restored in the register after the expiry of the period for which
the name was ordered to be removed.
d) Decision on complaint against delinquent registered pharmacist shall be taken within a time limit of 6 months.
e) During the pendency of the complaint the concerned State Pharmacy Council may restrain the registered
pharmacist from performing the procedure or practice which is under scrutiny.
f) Professional incompetence shall be judged by peer group as per guidelines prescribed by Pharmacy Council of
India.
g) For willful obstruction of an inspector appointed under the Drugs & Cosmetics Act, 1940 and Pharmacy Act,
1948, offence is punishable as provided under the respective Acts.
[ADVT-III/4/Exty./101/14]
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APPENDIX-1
DECLARATION
(see regulation 3.1)
(To be submitted at the time of application to the state pharmacy council for registration of name in the register of
pharmacists)
1. I solemnly pledge myself to consecrate my life to service of humanity.
2. Even under threat, I will not use my pharmacy knowledge contrary to the laws of Humanity.
3. I will maintain the utmost respect for human life from the time of conception.
4. I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between
my duty and my patient.
8. I will give to my teachers the respect and gratitude which is their due.
9. I will maintain by all means in my power, the honour and noble traditions of pharmacy profession.
11. I shall abide by the code of ethics as laid down by the Pharmacy Council of India.
I certify that I have read and agree to abide by the declarations made above.
Signature ………………………………………………………
Name ………………………………………………………
Place ………………………………………………………
Address :
………………………………………………
………………………………………………
………………………………………………
Date ………………………
APPENDIX-II
Age :
Sex :
Address :
40 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
Occupation :
Diagnosis :
Prescription :
Follow up
Date:
Observations:
Appendix III
Details of Position Title and job responsibilities of Pharmacist at Hospital Pharmacy practice site:
1. JOB IDENTIFICATION:
Ministry: Health;
1.3 Title of First Level Supervisor (Official title of the Supervisor): Dy. Chief/Sr. Pharmacist
___________________________________________________________________
Purpose: Provide technical services and logistics support for effective delivery of pharmaceutical care and
services.
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In Hospital:
� To correspond with the different hospitals and mobilize the shortly expiring drugs 10
� Miscellaneous work 10
3.4 Knowledge of language(s) and other specialized requirement: Should be fluent in English and
regional language
4. COMPLEXITY OF WORK (details of the intricacy of tasks, steps, processes or methods involved in work,
difficulty and originality involved in work):
42 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
The responsibilities involve monitoring the patient and providing health education which will have direct impact
on the overall health of the population and disease management. Its jurisdiction encompasses a wide range of
pharmaceutical services be it in a dispensary or a hospital. The laid out procedures and techniques needs to be
carried out in precise technical efficacy and accuracy. The working process involves scrutinizing every step to
prevent any mistakes in the work as it deals with human life. The management of life saving drugs is very
important and involves many steps so as to ensure timely supply of drugs to the needy patients.
5. SCOPE AND EFFECT OF WORK (Details of the breadth of work performance, and the effect the work has
on the work of others or the functions of the organization):
Drugs are the lifelines of the health system. The success of the health care system depends on how various factors like
patient compliance to the medicines, cost, and supply, rational utilization of resources, minimization of wastages and
rational prescribing. Pharmacist is fully involved in carrying out and promoting them, thus contributing to the overall
economy of the nation. The pharmacist is directly involved in counseling the patients, advising the prescribers on rational
selection of drugs and therefore it has a direct impact on the overall patient care.
6.1 Instructions (Details of the controls exercised over the work by the Superior; how work is
assigned, reviewed and evaluated):
Work is carried out based on the annual work plan and regular supervision from the senior pharmacists.
6.2 Guidelines (written or unwritten guidelines that are available, and the extent to which the employees
may interpret, adapt or devise new guidelines):
7. WORK RELATIONSHIPS (The frequency, nature and purpose of contacts with others within and outside the
assigned organization (other than contacts with superiors):
A pharmaceutical service requires constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The profession also requires constant
interaction with different health professionals at various levels to provide the best patient care.
8. SUPERVISION OVER OTHERS (the responsibility that this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and number of subordinates, both directly
and indirectly supervised are-):
Supervises the technicians and other health workers in the Basic Health Unit on the proper storage
management , distribution and proper utilization of medicines.
9. JOB ENVIRONMENT (the physical demands that are required, such as walking, standing, lifting heavy
objects, etc., and/or any risks or discomforts like exposure to hazards such as exposure to chemicals infections,
radiation, extreme weather and other hostile working conditions):
Compounding involves the use of chemicals and it is risky to have contact or inhale certain substances and may
give rise to chronic diseases in the long run. The contact with patients increases the risk of contacting
¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 43
communicable diseases and other profession related work hazards such as risk of needle pricks exposing
him/her to diseases like HIV and Hepatitis.
