Pharmaceutical Ethics and Related Acts One Shot Notes and MCQs
Pharmaceutical Ethics
Pharmaceutical ethics encompasses the moral principles that guide the behavior and decisions of pharmacists, pharmaceutical scientists, and healthcare professionals. The main goals are to protect patient welfare, ensure product safety, and maintain professional integrity.
- Patient Confidentiality: A pharmacist should respect and protect patient information, maintaining confidentiality in all transactions.
- Professional Competence: Pharmacists should continually update their knowledge to provide the best service and stay compliant with evolving drug laws and guidelines.
- Informed Consent: Before any clinical trials or patient interaction involving pharmaceutical products, informed consent is mandatory.
- Conflict of Interest: Any potential conflicts that may compromise professional decisions should be avoided or disclosed.
- Professional Responsibility: Pharmacists have a responsibility to report any adverse reactions, unsafe products, or unethical practices that may harm public health.
Pharmacy Act 1948
The Pharmacy Act of 1948 was enacted to regulate pharmacy education and the practice of pharmacy in India. The Act established the Pharmacy Council of India (PCI) to oversee standards in pharmacy education and regulate the practice of pharmacy professionals.
- Objectives: To ensure proper training for pharmacists and promote high standards of pharmaceutical practice.
- Pharmacy Council of India (PCI): Formed to regulate pharmacy education and maintain educational standards. It prescribes minimum qualifications, conducts examinations, and registers pharmacists.
- State Pharmacy Councils (SPCs): Established in every state to register pharmacists and enforce pharmacy regulations.
- Eligibility: To register as a pharmacist, an individual must hold at least a Diploma in Pharmacy (D.Pharm).
- Amendments: The Act has undergone amendments to adapt to advancements in pharmacy education and address the needs of the healthcare sector.
Drugs and Cosmetics Act 1940 and Rules 1945
The Drugs and Cosmetics Act 1940 regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India to ensure their safety, efficacy, and quality.
- Objectives:
- To prevent the sale of substandard drugs and cosmetics.
- To regulate the production, import, and export of pharmaceuticals and cosmetics in India.
- Drugs Technical Advisory Board (DTAB): Advises the central and state governments on technical issues related to drug control.
- Central Drugs Standard Control Organization (CDSCO): The primary regulatory body for drug control, led by the Drug Controller General of India (DCGI).
- Schedules:
- Schedule M: Good Manufacturing Practices (GMP) for drugs.
- Schedule H: Prescription drugs (only sold on a prescription).
- Schedule X: Narcotic and psychotropic substances requiring stringent control.
- Schedule Y: Guidelines for clinical trials and requirements for import/manufacture of new drugs.
- Amendments: This Act has been amended several times to cover new drug categories, clinical trial regulations, and enhanced penalties for non-compliance.
Medicinal & Toilet Preparations (Excise Duties) Act 1955
This Act was introduced to impose and collect excise duties on medicinal and toilet preparations containing alcohol, narcotics, or other controlled substances.
- Objectives:
- To regulate the use of alcohol and narcotic substances in medicinal and toilet products.
- To ensure proper taxation of products that could be potentially abused.
- Excise Duty: The tax imposed on medicinal products containing alcohol or narcotic ingredients, collected by the government.
- Regulatory Oversight: The Central Board of Excise and Customs oversees the collection of excise duties and ensures compliance with this Act.
- Rules and Licensing: Manufacturers of medicinal or toilet preparations must obtain a license from the government, and they are subject to regular inspections.
Narcotic Drugs & Psychotropic Substances Act 1985 & Rules
The Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985 is India’s principal law to regulate the production, sale, possession, and use of narcotic drugs and psychotropic substances.
- Objectives:
- To prevent drug abuse and illegal drug trafficking.
- To regulate the legal production and usage of narcotic and psychotropic substances for medical and scientific purposes.
- Central and State Control: The Act empowers central and state governments to control drug production, transportation, and distribution.
- Important Provisions:
- Possession and Punishment: Possession, sale, or transportation of narcotics without a license is punishable by law.
- NDPS Rules: Specifies regulations on the cultivation of cannabis, coca, and opium poppy plants for medical use.
- Punishment Severity: Penalties are based on the quantity of the substance, distinguishing between small and commercial quantities, and include heavy fines and imprisonment.
- Amendments: Over time, the Act has been amended to address emerging drug abuse trends, increase penalties, and refine medical-use permissions.
Drugs Price Control Order (DPCO)
The Drugs Price Control Order (DPCO) is a regulation issued by the government under the Essential Commodities Act to control the prices of essential drugs in India.
- Objectives:
- To ensure availability of essential drugs at affordable prices.
- To prevent drug price inflation and keep vital medicines within reach of the general population.
