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Download Pharmaceutical Jurisprudence MCQs Free PDF

Pharmaceutical Jurisprudence MCQ Quiz - Objective Question with Answer for Pharmaceutical Jurisprudence - Download Free PDF

Last updated on Mar 24, 2025

Latest Pharmaceutical Jurisprudence MCQ Objective Questions

Pharmaceutical Jurisprudence Question 1:

The Drugs and Cosmetic Act was passed in:

  1. 1940
  2. 1945
  3. 1947
  4. 1946

Answer (Detailed Solution Below)

Option 1 : 1940

Pharmaceutical Jurisprudence Question 1 Detailed Solution

Correct Answer: 1940
Introduction:
  • The Drugs and Cosmetics Act is a significant piece of legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. The primary aim of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to the prescribed quality standards.
Key Points:
  • The Drugs and Cosmetics Act was enacted in 1940 by the Government of India. This Act provides the legal framework for the control and regulation of the pharmaceutical and cosmetic industries in India.
  • The Act includes various provisions to prevent the sale of substandard, spurious, and misbranded drugs and cosmetics, thereby protecting public health.
  • It also lays down the procedures for the import, manufacture, sale, and distribution of drugs and cosmetics, ensuring that they meet the required safety and quality standards.
  • The Act has been amended several times to keep pace with the changing needs and advancements in the pharmaceutical and cosmetic sectors.
  • The Central Drugs Standard Control Organization (CDSCO) is the regulatory body under the Ministry of Health and Family Welfare that enforces the provisions of the Drugs and Cosmetics Act.
Explanation of Other Options:
1945
  • Rationale: This year does not mark the enactment of the Drugs and Cosmetics Act. However, it is noteworthy that the first set of rules under the Act, known as the Drugs Rules, were formulated in 1945 to provide detailed guidelines on various aspects of the Act.
1947
  • Rationale: This year is significant in Indian history as it marks the year of India's independence, but it does not relate to the enactment of the Drugs and Cosmetics Act.
1946
  • Rationale: There is no significant legislative event related to the Drugs and Cosmetics Act in this year. The Act was already in place by 1940, and the rules were formulated in 1945.
Conclusion:
  • The Drugs and Cosmetics Act, enacted in 1940, is a cornerstone of pharmaceutical regulation in India. It ensures that drugs and cosmetics available in the market are safe and effective for consumer use. The other options listed do not correspond to the year of enactment of this pivotal legislation.

Pharmaceutical Jurisprudence Question 2:

The life period of drug is dealt in.

  1. Schedule Q
  2. Schedule P
  3. Schedule M
  4. Schedule N

Answer (Detailed Solution Below)

Option 2 : Schedule P

Pharmaceutical Jurisprudence Question 2 Detailed Solution

Correct Answer: Schedule P
Rationale:
  • Schedule P of the Drugs and Cosmetics Act, 1940, in India, deals specifically with the life period (shelf life) of drugs. This schedule provides detailed information about the stability and storage conditions of various pharmaceutical products to ensure their efficacy and safety over time.
  • The life period or shelf life of a drug is crucial as it determines the duration for which the drug remains effective and safe for use. After this period, the drug may degrade or lose potency, which can affect its therapeutic efficacy.
  • Schedule P includes the list of drugs and their corresponding shelf lives, which are determined based on stability studies conducted under specified conditions. This helps in maintaining the quality of drugs throughout their intended shelf life.
Explanation of Other Options:
Schedule Q
  • Rationale: Schedule Q pertains to the list of permissible colors for use in drugs and cosmetics. It specifies the types of colorants that can be safely used in the formulation of pharmaceutical products and cosmetics, ensuring they do not pose any health risks to consumers.
Schedule M
  • Rationale: Schedule M deals with the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products. It lays down guidelines to ensure that drugs are consistently produced and controlled according to quality standards appropriate for their intended use.
Schedule N
  • Rationale: Schedule N outlines the requirements for the equipment required for the efficient running of a pharmacy. It includes a list of minimum equipment and apparatus that should be available in a pharmacy to ensure proper storage, compounding, and dispensing of medications.
Conclusion:
  • Among the given options, Schedule P is specifically dedicated to the life period or shelf life of drugs. It provides essential guidelines to ensure that pharmaceutical products remain effective and safe for their intended duration of use.

