B.Pharmacy 5th Semester Pharmaceutical Jurisprudence Important Question Answer
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| Pharmaceutical Jurisprudence Important Question Answer |
Pharmaceutical Jurisprudence Very Short Question Answer { 2-Marks}
1. What is Schedule G?
Schedule G of the Drugs and Cosmetics Rules lists drugs that are required to be taken under medical supervision. These include hormonal preparations and other potent medicines. The label must carry the warning: “Caution: It is dangerous to take this preparation except under medical supervision.”
2. Define spurious drug.
A spurious drug is a drug that is manufactured or sold under a name that belongs to another drug. It may be imitated, misbranded, or falsely claims to be from a genuine manufacturer. It may not contain the actual active ingredient or be of inferior quality.
3. Define psychotropic substance.
Psychotropic substance refers to any drug that affects the mind, emotions, or behavior. It is defined under the Narcotic Drugs and Psychotropic Substances Act, 1985 and includes substances listed in the Schedule of the Act such as LSD, MDMA, and barbiturates.
4. Define ‘registered pharmacist’ and ‘medical practitioner’.
A Registered Pharmacist is a person whose name is entered in the State Pharmacy Council register.
A Medical Practitioner is a person who holds a recognized medical qualification and is registered under the State Medical Council to practice modern scientific medicine.
5. What is Schedule M?
Schedule M of the Drugs and Cosmetics Rules specifies the requirements for Good Manufacturing Practices (GMP) for pharmaceuticals. It includes guidelines for premises, equipment, hygiene, quality control, and documentation required to ensure quality production.
6. Write the functions of Drug Inspector.
Inspect drug manufacturing and sale premises.
Take samples for testing.
Investigate complaints and enforce drug laws.
Ensure compliance with the Drugs and Cosmetics Act and Rules.
Initiate legal proceedings against offenders.
7. Define adulterated drug.
An adulterated drug is one that contains filthy, putrid, or decomposed substances, is prepared under insanitary conditions, or contains harmful or unauthorized substances. It fails to meet prescribed standards of strength, quality, or purity.
8. Define the terms ‘absolute alcohol’ and ‘denatured alcohol’.
Absolute Alcohol is pure ethyl alcohol containing not more than 1% water.
Denatured Alcohol is ethanol mixed with substances to make it unfit for human consumption, typically used for industrial purposes.
9. Write the objective of Right to Information Act.
The RTI Act, 2005 aims to promote transparency and accountability in the functioning of public authorities by providing citizens the right to access information under the control of the government.
10. Write the objective of Medicinal and Toilet Preparation Act, 1955.
The objective is to regulate the manufacture, possession, and sale of medicinal and toilet preparations containing alcohol, narcotic drugs, or other controlled substances, ensuring proper excise control.
11. What do you mean by jurisprudence?
Jurisprudence is the science or philosophy of law. In pharmacy, it refers to the study of laws and regulations related to the manufacture, sale, and use of pharmaceutical products.
12. What are the objectives of Drug and Cosmetics Act 1940?
To ensure the safety, efficacy, and quality of drugs and cosmetics.
To regulate import, manufacture, distribution, and sale.
To prevent substandard and misbranded products.
13. What do you mean by import of the drugs?
Import of drugs refers to bringing drugs into India from another country through legal means. It is regulated under the Drugs and Cosmetics Act and requires a valid license.
14. Define coca leaf.
Coca leaf means the leaf of the Erythroxylon coca plant, from which cocaine is derived. It includes leaves from which cocaine has not been extracted but does not include the extract itself.
15. Define prepared opium.
Prepared opium is a product made by processing raw opium, usually by boiling and filtering, for the purpose of smoking or consumption. It includes both chandu and madak.
16. Define bonded laboratory.
A bonded laboratory is an excise-approved facility where medicinal and toilet preparations containing alcohol can be manufactured and stored under supervision, without immediate payment of excise duty.
