Pharmaceutical Acts with Latest Amendments One Shot Notes and MCQs
A Brief Study of the Pharmaceutical Acts with Latest Amendments:
1. Poisons Act 1919
Overview:
The Poisons Act of 1919 was enacted to regulate the sale and use of poisons and substances that can be harmful to humans.
Main Provisions:
- Regulation of Sale: The act mandates that poisons must be sold only by licensed sellers.
- Record Keeping: Retailers must maintain a register of all poisons sold, including the buyer’s details and purpose.
- Labeling Requirements: All poison containers must bear labels indicating the nature of the contents and the word “Poison.”
- Penalty Provisions: Violators face penalties, including fines and imprisonment.
Latest Amendments:
The act has seen several amendments, with the latest focusing on the inclusion of newer substances classified as poisons and improving record-keeping standards.
2. Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
Overview:
This act aims to prohibit misleading advertisements related to drugs and magic remedies for the treatment of various diseases and conditions.
Main Provisions:
- Prohibition of Certain Advertisements: Advertisements that claim to cure specific diseases (like cancer, diabetes) using magic remedies are banned.
- Regulation of Advertisements: Advertisements must be truthful and not misleading. Claims must be supported by scientific evidence.
- Penalties: Violation of the act can lead to fines and imprisonment.
Latest Amendments:
Amendments have expanded the list of diseases and conditions that cannot be advertised and enhanced enforcement mechanisms.
3. Medical Termination of Pregnancy Act 1970 & Rules 1975
Overview:
The Act regulates the conditions under which a pregnancy may be terminated and aims to ensure women’s health and safety.
Main Provisions:
- Conditions for Termination: Abortions are allowed under certain conditions (e.g., risk to the mother’s life, fetal abnormalities, and cases of rape).
- Approval Process: Abortions up to 20 weeks can be performed by registered medical practitioners. For pregnancies between 20 to 24 weeks, approval from a medical board is required.
- Confidentiality: The act emphasizes patient confidentiality regarding the termination of pregnancy.
Latest Amendments:
Recent amendments have included an extension of the gestational limit for certain categories of women (such as minors and survivors of rape).
4. Prevention of Cruelty to Animals Act 1960
Overview:
This act aims to prevent the infliction of unnecessary pain or suffering on animals.
Main Provisions:
- Prohibition of Cruelty: The act prohibits various forms of cruelty to animals, including beating, mutilation, and abandonment.
- Regulation of Experiments: It regulates experimentation on animals in laboratories, requiring licenses for such activities.
- Animal Welfare Boards: The establishment of Animal Welfare Boards to promote animal welfare.
Latest Amendments:
Amendments have included stricter penalties for animal cruelty and provisions for the better treatment of laboratory animals.
5. State Shops and Establishments Act & Rules
Overview:
This act regulates the working conditions and rights of employees in shops and commercial establishments.
Main Provisions:
- Working Hours: Establishes maximum working hours, mandatory rest periods, and overtime compensation.
- Employee Rights: It ensures basic rights for employees, including leave provisions, payment of wages, and safety measures.
- Registration: All shops and establishments must be registered with local authorities.
Latest Amendments:
Recent amendments have focused on improving work conditions and simplifying compliance requirements for small businesses.
6. Insecticides Act 1968
Overview:
The act regulates the manufacture, sale, and use of insecticides in India to ensure safe agricultural practices.
Main Provisions:
- Registration of Insecticides: All insecticides must be registered before they can be manufactured or sold.
- Labeling Requirements: Proper labeling is mandated, detailing the ingredients, usage instructions, and safety measures.
- Testing and Approval: The act outlines the process for testing and approving insecticides to ensure they are safe for use.
Latest Amendments:
Amendments have focused on enhancing safety standards and procedures for approving new insecticides.
7. AICTE Act 1987
Overview:
The All India Council for Technical Education (AICTE) Act establishes a national council to oversee and promote technical education in India.
