The Pharmacy Act, 1948
By Arvind Sharma, B.Pharm, M.Pharm, Assistant Professor, MUIT
The Pharmacy Act, 1948: A Masterclass
Regulating the Profession and Practice of Pharmacy in India
Introduction to the Pharmacy Act, 1948
The Pharmacy Act, enacted in 1948 and effective from 4 March 1948, is a pivotal legislation designed to regulate the profession and practice of pharmacy in India. Its primary goal is to make better provision for the regulation of the profession and practice of pharmacy, and for that purpose, to constitute the Pharmacy Council.
This comprehensive Act comprises 5 chapters and 46 sections, laying down the foundation for pharmacy education, registration, and professional conduct.
Key Chapters of the Pharmacy Act
| Chapter No. | Title | Sections |
|---|---|---|
| Chapter I | Introduction | 1–2 |
| Chapter II | Pharmacy Council of India (PCI) | 3–18 |
| Chapter III | State Pharmacy Councils | 19–28 |
| Chapter IV | Registration of Pharmacists | 29–40 |
| Chapter V | Miscellaneous | 41–46 |
Important Sections Overview
- Section 3: Constitution of PCI
- Section 12: Approval of Courses
- Section 14: Foreign Qualifications
- Section 15A: Central Register
- Section 32C: Special provision for J&K pharmacists (2023)
Latest Amendments
- Pharmacy (Amendment) Act, 2023: Recognizes J&K pharmacists under Section 32C.
- Jan Vishwas Act, 2023: Decriminalizes minor offenses, effective from 31 Dec 2024.
Small offenses will no longer be treated as crimes.
Objectives of the Pharmacy Act
- Regulating and raising the status of the profession of pharmacy in India.
- Providing uniform education and training to persons willing to enter the profession of pharmacy.
- Maintaining control over the persons entering the profession of pharmacy.
- To constitute Pharmacy Council of India for setting new standards in pharmacy education.
- To provide constitution and functions of State Pharmacy Councils for registration of pharmacists.
- To regulate the activities of pharmacists.
The Pharmacy Council of India (PCI)
The Pharmacy Council of India (PCI) is the central regulatory body for pharmacy education and practice in India. It was constituted on 9th August, 1949 under Section 3 of the Pharmacy Act.
In January 2015, the PCI published the Pharmacy Practice Regulations, 2015, setting out critical provisions for regulating pharmacy practice in India.
Important Provisions (Pharmacy Practice Regulations, 2015)
| No. | Provision |
|---|---|
| a | Drugs can be dispensed only by a qualified registered pharmacist |
| b | Registered pharmacists shall not give their registration certificate at more than one pharmacy |
| c | Registered pharmacists shall comply with the dress code (white coat/apron with badge showing name & registration number) |
| d | Registered pharmacists shall dispense only medicines prescribed by a registered medical practitioner |
| e | Maintain medical/prescription records for 5 years from the start of treatment |
| f | Promote the rational use of drugs |
| g | Follow other ethical guidelines of pharmacist conduct |
Constitution of PCI
The Central Government constitutes a Central Council, known as the Pharmacy Council of India.
| Category | Members | Details / Source |
|---|---|---|
| Elected Members | 6 University Teachers | At least one teacher each in Pharmaceutical Chemistry, Pharmacology, Pharmacognosy (teaching staff of Indian University or affiliated college granting degree/diploma in pharmacy), elected by UGC |
| 1 Member | Elected by Medical Council of India (MCI) from its members | |
| 1 Registered Pharmacist per State | Elected by State Pharmacy Council from amongst its members | |
| Nominated Members | 6 Members | At least 4 possessing degree/diploma in pharmacy, engaged in practice of pharmacy or pharmaceutical chemistry, nominated by Central Government |
| 1 Member | Representative of UGC | |
| 1 Member | Representative of AICTE | |
| 1 Registered Pharmacist per State | Nominated by State Government/UT Administration | |
| Ex-Officio Members | Director General of Health Services | Automatic member (DGHS) |
| Director of Central Drugs Laboratory | Automatic member | |
| Drugs Controller of India | Automatic member |
If ex-officio members (DGHS or Director of Central Drugs Lab) are unable to attend any meeting, they may authorize a person in writing to attend in their place.