17. Write the full form of CPCSEA and NLEM.
CPCSEA: Committee for the Purpose of Control and Supervision of Experiments on Animals
NLEM: National List of Essential Medicines
18. Define advertisement.
An advertisement is any form of public communication or promotion made through print, broadcast, or digital media to promote the sale or use of a product, including drugs and remedies.
19. Define misbranded drug.
A drug is considered misbranded if it is labeled falsely or misleadingly, lacks required information, or is colored, coated, or shaped in a way that conceals damage or gives a false appearance.
20. What are the objectives of RTI Act?
Promote transparency in government operations.
Empower citizens to seek information.
Reduce corruption by ensuring accountability.
Increase participation in democratic processes.
21. Define adulterated drugs.
Adulterated drugs contain impurities, are contaminated, prepared under insanitary conditions, or include unauthorized substances, making them unsafe or ineffective for use.
22. What are Schedules J and M?
Schedule J lists diseases and conditions that cannot be claimed to be cured by any drug.
Schedule M outlines GMP standards for manufacturing drugs.
23. What do you mean by forensic pharmacy?
Forensic pharmacy deals with the application of legal and ethical principles to pharmaceutical practice. It includes laws relating to drug manufacture, sale, import, export, and ethical conduct.
24. Define the term “retail sale”.
Retail sale refers to the sale of drugs or medicines to an end consumer or patient for personal use and not for resale.
25. Define the term “restricted license”.
A restricted license allows the sale of certain classes of drugs (e.g., non-schedule prescription drugs) by individuals or establishments without a qualified pharmacist, under specific conditions.
26. Write the objectives of the Medicinal and Toilet Preparation Act.
Regulate production and taxation of alcohol-based preparations.
Ensure proper licensing of manufacturers.
Prevent misuse of alcohol in pharmaceutical products.
27. Define magic remedy.
A magic remedy includes talismans, mantras, or devices claimed to possess miraculous healing powers. Under the Drugs and Magic Remedies Act, such advertisements are prohibited.
28. What are CPCSEA guidelines?
CPCSEA guidelines regulate the ethical use of animals in research. They include standards for animal housing, care, breeding, experimentation, and require institutional ethical committee approvals.
29. Give a short note on the patent.
A patent is a legal right granted to an inventor to exclusively manufacture, use, and sell an invention for a specific period (usually 20 years). In pharmacy, it applies to drug formulations or processes.
30. Write the pharmacist’s oath.
"I swear to serve humanity and provide pharmaceutical care with honesty, integrity, and professionalism; to consider the welfare of patients as my primary concern; and to uphold the dignity of my profession."
Pharmaceutical Jurisprudence Short Question Answer { 5-Marks}
1. Write a short note on Intellectual Property Rights (IPR).
Intellectual Property Rights (IPR) are legal rights granted to individuals or organizations for their creations or inventions. These rights enable the creators to protect and control the use of their intellectual property (IP) such as inventions, brand names, artistic works, and designs.
Types of IPR include:
Patent: Protection for new inventions or processes.
Trademark: Symbols, logos, or names used to identify goods/services.
Copyright: Protection for literary and artistic works.
Designs: Protection for the aesthetic aspects of a product.
Geographical Indications (GI): Identifies goods from a specific place having qualities linked to location.
Trade secrets: Protection for confidential business information.
IPR encourages innovation by giving exclusive rights for a fixed period, usually 20 years for patents. It also promotes economic growth by fostering creativity and attracting investments. In pharmaceuticals, IPR is crucial for protecting drug formulations and R&D investments.
2. Discuss the GMP guidelines mentioned under the Schedule M.
Schedule M of the Drugs and Cosmetics Rules outlines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing units.
Key points include:
Factory Premises: Should be well-ventilated, clean, and constructed to avoid contamination.
Equipment: Must be appropriate, validated, and cleaned regularly.
Raw Materials: Should be tested and stored properly.
Documentation: Includes Batch Manufacturing Records, Standard Operating Procedures (SOPs), and Quality Control records.
Personnel: Adequately trained staff with protective clothing.
Quality Control: Finished products must be tested for strength, quality, and purity before release.
Storage: Finished products stored under appropriate conditions.
Waste Disposal: Proper disposal methods to prevent contamination.