- National Pharmaceutical Pricing Authority (NPPA): The NPPA is responsible for enforcing price control and setting ceiling prices for scheduled drugs.
- Scheduled and Non-Scheduled Drugs:
- Scheduled Drugs: Essential drugs included in the National List of Essential Medicines (NLEM) with price caps.
- Non-Scheduled Drugs: Prices of these drugs are not directly controlled, but price increases are monitored.
- Ceiling Prices: A maximum allowable price that manufacturers can charge for a specific drug.
- Recent Amendments: DPCO has evolved to include more drugs and address new challenges in drug affordability and availability.
MCQs on Pharmaceutical Ethics and Related Acts
1. What is the primary objective of pharmaceutical ethics?
a) To promote sales of pharmaceuticals
b) To protect patient welfare and ensure safety
c) To increase drug prices
d) To facilitate drug approvals
Answer: b) To protect patient welfare and ensure safety
2. Which of the following is NOT a responsibility of a pharmacist under ethical guidelines?
a) Respecting patient confidentiality
b) Promoting drug misuse
c) Providing accurate drug information
d) Reporting adverse drug reactions
Answer: b) Promoting drug misuse
3. The Pharmacy Act 1948 was enacted to regulate:
a) Drug prices
b) Drug marketing
c) Pharmacy education and practice
d) Drug research
Answer: c) Pharmacy education and practice
4. What organization was established by the Pharmacy Act 1948?
a) Central Drugs Standard Control Organization (CDSCO)
b) Drug Controller General of India (DCGI)
c) Pharmacy Council of India (PCI)
d) National Pharmaceutical Pricing Authority (NPPA)
Answer: c) Pharmacy Council of India (PCI)
5. Which Drugs and Cosmetics Act schedule outlines the requirements for Good Manufacturing Practices (GMP)?
a) Schedule H
b) Schedule M
c) Schedule Y
d) Schedule X
Answer: b) Schedule M
6. Under the Drugs and Cosmetics Act 1940, a “drug” is defined as:
a) Only prescription medications
b) Any substance used for diagnosis, treatment, or prevention of disease
c) Only synthetic medications
d) Natural substances only
Answer: b) Any substance used for diagnosis, treatment, or prevention of disease
7. What does Schedule H of the Drugs and Cosmetics Act regulate?
a) Over-the-counter drugs
b) Prescription drugs
c) Narcotic drugs
d) Herbal medicines
Answer: b) Prescription drugs
8. The primary purpose of the Medicinal and Toilet Preparations (Excise Duties) Act 1955 is to:
a) Regulate the sale of herbal products
b) Impose excise duties on certain products containing alcohol or narcotics
c) Control the distribution of antibiotics
d) Ensure drug quality and safety
Answer: b) Impose excise duties on certain products containing alcohol or narcotics