Main Provisions:
- Accreditation of Institutions: The act provides guidelines for the accreditation of technical institutions.
- Funding and Support: It facilitates funding for technical institutions and promotes research and innovation.
- Policy Framework: Establishes a framework for the development and regulation of technical education.
Latest Amendments:
Recent amendments have aimed at improving the quality of technical education and expanding the council’s role in policy-making.
8. Factories Act 1948
Overview:
This act aims to ensure the health, safety, and welfare of workers in factories.
Main Provisions:
- Health and Safety Regulations: The act mandates proper ventilation, cleanliness, and safety measures in factories.
- Working Hours: It regulates the maximum working hours and provides for rest intervals.
- Welfare Measures: Provisions for employee amenities, such as drinking water and sanitation facilities.
Latest Amendments:
Recent amendments have included stricter penalties for violations and provisions for the welfare of women employees.
9. Minimum Wages Act 1948
Overview:
The act provides for the fixation of minimum wages for workers in different sectors.
Main Provisions:
- Minimum Wage Fixation: States are required to fix minimum wages for different industries and occupations.
- Wage Boards: The act establishes wage boards to recommend wage rates based on living costs and economic conditions.
- Payment of Wages: It ensures timely payment of wages to workers.
Latest Amendments:
Recent amendments have sought to increase the minimum wage rates and improve compliance mechanisms.
10. Patents Act 1970
Overview:
The Patents Act governs the patenting process in India, promoting innovation while ensuring public access to essential medicines.
Main Provisions:
- Patent Eligibility: The act defines what constitutes a patentable invention and outlines the application process.
- Duration of Patents: Patents are granted for 20 years, after which the invention enters the public domain.
- Compulsory Licensing: Provisions exist for compulsory licensing to ensure access to essential medicines in public health emergencies.
Latest Amendments:
Amendments have focused on aligning the act with international patent laws and enhancing provisions for technology transfer.
MCQs on various pharmaceutical laws and acts
1. The Poisons Act was enacted in which year?
A) 1920
B) 1919
C) 1930
D) 1950
Answer: B) 1919
2. The main purpose of the Poisons Act 1919 is:
A) To control the sale and usage of poisons.
B) To regulate drug prices.
C) To prevent cruelty to animals.
D) To control insecticides.
Answer: A) To control the sale and usage of poisons.
3. Under the Poisons Act 1919, a person selling poisons must:
A) Have a government license.
B) Be a registered medical practitioner.
C) Have special training in toxicology.
D) Be a registered pharmacist.
Answer: A) Have a government license.
4. Which of the following is regulated under the Poisons Act 1919?
A) Antibiotics
B) Poisons
C) Cosmetics
D) Medical devices
Answer: B) Poisons
5. The purpose of the Drugs and Magic Remedies Act is to:
A) Ban misleading advertisements of drugs and treatments.
B) Regulate drug prices.
C) Control the sale of narcotics.
D) Oversee drug manufacturing processes.
Answer: A) Ban misleading advertisements of drugs and treatments.
6. Advertisements for which of the following are restricted under the Drugs and Magic Remedies Act?
A) Pain relief medications
B) Cough syrups
C) Weight loss cures
D) Antibiotics
Answer: C) Weight loss cures
7. Which year was the Drugs and Magic Remedies (Objectionable Advertisements) Act enacted?
A) 1955
B) 1947
C) 1954
D) 1962
Answer: C) 1954
8. The Medical Termination of Pregnancy Act 1970 primarily deals with:
A) Guidelines for sterilization
B) Regulations for abortion
C) Birth control policies
D) Contraceptive distribution
Answer: B) Regulations for abortion
9. The MTP Act 1970 was amended in:
A) 1975
B) 1980
C) 2002
D) 2021
Answer: D) 2021
10. According to the MTP Act, abortions can be legally performed up to:
A) 8 weeks
B) 12 weeks
C) 20 weeks (as per the 2021 amendment)
D) 16 weeks
Answer: C) 20 weeks
11. The Prevention of Cruelty to Animals Act was enacted in which year?
A) 1950
B) 1960
C) 1975
D) 1985
Answer: B) 1960
12. Under the Prevention of Cruelty to Animals Act, which committee oversees animal welfare?
A) CPCSEA
B) AICTE
C) MTP
D) FDA
Answer: A) CPCSEA
13. The primary aim of the Shops & Establishments Act is:
A) To regulate working hours and employment conditions.