Pharmaceutical Jurisprudence Question 3:

The medical termination of pregnancies in certain case are carried only by _______ under Medical Termination of pregnancy Act 1971.

  1. Any Doctor
  2. Any Physician
  3. Registered Medical Practitioner for this purpose
  4. Registered Pharmacist

Answer (Detailed Solution Below)

Option 3 : Registered Medical Practitioner for this purpose

Pharmaceutical Jurisprudence Question 3 Detailed Solution

Correct Answer: Registered Medical Practitioner for this purpose
Rationale:
  • The Medical Termination of Pregnancy Act, 1971, is an Act of the Parliament of India which provides for the termination of certain pregnancies by registered medical practitioners. The Act was created to reduce the incidence of illegal abortion and consequent maternal mortality and morbidity.
  • Under this Act, only a Registered Medical Practitioner (RMP) who has the requisite qualifications and experience as specified by the government is authorized to carry out medical termination of pregnancies. This ensures that the procedure is carried out safely and ethically.
  • The RMP must follow the guidelines and protocols laid out in the Act to ensure the safety of the patient and compliance with legal standards.
Explanation of Other Options:
Any Doctor
  • Rationale: The term "Any Doctor" is too broad and does not meet the specific legal requirements set by the Medical Termination of Pregnancy Act, 1971. Only those doctors who are registered and have the necessary qualifications and experience as specified by the Act can perform these procedures.
Any Physician
  • Rationale: Similar to "Any Doctor," the term "Any Physician" is also too broad. Not all physicians may have the specialized training or qualifications required to perform medical terminations of pregnancies safely and legally.
Registered Pharmacist
  • Rationale: A Registered Pharmacist is trained in the preparation and dispensing of medications but is not qualified to perform medical procedures, including the termination of pregnancies. Pharmacists do not have the medical training required for such procedures.
Conclusion:
  • Among the given options, only a "Registered Medical Practitioner for this purpose" meets the legal and medical criteria set by the Medical Termination of Pregnancy Act, 1971. This ensures that the procedure is carried out safely, ethically, and in compliance with the law.

Pharmaceutical Jurisprudence Question 4:

Schedule H drug belongs to......

  1. Narcotic drug
  2. Dangerous drug 
  3. Imported drug
  4. List of prescription drugs

Answer (Detailed Solution Below)

Option 4 : List of prescription drugs

Pharmaceutical Jurisprudence Question 4 Detailed Solution

Correct Answer: List of prescription drugs
Rationale:
  • Schedule H drugs are a category of drugs that are regulated under the Drugs and Cosmetics Rules in India. These drugs are only available with a prescription from a qualified healthcare professional.
  • The main purpose of this regulation is to ensure that these medications are used safely and effectively, as they may have potent effects or potential side effects that require supervision by a healthcare provider.
  • Examples of Schedule H drugs include certain antibiotics, antifungals, and medications for chronic conditions like hypertension and diabetes.
Explanation of Other Options:
Narcotic drug
  • Rationale: Narcotic drugs, also known as opioids, are substances that are used to treat severe pain but have a high potential for abuse and addiction. While some narcotic drugs may be included in Schedule H, not all Schedule H drugs are narcotics.
Dangerous drug
  • Rationale: The term "dangerous drug" is more generic and refers to any drug that can cause significant harm if misused. This can include narcotics, certain prescription medications, and illegal drugs. Schedule H drugs are specifically regulated prescription drugs, not all of which are classified as dangerous.
Imported drug
  • Rationale: An imported drug is simply a drug that is manufactured outside the country and brought in for use within the country. Schedule H drugs can be either domestically produced or imported, but not all imported drugs fall under Schedule H.
Conclusion:
  • Among the given options, Schedule H drugs specifically refer to a list of prescription drugs that require medical supervision for safe and effective use. This regulatory measure helps in preventing misuse and ensures that these potent medications are used appropriately.

Pharmaceutical Jurisprudence Question 5:

For the manufacturing of cosmetics, license is granted in....

