2. PHARMACY ACT-1948 AND RULES

PHARMACY ACT, 1948 AND RULES

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.

OBJECTIVES OF PHARMACY ACT

1. To make better provisions for regulating the profession and practice of pharmacy.
2. To raise the status of “Profession of Pharmacy” in India.
3. To constitute “Pharmacy Council of India” for setting new standards in pharmacy education.
4. To regulate pharmacy institutions, especially “Diploma in Pharmacy” through education regulations with registration of pharmacists.

DEFINITIONS UNDER PHARMACY ACT

• 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)

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

1. Providing simpler ways to become a licensed member (Education Regulations)
2. Ensuring consistent educational standards nationwide
3. Defining responsibilities of president, vice president, secretary, inspectors, and executive committee members
4. Authorising academic training institutes offering pharmacy courses
5. Revoking permission for non-compliance with prescribed standards
6. Approving foreign qualifications
7. 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

1. D.Pharm is the minimum qualification for a pharmacist.
2. Nature and timeframe of pharmacy course
3. At least 75 hours of practical training (minimum 3 months) at PCI-approved facility
4. Facilities and equipment required for institutions
5. Requirements for practical training institutions
6. 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

1. Fixes compensation rates for officers and allowances for members
2. Provides annual activity summary and financial statements to State Government and PCI
3. Gives one-half of received money to PCI annually
4. Appoints inspectors to examine pharmacies and investigate complaints
5. Regulates pharmacists’ registration and maintains registers
6. 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