PHARMACY ACT, 1948 AND RULES: A TEACHER’S COMPREHENSIVE GUIDE
Welcome, future pharmacists and healthcare professionals!
The Pharmacy Act, 1948 is the cornerstone legislation that regulates the pharmacy profession in India. It is a comprehensive collection of regulations covering topics related to the profession, procedures, courses, duration, qualifications, and punishments. Before independence, there were no regulations for the profession and practice of pharmacy. The Drug Enquiry Committee recommended that the person practicing pharmacy should have a proper educational background, and the Health Survey and Development Committee made similar recommendations. Consequently, the Pharmacy Act came into force in March 1948.
As a pharmacy educator with years of experience teaching Pharmacy Law and Ethics, I have observed that students often find this Act overwhelming due to its detailed provisions. However, understanding the Pharmacy Act is essential for every pharmacist—it defines who can practice, what qualifications are required, and what standards must be maintained. In this comprehensive guide, I will break down the Act into manageable sections, explaining the constitution of pharmacy councils, education regulations, registration procedures, and code of ethics. Let us begin our journey.
Dpharmguru’s exam insights:
The Pharmacy Act, 1948 is one of the most frequently tested topics in pharmacy law exams. Remember: It was passed in 1948 and amended in 1959, 1976, and 1982. The Act establishes the Pharmacy Council of India (PCI), regulates pharmacy education, and provides for the registration of pharmacists. Pay special attention to the constitution of PCI, Education Regulations, and the Code of Ethics—these are almost always asked in exams!
OBJECTIVES OF PHARMACY ACT, 1948
The Pharmacy Act, 1948 was passed with the main objective to regulate the profession and practice of pharmacy. The specific objectives are:
- To make better provisions for regulating the profession and practice of pharmacy.
- To raise the status of the profession of pharmacy in India.
- To constitute the Pharmacy Council of India for setting standards in pharmacy education.
- To regulate pharmacy institutions, especially Diploma in Pharmacy, through education regulations and registration of pharmacists.
Dpharmguru’s exam insights:
The four objectives of the Pharmacy Act are frequently tested. Remember them as: (1) Regulate profession, (2) Raise status, (3) Constitute PCI, (4) Regulate institutions. This is a common long-answer question in exams!
DEFINITIONS UNDER PHARMACY ACT
The Act defines several key terms that are essential for understanding its provisions:
1. Central Register
The Central Register is a register of pharmacists maintained by the Central Council (Pharmacy Council of India). It contains the names of all registered pharmacists in India.
2. Medical Practitioner
A Medical Practitioner is:
- A person who holds a qualification granted by an authority specified under Section 3 of the Indian Medical Degrees Act, 1916, or specified in the schedules of the Indian Medical Council Act, 1956.
- A person registered or eligible for registration in a medical register of a State for practicing modern scientific system of medicine.
- A person declared by the State Government as practicing modern scientific system of medicine.
- A person engaged in the practice of veterinary medicine with qualifications approved by the State Government.
3. Registered Pharmacist
A Registered Pharmacist is a person whose name is for the time being entered in the register of pharmacists of the State in which he is residing or carrying on his profession or business of pharmacy.
4. Repatriate
A Repatriate is any person of Indian origin who, on account of civil disturbances in any area now forming part of Burma, Sri Lanka, or Uganda, or any other country, has after the 14th day of April, 1957, left or been displaced from his place of residence and has since been residing in India.
5. University Grants Commission
The University Grants Commission (UGC) is the body established under Section 4 of the University Grants Commission Act, 1956.
6. Indian University
An Indian University means a university within the meaning of Section 3 of the UGC Act, 1956 and includes such other institutions established by or under a Central Act as the Central Government may specify.
PHARMACY COUNCIL OF INDIA (PCI)
After the enactment of the Pharmacy Act, the Central Government established the Pharmacy Council of India (PCI), which is required to be reconstituted every five years.
Constitution of PCI
A) Elected Members
- Six members elected by the University Grants Commission from among teachers working in universities or colleges granting degree or diploma in Pharmacy. Among these, only one teacher from each subject: Pharmaceutical Chemistry, Pharmacology, and Pharmacognosy.