GMP ensures safety, efficacy, and quality of pharmaceutical products and protects public health.
3. Describe the procedure for obtaining a patent. Write a note on opposition to grant of patent.
Procedure for Obtaining a Patent:
Filing of Application: A patent application is filed with the Indian Patent Office using Form-1, including a complete specification and claims.
Publication: After 18 months, the application is published unless an early publication request is filed.
Examination: On request, the application is examined, and objections (if any) are communicated.
Reply to Objections: The applicant responds to objections with clarifications or modifications.
Grant of Patent: If all conditions are met, the patent is granted and published in the Gazette.
Opposition to Grant of Patent:
Pre-grant opposition can be filed by any person after publication but before grant.
Post-grant opposition can be filed within one year from the date of grant by an interested party.
Grounds include lack of novelty, obviousness, non-patentable subject matter, or inadequate disclosure.
4. Give a detailed account on labelling and packing of drug.
As per the Drugs and Cosmetics Rules, labeling and packaging are mandatory to ensure patient safety and product quality.
Labeling Requirements:
Name of the drug (brand/generic)
Batch number
Manufacturing and expiry date
Schedule warning (e.g., “Rx” for prescription drugs)
Net content
Manufacturer’s details
Storage conditions
MRP (Maximum Retail Price)
Red/green symbols for non-vegetarian/vegetarian content
Packing Requirements:
Drugs should be packed in containers that protect them from damage or contamination.
For sterile products, tamper-evident and airtight packaging is mandatory.
Narcotic and psychotropic drugs require additional labeling and packaging controls.
Export drugs must be labeled “For export only.”
5. Write a note on constitution and functions of Pharmacy Council of India.
Constitution of PCI (under Pharmacy Act, 1948):
President: Elected by PCI members.
Members include:
Six members elected by UGC-recognized universities
Six nominated by Central Government
One member elected by each State Council
Director General of Health Services (ex-officio)
Drug Controller of India (ex-officio)
Functions of PCI:
Prescribe minimum standards for pharmacy education.
Regulate course content and examination standards.
Approve institutions offering pharmacy education.
Maintain Central Register of Pharmacists.
Frame regulations for professional conduct and ethics.
6. Describe the provisions for registration and removal of names as notified in the Pharmacy Act 1948.
The Pharmacy Act, 1948 provides guidelines for the registration of pharmacists to ensure that only qualified individuals are allowed to practice pharmacy.
Registration Process:
A person must apply to the State Pharmacy Council in prescribed form.
He/she should possess a minimum qualification recognized under the Act (e.g., Diploma or Degree in Pharmacy).
The applicant must pay the prescribed registration fee.
On acceptance, the name is entered in the State Register, and a Certificate of Registration is issued.
Provisions for Removal of Names:
A name can be removed from the register under the following conditions:
If the pharmacist is convicted of an offense involving moral turpitude.
If the registration was obtained by misrepresentation or fraud.
If the pharmacist is found to be mentally or physically unfit to practice.
If the renewal fee is not paid within the prescribed time.
The pharmacist must be given an opportunity to be heard before removal. Appeals can be made to the State Government if the pharmacist is aggrieved by the council’s decision.
7. Discuss the rules relating to the export, import and transshipment of Narcotic Drugs.
Under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985:
Import:
Only permitted by licensed entities.
Requires authorization from the Narcotics Commissioner.
Prohibited drugs cannot be imported unless permitted by the Central Government.
Export:
A valid export license must be obtained.
Quantity, purpose, and recipient must be declared.
Export must comply with the international obligations (e.g., Single Convention on Narcotic Drugs, 1961).
Customs authorities verify documentation before clearance.
Transshipment:
Movement of narcotic drugs through Indian territory to another country.
Requires special transit permission.
Should be sealed and accompanied by proper documentation.
Supervised strictly by customs and narcotic control agencies.
Violation of these rules results in severe penalties, including imprisonment and cancellation of licenses.
8. Write in brief about Schedule M.
Schedule M of the Drugs and Cosmetics Rules deals with Good Manufacturing Practices (GMP) for pharmaceuticals and the general requirements for factory premises.