Functions of PCI: The "GRIPED" Mnemonic
The PCI "GRIPED" – a mnemonic to remember its core functions in maintaining quality, ethics, and professional standards in the pharmacy profession.
1. G – Guide Education
Function: Prescribe minimum standards of education for pharmacists in India.
Explanation: The PCI ensures that all pharmacy programs (D.Pharm, B.Pharm, M.Pharm, Pharm.D) comply with defined minimum curriculum standards. It determines subjects, practical training, and assessment criteria to ensure pharmacists acquire necessary knowledge and skills.
2. R – Regulate Institutions
Function: Approve or withdraw approval of pharmacy colleges and courses.
Explanation: The PCI evaluates institutions based on infrastructure, faculty, laboratories, library resources, and clinical affiliations. Approval can be withdrawn if institutions fail to meet PCI standards (e.g., barring 89 colleges in Maharashtra in 2025 due to non-compliance).
3. I – Inspect and Verify
Function: Conduct inspections to ensure compliance with educational standards.
Explanation: PCI inspectors assess faculty qualifications, laboratory facilities, library resources, and overall infrastructure. Regular inspections are mandatory for institutions to retain approval.
4. P – Professional Oversight
Function: Ensure ethical practices and rational use of medicines by pharmacists.
Explanation: Monitors registered pharmacists to ensure adherence to ethical standards and professional conduct, encouraging rational dispensing, proper record maintenance, and responsible patient counseling.
5. E – Examine and Recognize Courses
Function: Recognize pharmacy courses, examinations, and foreign qualifications.
Explanation: Evaluates Indian pharmacy programs for compliance with national standards and can recognize foreign pharmacy qualifications if they meet Indian requirements, ensuring competency and legal eligibility to practice.
6. D – Digital and Modern Updates
Function: Update regulations to incorporate modern practices, including e-pharmacy, digital records, and Continuing Professional Development (CPD).
Explanation: Regulates e-pharmacy, promotes digital record maintenance, encourages CPD programs, and incorporates modern inspection tools to keep the profession updated.
Administration of the Central Council
President and Vice-President
- Elected by the Council members from among themselves.
- Hold office for a maximum of 5 years or until their membership expires.
- Eligible for re-election.
Terms of Office and Casual Vacancies
- Any nominated/elected member shall hold office for 5 years from date of nomination/election or until successor is duly nominated/elected.
- A member may resign in writing to the President.
- A member is deemed to vacate seat if absent, without sufficient reason, from three consecutive meetings of the Central Council.
- Casual vacancy is filled by fresh nomination/election, and member so appointed holds office only for remaining term.
- Members are eligible for re-nomination or re-election.
Executive Committee
Composed of the President (Chairman), Vice-President, and other members elected by the Central Council from among themselves. Members hold office until the expiry of their Central Council membership term and are eligible for re-election.
Powers of Central Council to Make Regulations
- The Council is authorized to:
- Lay down rules for its procedure.
- Fix allowances for members/committee members (sanctioned by Central Govt).
- Decide modes of election.
- Lay down rules for:
- Management of property.
- Maintenance and auditing of accounts.
- Holding of meetings.
- Fixing functions, duties and powers of Executive Committee, President, Vice-President.
- Qualifications, terms of office, power and duties of Secretary, Inspectors, and other officers.
- The Council may constitute committees for general or special purposes as deemed necessary.
- The Council must furnish copies of its minutes and those of Executive Committee, along with summary of annual activities and accounts, to the Central Government.
- The Central Government may publish any report or abstract in such manner as it thinks proper.