- One member elected by the Medical Council of India from among its members.
- One registered pharmacist to represent each State, elected by members of each State Pharmacy Council.
B) Nominated Members
- Six members nominated by the Central Government, of whom at least four shall possess degree or diploma and are in practice of pharmacy or pharmaceutical chemistry.
- A representative of the University Grants Commission.
- A representative of the All India Council for Technical Education (AICTE).
C) Ex-Officio Members
- Director General of Health Services
- Drug Controller of India
- Director of Central Drugs Laboratory
D) President and Vice-President
The members of the Council elect among themselves the President and Vice-President for a period of five years, not beyond the expiry of their term as members.
The Central Council shall:
- Appoint a Registrar who acts as Secretary to the Council and also as Treasurer if required.
- Appoint other officers and staff necessary to carry out its functions.
Functions of PCI
- To prescribe minimum educational standards required to become a registered pharmacist.
- To ensure uniform implementation of education standards throughout the country.
- To define roles and responsibilities of council members.
- To approve institutions providing pharmacy education.
- To withdraw approval if institutions fail to maintain prescribed standards.
- To approve foreign pharmacy qualifications.
- To maintain the Central Register of Pharmacists.
Dpharmguru’s exam insights:
The constitution of PCI is frequently tested. Remember: Elected members (6 from UGC teachers + 1 from MCI + 1 from each State), Nominated members (6 from Central Govt + UGC rep + AICTE rep), and Ex-Officio members (DGHS + DCI + CDL Director). The President and Vice-President are elected by the members for a 5-year term. Also remember the key functions of PCI—especially approval of institutions and maintaining the Central Register!
EDUCATION REGULATIONS
As per Section 10 of the Pharmacy Act, 1948, the Central Council, with the approval of the Central Government, makes regulations prescribing the minimum educational standards required for qualification as a pharmacist.
Minimum Qualifications for Registration
- Diploma in Pharmacy (D.Pharm) is the minimum qualification for registration as a pharmacist.
- The nature and duration of the pharmacy course must be specified.
- Practical training of at least 75 hours over a minimum period of three months in a hospital, pharmacy, or dispensary approved by the Central Council.
- Facilities and equipment required for institutions to provide proper education and training.
- Conditions to be fulfilled by institutions conducting practical training.
- Conditions to be fulfilled by examining authorities conducting examinations.
Application of Education Regulations to States
The State Government may declare the date on which Education Regulations shall come into force in that State. If no such declaration is made, the Education Regulations automatically come into force three years after the constitution of the State Pharmacy Council.
Dpharmguru’s exam insights:
The Education Regulations under Section 10 are frequently tested. Remember: D.Pharm is the minimum qualification, 75 hours of practical training over 3 months is required. Also note that Education Regulations automatically come into force 3 years after the State Pharmacy Council is constituted if no specific declaration is made by the State Government.
STATE AND JOINT STATE PHARMACY COUNCILS
According to the Pharmacy Act, a State Pharmacy Council is constituted under each State Government. This includes Joint State Council of Pharmacy in accordance with an agreement under Section 20 of the Pharmacy Act, 1948. These Councils maintain a register for pharmacists of the State and monitor their activities regarding the profession.
Constitution of State Pharmacy Council
Section 19 of the Pharmacy Act, 1948 provides for the constitution and composition of the State Council.
Elected Members
- Six members elected by registered pharmacists of the State from among themselves.
- One member elected by the State Medical Council from among its members.
Nominated Members
- Five members nominated by the State Government, of whom at least three shall possess degree or diploma in pharmacy or pharmaceutical chemistry or shall be registered pharmacists.
Ex-Officio Members
- Chief Administrative Medical Officer of the State
- Officer-in-charge of the State Drugs Control Administration
- Government Analyst appointed by the State Government
President and Vice-President
The President and Vice-President are elected by members of the State Pharmacy Council from among themselves. They hold office for five years and are eligible for re-election.