Details of Position Title and job responsibilities of Senior Pharmacist at Hospital Pharmacy practice site:
1. JOB IDENTIFICATION:
Ministry: Health;
1.3 Title of First Level Supervisor (Official title of the Supervisor): Chief/Deputy Chief of the
respective fields.
________________________________________________________________________
2. PURPOSE, DUTIES AND RESPONSIBILITIES ( the purpose, duties and responsibilities, indicating what
is done how it is done. Purpose should be a short statement linking the position to the mission and goals of the
organization and specifying outputs of the position. Duties should be presented in decreasing order of
percentage of time spent on them, or in order of relative importance):
Purpose: Provide technical services and logistics support for effective delivery of pharmaceutical services,
efficient production and supply management; enforce regulation and promote quality assurance of the drugs and
other medical supplies; and manages the pharmacy services at a hospital.
In Hospital:
In Supplies Management
Should be fluent in regional languages and English and ability to converse in other dialects is a good
asset.
4. COMPLEXITY OF WORK (the intricacy of tasks, steps, processes or methods involved in work, difficulty
and originality involved in work):
Pharmaceutical services are a very technical profession and it requires self-motivation and professional ethics;
its jurisdiction encompasses a wide range of services. Under general supervision, senior pharmacist performs
duties of broad scope, which requires extensive experience, and application of knowledge of the total pharmacy
services in a 60-bedded hospital or in relevant pharmaceutical fields. The position also requires management
of life saving drugs involving many steps so as to ensure timely supply of drugs to the needy patients.
5. SCOPE AND EFFECT OF WORK ( the breadth of work performance, and the effect the work has on the
work of others or the functions of the organization):
The position is a hospital–wide recognized professional authority in such areas such as Pharmacokinetics, infectious
disease therapy, adverse reactions, pharmaco-vigilance, provide authoritative professional guidance to the staff of the
hospital and related organizations. The work consists of execution of specific rules, regulations or procedures effecting
the accuracy, reliability or acceptability of other processes and services having direct bearing on the patients.
¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 45
6.1 Instructions ( controls exercised over the work by the Superior; how work is assigned, reviewed
and evaluated):
Assignment of work is based on the annual work plan. The work requires evaluation by self and the
supervisors in order to monitor the work efficiency and maintain progress.
6.2 Guidelines (Indicate which written or unwritten guidelines are available, and the extent to which the
employees may interpret, adapt or devise new guidelines):
� Financial Manual
� Pharmacy Act and other legislations mentioned in these regulations
� Policy documents
� Five-year plan document
7. WORK RELATIONSHIPS ( the frequency, nature and purpose of contacts with others within and outside the
assigned organization (other than contacts with superiors):
A pharmaceutical service requires constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. Besides above, the position needs to interact
with agencies such as state/central government, Pharmacy retailers, international pharmaceutical firms to
prevent drug related problems, legalize retailers, monitor drug quality and compliance of retailers to standard
practices and for supply of drugs with pharmaceutical firms.
8. SUPERVISION OVER OTHERS (responsibility of this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and number of subordinates, both directly
and indirectly supervised):
Supervises the pharmacists, trainees and other related professionals in the hospitals and the Basic Health Units
on the proper utilization of the medicines and proper store management of the medicines.
9. JOB ENVIRONMENT (physical demands required, such as walking, standing, lifting heavy objects, etc.,
and/or any risks or discomforts like exposure to hazards such as exposure to chemicals infections, radiation,
extreme weather and other hostile working conditions):
The pharmaceutical services in all the area of work need long hour duties with constant standing and frequent
exposure to chemicals and other toxins. The contact with patients increases the risk of contacting communicable
diseases and other profession related work hazards. The position is also required to travel frequently to the
districts to monitor the pharmaceutical activities, to conduct research and assure quality of drugs and supplies.
Details of Position Title and job responsibilities of Chief Pharmacist at Hospital Pharmacy practice site:
1. JOB IDENTIFICATION:
Ministry: Health;
Unit: Hospital/dispensary/warehouse
1.3 Title of First Level Supervisor (Official title of the Supervisor): Head of the Department/hospital
_______________________________________________________________________
2. PURPOSE, DUTIES AND RESPONSIBILITIES (Describe the purpose, duties and responsibilities,
indicating what is done how it is done. Purpose should be a short statement linking the position to the mission
and goals of the organization and specifying outputs of the position. Duties should be presented in decreasing
order of percentage of time spent on them, or in order of relative importance):
Purpose: Provide advanced technical services and logistics support for effective delivery of clinical services,
efficient production and supply management; and ensure regulation and quality assurance of the drugs and other
medical supplies; and manages the pharmacy department of the hospital.