Education Regulations
1. Education Regulations, 1991 (ER 1991)
The Pharmacy Council of India (PCI) makes regulations known as Education Regulations (ER), 1991, which govern pharmacy education in India under Section 10 of the Pharmacy Act, 1948. These regulations prescribe the minimum standards of education required to qualify as a pharmacist.
Key Provisions of ER-1991
| S. No | Provision | Details |
|---|---|---|
| 1 | Minimum Qualification for Admission | Candidates must have passed any of the following: Intermediate examination in Science; First year of three-year degree course in Science; 10+2 examination (academic stream) in Science; Pre-degree examinations; Any other qualification approved by PCI as equivalent |
| 2 | Duration of Course | Two years (Part I & Part II) followed by practical training (Part III) |
| 3 | Practical Training | Minimum 500 hours over ≥3 months, with at least 250 hours devoted to actual dispensing |
| 4 | Approval of Institutions | Must be approved by PCI under Section 12 of the Pharmacy Act, 1948 |
| 5 | Inspection & Approval Process | Institutions must apply, undergo inspection by PCI, and receive approval before offering courses |
| 6 | Withdrawal of Approval | If an institution does not conform to ER, PCI may withdraw approval after considering representation |
| 7 | Subjects & Examination Standards | PCI prescribes subjects and standards of examination for the course |
| 8 | Facilities & Equipment | Institutions must provide prescribed equipment and facilities for students |
| 9 | Conditions for Practical Training & Examinations | Institutions and authorities conducting practical training or examinations must fulfill specified conditions |
Procedure for Approval
Application to States
- After constituting the State Council, the State Government may notify the ER in the Official Gazette.
- If no notification is made, the ER automatically takes effect 3 years after the constitution of the State Council.
2. Pharm.D Regulations 2008
The Pharm.D Regulations, 2008 establish the Doctor of Pharmacy (Pharm.D.) program in India for clinical pharmacy practice.
Types of Pharm.D Programs
| Program | Duration | Phases | Details |
|---|---|---|---|
| Pharm.D (Regular) | 6 academic years (5 years study + 1 year internship/residency) | Phase-I: 1st–5th years (classroom & lab study); Phase-II: 6th year (hospital internship/residency in specialty units) | Exposure to actual clinical pharmacy practice |
| Pharm.D (Post Baccalaureate) | 3 academic years (2 years study + 1 year internship/residency) | Phase-I: 1st & 2nd years; Phase-II: 3rd year (hospital internship/residency) | Practical exposure to clinical pharmacy services |
Each academic year consists of ≥200 working days.
Minimum Qualification for Admission
| Program | Qualification |
|---|---|
| Pharm.D (Regular) |
|
| Pharm.D (Post Baccalaureate) | B.Pharm from PCI-approved institution under Section 12 of the Pharmacy Act |
Other Key Points
- Reservation: SC, ST, and OBC candidates as per Central/State/UT directives.
- Number of Seats: PCI prescribes; currently 30 for Pharm.D, 10 for Pharm.D (Post Bacc).
- Permission: Institutions running B.Pharm may run Pharm.D only after PCI approval; Pharm.D institutions may run Post Bacc programs after PCI approval.
Withdrawal of Approval
- Executive Committee reports non-conformity with ER.
- Central Council issues notice of intent to withdraw approval.
- Institution submits representation within 3 months via State Government.
- Council decides to conditionally continue or withdraw approval based on compliance.
The Central Register of Pharmacists
As per Section 15-A of the Pharmacy Act (Amendment 1976), a Central Register of Pharmacists is maintained to consolidate information on all registered pharmacists across India.
Responsibilities of Central Council
- Maintain a Central Register of Pharmacists, containing names of all registered pharmacists from each state.
- Each State Council must supply five copies of its register annually after April 1 and report all additions and amendments to the Central Council.
- The Registrar of the Central Council maintains, revises, and publishes the Central Register in the Gazette of India.
- The Central Register is deemed a public document under the Indian Evidence Act, 1872. A published copy is sufficient for legal purposes.
Registration Procedure
After receiving the report of registration from a State Register, the Registrar of Central Council enters the name of the person in the Central Register.