Key Features:
Location and Surroundings: Must be away from contamination sources.
Building and Equipment: Clean, ventilated, and hygienic with validated equipment.
Water Supply: Potable and purified water required for manufacturing.
Personnel: Must have proper qualifications and training.
Documentation: Batch records, SOPs, validation protocols to be maintained.
Quality Control: Every batch must be tested before release.
Storage: Appropriate conditions for raw materials and finished products.
Waste Disposal: Proper handling of pharmaceutical waste and rejected material.
GMP ensures quality, safety, and efficacy of pharmaceutical products throughout manufacturing.
9. Write in brief about wholesale and retail sale.
As per Drugs and Cosmetics Rules:
Wholesale Sale:
Involves sale to retailers, hospitals, or other authorized persons.
Requires Form 20B/21B license.
Conducted by qualified persons, though not necessarily a registered pharmacist.
Must maintain sales records and invoices.
Retail Sale:
Sale to end consumers or patients.
Requires Form 20/21 license.
Must be carried out under the supervision of a Registered Pharmacist.
Maintenance of prescription records for scheduled drugs is mandatory.
Includes pharmacy shops and hospital dispensaries.
Both types are regulated to prevent misuse, ensure quality, and protect public health.
10. What are the prohibited advertisements?
Under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, certain advertisements are prohibited:
Prohibited Areas:
Curing diseases like cancer, AIDS, diabetes, sexual impotence, etc. (Schedule J diseases).
Use of magic remedies such as talismans, mantras, etc.
Misleading claims regarding efficacy or miraculous cures.
Promoting self-medication for serious illnesses.
Advertisements targeting pregnant women or promoting abortion.
Penalties:
Offenders can face imprisonment up to 6 months and/or fines.
Repeated offenses may attract higher penalties.
The law aims to protect the public from deceptive and potentially harmful advertising.
11. Write in brief about objectives of Prevention of Cruelty to Animals Act, 1960.
The Prevention of Cruelty to Animals Act, 1960 was enacted to prevent the infliction of unnecessary pain or suffering on animals and to promote their humane treatment.
Objectives:
To prevent cruelty against animals during handling, transportation, experimentation, and slaughter.
To establish guidelines for housing and feeding of animals.
To regulate scientific experiments on animals.
To set up Animal Welfare Board of India (AWBI) to advise the government on animal welfare laws and policies.
To define offenses such as beating, overloading, or mutilating animals and provide penalties.
This Act laid the foundation for ethical animal use in laboratories, agriculture, and other sectors in India.
12. Write a note on registration of pharmacists.
Under the Pharmacy Act, 1948, every pharmacist must be registered with the respective State Pharmacy Council to legally practice or dispense medicines.
Registration Process:
Fill application with qualification proof (e.g., D.Pharm or B.Pharm).
Pay prescribed fees.
Name entered into the State Register of Pharmacists.
Certificate of registration issued.
Renewal: Usually done every 5 years or as per council rules.
Central Register: Maintained by the Pharmacy Council of India (PCI) with data from state councils.
Benefits:
Legal recognition of profession.
Ensures only qualified individuals dispense medicines.
Enables ethical and professional accountability.
13. Write a note on retail price of formulations.
As per the Drugs (Prices Control) Order (DPCO), 2013, the retail price of drug formulations is regulated to ensure affordability and prevent exploitation.
Retail Price Fixation:
National Pharmaceutical Pricing Authority (NPPA) fixes prices of essential medicines under National List of Essential Medicines (NLEM).
Manufacturers cannot exceed the Maximum Retail Price (MRP) set by NPPA.
MRP must include cost of production, profit margin, and applicable taxes.
For non-scheduled drugs, companies can fix prices but must inform NPPA.
Label Requirements:
MRP must be printed on label with "inclusive of all taxes".
It ensures that life-saving drugs remain accessible to the public.
14. Write in brief about manufacturing outside bond.
“Manufacturing outside bond” refers to the production of medicinal and toilet preparations containing alcohol without being under the direct supervision of excise officers, but after paying applicable excise duty in advance.