3.1 Education:
OR
OR
3.2 Training: Short course in organizational management, human resource development and management, and
financial management and policies, research and specialization in pharmaceutical related fields.
¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 47
3.3 Length and type of practical experience required: Minimum of 4 years experience as a Sr.Pharmacist
or equivalent experience.
Fluent in regional languages and English. Should be also conversant in government policies, rules and
regulations.
4. COMPLEXITY OF WORK (Describe the intricacy of tasks, steps, processes or methods involved in work,
difficulty and originality involved in work):
The position needs a competent person with in-depth technical knowledge and policy issues and must be
capable of executing responsibilities independently. The position is required to fulfill the professional and
administrative responsibilities for the department that provides comprehensive pharmaceutical services through
large number of professional and technical personnel. It involves advising the technical bodies and commissions
(National Drug Committee, Drug Advisory Committee, National HIV/AIDS Commission) on embarking right
policy decisions. The position is also required to give constant feedback and assistance to the higher authorities.
5. SCOPE AND EFFECT OF WORK (Describe the breadth of work performance, and the effect the work has
on the work of others or the functions of the organization):
The success and image of the health system is directly influenced by the clinical care provided to the patients.
The pharmaceutical service is the backbone of the clinical services and has direct impact on the overall health
care. The quality of the pharmaceutical services will entirely depend on how they are planned and implemented
and this position category play a vital role in extending the services to the public.
6.1 Instructions (Describe controls exercised over the work by the Superior; how work is assigned,
reviewed and evaluated):
The work output will be reviewed through meetings, reports, publications and successful
implementation of the planned activities. However, supervision is received from the head of the
department on policy and management issues, and from the specialists on technical areas as and when
required.
6.2 Guidelines (Indicate which written or unwritten guidelines are available, and the extent to which the
employees may interpret, adapt or devise new guidelines):
The position is required to collaborate with various international agencies and intergovernmental organizations
for constant upgrading of the policies and programs relating to matters of pharmaceutical services. The position
is required to co-ordinate in-puts from relevant professional groups and agencies in order to promote the
professional integrity and for better developmental goals and better patient care.
48 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
8. SUPERVISION OVER OTHERS (Describe responsibility this position has for supervision of other
employees, including the nature of supervisory responsibilities and categories and number of subordinates, both
directly and indirectly supervised):
Supervises the Deputy Chief Pharmacists and Pharmacists; and oversees the private pharmaceutical dealers to
improve the quality of work and to ensure the quality, efficacy and safety of medicinal products to safeguard the
public health.
9. JOB ENVIRONMENT (Describe physical demands required, such as walking, standing, lifting heavy objects,
etc., and/or any risks or discomforts like exposure to hazards such as exposure to chemicals infections,
radiation, extreme weather and other hostile working conditions):
The work involves frequent exposure to chemicals and other toxins. The contact with patients through research
works also increase the risk of contacting communicable diseases and other profession related work hazards.
The position is also required to travel frequently to the districts to monitor the pharmaceutical activities, to
conduct research and assure quality of drugs and supplies.
Details of Position Title and job responsibilities of Community Pharmacist at community Pharmacy practice site
( Drug Store/ Pharmacy)
1. JOB IDENTIFICATION:
Purpose: Provide technical services and logistics support for effective delivery of pharmaceutical care and services.
� undertaking Medicine Use Reviews (MUR), an advanced service to help patients understand how their
medicines work and why they have to take them;
� providing a prescription intervention service;
� managing a needle and syringe exchange;
� dispensing emergency hormonal contraception;
� measuring and fitting compression hosiery;
� monitoring blood pressure and cholesterol levels;
� offering a diabetes screening service;
� providing pregnancy testing;
� arranging the delivery of prescription medicines to patients;
� overseeing the ordering and safe storage of medical products;
� maintaining computerised records;
� managing, supervising and training pharmacy support staff;
� selling healthcare and other products, such as toiletries, cosmetics and photographic items;
� budgeting and financial management;
� promoting sales and developing the business;
� keeping up to date with current pharmacy practice, new drugs and their uses.
3.4 Knowledge of language(s) and other specialized requirement: Should be fluent in English and
regional language.
4. COMPLEXITY OF WORK (details of the intricacy of tasks, steps, processes or methods involved in work,
difficulty and originality involved in work):
The responsibilities involve monitoring the patient and providing health education which will have direct impact
on the overall health of the population and disease management. Its jurisdiction encompasses a wide range of
pharmaceutical services be it in a dispensary or a hospital. The laid out procedures and techniques needs to be
carried out in precise technical efficacy and accuracy. The working process involves scrutinizing every step to
prevent any mistakes in the work as it deals with human life. The management of life saving drugs is very
important and involves many steps so as to ensure timely supply of drugs to the needy patients.