State and Joint State Pharmacy Councils
1. State Council of Pharmacy
Definition: A State Council means a State Council of Pharmacy constituted under the Pharmacy Act, 1948, including a Joint State Council formed under an agreement under Section 20 of the Act.
2. Joint State Pharmacy Council
Definition: A Joint State Council is constituted by agreement between two or more State Governments to collectively manage pharmacy regulation.
Constitution of SPC and JSPC
| Component | State Pharmacy Council (Single State) | Joint State Pharmacy Council (Multiple States) |
|---|---|---|
| Elected Members | 6 members elected by registered pharmacists of the State | 3–5 members elected by registered pharmacists of each participating State |
| Medical Council Representative | 1 member elected by members of the State Medical Council or Council of Medical Registration | 1 member elected by members of the Medical Council or Council of Medical Registration of each participating State |
| Nominated Members | 5 members, of which at least 3 must possess: Degree/diploma in Pharmacy or Pharmaceutical Chemistry OR be registered pharmacists | 2–4 members nominated by each participating State Government (must have degree/diploma in Pharmacy or be registered pharmacist) |
| Ex-Officio Members | 3 members: i) Chief Administrative Medical Officer of the State; ii) Officer-in-charge of Drugs Control Organization of the State; iii) Government Analyst | 3 members per State: i) Chief Administrative Medical Officer of each participating State; ii) Officer-in-charge of Drugs Control Organization of each participating State; iii) Government Analyst of each participating State |
3. President and Vice-President
- Elected by Council members from among themselves.
- For first 5 years after constitution, President is nominated by the State Government.
- Term: Maximum 5 years or till the expiry of membership term.
- Eligible for re-election.
4. Terms of Office & Casual Vacancies
| Clause | Details |
|---|---|
| Term of Office | 5 years from date of nomination/election |
| Resignation | Member may resign in writing to the President |
| Absence | Absent without sufficient reason for 3 consecutive meetings → seat deemed vacated |
| Vacancy due to Qualification Loss | Member elected as pharmacist or medical council member must vacate if ceases to hold that position |
| Casual Vacancy | Filled by fresh nomination/election; new member serves only remaining term |
| Re-nomination | Members are eligible for re-election or re-nomination |
5. Staff, Remuneration, and Allowances
With State Government sanction, State Council may:
- Appoint a Registrar (also Secretary and Treasurer) for 4 years from first constitution; appointment made by State Government.
- Appoint other officers/servants as needed to carry out functions.
- Fix remuneration and allowances of President, Vice-President, and other members.
- Fix pay, allowances, and service conditions of officers and servants.
6. Inspectors
Inspectors are appointed by the State Council with State Government approval and must possess prescribed qualifications.
Powers of Inspectors
| Power | Details |
|---|---|
| Inspection | Inspect premises where drugs are compounded/dispensed |
| Verification | Check if persons compounding/dispensing drugs are registered pharmacists |
| Complaints | Investigate complaints made in writing regarding violations |
| Prosecution | Initiate prosecution under Executive Committee orders |
| Other Powers | Exercise other powers necessary to enforce provisions of the Act |
Legal Status
- Inspectors are public servants under Section 21 IPC.
- Willful obstruction → imprisonment ≤6 months, fine ₹1,000, or both.
7. Executive Committee of State Council
- Composed of President (Chairman), Vice-President, and other members elected by the State Council.
- Members hold office until expiry of their State Council membership term.
- Eligible for re-election.
Registration of Pharmacists
1. Definition: Registered Pharmacist
Registered Pharmacist: A person whose name is for the time being entered in the register of the State in which he is residing or carrying on his profession or business of pharmacy [2].
2. Legal Basis
The Pharmacy Act, 1948 (Chapter 4) provides for the registration of pharmacists in all States in India.
- After the chapter takes effect in a State, the first register of pharmacists must be prepared by the State Government.
- A State Pharmacy Council is constituted soon after the first register is prepared. Once constituted, the register is handed over to the State Council, which is responsible for its maintenance.