Key Points:
License under Medicinal and Toilet Preparations (Excise Duties) Act, 1955 is required.
The manufacturer must maintain records of alcohol usage and product yield.
Daily records of manufacture and sales must be submitted to the Excise Department.
Products must be labeled with license details and comply with labeling norms.
Inspections can be conducted by excise officials.
It is contrasted with manufacturing in bond, where duty is paid after production under strict excise control.
15. Explain the qualifications, powers, and duties of Drug Inspectors.
Qualifications:
Degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology.
Appointed under Section 21 of Drugs and Cosmetics Act, 1940.
Powers:
Inspect manufacturing and distribution premises.
Take samples for testing.
Seize drugs suspected to be substandard or spurious.
Search premises with warrant.
Launch prosecution in case of violations.
Duties:
Ensure compliance with Drugs and Cosmetics Act and Rules.
Maintain inspection records.
Submit reports to controlling authority.
Educate sellers and manufacturers about legal obligations.
Drug Inspectors play a key role in maintaining drug quality and public health safety.
16. Write offense and penalties under the Sale of Drugs.
Under the Drugs and Cosmetics Act, 1940, various offenses and their penalties are listed:
Offenses Include:
Sale of spurious, adulterated, or misbranded drugs.
Sale of drugs without a valid license.
Sale of expired or non-standard quality drugs.
Improper labeling or non-compliance with storage norms.
Penalties:
Imprisonment from 1 to 10 years depending on the severity.
Fines ranging from ₹20,000 to ₹10,00,000.
Cancellation or suspension of drug license.
Confiscation of stock.
Repeat offenders may face enhanced punishment. These provisions aim to protect consumers from harmful products.
17. Discuss the classes of drugs and cosmetics prohibited from import.
As per Section 10 of the Drugs and Cosmetics Act, 1940, the following are prohibited from import:
Spurious drugs: Not genuine or imitating another product.
Adulterated drugs: Contain harmful or substandard substances.
Misbranded drugs: False or misleading labels.
Expired drugs.
Drugs not permitted in the country of origin.
Cosmetics with unsafe ingredients or in violation of labeling norms.
Drugs without proper import licenses.
Violation can result in confiscation, fines, or imprisonment. The aim is to prevent entry of harmful or substandard products.
18. What do you understand by loan license and repacking license?
Loan License (Form 25-A):
Granted to an applicant who does not own manufacturing facilities but uses another licensed manufacturer’s premises.
The loan licensee is responsible for quality control and documentation.
Common in contract manufacturing.
Repacking License (Form 25-B):
Granted to entities involved in repacking bulk drugs into smaller packs for sale.
Must follow labeling, packaging, and quality norms.
Separate license for Schedule C & C1 drugs.
Both licenses are governed under the Drugs and Cosmetics Rules, 1945 and ensure control over drug handling and safety.
19. Write terms and conditions for the cultivation and collection of the opium poppy.
Under the NDPS Act, 1985, cultivation of opium poppy is strictly regulated:
Terms and Conditions:
Cultivation only in authorized areas declared by the Central Government.
Must obtain a license from the Narcotics Commissioner.
Only licensed farmers can cultivate specified land area.
Full harvest must be sold to the government at fixed rates.
Farmers must report area sown and yield.
Any diversion or illegal sale is punishable.
These provisions help prevent misuse and diversion of narcotics.
20. What do you mean by Intellectual Property Rights (IPR)?
(Already answered in Q1 above. Here's a brief restatement.)
Intellectual Property Rights (IPR) are legal protections for creations of the mind, such as inventions, artistic works, designs, and brand names. IPR encourages innovation and allows creators exclusive rights to use and profit from their creations for a specified period, such as 20 years for patents. In pharmaceuticals, IPR helps protect novel drug formulations, processes, and products from unauthorized copying.
21. Define advertisement; What do you mean by exempted advertisement?
Advertisement is any public notice, display, or communication promoting a product or service. In pharmacy, it includes printed, broadcast, or online messages promoting drugs or remedies.
