Pharmacy Act of 1948 Quiz

Pharmacy Law and Ethics - D Pharma Second Year

• This document is about Pharmacy law and ethics for second-year D Pharma students, written in easy English.
• The author of the document (S R Pharmacy) provides it for free, but requests a fee of 100 rupees for those who request a copy.
• The document provides details of various acts related to drug and pharmacy practices.

Table of Contents

• The table of contents lists the various chapters and their respective page numbers in the document, covering topics like general principles, different acts related to the pharmacy profession, and the National Pharmaceutical Pricing Authority (NPPA).

General Principles of Law

• The document details general legal principles, including:
  • Rule of Law
  • Separation of power
  • Ignorance of law is not an excuse
  • Consent is not a cause of action if harm was willingly placed
  • An act does not make someone guilty unless the intent is present
  • No one should be punished twice for the same offense
  • No person can be judge in his own case.
• These principles are relevant to understanding various pharmacy-related legal concepts.

Pharmacy Act 1948 and Rules

• The Pharmacy Act 1948 and Rules define the rules, regulations, course duration, qualifications, and penalties, all pertaining to the pharmacy profession.
• Objectives of the Act were to regulate the profession better, improve status, provide standard in education, create a pharmacy council for India and regulate pharmacy institutions.
• Definitions of terms like Central Council, State Council, Registered Pharmacist, etc. are present in the document, with details about these.

History and Various Acts Related to Drugs and Pharmacy Profession

• The document details the history of modern drug manufacturing, which began in India in the late 19th century, and the development of pharmacy acts.
• These include the Pharmacy Act, Drug and Cosmetic Act, Narcotic Drugs and Psychotropic Substances Act, Drugs and Magic Remedies Act, Prevention of Cruelty to Animals Act, Poison Act, FSSAI Act and Rules, Medical termination of pregnancy Act, Clinical Establishment Act, and the Consumer Protection Act.

Pharmacy Act 1948 and Rules (Continued)

• The document details the objectives of the Pharmacy Act of 1948, which focused on establishing standards for the pharmacy profession, and definitions of important terms. This section continues the focus on the legal aspects of the field.

Other Act Descriptions (Summarized)

• The document details different acts related to drugs and pharmacy, such as the Drug and Cosmetic Act, Narcotic Drugs and Psychotropic Substances Act, Preventing Cruelty to Animals Act, and the act pertaining to Poison.
• This section describes the different categories of drugs and covers their manufacture, handling, import, and sale, emphasizing regulations and standards.
• It also tackles the roles of different government authorities and agencies like the Central Drugs Standard Control Organisation (CDSCO) and the Indian Pharmacopoeia Commission (IPC) which are very relevant .

Good Regulatory Practices

• The document outlines good regulatory practices for pharmacies, emphasizing the need for proper maintenance, records, registration processes, documentation of drug purchases for sale and storage, and procedures pertaining to prescriptions.
• Specific requirements for licenses are included.

National Pharmaceutical Pricing Authority (NPPA)

• The document talks about the National Pharmaceutical Pricing Authority (NPPA) and its role in setting and controlling the price of essential drugs.
• The document details the objectives, definitions, responsibilities, and functions of the NPPA.
• The document describes the essential medicines list and regulations, and mentions details about the act (DPCO) and different drug classifications in relation to price control.

New Drug Development

• This section describes the Biopharmaceutics Classification System , different classifications of drugs.
• This section details important aspects of new drug applications (NDA) and clinical trials, as well as aspects of intellectual property and emergency use authorizations.

Blood Bank

• It outlines the requirements and functionality of blood banks, including premises, personnel, equipment, procedures, and storage of blood products.
• It comprehensively details the types of blood products and their appropriate storage conditions.

Clinical Establishment Act and Rules

• Describes rules for establishing clinical establishments in accordance with Indian law, including requirements like registration, documentation, types of registration (provisional and permanent), information needed for registration, and penalties for non-compliance.

Biomedical Waste Management Rules 2016

• This section details the rules pertaining to biomedical waste management policies, classification of waste materials, appropriate handling, duties and responsibilities of parties involved, and general waste handling procedures.

Bioethics

• This section introduces the concept of bioethics, covering its history and principles, which include respect for autonomy, beneficence, non-maleficence, and justice.
• It touches on significant events historically and their importance to present day bioethics practice.

Consumer Protection Act

• It discusses the Consumer Protection Act of 2019, emphasizing its objective to provide protection to consumers through various measures and activities like investigation, resolving disputes both in the national, district, state levels and online.
• It describes the types of complaints and their thresholds and requirements for each level of filing a complaint.

Introduction to the Disaster Management Act

• This chapter focuses on the Disaster Management Act of 2005. It discusses what constitutes a disaster, the roles and responsibilities of different authorities in disaster management (both central and state), and plans, activities, and guidelines for disaster management (including the National Disaster Response Force).

Medical Devices Act

• This section outlines the Medical Devices Act and related regulations, covering the categorization of medical devices by risk level (low, moderate, high).
• Focuses on regulatory approval requirements, quality controls, clinical and regulatory considerations.