3. Contents of the Register
The register includes the following particulars:
- Full name and residential address of the registered person.
- Date of first entry in the register.
- Qualification for registration.
- Professional address and, if employed, the name of the employer.
- Any further particulars as may be prescribed.
4. Preparation of First Register
5. Qualification for Entry in First Register
A person who has attained 18 years of age and resides or carries on pharmacy business/profession in the State is eligible upon payment of prescribed fee. Qualifications include:
- Degree or diploma in pharmacy, pharmaceutical chemistry, or chemist & druggist diploma from an Indian University, or a prescribed qualification granted by an authority outside India.
- Degree from an Indian University (other than pharmacy/chemistry) and engaged in compounding of drugs in hospitals/dispensaries for ≥3 years.
- Passed an examination recognized by the State Government for compounders and dispensers.
- Minimum 5 years’ experience of compounding and dispensing in hospitals/dispensaries prior to the date notified for first register application.
6. Subsequent Register
Before Education Regulations:
- Age ≥18 years and payment of prescribed fee.
- Must reside or carry on pharmacy business in the State.
- Qualifications:
- Satisfies conditions for first register or is at least matriculate.
- Registered pharmacist in another State.
- Qualification granted outside India, at least matriculate.
After Education Regulations:
- Age ≥18 years and payment of prescribed fee.
- Must reside or carry on pharmacy business in the State.
- Qualifications:
- Passed an approved examination.
- Possesses foreign qualification.
- Registered pharmacist in another State.
7. Special Provisions (Pharmacy Amendment Act, 1959)
Special registration provisions were made for certain persons affected by historical events such as the Partition of 1947, Reorganization of States in 1956, transfer of foreign settlements, or migration to India after the Act.
Eligible Classes include:
- Displaced persons practicing pharmacy before 4th March 1948.
- Indian citizens practicing pharmacy outside India.
- Persons residing in areas incorporated into India after the Act.
- Persons who applied before the appointed date but were not registered.
- Persons with ≥5 years’ experience in hospitals/dispensaries before appointed date.
- Persons qualified for registration in a pre-1956 State but transferred to another State.
- Persons registered in a pre-1956 State that became part of another State.
- Persons residing or carrying on pharmacy business in an area where registration chapter applies post-1959 amendment.
Application:
- Must be submitted to State Council with prescribed fee.
- Operative for 2 years from commencement; extendable by notification up to 2 years in aggregate.
8. Scrutiny of Applications
- Applications post-deadline are addressed to Registrar of State Pharmacy Council.
- Registrar directs entry in register if applicant qualifies.
- Persons removed from any State register cannot register without State Council approval.
- Rejected applications may appeal to State Council within 3 months.
- Certificate of registration issued upon entry.
9. Renewal Fees
- Name retained in register after 31st December of the following year, subject to annual payment before 1st April.
- Non-payment leads to removal; can be restored on conditions.
- Receipt of fee serves as proof of renewal.
- Additional qualifications can be entered on payment of fee.
10. Removal of Names from Register
Conditions for removal by Executive Committee:
- Entry by error, misrepresentation, or suppression of material fact.
- Conviction for any offence or infamous conduct rendering the pharmacist unfit.
- Employees’ offences if the pharmacist employed them and had knowledge.
Additional Criteria:
- Offence/conduct instigated or known by pharmacist.
- Similar offence in previous 12 months.
- Offence continued over long period with knowledge.
- Offence under Drugs & Cosmetics Act without pharmacist’s oversight.
Procedure:
- Removal can be permanent or temporary.
- Order confirmed by State Pharmacy Council, effective after 3 months.
- Aggrieved person may appeal to State Government within 30 days.
- Surrender of registration certificate required; removal published in Official Gazette.
11. Restoration of Names
- State Council may restore a removed name upon payment of fee.
- If appeal rejected by State Government, restoration requires Government confirmation.
