Pharmacy is a field of medicine and a profession that is concerned with the creation, distribution, and safe administration of pharmaceuticals and treatments. Pharmacists ensure patients receive the right prescriptions in the right doses. A pharmacist is a qualified person who explains safe and effective administration of medicine to patients. Pharmacy plays a crucial part in the healthcare system.
The Pharmacy Act of 1948 is an essential legislation of Indian law regulating pharmacy practice and how pharmacies are run nationwide. The Act has undergone numerous amendments to reflect the evolving state of pharmacy practice and healthcare. The Pharmacy Act specifies the criteria for operating pharmacy institutions and programs in India. The Act establishes requirements for the education and qualifications of how a person can become a chemist. In India, only registered chemists can dispense medicine. The Pharmacy Act allows the government to control the standards for medications and pharmaceuticals. Drug control authorities at both the State and Central levels help in implementing drug-related legislation.
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The Pharmacy Act
The Pharmacy Act of 1948 was enacted to formulate pharmacy-related rules. The Pharmacy Act received assent on 04 March 1948. The Act has a total of 46 Sections and 5 Chapters. Pre-Independence, a law governing the pharmacy profession in India was yet to be formulated. Because requirements were not set for chemists, this created oversight, raising concerns regarding the reliability and safety of medications. To assure the safety and effectiveness of medicines, the Indian government realised the necessity to maintain the pharmacy profession. The Pharmacy Bill, further known as the Pharmacy Act of 1948, was introduced.
The Pharmacy Council of India Under the Pharmacy Act of 1948
Chapter 2 Section 3 of the Pharmacy Act discusses the Constitution and Composition of the Central Council. The Central Government constitutes the Central Council:
- The council is delineated to have six members, and one person as a teacher in pharmaceutical chemistry, pharmacy, pharmacology, or pharmacognosy will be elected by the University Grants Commission from Indian University or affiliated College.
- Four members are nominated by the Central Government. These members must possess a degree or diploma in pharmacy or pharmaceutical chemistry.
- The Medical Council of India will elect one member.
- The ex-officio members will be the Director General of Health Services, the Drug Controller of India, and the Director of the Central Drug Authority.
- The State Council will elect one member to represent his state, and he/she must be a registered Pharmacist.
- The State Council will nominate one member to represent his/her state, and he/she must be a registered Pharmacist.
Section 10 of the Pharmacy Act provides Educational Regulations for Pharmacists. This section gives authority to the Central Council on the Central Government’s approval for creating the Education Regulations and setting the minimum education standards for qualification as a pharmacist.
- The regulations must include the nature and duration of education and practical training that is required before a student can take an examination.
- The regulations must include facilities and resources that educational institutions provide for students in approved courses.
- The subjects for examinations and the required performance standards.
- Any other criteria for eligibility to take examinations.
- Before submitting these regulations or any amendments for the Central Government’s approval, the Central Council has to share drafts and changes with all State Governments. They have to consider comments from State Governments, which are received within 3 months.
- When these regulations are approved, the regulations are published in the Official Gazette and as directed by the Central Council.
- The Executive Committee periodically assesses the effectiveness of these regulations and can propose amendments to the Central Council.
Section 12 of the Act describes the approved course of study and examination:
- Any State authority offering a Pharmacy course must seek approval from the Central Council. On approval, the course is recognised as an approved course of study. This recognition allows students to become recognised pharmacist examinations upon completion.
- State authorities conducting pharmacist exams can apply for Central Council approval. Approved examinations enable successful candidates to register as pharmacists under the Act.
- State authorities conducting approved courses or exams must provide requested information to the Central Council. Information includes curriculum, training, age requirements, and other relevant exam details. This ensures transparency and quality control in pharmacy education and examination processes.
Registration of Pharmacists Under the Pharmacy Act,1948
Section 30 of the Pharmacy Act details the preparation of a register:
- State Government establishes a Registration Tribunal with three members and a Registrar as Secretary.
- Applicants submit registration applications and fees by a specified deadline.
