Pharmacy Practice Regulations, 2015

(Updated in 2025) [As amended by No. 14-148/2024-PCI. dt. 03/04/2025 Amendment in Appendix III Noti. No. 14-148/2020-PCI, dt.30/06/2021] [15th January, 2015] In exercise of the powers conferred by Sections 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--

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S.Regulation 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.

S.Regulation 3 Code of Pharmacy Ethics.--

S.Regulation 4 Duties and responsibilities of the registered pharmacist in general.--

S.Regulation 5 Pharmacy Inspectors to inspect pharmacies.--

(a) The owner/registered pharmacist shall allow and co-operate with the inspectors appointed under the Drugs and Cosmetics Act, 1940 and Section 26-A 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 thereunder.

S.Regulation 6 Maintaining good pharmacy practice.--

S.Regulation 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.

S.Regulation 8 Duties of registered pharmacists to their patients.--

S.Regulation 9 Duties of registered pharmacist.--

S.Regulation 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.

S.Regulation 11 Duties of registered pharmacist to the Public and to the Profession.--

S.Regulation 12 Unethical Acts.--

Unethical Acts.-A registered pharmacist shall not aid or abet or commit any of the following acts which shall be construed as unethical--

S.Regulation 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

S.Regulation 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 professiona

S.1

APPENDIX I

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.

S.2

APPENDIX II

Format for Prescription Record

[See Regulation 6.2]

Name of the patient:

Age:

Sex:

Address:

Occupation:

Date of 1st visit:

Diagnosis:

Prescription:

Follow up
Date:

Observations:

Signature in full ...............................

Name of registered pharmacist and Registration No.

S.Pharmaceutical

APPENDIX III

Details of Position Title and job responsibilities of Pharmacist at Hospital Pharmacy practice site:

1. JOB IDENTIFICATION:

1.1 Position Title: Pharmacist

1.2 Job Location (As appropriate):

Ministry: Health;

Department: Medical Services;

Division: Health Care and Diagnostic Services;

Section: Pharmaceutical Services;

Unit: Hospital Pharmacy/dispensary/Warehouse

1.3 Title of First Level Supervisor (Official title of the Supervisor): Dy. Chief/Sr. Pharmacist

2. PURPOSE, DUTIES AND RESPONSIBILITIES:

Purpose: Provide technical services and logistics support for effective delivery of pharmaceutical care and services.

S.Pharmacy Practice (Amendment) Regulations, 2025 All Amendments incorporated at appropriate place

PHARMACY COUNCIL OF INDIA

NOTIFICATION

New Delhi, the 27th March, 2025

No. 14-148/2024-PCI..-- In exercise of the powers conferred by sections 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 further to amend the Pharmacy Practice Regulations, 2015, namely:--

1. (1) These regulations may be called the Pharmacy Practice (Amendment) Regulations, 2025.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Pharmacy Practice Regulations, 2015,

S.Regulation 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 counselling 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 labelling of drugs and devices (except labelling 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 labelling of a drug or device--

(i) as the r