Exempted Advertisements (as per Drugs and Magic Remedies Act, 1954):
Advertisements for registered medical practitioners.
Government publications.
Notices to trade or business circles.
Labels or leaflets prescribed under law.
Advertisements for preventive or social campaigns approved by the government.
These are allowed under specific conditions to ensure public health and ethical marketing.
Pharmaceutical Jurisprudence Long Question Answer { 10-Marks}
1. Explain in detail about Medical Termination of Pregnancy Act.
The Medical Termination of Pregnancy (MTP) Act, 1971, legalizes and regulates the termination of certain pregnancies by registered medical practitioners, ensuring women's health and safety while preventing illegal and unsafe abortions. The Act was amended in 2021 to enhance access and align with medical advancements.
Key Provisions of the MTP Act:
Conditions for Termination:
Up to 20 weeks: One registered medical practitioner’s opinion is required.
Between 20 to 24 weeks: Allowed only in specific categories such as rape survivors, minors, or in cases of fetal abnormalities; two doctors’ opinions are needed.
Beyond 24 weeks: Permitted only if substantial fetal abnormalities are detected, and only after approval from a state-level medical board.
Grounds for Termination:
Risk to the life or physical/mental health of the woman.
Substantial risk that the child, if born, would suffer from serious physical or mental abnormalities.
Pregnancy due to rape or failure of contraceptive (now includes unmarried women).
Consent:
Consent of the pregnant woman is mandatory.
For minors or mentally ill patients, guardian’s consent is required.
Place and Person:
Only registered medical practitioners can perform abortions.
Abortions must be done at places approved by the government.
Confidentiality:
The identity and personal details of the woman must be kept confidential.
Breach of confidentiality is punishable by law.
Importance:
The Act ensures safe medical practices, reduces maternal mortality, and upholds women’s reproductive rights. The 2021 amendment is a significant step towards empowering women with choices over their reproductive health.
2. Write a note on licenses required for wholesale of drugs under the provisions of Drug and Cosmetic Act.
The Drugs and Cosmetics Act, 1940 along with Rules, 1945, lays down licensing requirements for the wholesale of drugs to regulate quality, legality, and safety.
Licenses Required:
Form 20B – For wholesale of general drugs (non-schedule C & C1).
Form 21B – For wholesale of Schedule C & C1 drugs (e.g., biological and injectable products).
Conditions to Obtain License:
The applicant must have a qualified person (preferably a registered pharmacist or one with sufficient pharmaceutical experience).
The premises should meet standards (minimum area ~10 square meters).
Adequate storage facility, especially for temperature-sensitive drugs.
Maintain records of purchases and sales.
Display of license in the premises.
Validity:
Licenses are valid for 5 years and must be renewed.
If not renewed within prescribed time, operations must cease.
Importance:
Licensing ensures proper monitoring of the supply chain, restricts unauthorized distribution, and ensures public safety by preventing circulation of spurious or substandard drugs.
3. Discuss in brief about CPCSEA guidelines for Breeding and Stocking of Animals.
The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is a statutory body under the Prevention of Cruelty to Animals Act, 1960, responsible for regulating animal experiments.
Guidelines for Breeding and Stocking of Animals:
Registration:
All institutions breeding animals for experiments must register with CPCSEA.
Housing and Environment:
Animals must be housed in clean, well-ventilated, and appropriately sized enclosures.
Environmental enrichment and natural light must be provided.
Species-specific requirements should be followed.
Record Keeping:
Detailed records of animal breeding, health, morbidity, mortality, and usage must be maintained.
Breeding should avoid genetic abnormalities or inbreeding.
Veterinary Care:
Regular checkups and emergency treatment by qualified veterinarians is mandatory.
Ethical Approval:
Prior approval from the Institutional Animal Ethics Committee (IAEC) is required before animal use.
Transportation:
Safe and humane transportation with minimum stress to animals is compulsory.
Importance:
These guidelines ensure ethical treatment of animals, promote humane science, and align with international standards for laboratory animal care.