9. Which body is responsible for collecting excise duties under the Medicinal & Toilet Preparations Act?
a) State Pharmacy Council
b) Central Board of Excise and Customs
c) Drug Controller General of India
d) National Pharmaceutical Pricing Authority
Answer: b) Central Board of Excise and Customs
10. The Narcotic Drugs and Psychotropic Substances Act 1985 is designed to:
a) Regulate cosmetic products
b) Prevent drug abuse and illegal trafficking
c) Increase the availability of narcotics
d) Promote pharmaceutical education
Answer: b) Prevent drug abuse and illegal trafficking
11. What does the term “commercial quantity” refer to in the context of the NDPS Act?
a) Amount for personal use
b) Amount that may be sold legally
c) A quantity that attracts severe penalties
d) A quantity exempt from regulation
Answer: c) A quantity that attracts severe penalties
12. Which of the following is classified as a narcotic drug under the NDPS Act?
a) Aspirin
b) Codeine
c) Paracetamol
d) Ibuprofen
Answer: b) Codeine
13. What is the main purpose of the Drugs Price Control Order (DPCO)?
a) To regulate drug manufacturing processes
b) To control the prices of essential drugs
c) To encourage pharmaceutical exports
d) To prevent drug shortages
Answer: b) To control the prices of essential drugs
14. Under DPCO, which of the following drugs is likely to have a ceiling price?
a) Herbal medicines
b) Non-prescription vitamins
c) Scheduled drugs
d) Over-the-counter analgesics
Answer: c) Scheduled drugs
15. The National Pharmaceutical Pricing Authority (NPPA) is primarily responsible for:
a) Drug marketing
b) Drug safety
c) Monitoring drug prices and controlling costs
d) Conducting clinical trials
Answer: c) Monitoring drug prices and controlling costs
16. Which of the following principles is NOT a part of pharmaceutical ethics?
a) Beneficence
b) Non-maleficence
c) Autonomy
d) Profit maximization
Answer: d) Profit maximization
17. In which of the following situations is a pharmacist most likely to breach ethical standards?
a) Providing accurate information to a patient
b) Selling a drug without a prescription
c) Ensuring patient confidentiality
d) Reporting adverse effects of drugs
Answer: b) Selling a drug without a prescription
18. The term “heptan” refers to:
a) A type of drug
b) A low-molecular-weight antigen
c) A high-molecular-weight protein
d) A type of vaccine
Answer: b) A low-molecular-weight antigen
19. What is a key component of informed consent in pharmacy practice?
a) Prescribing as many medications as possible
b) Providing full disclosure of treatment options and risks
c) Maintaining strict confidentiality of all patient information
d) Offering discounts for medications
Answer: b) Providing full disclosure of treatment options and risks
20. Which of the following acts regulates the testing and approval of new drugs in India?
a) Pharmacy Act 1948
b) Drugs and Cosmetics Act 1940
c) Medicinal & Toilet Preparations Act 1955
d) Narcotic Drugs Act 1985
Answer: b) Drugs and Cosmetics Act 1940
21. The Pharmacy Act 1948 mandates that a pharmacist must possess at least:
a) A Doctor of Pharmacy degree
b) A Bachelor of Pharmacy degree
c) A Diploma in Pharmacy
d) No formal qualification
Answer: c) A Diploma in Pharmacy
22. Which section of the Drugs and Cosmetics Act deals with the prohibition of misbranded drugs?
a) Section 16
b) Section 17
c) Section 18
d) Section 19
Answer: b) Section 17
23. Under the Drugs and Cosmetics Act, the term “adulterated drug” refers to a drug that:
a) Contains an active ingredient in insufficient quantity
b) Is expired
c) Has not been approved by the FDA
d) Is a non-prescription drug
Answer: a) Contains an active ingredient in insufficient quantity
24. The maximum punishment for possession of a narcotic drug under the NDPS Act is:
a) 1 year imprisonment
b) 5 years imprisonment
c) 10 years imprisonment
d) Life imprisonment
Answer: d) Life imprisonment
25. What is a primary reason for imposing excise duties on medicinal preparations?
a) To enhance product quality
b) To prevent misuse of products
c) To generate government revenue
d) To encourage pharmaceutical innovation
Answer: c) To generate government revenue
26. Which of the following statements regarding the DPCO is TRUE?
a) It only applies to non-prescription drugs.
b) It aims to keep drug prices high.
c) It provides ceiling prices for scheduled drugs.
d) It is optional for pharmaceutical companies.
