PHARMACY ACT, 1948 AND RULES: A TEACHER’S COMPREHENSIVE GUIDE TO PHARMACY COUNCIL OF INDIA, REGISTRATION, AND PRACTICE REGULATIONS
Welcome, future pharmacists and healthcare professionals!
As a pharmacy law and ethics educator with years of experience teaching pharmaceutical legislation, I have observed that the Pharmacy Act, 1948, is one of the most important pieces of legislation governing the pharmacy profession in India. The Pharmacy Act, 1948 is a collection of regulations covering topics linked to pharmacy, including the profession, procedures, course, duration, qualifications, and punishments. The Act was implemented everywhere in India and amended in 1959, 1976, and 1982.
In this comprehensive guide, I will take you through the objectives, definitions, constitution and functions of the Pharmacy Council of India, Education Regulations, State Pharmacy Councils, registration of pharmacists, offences and penalties, and the Pharmacy Practice Regulations, 2015. By the end of this article, you will have a thorough understanding of the legal framework governing the pharmacy profession in India. Let us begin.
OBJECTIVES OF PHARMACY ACT
The Pharmacy Act, 1948, was enacted with several important objectives:
- To make better provisions for regulating the profession and practice of pharmacy.
- To raise the status of “Profession of Pharmacy” in India.
- To constitute “Pharmacy Council of India” for setting new standards in pharmacy education.
- To regulate pharmacy institutions, especially “Diploma in Pharmacy” through education regulations with registration of pharmacists.
DEFINITIONS UNDER PHARMACY ACT
Understanding the key definitions under the Pharmacy Act, 1948, is essential for interpreting and complying with the regulations:
- Central Register: Register of pharmacists maintained by the Central Council.
- Medical Practitioner: Person holding qualification under Indian Medical Degrees Act, 1916 or Indian Medical Council Act, 1956; or registered in a state medical register; or practicing veterinary medicine with state-approved qualification.
- Registered Pharmacist: Person whose name is entered in the register of pharmacists of the state where he resides or carries on pharmacy business.
- Repatriate: Person of Indian origin displaced from Burma, Sri Lanka, Uganda, or other countries after 14th April 1957 and residing in India.
- University Grants Commission: UGC established under section 4 of UGC Act, 1956.
- Indian University: University within the meaning of Section 3 of UGC Act, 1956.
PHARMACY COUNCIL OF INDIA (PCI)
The Pharmacy Council of India (PCI) is the statutory body constituted under the Pharmacy Act, 1948, to regulate the pharmacy profession and education in India. The Council plays a crucial role in maintaining standards of pharmacy education and professional conduct.
Constitution of PCI
Elected Members
- Six members elected by UGC from teachers of pharmacy (one each from Pharmaceutical Chemistry, Pharmacology, Pharmacognosy)
- One member elected by Medical Council of India
- One registered pharmacist from each state (selected by state council members)
Nominated Members
- Six members nominated by Central Government (at least four with degree/diploma in pharmacy)
- Representative of UGC
- Representative of AICTE
Ex-officio Members
- Director General of Health Services
- Drug Controller of India
- Director of Central Drug Laboratory
Functions of PCI
- Providing simpler ways to become a licensed member (Education Regulations)
- Ensuring consistent educational standards nationwide
- Defining responsibilities of president, vice president, secretary, inspectors, and executive committee members
- Authorising academic training institutes offering pharmacy courses
- Revoking permission for non-compliance with prescribed standards
- Approving foreign qualifications
- Updating Central Register of Pharmacists
EDUCATION REGULATIONS (ER)
As per Section 10 of the Pharmacy Act, 1948, the Central Council sets the minimum educational requirements for becoming a pharmacist.
Key Provisions
- D.Pharm is the minimum qualification for a pharmacist.