4. Write in detail about import of the drug and classes of the drug prohibited from import.
Under the Drugs and Cosmetics Act, 1940, the import of drugs into India is strictly regulated to ensure safety, quality, and efficacy. The provisions related to import are laid down in Sections 10 and 10A of the Act and Rules 21 to 31 of the Drugs and Cosmetics Rules, 1945.
Licensing Requirements for Import:
Import License:
Required under Form 10 for finished drugs and Form 10-A for diagnostic kits.
Issued by the Central Drugs Standard Control Organization (CDSCO).
Application made in Form 8 or 8-A with relevant fees and documents.
Registration Certificate:
Before import license is granted, a Registration Certificate (Form 41) must be obtained.
The manufacturer must register the premises and products intended for import (Form 40).
Testing and Inspection:
Imported drugs may be tested at the Central Drugs Laboratory.
Customs clearance is granted only after satisfaction of standards and license verification.
Drugs Prohibited from Import (Section 10):
The following categories are banned from being imported into India:
Misbranded Drugs:
If labeling is false, misleading, or deceptive.
Adulterated Drugs:
If it contains filthy, putrid, or harmful substances.
Spurious Drugs:
If it mimics another brand or is falsely labeled.
Expired Drugs:
Import of drugs beyond shelf life is prohibited.
Drugs Banned in Country of Origin:
Drugs not permitted to be sold or distributed in the country of manufacture.
Unlicensed Drugs:
Import without proper authorization or registration.
Cosmetics Containing Harmful Ingredients:
Those containing mercury compounds or banned dyes.
Penalties:
Violation of import regulations may lead to:
Confiscation of goods
Heavy fines
Imprisonment
Cancellation of license
These rules ensure that substandard and dangerous drugs do not enter the Indian market and protect consumer health.
5. Write in detail about PCI and its constitution with its functions.
The Pharmacy Council of India (PCI) is a statutory body constituted under the Pharmacy Act, 1948, functioning under the Ministry of Health and Family Welfare, Government of India.
Constitution of PCI (Under Section 3 of the Act):
President: Elected from among members.
Vice President: Also elected.
Members Include:
Six members elected by the University Grants Commission from pharmacy institutions.
One member elected by the Medical Council of India.
One member nominated by the Central Government.
Six members nominated by the Central Government (pharmacy experts).
One member elected from each State Pharmacy Council.
The Director General of Health Services (ex-officio).
The Drug Controller General of India (ex-officio).
Functions of PCI (Section 10):
Education Regulation:
Prescribes minimum educational qualification for pharmacists.
Approves courses, syllabi, and institutions offering pharmacy education.
Inspection:
Sends inspectors to verify standards in colleges.
Can withdraw approval if institutions fail to meet standards.
Registration:
Maintains Central Register of Pharmacists.
Coordinates with State Councils for updating records.
Professional Conduct:
Frames code of ethics for pharmacists.
Handles cases of professional misconduct.
Recognition of Qualifications:
Approves pharmacy qualifications granted outside India.
Importance:
PCI is the apex regulatory body ensuring quality in pharmacy education and professional practice, thus safeguarding public health.
6. Write in detail about pharmaceutical legislations.
Pharmaceutical legislation refers to a body of laws enacted to regulate the import, manufacture, distribution, sale, and use of drugs, cosmetics, and related substances in India.
Major Pharmaceutical Legislations in India:
Drugs and Cosmetics Act, 1940:
Governs import, manufacture, sale, and distribution of drugs and cosmetics.
Ensures quality and safety of drugs.
Pharmacy Act, 1948:
Regulates pharmacy education and profession.
Provides for registration and practice of pharmacists.
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954:
Prohibits misleading advertisements of drugs and remedies.
Medicinal and Toilet Preparations (Excise Duties) Act, 1955:
Controls manufacture of alcohol-containing medicinal products.
Ensures proper excise duty collection.
Narcotic Drugs and Psychotropic Substances Act, 1985:
Controls narcotics and psychotropics.
Prevents drug abuse and illegal trafficking.
Prevention of Cruelty to Animals Act, 1960 (CPCSEA):
Regulates animal use in experiments.