- The tribunal evaluates applications, adds approved registrations to the First Register, and subsequently publishes it.
- Dissatisfied parties can appeal within 60 days; the Registrar updates the register per the authority’s decision and issues certificates. Registration custody transfers and application fees may be credited to the Council’s account if a State Council is formed as per State Government instruction.
Section 36 of the Pharmacy Act: The removal of Pharmacist’s name from the Register can occur as follows:
- Executive Committee empowered to remove pharmacist’s name from register based on certain conditions:
- Incorrect or deceptive registration.
- Pharmacists convicted of an offence or involved in unprofessional conduct, including their employees.
- The order may include permanent ineligibility or a specified suspension period; the State Council must confirm it.
- The order takes effect 3 months from confirmation.
- Right to appeal confirmed order to State Government within 30 days; State Government’s decision final.
- Individual surrenders registration certificate; removal published in Official Gazette.
List of Amendments under The Pharmacy Act,1948
Pharmacy (Amendment) Act, 1959 details changes related to the constitution and functions of the Pharmacy Council of India (PCI).
Pharmacy (Amendment) Act, 1976, expanded the scope of the Pharmacy Act to include the registration of pharmacy teachers.
Pharmacy (Amendment) Act, 1995, introduced provisions for the registration of pharmacists and pharmacy institutions as well as the recognition of pharmacy qualifications.
The Pharmacy (Amendment) Act, 2008, primarily focused on expanding the definition of ‘pharmacist’ and included provisions related to the conduct of pharmacy courses, examinations, and the recognition of pharmacy institutions.
The Pharmacy (Amendment) Act, 2012, is focused on regulating pharmacy education and establishing new pharmacy institutions.
Pharmacy (Amendment) Act 2016 is primarily focused on changes in the composition of the Pharmacy Council of India and expanded its functions.
Provisions in the Act for Regulation of Online Pharmacies
No specific regulations exist for online sales in the pharmacy sector. However, the following acts can be considered to encompass online sales and pharmacy-related matters:
- Drugs and Cosmetics Act, 1940
- Information Technology Act, 2000
- Guidelines Issued by Regulatory Authorities
- Indian Medical Council Act, 1956
- Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulation 2002)
- Drugs and Cosmetics Act, 1940 and Rules 1945
- Clinical Establishment (Registration and Regulation) Act, 2010.
The scope of practice for pharmacists can expand in the future. This may entail granting chemists the authority to perform health checks, immunisations, prescribe specific medications, and provide broad patient care services. The expansion of e-pharmacies has rendered it necessary to include particular rules in the Act to control how online pharmacy platforms are operated, licensed, and ensured to provide superior services. In the future, an amendment to the Pharmacy Act can be required to provide regulatory issues relating to telemedicine and online pharmacy services because of the expanding role of telemedicine.
Providing ethical and safe pharmacological treatment through these platforms is critical. To guarantee that Indian chemists are well-prepared to participate in worldwide healthcare programs and interactions, the Act also requires certain provisions to align with trends in pharmacy practice and education and some training for individuals around the world.
FAQs on the Pharmacy Act 1948
What is the Pharmacy Act of 1948?
The Pharmacy Act of 1948 in India regulates the pharmacy profession, pharmaceutical education, and pharmacy practice. The Pharmacy Act applies to pharmacists, pharmacy institutions, and pharmacy education in India. The Act sets standards for the education and practice of pharmacists.
What are the powers and functions of the PCI?
Section 19 details PCI's powers and functions, which include regulating pharmacy education, maintaining the Pharmacist Register, prescribing standards of education, and promoting research in pharmaceutical sciences.
What is the significance of Section 33 in the Pharmacy Act?
Section 33 presents the PCI the power to create rules known as Education Regulations. These regulations can establish the minimum education standards required for qualification as a pharmacist.
Can a person with a foreign pharmacy degree be granted registration?
If the Pharmacy Council of India recognises the degree under Section 31 of the Act, then individuals with foreign pharmacy qualifications can be registered under certain conditions.