Answer: c) It provides ceiling prices for scheduled drugs
27. In which of the following scenarios would a pharmacist likely violate ethical standards?
a) Disclosing a patient’s medication history without consent
b) Offering to counsel patients on medication use
c) Refusing to fill a prescription for a suspected misuse
d) Keeping patient information confidential
Answer: a) Disclosing a patient’s medication history without consent
28. According to the Pharmacy Act 1948, the minimum age for registration as a pharmacist is:
a) 18 years
b) 21 years
c) 25 years
d) 30 years
Answer: a) 18 years
29. Which of the following is an example of a psychotropic substance under the NDPS Act?
a) Morphine
b) Cocaine
c) Diazepam
d) Codeine
Answer: c) Diazepam
30. Which is NOT a primary function of the Central Drugs Standard Control Organization (CDSCO)?
a) Conducting clinical trials
b) Monitoring drug quality
c) Approving new drug applications
d) Setting prices for drugs
Answer: d) Setting prices for drugs
31. The primary goal of the Narcotic Drugs and Psychotropic Substances Act is to:
a) Increase access to narcotics for medical use
b) Regulate the production of all drugs
c) Combat drug trafficking and abuse
d) Reduce pharmaceutical costs
Answer: c) Combat drug trafficking and abuse
32. Under the DPCO, what determines the ceiling price for a drug?
a) Market demand
b) Production cost
c) The price set by the manufacturer
d) Government guidelines
Answer: d) Government guidelines
33. Pharmaceutical ethics emphasizes the importance of which of the following?
a) Profiting from patients
b) Transparency in drug pricing
c) Researching only profitable drugs
d) Patient autonomy and welfare
Answer: d) Patient autonomy and welfare
34. Which of the following acts includes provisions for the approval and registration of drugs in India?
a) Pharmacy Act 1948
b) Drugs and Cosmetics Act 1940
c) Medicinal and Toilet Preparations Act 1955
d) Narcotic Drugs and Psychotropic Substances Act 1985
Answer: b) Drugs and Cosmetics Act 1940
35. A pharmacist’s role in clinical trials includes:
a) Developing new drugs
b) Ensuring patient safety and compliance
c) Marketing the drug
d) Conducting the trial independently
Answer: b) Ensuring patient safety and compliance
36. What is the penalty for selling drugs without a license as per the Drugs and Cosmetics Act?
a) Fine only
b) Imprisonment only
c) Both fine and imprisonment
d) No penalty
Answer: c) Both fine and imprisonment
37. Under the NDPS Act, which of the following is a Schedule I drug?
a) Cannabis
b) Cocaine
c) Heroin
d) All of the above
Answer: d) All of the above
38. What type of drugs does the Medicinal and Toilet Preparations (Excise Duties) Act regulate?
a) Prescription drugs only
b) Non-prescription drugs only
c) Alcohol-containing medicinal and toilet preparations
d) Herbal remedies
Answer: c) Alcohol-containing medicinal and toilet preparations
39. Which body is responsible for the enforcement of the Narcotic Drugs and Psychotropic Substances Act?
a) State Police
b) Central Bureau of Narcotics
c) Food and Drug Administration (FDA)
d) Pharmacy Council of India
Answer: b) Central Bureau of Narcotics
40. The Drugs Price Control Order was first introduced in which year?
a) 1982
b) 1995
c) 1970
d) 1991
Answer: c) 1970
41. What does “ethical practice” in pharmacy involve?
a) Maximizing profit at the expense of care
b) Providing unnecessary medications
c) Balancing profit with patient care and safety
d) Avoiding any contact with patients
Answer: c) Balancing profit with patient care and safety
42. The Pharmacy Act allows for the establishment of what type of councils?
a) Local Pharmacy Councils
b) National Pharmacy Council
c) State Pharmacy Councils
d) All of the above
Answer: d) All of the above
43. The Drugs and Cosmetics Act mandates that clinical trials must adhere to which set of guidelines?
a) WHO guidelines
b) Local state laws
c) DPCO regulations
d) None of the above
Answer: a) WHO guidelines
44. Which of the following statements about the Drugs Price Control Order is FALSE?
a) It applies only to scheduled drugs.
b) It allows for free pricing of all drugs.
c) It helps ensure affordable access to essential medicines.
d) It is enforced by the NPPA.
Answer: b) It allows for free pricing of all drugs.
45. Pharmacists are required to report adverse drug reactions under which act?
a) Drugs and Cosmetics Act
b) Pharmacy Act
c) Narcotic Drugs Act
d) All of the above
Answer: a) Drugs and Cosmetics Act
46. What does the term “adverse drug reaction” (ADR) refer to?
a) Any effect of a drug
b) Harmful effects of a drug that occur at normal doses
c) Allergic reactions only
d) Drug interactions
Answer: b) Harmful effects of a drug that occur at normal doses
47. What is the role of the Pharmacy Council of India (PCI)?
a) To set prices for drugs
b) To regulate pharmacy education and practice standards
c) To approve clinical trials
d) To conduct research on pharmaceuticals
Answer: b) To regulate pharmacy education and practice standards
48. Which act governs the manufacture and sale of narcotic drugs?
a) Pharmacy Act 1948
b) Drugs and Cosmetics Act 1940
c) Narcotic Drugs and Psychotropic Substances Act 1985
d) Medicinal and Toilet Preparations Act 1955
Answer: c) Narcotic Drugs and Psychotropic Substances Act 1985
49. What is the penalty for unauthorized possession of narcotic drugs under the NDPS Act?
a) Warning
b) Fine only
c) Imprisonment
d) Both fine and imprisonment
Answer: d) Both fine and imprisonment
50. Which of the following actions is considered a breach of pharmaceutical ethics?
a) Reporting incorrect medication administration
b) Discussing a patient’s case with their consent
c) Overriding a physician’s prescription without justification
d) Offering medication counseling
Answer: c) Overriding a physician’s prescription without justification
51. What is the main goal of the excise duties imposed under the Medicinal and Toilet Preparations Act?
a) To enhance product marketing
b) To prevent the misuse of alcohol in medicines
c) To support pharmaceutical education
d) To increase the availability of narcotics
Answer: b) To prevent the misuse of alcohol in medicines
52. Which regulatory body is primarily responsible for ensuring drug safety in India?
a) Central Board of Excise and Customs
b) Central Drugs Standard Control Organization
c) National Pharmaceutical Pricing Authority
d) Drug Controller General of India
Answer: b) Central Drugs Standard Control Organization
53. Under the Drugs and Cosmetics Act, which of the following products is exempt from regulation?
a) Prescription drugs
b) Herbal supplements
c) Over-the-counter medications
d) All drugs are regulated
Answer: b) Herbal supplements
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