- Nature and timeframe of pharmacy course
- At least 75 hours of practical training (minimum 3 months) at PCI-approved facility
- Facilities and equipment required for institutions
- Requirements for practical training institutions
- Requirements for exam authorities
STATE AND JOINT STATE PHARMACY COUNCILS
Constitution of State Pharmacy Council
- Elected: Six from registered pharmacists; one from State Medical Council
- Nominated: Five by State Government (at least three with degree/diploma in pharmacy)
- Ex-officio: Chief administrative medical officer; Drug Controller; Government Analyst
Functions of State Pharmacy Council
- Fixes compensation rates for officers and allowances for members
- Provides annual activity summary and financial statements to State Government and PCI
- Gives one-half of received money to PCI annually
- Appoints inspectors to examine pharmacies and investigate complaints
- Regulates pharmacists’ registration and maintains registers
- Provides 5 copies of register to PCI annually after April 1st
REGISTRATION OF PHARMACISTS
Conditions for Registration
- Attained age of 18 years
- Resides or carries on pharmacy business/profession in the State
- Has passed approved examination or possesses approved foreign qualification
- Is a registered pharmacist in another State
Particulars in Register
- Full name and residential address
- Date of first admission to register
- Qualifications for registration
- Professional address and employer name
- Other prescribed particulars
OFFENCES AND PENALTIES
- False claim as Registered Pharmacist: Fine up to ₹500 (first conviction)
- Dispensing by unregistered persons: Imprisonment up to 6 months or fine up to ₹1,000 or both
- Failure to surrender certificate of registration: Fine up to ₹50
PHARMACY PRACTICE REGULATIONS, 2015
Key Definitions
- Practice of Pharmacy: Interpretation, evaluation, implementation of medical orders; dispensing; drug selection; patient counselling; compounding; pharmaceutical care.
- Compounding: Preparation, mixing, assembling, packing or labelling of a drug or device.
- Dispensing: Interpretation, evaluation, supply and implementation of a prescription.
- Patient Counselling: Oral communication by pharmacist to ensure proper use of drugs.
- Pharmaceutical Care: Provision of drug therapy to achieve disease outcomes, symptom reduction, or slowing disease process.
Types of Pharmacy Practitioners
- Community Pharmacist: Works according to legal/ethical guidelines to ensure correct and safe supply of medical products to the public.
- Hospital Pharmacist: Works in hospital pharmacy; ensures safe, appropriate, cost-effective use of medicines; collaborates with healthcare professionals.
- Clinical Pharmacist: Provides patient care optimizing medication use; promotes health, wellness, and disease prevention.
Duties of Registered Pharmacist
- Display name, registration number, qualification, and photograph at pharmacy
- Wear clean white overall/coat/apron with badge displaying name and registration number
- Attend minimum 2 refresher courses (each minimum 1 day) in 5 years for renewal of registration
- Dispense only medicines prescribed by Registered Medical Practitioner (no substitution)
- Maintain patient medical/prescription records for 5 years
- Maintain patient confidentiality at all times
- Provide patient counselling on drug name, dosage, side effects, storage, refill information, etc.
Unethical Acts
- Advertising or self-photographs for publicity
- Giving/soliciting rebates, commission, or bonus
- Prescribing/dispensing secret remedies (unknown composition)
- Substitution of prescription without medical practitioner’s approval
- Allowing owner to use registration certificate without attending pharmacy
- Using one registration certificate at more than one pharmacy
- Working simultaneously at another pharmacy, college, or industry
Punishment and Disciplinary Action
- Complaints of professional misconduct brought before PCI or State Pharmacy Council
- Council holds inquiry with opportunity for pharmacist to be heard
- Punishment may include removal from register (temporary or permanent)
- Deletion from register publicized in local press and pharmacy publications
- Decision on complaint within 6 months
- Professional incompetence judged by peer group as per PCI guidelines
SUMMARY: KEY OFFENCES AND PENALTIES
| Offence | Penalty |
|---|---|
| False claim as Registered Pharmacist | Fine up to ₹500 (first conviction) |
| Dispensing by unregistered person | Imprisonment up to 6 months or fine up to ₹1,000 or both |
| Failure to surrender registration certificate | Fine up to ₹50 |
A TEACHER’S LEGAL INSIGHTS
Over my years of teaching pharmaceutical legislation, I have developed a few key insights about the Pharmacy Act, 1948, that I always share with my students:
- The Pharmacy Act, 1948, is the foundation of the pharmacy profession in India. It establishes the Pharmacy Council of India and State Pharmacy Councils to regulate pharmacy education and practice.
