Pharmacy Act, 1948: In-Depth Analysis

Introduction

The Pharmacy Act, 1948 is a crucial piece of legislation in India that regulates the education and profession of pharmacy to ensure the availability of qualified pharmacists in the country. It was enacted on 4th March 1948 and came into force on 1st September 1949. The primary objective of this Act is to establish a uniform standard of education and practice for pharmacists throughout India.

Objectives of the Pharmacy Act, 1948

The Pharmacy Act, 1948, was introduced with the following objectives:

1. Regulation of the pharmacy profession by establishing State Pharmacy Councils (SPCs) and the Pharmacy Council of India (PCI).
2. Maintaining uniformity in pharmacy education by setting standards for courses, examinations, and qualifications.
3. Ensuring proper registration of pharmacists to prevent unqualified individuals from practicing pharmacy.
4. Promoting ethical practices and professional conduct in the field of pharmacy.
5. Protecting public health by ensuring that medicines are dispensed only by qualified professionals.

Key Provisions of the Pharmacy Act, 1948

The Act consists of five chapters covering definitions, pharmacy councils, education regulations, registration of pharmacists, and miscellaneous provisions.

Chapter I: Preliminary (Sections 1–2)

• Defines key terms such as “pharmacist,” “registered pharmacist,” and “State Pharmacy Council.”
• Specifies the applicability of the Act throughout India except for Jammu and Kashmir (initially, but now applicable after Article 370 was repealed).

Chapter II: The Pharmacy Council of India (Sections 3–15)

This chapter deals with the establishment, composition, and functions of the Pharmacy Council of India (PCI).

1. Constitution of the Pharmacy Council of India (PCI)

The PCI is the apex regulatory body under the Act and consists of:

• Six members elected by the University Grants Commission (UGC) from faculty members of pharmacy colleges.
• Six members nominated by the Central Government.
• One representative from the Medical Council of India (MCI).
• One representative from each State Pharmacy Council (SPC).
• A Director-General from the Health Services of India.
• A Drug Controller of India or his nominee.

2. Functions of the Pharmacy Council of India (PCI)

The PCI has the following major functions:

1. Framing education regulations for pharmacy courses (such as Diploma in Pharmacy (D. Pharm), Bachelor of Pharmacy (B. Pharm), and Master of Pharmacy (M. Pharm)).
2. Approval and recognition of pharmacy institutions in India.
3. Prescribing minimum standards of education required for qualifying as a pharmacist.
4. Maintaining a central register of pharmacists.
5. Advising the State Governments on matters related to pharmacy education and practice.

Chapter III: State Pharmacy Councils (Sections 16–19)

Each state is required to establish a State Pharmacy Council (SPC) to regulate the pharmacy profession at the state level.

1. Constitution of the State Pharmacy Council (SPC)

The SPC consists of:

• Six elected members from registered pharmacists.
• One representative from the Medical Council of India (MCI).
• One representative of the State Government.
• The Chief Administrative Officer of the Drug Control Department.

2. Functions of the State Pharmacy Council (SPC)

• Maintaining the register of pharmacists at the state level.
• Granting and renewing pharmacist registrations.
• Taking disciplinary actions against erring pharmacists.
• Ensuring that only qualified individuals practice as pharmacists.

Chapter IV: Education Regulations (Sections 10–21)

• Prescribes minimum qualifications for pharmacists.
• Sets the syllabus and curriculum for pharmacy courses.
• Specifies conditions for practical training.
• Empowers the PCI to approve or disapprove institutions that offer pharmacy education.
• Mandates state governments to appoint Inspectors to ensure that institutions maintain the prescribed standards.

Chapter V: Registration of Pharmacists (Sections 25–41)

This chapter deals with the registration process of pharmacists in India.

1. Conditions for Registration

To be registered as a pharmacist, an individual must:

1. Hold a recognized pharmacy qualification (D. Pharm or B. Pharm).
2. Have practical training as prescribed by the PCI.
3. Be of sound mind and good character.

2. State Registers of Pharmacists

• Each SPC maintains a state register of pharmacists.
• Only those who are registered can legally practice pharmacy.
• The Central Register of Pharmacists is maintained by the PCI.

3. Renewal and Removal of Names

• Pharmacists need to renew their registration periodically.
• The SPC has the authority to remove a pharmacist’s name in case of professional misconduct.

Amendments to the Pharmacy Act, 1948

Several amendments have been made to the Act to keep it relevant with changing times. Some of the significant amendments include:

1. Pharmacy (Amendment) Act, 1959 – Expanded the role of the PCI.
2. Pharmacy (Amendment) Act, 1976 – Strengthened education regulations.
3. Pharmacy (Amendment) Act, 1982 – Allowed diploma holders to continue practice.
4. Recent Amendments – Modernized the syllabus to include clinical pharmacy, industrial pharmacy, and pharmaceutical technology.

Impact of the Pharmacy Act, 1948

The Act has had a significant impact on the pharmacy profession in India:

1. Improved pharmacy education standards through PCI regulations.
2. Eliminated unqualified practitioners from the profession.
3. Established a structured regulatory framework through PCI and SPCs.
4. Promoted ethical dispensing practices to protect public health.
5. Enhanced recognition of pharmacists as healthcare professionals.

Challenges in Implementation

Despite its success, the Act faces several challenges:

1. Variations in pharmacy education quality across different states.
2. Lack of enforcement in rural areas.
3. Illegal practice by unqualified individuals in some regions.
4. Need for modernization to align with global pharmacy standards.

Conclusion

The Pharmacy Act, 1948, serves as the backbone of the pharmacy profession in India. It has played a pivotal role in regulating pharmacy education, licensing, and professional practice. However, continuous updates and effective enforcement are required to keep pace with advancements in pharmacy and healthcare.

The Act ensures that only qualified pharmacists handle medicines, thereby safeguarding public health and enhancing the credibility of the pharmacy profession in India.