Constitution of Joint State Pharmacy Council
Section 20 of the Pharmacy Act, 1948 provides for the constitution and composition of the Joint State Council.
Elected Members
- Six members elected by registered pharmacists of participating States.
- One member elected by the Medical Council of each participating State.
Nominated Members
- Two to four members nominated by each participating State Government, at least half of whom must be registered pharmacists or possess pharmacy qualifications.
Ex-Officio Members
- Chief Administrative Medical Officer of each participating State
- Officer-in-charge of Drugs Control Administration of each State
- Government Analyst of each State
Functions of State Pharmacy Council
- Maintaining the register of pharmacists.
- Regulating registration of pharmacists.
- Fixing fees for registration.
- Appointing inspectors to inspect pharmacies.
- Investigating complaints against pharmacists.
- Taking disciplinary action when necessary.
- Providing annual reports and financial statements to PCI and State Government.
- Sending copies of updated registers to PCI every year.
Functions of Joint State Pharmacy Council
- Maintaining the register of pharmacists.
- Regulating pharmacist registration.
- Preparing annual accounts.
- Sharing expenses among participating States.
- Providing updated registers to PCI annually.
REGISTRATION OF PHARMACISTS
After the Education Regulations have come into force in a State, a person is entitled to have his/her name entered in the register of pharmacists if he/she fulfills the following conditions:
- He/she has attained the age of eighteen years.
- He/she resides or carries on the profession or business of pharmacy in the State.
- He/she has passed an approved examination or possesses a qualification approved by the Central Council.
- He/she is a registered pharmacist in another State.
Particulars Entered in the Register
- Full name and residential address of the pharmacist.
- Date of first registration.
- Qualification for registration.
- Professional address and employer’s name, if employed.
- Other prescribed particulars.
Maintenance of Register
The registers are of two types:
- First Register: Prepared initially by the State Government through a Registration Tribunal. The tribunal examines applications and enters the names of qualified applicants. After constitution of the State Pharmacy Council, the register is transferred to its custody.
- Subsequent Register: Maintained by the State Pharmacy Council for new registrations after the first register is prepared.
Qualification for Entry in First Register
A person is eligible if:
- He/she has attained the age of eighteen years.
- He/she resides or practices pharmacy in the State.
- He/she possesses any of the following qualifications:
- Degree or diploma in pharmacy or pharmaceutical chemistry, or
- Degree in another subject with three years experience in compounding drugs, or
- Passed recognized examination for compounders or dispensers, or
- Five years experience in compounding drugs before the notified date.
Subsequent Register
After the preparation of the first register and before Education Regulations come into force, a person may be registered if:
- He/she satisfies prescribed conditions.
- He/she has passed matriculation or equivalent examination.
- He/she is registered in another State, or
- He/she possesses foreign qualification approved by PCI.
Renewal of Registration
- The registration must be renewed periodically.
- If renewal fee is not paid, the name may be removed from the register.
- Upon payment of renewal fee, registration is renewed and receipt is issued.
- Pharmacists may also pay advance renewal fees to avoid interruption.
Dpharmguru’s exam insights:
Registration procedures are frequently tested. Remember: Age 18+ is required for registration. The First Register is prepared by a Registration Tribunal appointed by the State Government. The Subsequent Register is maintained by the State Pharmacy Council. Also remember the alternative qualifications for entry in the First Register—especially the 5 years experience provision.
OFFENCES AND PENALTIES
1. Falsely Claiming to be a Registered Pharmacist
A person falsely claiming to be a registered pharmacist or using words like ‘Pharmacist’, ‘Chemist’, ‘Druggist’, ‘Dispenser’, or their combinations is punishable with a fine up to ₹500 on the first conviction.
2. Dispensing by Un-registered Persons
If a person is not a registered pharmacist, he is not eligible for compounding, mixing, or dispensing drugs on the prescriptions of Medical Practitioners. A person is punished with imprisonment up to six months or a fine up to ₹1,000 or both if this rule is breached.