5. SCOPE AND EFFECT OF WORK (Details of the breadth of work performance, and the effect the work has
on the work of others or the functions of the organization):
Drugs are the lifelines of the health system. The success of the health care system depends on how various
factors like patient compliance to the medicines, cost, and supply, rational utilization of resources, minimization
of wastages and rational prescribing. Pharmacist is fully involved in carrying out and promoting them, thus
contributing to the overall economy of the nation. The pharmacist is directly involved in counseling the patients,
advising the prescribers on rational selection of drugs and therefore it has a direct impact on the overall patient
care.
50 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
6.1 Instructions (Details of the controls exercised over the work by the Superior; how work is
assigned, reviewed and evaluated):
Work is carried out based on the annual work plan and regular supervision from the senior pharmacists.
6.2 Guidelines (written or unwritten guidelines that are available, and the extent to which the employees
may interpret, adapt or devise new guidelines):
A pharmaceutical service requires constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The profession also requires constant
interaction with different health professionals at various levels to provide the best patient care.
8. SUPERVISION OVER OTHERS (the responsibility that this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and number of subordinates, both directly
and indirectly supervised are):-
Supervises the technicians and other health workers in the community Pharmacy on the proper storage
management, distribution and proper utilization of medicines.
9. JOB ENVIRONMENT (the physical demands that are required, such as walking, standing, lifting heavy
objects, etc., and/or any risks or discomforts like exposure to hazards such as exposure to chemicals infections,
radiation, extreme weather and other hostile working conditions):
Compounding involves the use of chemicals and it is risky to have contact or inhale certain substances and
may give rise to chronic diseases in the long run. The contact with patients increases the risk of contacting
communicable diseases and other profession related work hazards such as risk of needle pricks exposing
him/her to diseases like HIV and Hepatitis.
Details of Position Title and job responsibilities of Drug Information Pharmacist at Pharmacy practice site in a
health care setting (Drug Store/ Pharmacy)
1. JOB IDENTIFICATION:
Purpose: Provide patient care that optimizes the use of medication and promotes health, wellness and disease
prevention.
3.4 Knowledge of language(s) and other specialized requirement: Should be fluent in English and
regional language
4. COMPLEXITY OF WORK (details of the intricacy of tasks, steps, processes or methods involved in work,
difficulty and originality involved in work):
The responsibilities involve monitoring the patient and providing health education which will have direct impact
on the overall health of the population and disease management. Its jurisdiction encompasses a wide range of
pharmaceutical services be it in a dispensary or a hospital.
5. SCOPE AND EFFECT OF WORK (Details of the breadth of work performance, and the effect the work has
on the work of others or the functions of the organization):
Drugs are the lifelines of the health system. The success of the health care system depends on how various factors like
patient compliance to the medicines, cost, and supply, rational utilization of resources, minimization of wastages and
rational prescribing. Pharmacist is fully involved in carrying out and promoting them, thus contributing to the overall
economy of the nation. The pharmacist is directly involved in counseling the patients, advising the prescribers on rational
selection of drugs and therefore it has a direct impact on the overall patient care.
6.1 Instructions (Details of the controls exercised over the work by the Superior; how work is
assigned, reviewed and evaluated):
Work is carried out based on the annual work plan and regular supervision from the senior pharmacists.
6.2 Guidelines (written or unwritten guidelines that are available, and the extent to which the employees
may interpret, adapt or devise new guidelines):
52 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
A pharmaceutical service requires constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The profession also requires constant
interaction with different health professionals at various levels to provide the best patient care.
Professions exist to serve society. The mission of the pharmacy profession is to render service to humanity with
full respect for the dignity of profession and man, besides addressing the needs of society and of individual patients. The
public places great trust in the knowledge, skills and professional judgments of pharmacists. This trust requires the
pharmacists to ensure and maintain throughout their career high standards of personal and professional conduct, up-to
date knowledge and professional competence relevant to their domain of practice. The registered pharmacist should merit
the confidence of patients entrusted to their care, rendering to each a full measure of service and devotion. For which the
registered pharmacist should try continuously to improve his knowledge and skills and should make available to their
patients and colleagues the benefits of their professional attainments.
The registered pharmacist should practice methods of practice founded on scientific basis and should not associate
professionally with anyone who violates this principle. The honoured ideals of the pharmacy profession imply that the
responsibilities of the registered pharmacist extend not only to individuals but also to society.
This calls for framing of the regulations for practice of pharmacy laying down responsibilities of pharmacist towards
patient, another registered pharmacist and the public in general. Primary reasons to regulate pharmacy profession are:
It is also a call for laying down the activities which may be construed as misconduct and provision for taking disciplinary
action.
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