  1. Form-25 c
  2. Form-20 d
  3. Form-204
  4. Form-32

Answer (Detailed Solution Below)

Option 4 : Form-32

Pharmaceutical Jurisprudence Question 5 Detailed Solution

Correct Answer: Form-32
Rationale:
  • In the context of the manufacturing of cosmetics, the license is granted in Form-32 as per the regulations governing the production and sale of cosmetic products.
  • Form-32 is specifically designed to ensure that manufacturers comply with the necessary standards and guidelines to produce safe and effective cosmetic products.
  • This form includes details about the manufacturing process, quality control measures, and other critical information required for the approval of cosmetic products.
Explanation of Other Options:
Form-25 c
  • Rationale: Form-25 c is not related to the manufacturing of cosmetics. It is typically used for the licensing of the manufacture of drugs other than those specified in Schedule C, C1, and X. Therefore, it is not relevant to cosmetics.
Form-20 d
  • Rationale: Form-20 d pertains to the licensing for the sale of drugs and cosmetics, but not specifically for the manufacturing of cosmetics. This form is generally used for retail and wholesale drug licenses.
Form-204
  • Rationale: Form-204 does not exist in the context of cosmetics manufacturing licenses. It may have been a typographical error or a non-existent form.
Conclusion:
  • Among the given options, Form-32 is the correct form used for granting a license for the manufacturing of cosmetics. It ensures compliance with the necessary regulatory standards to produce safe and effective cosmetic products.

Top Pharmaceutical Jurisprudence MCQ Objective Questions

Pharmaceutical Jurisprudence Question 6:

For the manufacturing of cosmetics, license is granted in....

  1. Form-25 c
  2. Form-20 d
  3. Form-204
  4. Form-32

Answer (Detailed Solution Below)

Option 4 : Form-32

Pharmaceutical Jurisprudence Question 6 Detailed Solution

Correct Answer: Form-32
Rationale:
  • In the context of the manufacturing of cosmetics, the license is granted in Form-32 as per the regulations governing the production and sale of cosmetic products.
  • Form-32 is specifically designed to ensure that manufacturers comply with the necessary standards and guidelines to produce safe and effective cosmetic products.
  • This form includes details about the manufacturing process, quality control measures, and other critical information required for the approval of cosmetic products.
Explanation of Other Options:
Form-25 c
  • Rationale: Form-25 c is not related to the manufacturing of cosmetics. It is typically used for the licensing of the manufacture of drugs other than those specified in Schedule C, C1, and X. Therefore, it is not relevant to cosmetics.
Form-20 d
  • Rationale: Form-20 d pertains to the licensing for the sale of drugs and cosmetics, but not specifically for the manufacturing of cosmetics. This form is generally used for retail and wholesale drug licenses.
Form-204
  • Rationale: Form-204 does not exist in the context of cosmetics manufacturing licenses. It may have been a typographical error or a non-existent form.
Conclusion:
  • Among the given options, Form-32 is the correct form used for granting a license for the manufacturing of cosmetics. It ensures compliance with the necessary regulatory standards to produce safe and effective cosmetic products.

Pharmaceutical Jurisprudence Question 7:

Who was the chairman of a committee which was appointed to see into the problem of pharmacy in India and recommend the measures to be tackled..... 

  1. Adv. R.C. Chandra
  2. W.B. Malhotra 
  3. R.N. Chopra
  4. Dr. L.R. Mahadevan

Answer (Detailed Solution Below)