B) To control drug prices.
C) To monitor pharmacy licenses.
D) To oversee medical devices.
Answer: A) To regulate working hours and employment conditions.
14. The Insecticides Act 1968 controls:
A) Production of insecticides.
B) Advertisement of insecticides.
C) Distribution of insecticides.
D) All of the above
Answer: D) All of the above
15. The primary purpose of the Insecticides Act 1968 is:
A) Regulate pesticides in agriculture.
B) Control drug prices.
C) Enforce pharmaceutical education standards.
D) Regulate pharmacy establishments.
Answer: A) Regulate pesticides in agriculture.
16. The AICTE Act was introduced in which year?
A) 1985
B) 1987
C) 1990
D) 1995
Answer: B) 1987
17. The AICTE Act is responsible for overseeing:
A) Animal testing standards.
B) Agricultural product quality.
C) Technical and professional education.
D) Drug manufacturing.
Answer: C) Technical and professional education.
18. The Factories Act 1948 was primarily enacted to ensure:
A) Minimum wages.
B) Safety and welfare of workers.
C) Standards for technical education.
D) Promotion of export of goods.
Answer: B) Safety and welfare of workers.
19. The Factories Act mandates a maximum workweek of:
A) 48 hours
B) 40 hours
C) 36 hours
D) 50 hours
Answer: A) 48 hours
20. The Minimum Wages Act ensures:
A) Regular salary increments.
B) Fixed minimum wages for various occupations.
C) Safe working conditions.
D) Maternity benefits.
Answer: B) Fixed minimum wages for various occupations.
21. The Patents Act was enacted in which year?
A) 1947
B) 1955
C) 1970
D) 1985
Answer: C) 1970
22. The main objective of the Patents Act 1970 is:
A) To regulate drug prices.
B) To grant exclusive rights to inventors.
C) To control import/export.
D) To monitor pharmacy establishments.
Answer: B) To grant exclusive rights to inventors.
23. Under the Patents Act, a patent can be granted for:
A) 5 years
B) 10 years
C) 15 years
D) 20 years
Answer: D) 20 years
24. Under the Drugs and Magic Remedies Act, which of the following is prohibited?
A) Advertisements for diabetes cures
B) Advertisements for weight loss
C) Advertisements for mental health cures
D) All of the above
Answer: D) All of the above
25. Which act regulates the import, sale, and use of insecticides?
A) Poisons Act 1919
B) Insecticides Act 1968
C) Drugs and Cosmetics Act 1940
D) AICTE Act 1987
Answer: B) Insecticides Act 1968
26. Under the Pharmacy Act, the minimum qualification for a registered pharmacist is:
A) Bachelor’s degree in Pharmacy
B) Diploma in Pharmacy
C) High school diploma
D) Any science degree
Answer: B) Diploma in Pharmacy
27. The Patents Act provides patent rights for a duration of:
A) 15 years
B) 20 years
C) 25 years
D) 10 years
Answer: B) 20 years
28. The Medical Termination of Pregnancy Act permits abortion up to:
A) 8 weeks
B) 12 weeks
C) 20 weeks
D) 16 weeks
Answer: C) 20 weeks
29. Under the Minimum Wages Act, employers must:
A) Provide health insurance
B) Pay a fixed minimum wage
C) Provide free meals
D) Offer retirement benefits
Answer: B) Pay a fixed minimum wage
30. AICTE Act regulates:
A) Technical education
B) Drug prices
C) Animal welfare
D) Minimum wages
Answer: A) Technical Education
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