12. Issue of Duplicate Certificates
- If registration certificate is lost/destroyed, Registrar may issue a duplicate certificate on payment of prescribed fee.
Offences and Penalties under the Pharmacy Act 1948
The Pharmacy Act, 1948, defines offences related to unauthorized practice and false claims by persons not registered as pharmacists. Penalties ensure protection of public health and professional accountability.
1. Falsely Claiming to Be a Registered Pharmacist
Definition: Any person whose name is not entered in the State register of pharmacists who: Falsely claims to be a registered pharmacist, or Uses any title, description, or letters suggesting registration, such as: Pharmacist, Chemist, Druggist, Pharmaceutist, Dispenser, Dispensing Chemist, Any combination of the above.
Punishment:
- First conviction: Fine up to ₹500.
- Subsequent conviction: Imprisonment up to 6 months, or fine up to ₹1,000, or both.
Exemption:
- A person who is a registered pharmacist in another State and has filed an application for registration in the State will not be guilty of this offence.
Cognizance:
- Legal action can only be taken upon complaint by the State Government or the Executive Committee of the State Pharmacy Council.
2. Dispensing by Unregistered Persons
Definition: Any person other than a registered pharmacist who dispenses medicines to patients.
Punishment:
- Imprisonment up to 6 months, or
- Fine up to ₹1,000, or
- Both imprisonment and fine.
Objective:
- Ensures that only qualified and registered pharmacists dispense medicines.
- Prevents unqualified individuals from compromising patient safety.
Summary of Offences and Penalties
| Offence | Definition | Punishment | Notes |
|---|---|---|---|
| False claim | Using titles like Pharmacist, Chemist, Druggist without registration | 1st: Fine ₹500; Subsequent: Imprisonment for not more than 6 months or fine up to ₹1,000, or both | Not guilty if registered in another State & applied for registration |
| Unregistered dispensing | Dispensing medicines without being registered | Imprisonment for not more than 6 months or fine up to ₹1,000, or both | Only registered pharmacists can dispense |
Key Concepts
- Pharmacy Act, 1948: Legislation regulating pharmacy profession in India.
- Pharmacy Council of India (PCI): Central regulatory body for pharmacy education and practice.
- State Pharmacy Councils (SPC): State-level bodies for pharmacist registration and local regulation.
- Education Regulations (ER): Standards prescribed by PCI for pharmacy education.
- Central Register of Pharmacists: National database of all registered pharmacists.
- Registered Pharmacist: A person legally qualified and registered to practice pharmacy.
- Dispensing: The act of preparing and providing medicines to patients.
Important Points
- The Pharmacy Act came into effect on 4 March 1948.
- PCI was constituted on 9th August, 1949.
- The PCI's functions can be remembered by the mnemonic "GRIPED".
- Minimum practical training for D.Pharm under ER-1991 is 500 hours over ≥3 months.
- Casual vacancies in councils are filled for the remaining term only.
- Inspectors are public servants under Section 21 IPC.
- Falsely claiming to be a registered pharmacist or dispensing by an unregistered person carries penalties up to 6 months imprisonment or ₹1,000 fine (or both) for subsequent offenses.
- Latest amendments in 2023 include recognition of J&K pharmacists and decriminalization of minor offenses.
Summary
The Pharmacy Act, 1948, is the cornerstone legislation governing the pharmacy profession in India. It established the Pharmacy Council of India (PCI) to set and maintain educational standards (ER-1991, Pharm.D Regulations 2008), approve institutions, and regulate professional conduct. The Act also mandates the constitution of State and Joint State Pharmacy Councils for the registration of pharmacists and local oversight. Key provisions cover the eligibility for registration, maintenance of registers (including a Central Register), renewal procedures, and grounds for removal or restoration of names. Crucially, the Act defines offences such as falsely claiming to be a registered pharmacist or dispensing by unregistered individuals, imposing penalties to safeguard public health and uphold professional accountability. Recent amendments, like those in 2023, reflect the evolving landscape of pharmacy practice and legal reform.