Option 3 : R.N. Chopra

Pharmaceutical Jurisprudence Question 7 Detailed Solution

Correct Answer: R.N. Chopra
Rationale:
  • R.N. Chopra was the chairman of the committee appointed to address the problems related to pharmacy in India and recommend measures to tackle these issues. This committee was significant as it laid the groundwork for the development of the pharmacy profession and pharmaceutical education in India.
  • The recommendations made by the R.N. Chopra committee have had a lasting impact on the regulation and standardization of pharmacy practice in India, leading to the establishment of various educational and professional standards in the field.
Explanation of Other Options:
Adv. R.C. Chandra
  • Rationale: Adv. R.C. Chandra is not known for chairing any significant committee related to pharmacy in India. His name does not appear in the context of influential figures in the development of pharmacy regulations or education in the country.
W.B. Malhotra
  • Rationale: W.B. Malhotra also does not have a recognized association with the major developments or committees related to pharmacy in India. There are no records indicating his involvement in such capacities.
Dr. L.R. Mahadevan
  • Rationale: Dr. L.R. Mahadevan is not documented as having chaired a committee that focused on pharmacy issues in India. While he may be a professional in the medical or pharmaceutical field, he did not lead the pivotal committee discussed.
Conclusion:
  • Among the given options, R.N. Chopra is the correct answer as he chaired the committee that was instrumental in examining and addressing the problems of pharmacy in India, thus setting the stage for future advancements in the field.

Pharmaceutical Jurisprudence Question 8:

A drug consist, in full or in whole or in part, of any filthy, putrid or decomposed substance.

  1. Adultered drug
  2. Spurious drug 
  3. Misbranded drug 
  4. Patent drug

Answer (Detailed Solution Below)

Option 1 : Adultered drug

Pharmaceutical Jurisprudence Question 8 Detailed Solution

Correct Answer: Adulterated drug
Rationale:
  • An adulterated drug is defined as a drug that consists, in full or in part, of any filthy, putrid, or decomposed substance. This means that the drug is contaminated and not fit for consumption. Adulteration can occur due to poor manufacturing practices, contamination during packaging, or improper storage conditions.
  • The presence of any such contaminants can render the drug unsafe and ineffective, posing serious health risks to consumers.
Explanation of Other Options:
Spurious drug
  • Rationale: A spurious drug is one that is falsely labeled or misrepresented in terms of its identity, composition, or source. These drugs are often counterfeit and are intended to deceive consumers about their authenticity.
  • Spurious drugs may contain incorrect ingredients, incorrect dosages, or harmful substances, but the key issue is the intentional misrepresentation.
Misbranded drug
  • Rationale: A misbranded drug is one that is improperly labeled in a way that is misleading or does not comply with regulatory labeling requirements. This could include incorrect information about the drug's uses, dosage, or side effects.
  • Misbranding does not necessarily mean the drug is harmful or contaminated, but it can lead to misuse or misunderstanding by consumers.
Patent drug
  • Rationale: A patent drug is one that is protected by a patent, granting exclusive rights to the manufacturer to produce and sell the drug for a certain period. This term does not relate to the quality, safety, or branding of the drug.
  • Patent drugs are typically associated with new, innovative treatments that have gone through rigorous testing and approval processes.
Conclusion:
  • Among the given options, an adulterated drug is the one that consists, in full or in part, of any filthy, putrid, or decomposed substance. This classification is crucial for ensuring drug safety and protecting public health by identifying and removing contaminated or unsafe drugs from the market.

Pharmaceutical Jurisprudence Question 9:

The Schedule in Drugs and Cosmetics Act that deals with the requirements and guidelines for clinical trials, import manufacture of new drugs is.

  1. Schedule-O
  2. Schedule-M
  3. Schedule-F
  4. Schedule-Y

Answer (Detailed Solution Below)

Option 4 : Schedule-Y

Pharmaceutical Jurisprudence Question 9 Detailed Solution

Correct Answer: Schedule-Y
Rationale:
  • Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules 1945, provides the requirements and guidelines for clinical trials, import, and manufacture of new drugs in India. This schedule is crucial for ensuring that clinical trials and drug manufacturing processes meet the necessary safety and efficacy standards.
  • It outlines the application procedures for permission to conduct clinical trials, including the submission of data, ethical considerations, and the responsibilities of sponsors and investigators.
  • Schedule Y also includes provisions for post-marketing surveillance, adverse drug reaction reporting, and the regulatory framework for the import and manufacture of new drugs.
Explanation of Other Options:
Schedule-O
  • Rationale: Schedule O pertains to the standards for disinfectants and antiseptics. It specifies the requirements and testing methods for products used to disinfect and maintain hygiene, rather than guidelines for clinical trials or new drug manufacturing.
Schedule-M
  • Rationale: Schedule M outlines the Good Manufacturing Practices (GMP) for pharmaceuticals. It focuses on the standards for manufacturing facilities, equipment, and processes to ensure that drugs are produced consistently and meet quality standards. It does not cover clinical trials or new drug guidelines.
Schedule-F
  • Rationale: Schedule F deals with the standards for blood banks and blood products. It includes guidelines for the collection, storage, processing, and distribution of blood and blood components, and does not relate to clinical trials or new drug manufacturing.
Conclusion:
  • Among the given options, Schedule Y is the correct answer as it specifically addresses the requirements and guidelines for clinical trials, import, and manufacture of new drugs. The other schedules focus on different aspects of drug regulation and standards, such as disinfectants (Schedule O), manufacturing practices (Schedule M), and blood products (Schedule F).