3. Failure to Surrender Certificate of Registration
A person is punishable with a fine up to ₹50 if his/her name has been removed from the State Register and he/she has not surrendered the registration certificate without sufficient reason.
Dpharmguru’s exam insights:
Offences and penalties are frequently tested. Remember: False claim = ₹500 fine; Dispensing by unregistered person = 6 months imprisonment OR ₹1,000 fine OR both; Failure to surrender certificate = ₹50 fine. These specific amounts are often asked in MCQ-type questions!
PHARMACY PRACTICE REGULATIONS, 2015
In exercise of the powers conferred under Section 10 and Section 18 of the Pharmacy Act, 1948, the Pharmacy Council of India, with the approval of the Central Government, has made the Pharmacy Practice Regulations, 2015. These regulations came into force from the date of their publication in the Official Gazette.
Key Definitions
- Practice of Pharmacy includes: interpretation and evaluation of medical orders; dispensing of prescriptions; participation in drug and device selection; drug regimen reviews; patient counseling; compounding and labeling of drugs; and proper storage of drugs.
- Compounding means the preparation, mixing, assembling, packing, or labeling of a drug or device as the result of a practitioner’s prescription drug order.
- Dispensing means the interpretation, evaluation, supply, and implementation of a prescription, including the preparation and delivery of a drug or device to a patient.
- Patient Counseling means the oral communication by the pharmacist of information to the patient or caregiver to ensure proper use of drugs and devices.
- 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.
Types of Pharmacy Practitioners
- Community Pharmacist: Works according to legal and ethical guidelines to ensure the correct and safe supply of medical products to the general public.
- Hospital Pharmacist: Works in a hospital pharmacy service, responsible for ensuring the safe, appropriate, and cost-effective use of medicines.
- Clinical Pharmacist: Provides patient care that optimizes the use of medication and promotes health, wellness, and disease prevention.
CODE OF PHARMACY ETHICS
The Pharmacy Practice Regulations, 2015 lay down a comprehensive Code of Pharmacy Ethics that all registered pharmacists must follow.
Duties and Responsibilities of Registered Pharmacists
- Character: The prime object of the pharmacy profession is to render service to humanity; reward or financial gain is a subordinate consideration.
- Renewal of Registration: Pharmacists must attend minimum 2 refresher courses in a span of 5 years.
- Dispensing: Only dispense medicines as prescribed by Registered Medical Practitioners and shall not substitute the prescription.
- Patient Confidentiality: Confidences concerning patients shall never be revealed unless required by law.
- Maintenance of Patient Records: Medical/prescription records must be maintained for 5 years from the date of commencement of treatment.
Unethical Acts
- Advertising: Soliciting patients directly or indirectly is unethical. Self-photographs on letterheads or signboards are regarded as self-advertisement.
- Rebates and Commission: Giving, soliciting, or receiving any gift, gratuity, commission, or bonus for referring patients is unethical.
- Secret Remedies: Prescribing or dispensing secret remedial agents of unknown composition is prohibited.
- Human Rights: Pharmacists shall not aid or abet torture or concealment of torture.
Professional Misconduct
- Violation of regulations framed under the Act.
- Substitution of the prescription without approval.
- Allowing the owner of the pharmacy to use the registration certificate without attending the pharmacy.
- Giving registration certificate to more than one pharmacy.
- Not displaying the registration certificate in the pharmacy.
- Wilfully obstructing an inspector.
- Disclosing patient secrets except in court or notifiable diseases.
- Using touts or agents for procuring patients.
- Working in another pharmacy or institution while employed elsewhere.
Punishment and Disciplinary Action
- Complaints of professional misconduct can be brought before the Pharmacy Council of India or concerned State Pharmacy Council.
- The Council holds an enquiry and gives the pharmacist an opportunity to be heard.
- Punishment may include removal from the register permanently or for a specified period.
- Deletion from the Register shall be widely publicized.
- Decisions on complaints shall be taken within 6 months.