Drugs Price Control Order (DPCO), 2013:
Controls drug prices.
Ensures availability of essential medicines at affordable rates.
Objectives of Legislation:
Safeguard public health.
Ensure ethical pharmaceutical practices.
Promote rational drug use.
Prevent misuse or abuse of drugs.
Promote fair trade and prevent exploitation.
These laws create a framework to ensure the pharmaceutical sector functions safely, ethically, and efficiently.
7. Discuss in detail about Right to Information Act (RTI).
The Right to Information (RTI) Act, 2005 empowers Indian citizens to seek information from government authorities, promoting transparency and accountability.
Objectives:
Ensure citizens have access to information held by public authorities.
Promote transparency in governance.
Reduce corruption by increasing accountability.
Empower citizens in democratic processes.
Applicability:
Applies to all public authorities: ministries, departments, PSUs, and institutions receiving government funds.
Includes constitutional authorities and judiciary (with limitations).
Key Provisions:
Right to Access Information:
Any citizen can request information in writing or electronically.
Application fee: ₹10 (standard).
Time Frame:
Information must be provided within 30 days.
If life or liberty is involved, then within 48 hours.
Public Information Officer (PIO):
Designated officer in each department to handle RTI applications.
Appeal Mechanism:
First appeal to a senior officer.
Second appeal to the Central/State Information Commission.
Exemptions:
Information that affects national security, personal privacy, or cabinet discussions is exempted.
Relevance in Pharmacy Sector:
RTI can be used to seek drug approval data, pricing details, regulatory decisions, and inspection reports.
It strengthens participative democracy and encourages responsible administration.
8. What is the National List of Essential Medicines (NLEM)? Write objectives of Drug Price Control Order (DPCO).
National List of Essential Medicines (NLEM):
NLEM is a list of medicines considered essential for the health system of India. These are selected based on disease prevalence, safety, efficacy, and cost-effectiveness.
Latest Version: NLEM 2022
Total Drugs Listed: 384
Categories Include:
Antibiotics
Antipyretics
Antihypertensives
Anticancer drugs
Vaccines
Contraceptives
Objectives:
Ensure availability of quality medicines at affordable prices.
Promote rational use of medicines.
Guide procurement in public health facilities.
Drug Price Control Order (DPCO), 2013:
Issued under the Essential Commodities Act, DPCO regulates prices of medicines to make them affordable.
Objectives of DPCO:
Fix ceiling prices of medicines in NLEM.
Prevent profiteering in essential drugs.
Ensure supply of medicines at reasonable prices.
Promote cost-effective treatment in healthcare.
Enforcement Authority:
National Pharmaceutical Pricing Authority (NPPA) monitors and enforces compliance.
Together, NLEM and DPCO work to ensure accessibility and affordability of life-saving medicines in India.
9. Write the constitution and functions of the Narcotic & Psychotropic Consultative Committee.
The Narcotic and Psychotropic Substances Consultative Committee is constituted under the NDPS Act, 1985, by the Central Government to advise on the regulation and control of narcotic drugs and psychotropic substances.
Constitution:
Headed by a Chairperson, nominated by the Central Government.
Includes representatives from:
Ministry of Health & Family Welfare
Ministry of Finance (Department of Revenue)
Drug Controller General of India (DCGI)
Narcotics Commissioner
Experts in pharmacology, medicine, and law.
Functions:
Advisory Role:
Advise government on policy matters related to narcotics and psychotropics.
Review of Schedules:
Suggest addition or removal of substances from the NDPS schedules based on abuse potential or medical utility.
Inter-Ministerial Coordination:
Facilitate cooperation between ministries and regulatory bodies.
Monitoring of Drug Use:
Assess misuse trends and suggest measures to counter abuse.
Legislative Suggestions:
Recommend amendments to strengthen drug control laws.
This committee plays a pivotal role in ensuring that narcotics are used legally, safely, and only for medical and scientific purposes.
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B.Pharmacy 5th Semester Pharmaceutical Jurisprudence Important Question Answer
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