Pharmaceutical Jurisprudence Question 10:

The schedule for: Good manufacturing practices and requirements of factory premises for the manufacture of belongs to.

  1. Schedule-X
  2. Schedule-W
  3. Schedule-L
  4. Schedule-M

Answer (Detailed Solution Below)

Option 4 : Schedule-M

Pharmaceutical Jurisprudence Question 10 Detailed Solution

Correct Answer: Schedule-M
Rationale:
  • Schedule-M of the Drugs and Cosmetics Act in India lays down the Good Manufacturing Practices (GMP) and requirements of factory premises necessary for the manufacture of pharmaceutical products. It is a critical regulation that ensures the quality, safety, and efficacy of pharmaceutical products manufactured in India.
  • GMP guidelines under Schedule-M cover various aspects such as the design and maintenance of manufacturing premises, hygiene protocols, equipment standards, raw material handling, and quality control measures.
  • Adherence to Schedule-M is mandatory for pharmaceutical manufacturers to obtain and maintain their manufacturing licenses. Non-compliance can lead to severe penalties, including the suspension or cancellation of the manufacturing license.
  • The guidelines are designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product alone. They ensure that products are consistently produced and controlled according to quality standards appropriate for their intended use.
Explanation of Other Options:
Schedule-X
  • Rationale: Schedule-X pertains to the regulation of certain drugs that are prone to abuse and requires special prescription and handling. It includes narcotic and psychotropic substances but does not relate to GMP or factory premises requirements.
Schedule-W
  • Rationale: Schedule-W is not a recognized schedule under the Drugs and Cosmetics Act. Therefore, it does not pertain to any regulatory guidelines or requirements in the context of pharmaceutical manufacturing.
Schedule-L
  • Rationale: Schedule-L deals with the standards for diagnostic and laboratory reagents. It sets the requirements for the quality control of these reagents but does not cover GMP or factory premises for pharmaceutical manufacturing.
Conclusion:
  • Among the given options, Schedule-M is the correct answer as it specifically deals with the Good Manufacturing Practices and requirements of factory premises for the manufacture of pharmaceutical products. This ensures that the manufacturing process is consistent, controlled, and produces high-quality pharmaceutical products.
```

Pharmaceutical Jurisprudence Question 11:

The DPO (Drug Price Control Order) was exercised by central government in.

  1. 1985
  2. 1995
  3. 1987
  4. 1997

Answer (Detailed Solution Below)

Option 2 : 1995

Pharmaceutical Jurisprudence Question 11 Detailed Solution

Correct Answer: 1995
Rationale:
  • The Drug Price Control Order (DPCO) is a regulatory measure enacted by the Government of India to ensure that essential and lifesaving medicines are available at reasonable prices. It is an order issued under the Essential Commodities Act, 1955, which enables the government to fix the prices of certain drugs to ensure that they are affordable for the general public.
  • The DPCO was first issued in 1979, but the significant amendment and the version that is most commonly referred to came into effect in 1995. This order was aimed at controlling the prices of bulk drugs and their formulations to make essential medicines more accessible.
Explanation of Other Options:
1985
  • Rationale: While the concept of drug price control was already in place, the specific and widely recognized DPCO that is referred to in most contexts was not introduced in 1985. This year saw various amendments and policies in the pharmaceutical sector, but not the introduction of the DPCO as it is known today.
1987
  • Rationale: In 1987, there were no significant changes or introductions related to the DPCO. The regulatory framework for drug price control was evolving, but the landmark 1995 order had not yet been introduced.
1997
  • Rationale: The year 1997 did not see the introduction of the DPCO. By this time, the DPCO 1995 was already in effect and was the prevailing regulation for drug price control in India.
Conclusion:
  • The DPCO 1995 is a critical regulation in India's pharmaceutical industry, aimed at making essential medicines affordable and accessible. It marked a significant step in the government's efforts to regulate drug prices and ensure public health. The other years mentioned in the options do not correspond to the introduction of this specific order.
```