Dr. Saint Paul’s Exam Insights:
The Code of Ethics under the Pharmacy Practice Regulations, 2015 is a goldmine for exam questions. Remember: Patient records must be maintained for 5 years; 2 refresher courses in 5 years are required for renewal; unethical acts include advertising, rebates, and secret remedies; misconduct includes substitution, obstruction, and multiple registrations. The punishment can include removal from the register—this is the most severe penalty!
COMPARISON: CENTRAL VS STATE PHARMACY COUNCIL
| Feature | Central Council (PCI) | State Council |
|---|---|---|
| Establishment | Central Government | State Government |
| Register Maintained | Central Register | State Register |
| Elected Members | 6 (UGC teachers) + 1 (MCI) + 1 per State | 6 (State pharmacists) + 1 (State Medical Council) |
| Nominated Members | 6 (Central Govt) + UGC rep + AICTE rep | 5 (State Govt) |
| Ex-Officio Members | DGHS + DCI + CDL Director | CMO + Drug Controller + Govt Analyst |
| Key Function | Prescribes education standards, maintains Central Register | Maintains State Register, regulates registration |
FREQUENTLY ASKED QUESTIONS (FAQs)
1. When was the Pharmacy Act, 1948 enacted?
The Pharmacy Act was enacted in March 1948. It was amended in 1959, 1976, and 1982.
2. What is the minimum qualification for registration as a pharmacist?
The Diploma in Pharmacy (D.Pharm) is the minimum qualification for registration as a pharmacist under the Pharmacy Act, 1948.
3. How long is the practical training required for pharmacy students?
Pharmacy students must complete at least 75 hours of practical training over a minimum period of three months in a hospital, pharmacy, or dispensary approved by the Central Council.
4. What is the penalty for falsely claiming to be a registered pharmacist?
A person falsely claiming to be a registered pharmacist is punishable with a fine up to ₹500 on the first conviction.
5. How long must patient records be maintained?
According to the Pharmacy Practice Regulations, 2015, patient medical/prescription records must be maintained for 5 years from the date of commencement of treatment.
6. What is the constitution of the Pharmacy Council of India?
PCI consists of: Elected members (6 from UGC teachers + 1 from MCI + 1 from each State), Nominated members (6 from Central Govt + UGC rep + AICTE rep), and Ex-Officio members (DGHS + DCI + CDL Director). The President and Vice-President are elected by members for a 5-year term.
7. What constitutes professional misconduct?
Professional misconduct includes: violation of regulations, substitution of prescriptions, allowing others to use registration certificate, multiple registrations, obstructing inspectors, disclosing patient secrets, using touts, and working in multiple pharmacies.
SUMMARY
The Pharmacy Act, 1948 is the foundational legislation that regulates the pharmacy profession in India. It establishes the Pharmacy Council of India to set educational standards, provides for State Pharmacy Councils to maintain registers of pharmacists, and lays down detailed Education Regulations for pharmacy courses. The Act also provides for the registration of pharmacists, defines offences and penalties, and establishes a comprehensive Code of Ethics through the Pharmacy Practice Regulations, 2015.
As I always tell my students: “The Pharmacy Act is not just a law—it is a professional identity document. It defines who we are as pharmacists and sets the standards we must uphold.” Understanding the Act is not just about passing exams—it is about understanding your rights, responsibilities, and the ethical framework that guides the pharmacy profession.
REFERENCES AND FURTHER READING
- Pharmacy Council of India (PCI). (2022). Pharmacy Act, 1948. New Delhi: PCI.
- Pharmacy Council of India (PCI). (2015). Pharmacy Practice Regulations, 2015. New Delhi: PCI.
- Ministry of Health and Family Welfare. (2022). Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.
- University Grants Commission Act, 1956. Government of India.
- Indian Medical Council Act, 1956. Government of India.
- World Health Organization (WHO). (2022). Good Pharmacy Practice Guidelines. Retrieved from https://www.who.int.
Disclaimer: This article is for educational purposes only and does not constitute legal advice. Pharmacy laws and regulations may change over time—always refer to the latest official gazette notifications and consult qualified legal professionals for specific legal matters.
written by:
Dr. N. Sujith Kumar
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