Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence Flashcards

License for pharmacy is granted by:

Answer: State Drug Authority

In India, licenses for establishing and operating a pharmacy (whether retail or wholesale) are granted by the State Drug Authority. This authority, operating under the State Drug Control Department, ensures that pharmacies comply with the Drugs and Cosmetics Act and Rules, maintaining standards for drug storage, dispensing, and record-keeping to safeguard public health.

The year when the Magic remedies act was passed is:

Answer: 1954

The Drugs and Magic Remedies (Objectionable Advertisements) Act was passed in India in the year 1954. This landmark legislation was enacted to prohibit the advertisement of certain drugs and remedies that claim to possess magical properties for the treatment of specific diseases and conditions, aiming to protect the public from exploitation by misleading claims.

The following commercial is an example of a cure for cancer:

Answer: Prohibited

Under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, advertisements claiming to cure serious diseases like cancer are strictly prohibited. This legislation aims to prevent the public from being misled by false or exaggerated claims about remedies for severe illnesses, which could deter them from seeking proper and timely medical treatment.

Prescription medicine ads are intended for:

Answer: Physician

Advertisements for prescription medicines are primarily targeted at physicians and other healthcare professionals, not the general public. This is because these drugs require a doctor's prescription, and the advertisements aim to inform prescribers about the drug's efficacy, safety, and indications. This enables healthcare providers to make informed treatment decisions for their patients.

List of Ayurvedic drugs that cause shedule

Answer: E1

Schedule E1 of the Drugs and Cosmetics Rules (India) specifically lists poisonous substances used in Ayurvedic, Siddha, and Unani (ASU) systems of medicine. This schedule mandates specific labeling requirements for these drugs, including a clear warning that they should be taken under medical supervision, to ensure patient safety and prevent misuse.

Drug imports intended for individual use typically contain up to:

Answer: 100

As per Indian regulations, individuals are generally permitted to import small quantities of drugs for personal use, typically limited to a maximum of 100 dosage units. This provision allows patients to bring in necessary medications that might not be readily available in India, provided they have a valid prescription and the quantity is reasonable for personal consumption.

Records for medications with expiration dates should be kept for at least:

Answer: 2 years

According to pharmaceutical regulations, records pertaining to the sale, purchase, and dispensing of medications, especially those with expiration dates, must be maintained for a minimum period of two years. This requirement ensures traceability, accountability, and facilitates investigations in case of adverse events, product recalls, or quality control issues, protecting both consumers and the supply chain.

Drugs that are spurious signify:

Answer: All of the above

Spurious drugs are those that are not what they claim to be, often being fake or misrepresented. This includes drugs that merely resemble genuine products, are imitations of authentic medications, or are substitutes containing different ingredients than declared. Therefore, all the listed characteristics—resembled drugs, imitations, and substitutes—fall under the definition of spurious drugs, making 'All of the above' the correct answer.

A shedule G drug example is:

Answer: Glibenclamide

Schedule G drugs, as per the Indian Drugs and Cosmetics Act, are potent substances that must be taken strictly under medical supervision and carry a specific warning label. Glibenclamide, an oral hypoglycemic agent used for diabetes, falls into this category due to its significant pharmacological effects and the need for careful monitoring to prevent adverse reactions like severe hypoglycemia. Other options like Paracetamol and Ibuprofen are generally less restricted, while Tetracycline is a Schedule H drug requiring a prescription.

Biologicals are examined at:

Answer: Kasauli

The Central Drugs Laboratory (CDL) at Kasauli, Himachal Pradesh, is the designated national laboratory in India for the testing and quality control of biological products. This includes vaccines, antitoxins, and sera, which are critical for public health. Its specialized facilities and expertise ensure the safety, potency, and efficacy of these complex pharmaceutical preparations.

With the following people's permission, a pregnancy of 20 weeks may be ended:

Answer: Two registered medical practitionars

According to the Medical Termination of Pregnancy (MTP) Act in India, for pregnancies between 12 and 20 weeks, the termination requires the opinion of two registered medical practitioners. This legal provision ensures that the decision to terminate is made after thorough medical assessment and consensus, prioritizing the woman's health and safety. For pregnancies up to 12 weeks, the opinion of one registered medical practitioner is sufficient.

The following entities are granted licenses to manufacture drugs and toilet preparations under bond:

Answer: Excise Commissioner

Licenses for manufacturing drugs and toilet preparations, especially those containing alcohol or narcotics, are granted under bond by the Excise Commissioner. This authority is responsible for regulating the production and movement of excisable goods to ensure proper collection of excise duties and to prevent misuse. The bond serves as a guarantee for the payment of these duties.

The entire opium straw, with the exception of:

Answer: Seed

Opium straw refers to all parts of the opium poppy plant (Papaver somniferum) after the opium has been extracted, with the specific exclusion of the seeds. Poppy seeds contain negligible amounts of opium alkaloids and are widely used as a food ingredient. Therefore, for regulatory purposes concerning narcotic control, the seeds are typically differentiated from the rest of the plant material.

Shedule N represents

Answer: Minimum equipments needed for retail pharmacy

Schedule N of the Indian Drugs and Cosmetics Rules specifies the minimum equipment and facilities required for the efficient running of a retail pharmacy. This schedule ensures that pharmacies are adequately equipped to store, dispense, and compound medicines safely and effectively. Other schedules cover different aspects, such as the life period of drugs (Schedule P) or specific drug categories.

Which one of these illnesses is not Shedule J's

Answer: Diphtheria

Schedule J of the Indian Drugs and Cosmetics Rules lists diseases and ailments for which a drug cannot claim to prevent or cure. This provision aims to protect the public from misleading advertisements and false claims about miraculous cures for serious or chronic conditions. Diphtheria is an infectious disease that can be prevented by vaccination and treated with specific medications, and it is not typically included in Schedule J, unlike conditions such as glaucoma, diabetes, or leucoderma.

D.T.A.B is composed of:

Answer: Central government

The Drugs Technical Advisory Board (DTAB) is a statutory body established by the Central Government under the Drugs and Cosmetics Act, 1940. Its primary role is to advise both the Central and State Governments on technical matters related to the administration of the Act. While it comprises members from various expert bodies, its constitution and mandate originate from the Central Government.