Pharmaceutical Jurisprudence Question 12:

Drug & cosmetics Act 1940 & rules 1945 contains the study of schedule

  1. A
  2. D
  3. X
  4. P5

Answer (Detailed Solution Below)

Option 3 : X

Pharmaceutical Jurisprudence Question 12 Detailed Solution

Correct Answer: Schedule X
Rationale:
  • The Drugs & Cosmetics Act 1940 and Rules 1945 is a significant piece of legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics in the country. It ensures that drugs and cosmetics sold in India are safe, effective, and conform to state quality standards.
  • Schedule X under this act specifically pertains to certain drugs that require stringent control due to their potential for abuse and addiction. These drugs can only be sold on the prescription of a registered medical practitioner and must be stored in a locked cupboard or safe to prevent unauthorized access.
Explanation of Other Options:
Schedule A
  • Rationale: Schedule A details the forms and applications required under the Drugs and Cosmetics Rules. It includes various forms for licenses, certificates, and other regulatory documents. It does not pertain to specific drugs or their control measures.
Schedule D
  • Rationale: Schedule D lists the substances that are exempt from certain provisions of the Drugs and Cosmetics Act. These exemptions typically apply to drugs that are imported for the purpose of examination, test, or analysis. It does not address the control of specific drugs with abuse potential.
Schedule P
  • Rationale: Schedule P specifies the life period of drugs, meaning the period during which the drug is expected to remain effective and safe for use. This schedule is related to the shelf life and stability of drugs, not their control or abuse potential.
Schedule V
  • Rationale: Schedule V contains the standards for patent and proprietary medicines, including those that are not included in the pharmacopoeia. It deals with the quality and standards of these medicines rather than their control or regulation due to abuse potential.
Conclusion:
  • Among the given options, Schedule X is the correct schedule under the Drugs & Cosmetics Act 1940 and Rules 1945 that deals with the control of certain drugs due to their potential for abuse and addiction. It mandates stringent regulations to ensure these drugs are used safely and responsibly.

Pharmaceutical Jurisprudence Question 13:

A drug consisting in full or in whole or in part of any filthy, putrid or decomposed substance is called.

  1. Adultered drug 
  2. Spurious drug
  3. Misbranded drug
  4. Patent drug

Answer (Detailed Solution Below)

Option 1 : Adultered drug 

Pharmaceutical Jurisprudence Question 13 Detailed Solution

Correct Answer: Adulterated drug
Rationale:
  • An adulterated drug is defined as a drug that consists in full or in part of any filthy, putrid, or decomposed substance. This definition is set to ensure the safety and efficacy of drugs, protecting consumers from harmful or ineffective medications.
  • Such drugs can pose serious health risks to consumers, including infections, toxicity, and decreased therapeutic effects.
  • Regulatory bodies like the FDA (Food and Drug Administration) have strict guidelines to identify and prevent the distribution of adulterated drugs to safeguard public health.
Explanation of Other Options:
Spurious drug
  • Rationale: A spurious drug is a counterfeit drug that is deliberately and fraudulently mislabeled with respect to identity and/or source. It may contain incorrect ingredients, improper dosages, or be completely devoid of any active ingredients.
Misbranded drug
  • Rationale: A misbranded drug is one that is misleadingly labeled. This could include false or misleading information on the packaging, lack of required information, or claims that cannot be substantiated. Misbranding can lead to improper use of the drug and potential harm.
Patent drug
  • Rationale: A patent drug, often referred to as a proprietary drug, is a medication that is protected by a patent. This means the drug's formulation or production process is legally protected, and only the patent holder can manufacture or sell the drug. Patent drugs are not necessarily related to the quality or safety concerns implied by adulteration.
Conclusion:
  • Among the given options, an adulterated drug specifically refers to a drug that contains any filthy, putrid, or decomposed substance. This classification is crucial for maintaining drug safety and ensuring that medications are free from harmful contaminants.