- Registration with the State Pharmacy Council is mandatory for practicing pharmacy. Without registration, a person cannot dispense medicines or use the title “Registered Pharmacist.”
- The Pharmacy Practice Regulations, 2015, provide detailed guidelines for professional conduct, including duties of registered pharmacists, ethical practices, and disciplinary procedures.
- Continuing education is essential for pharmacists. The requirement to attend refresher courses ensures that pharmacists stay updated with the latest developments in pharmacy practice.
FREQUENTLY ASKED QUESTIONS (FAQs)
1. What is the Pharmacy Act, 1948?
The Pharmacy Act, 1948, is an Indian legislation that regulates the profession and practice of pharmacy, establishes the Pharmacy Council of India, and sets standards for pharmacy education and registration.
2. What is the minimum qualification for a pharmacist under the Act?
Diploma in Pharmacy (D.Pharm) is the minimum qualification for a pharmacist under the Pharmacy Act, 1948.
3. How many members are there in the Pharmacy Council of India?
The Pharmacy Council of India consists of elected members (from UGC, MCI, and state councils), nominated members (by Central Government, UGC, AICTE), and ex-officio members (DGHS, Drug Controller of India, Director CDL).
4. What is the penalty for dispensing by an unregistered person?
Dispensing by an unregistered person is punishable with imprisonment up to 6 months or fine up to ₹1,000, or both.
5. How many hours of practical training are required for D.Pharm?
At least 75 hours of practical training (minimum 3 months) at a PCI-approved facility is required for the D.Pharm course.
6. What is the Pharmacy Practice Regulations, 2015?
The Pharmacy Practice Regulations, 2015, are regulations issued by the Pharmacy Council of India that define the practice of pharmacy, types of pharmacy practitioners, duties of registered pharmacists, and ethical standards.
7. How long must a pharmacist maintain patient records?
A pharmacist must maintain patient medical/prescription records for 5 years.
SUMMARY
The Pharmacy Act, 1948, is a comprehensive legislation that regulates the pharmacy profession in India. It establishes the Pharmacy Council of India and State Pharmacy Councils to regulate pharmacy education and practice. The Act sets minimum educational qualifications for pharmacists, provides for registration of pharmacists, and establishes penalties for offences. The Pharmacy Practice Regulations, 2015, provide detailed guidelines for professional conduct, including duties of registered pharmacists, ethical practices, and disciplinary procedures. Understanding the provisions of the Pharmacy Act is essential for pharmacy professionals to ensure compliance with the law and maintain professional standards.
As I always tell my students: “The Pharmacy Act is not just a set of rules—it is the foundation of our professional identity. It protects the public and upholds the dignity of the pharmacy profession.”
REFERENCES AND FURTHER READING
- The Pharmacy Act, 1948. Government of India.
- The Pharmacy Rules, 1948. Government of India.
- Pharmacy Council of India (PCI). (2022). Education Regulations and Pharmacy Practice Regulations. Retrieved from https://www.pci.nic.in.
- Ministry of Health and Family Welfare. (2022). Pharmacy Act Amendments. Government of India.
- World Health Organization (WHO). (2022). Pharmacy Practice Guidelines. Retrieved from https://www.who.int.
Disclaimer: This article is for educational purposes only and does not constitute legal advice. Always refer to the latest regulatory guidelines and consult legal experts for compliance matters.
Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.
He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.
At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.
His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.
