Pharmacy Practice Regulations 2015, By PCI India

edited January 6 in Healthcare
PHARMACY COUNCIL OF INDIA
(Pharmacy Practice Regulations, 2015)
NOTIFICATION

New Delhi, the 15th January, 2015
No. 14-148/ 2012- PCI.


This regulation is published in Gazette of India , No. 17] NEW DELHI, FRIDAY, JANUARY 16, 2015/PAUSA 26, 1936


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

1. Short title and commencement. –
(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:
(a) “Act” means the Pharmacy Act, 1948 (8 of 1948)
(b) “Practice of Pharmacy”means
: –
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,
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 a
nd 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

(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 the 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.
Note- Types of prescriptions and content of prescription are given below:

Types of Prescription :
(i) Prescription for Extemporaneous preparations.
(ii) Prescription for Official preparations.
(iii) Prescription for Patent preparations
Contents of the 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. Code of Pharmacy Ethics

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.

3.3 Displaying name of owner and registered pharmacist:
(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.
(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.

3.4 Owner to appoint registered pharmacist:
(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 app
ointment 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.

4. Duties and responsibilities of the registered pharmacist in general:


4.1 Character of 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.

4.2 Renewal of Registration :
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.
(i) Pharmacy Council of India.
(ii) State Pharmacy Councils.
(iii) Central Govt./State Govts.
(iv) Professional bodies recognized by the Council.

4.3 Dispensing against prescription of Registered Medical Practitioner only : Every registered pharmacist shall
dispense only those medicines as prescribed by the Registered Medical Practitioner and shall not substitute the prescription.

4.4 Practical training to student pharmacists.
(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 fro
m time to time under Education Regulations framed u/s 10 of the Act under intimation to the examining authority.
(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.

5. Pharmacy Inspectors to inspect pharmacies.

(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.
(b) Any Inspector may –
(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 there under.

6. Maintaining good pharmacy practice:

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.

6.2 Maintenance of patient records:
(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 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


8. DUTIES OF REGISTERED PHARMACISTS TO THEIR PATIENTS


8.1 Obligations to the Sick:
(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.

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 will fully commit an act of negligence that may deprive his patient or patients from necessary medical care.

CHAPTER-4


9. DUTIES OF REGISTERED PHARMACIST


9.1 Dispensing/Supply of Drugs:
(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.
(c) Patient confidentiality shall be maintained at all times.
(d) Appropriate information shall be provided to the patient or the care giver and, where possible, understanding of this information should be checked.
(e) For all prescriptions handled by the pharmacy:
(i) Patient details shall be checked and confirmed;
(ii) Pharmaceutical assessment shall be made;
(iii) Proper documentation shall be maintained.
(f) Assessment of the prescription should include but not be limited to assessment of whether :
(i) The prescription is legally valid.
(ii) The prescription includes an appropriate dosage form and appropriate route of administration.
(iii) Prescription is appropriate to the patient’s condition.
(iv) Duration of treatment is correct.
(v) Prescription is appropriate according to patient’s para-meters (age, weight etc.) and previous medication.
(vi) Prescription is compatible with other medications.
(vii) Prescription is consistent with formulary and guidelines, if any.
(viii) Possibility of side effects and ad-verse drug reactions exist.
(ix) Contra-indicated.
(x) Potential for misuse and inappropriate use of the medicines in prescription by patient exists.
(xi) Prescription is complying with labeling requirements.
(g) Compounding, dispensing and labeling of required drug products should ensure that

(i) The drug product matches the prescription.
(ii) The drug product has not expired.
(iii) The drug product is appropriately compounded (if necessary), packed and labeled appropriately.
(iv) The accuracy of dispensing is checked by Registered Pharmacist.
(v) Proper documentation is made.
(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.
(ii) Appropriate information on drugs is provided to the patient/ carer.

9.2 Pharmacist for promotion of rational drug use:
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.
(ii) Critical assessment of promotional materials prepared by the drug companies.
(iii) Dissemination of evaluated information through authorized sources.
(iv) Updating the knowledge of drugs through continuing education programmmes and also to organize
educational programmes for health professionals.
v) Preparation and dissemination of patient information leaflets.

9.3 Patient counselling :
(a) Upon receipt of a prescription (prescription drug order) and following a review of the patient’s record, a Registered Pharmacist shall personally initiate discussion of matters that will enhance or optimize drug therapy with each patient or care given of such patient. Such discussion shall be in person, whenever practicable or by telephone and shall include appropriate elements of patient counseling. Such elements may include the following :
(i)Name and description of the drugs
(ii)The dosage form, dose, route of administration, and duration of drug therapy
(iii)Intended use of the drug and expected action
(iv)Special directions and precautions for the drug
(v)Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur ;
(vi)Techniques for self monitoring drug therapy
(vii)Proper storage of the drugs
(viii)Prescription refill information
(ix)Action to be taken in the event of a missed dose
(x)To ensure rational use of drugs
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 Pharmaco-epidemiological studies.

(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 dependents.

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. DUTIES OF REGISTERED PHARMACIST TO THE PUBLIC AND TO THE PROFESSION

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


12. UNETHICAL ACTS :

A registered pharmacist shall not aid or abet or commit any of the following acts which shall be const
rued as unethical –

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.

12.2 Rebates and Commission:
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.

(a) Violation of the regulations framed under the Act
(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.
(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.
(l) Issuing of certificates of efficiency in modern medicine to unqualified person.
(Note: The foregoing does not restrict the proper training and instruction of bonafide student pharmacists u
nder 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

(i) in a court of law under orders of the presiding judicial officer
(ii) in circumstances where there is a serious and identified risk to a specific person and /or community; and
(iii) notifiable diseases.

(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.

(r) Using touts or agents for procuring patients.

(s) Claiming himself to be specialist.

(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 .

(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
>

14. PUNISHMENT AND DISCIPLINARY ACTION

(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.

ARCHNA MUDGAL, Registrar-cum-Secy.
[ADVT-III/4/Exty./101/14]

For Hindi text, Appendix, and for above text PDF download, click here: http://www.pci.nic.in/Circulars/Pharmacy Practice Regulations.pdf

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