Pharmaceutical Jurisprudence Question 14:

The Drugs and Cosmetic Act was passed in:

  1. 1940
  2. 1945
  3. 1947
  4. 1946

Answer (Detailed Solution Below)

Option 1 : 1940

Pharmaceutical Jurisprudence Question 14 Detailed Solution

Correct Answer: 1940
Introduction:
  • The Drugs and Cosmetics Act is a significant piece of legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. The primary aim of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to the prescribed quality standards.
Key Points:
  • The Drugs and Cosmetics Act was enacted in 1940 by the Government of India. This Act provides the legal framework for the control and regulation of the pharmaceutical and cosmetic industries in India.
  • The Act includes various provisions to prevent the sale of substandard, spurious, and misbranded drugs and cosmetics, thereby protecting public health.
  • It also lays down the procedures for the import, manufacture, sale, and distribution of drugs and cosmetics, ensuring that they meet the required safety and quality standards.
  • The Act has been amended several times to keep pace with the changing needs and advancements in the pharmaceutical and cosmetic sectors.
  • The Central Drugs Standard Control Organization (CDSCO) is the regulatory body under the Ministry of Health and Family Welfare that enforces the provisions of the Drugs and Cosmetics Act.
Explanation of Other Options:
1945
  • Rationale: This year does not mark the enactment of the Drugs and Cosmetics Act. However, it is noteworthy that the first set of rules under the Act, known as the Drugs Rules, were formulated in 1945 to provide detailed guidelines on various aspects of the Act.
1947
  • Rationale: This year is significant in Indian history as it marks the year of India's independence, but it does not relate to the enactment of the Drugs and Cosmetics Act.
1946
  • Rationale: There is no significant legislative event related to the Drugs and Cosmetics Act in this year. The Act was already in place by 1940, and the rules were formulated in 1945.
Conclusion:
  • The Drugs and Cosmetics Act, enacted in 1940, is a cornerstone of pharmaceutical regulation in India. It ensures that drugs and cosmetics available in the market are safe and effective for consumer use. The other options listed do not correspond to the year of enactment of this pivotal legislation.

Pharmaceutical Jurisprudence Question 15:

The life period of drug is dealt in.

  1. Schedule Q
  2. Schedule P
  3. Schedule M
  4. Schedule N

Answer (Detailed Solution Below)

Option 2 : Schedule P

Pharmaceutical Jurisprudence Question 15 Detailed Solution

Correct Answer: Schedule P
Rationale:
  • Schedule P of the Drugs and Cosmetics Act, 1940, in India, deals specifically with the life period (shelf life) of drugs. This schedule provides detailed information about the stability and storage conditions of various pharmaceutical products to ensure their efficacy and safety over time.
  • The life period or shelf life of a drug is crucial as it determines the duration for which the drug remains effective and safe for use. After this period, the drug may degrade or lose potency, which can affect its therapeutic efficacy.
  • Schedule P includes the list of drugs and their corresponding shelf lives, which are determined based on stability studies conducted under specified conditions. This helps in maintaining the quality of drugs throughout their intended shelf life.
Explanation of Other Options:
Schedule Q
  • Rationale: Schedule Q pertains to the list of permissible colors for use in drugs and cosmetics. It specifies the types of colorants that can be safely used in the formulation of pharmaceutical products and cosmetics, ensuring they do not pose any health risks to consumers.
Schedule M
  • Rationale: Schedule M deals with the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products. It lays down guidelines to ensure that drugs are consistently produced and controlled according to quality standards appropriate for their intended use.
Schedule N
  • Rationale: Schedule N outlines the requirements for the equipment required for the efficient running of a pharmacy. It includes a list of minimum equipment and apparatus that should be available in a pharmacy to ensure proper storage, compounding, and dispensing of medications.
Conclusion:
  • Among the given options, Schedule P is specifically dedicated to the life period or shelf life of drugs. It provides essential guidelines to ensure that pharmaceutical products remain effective and safe for their intended duration of use.

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