Ten Important Concepts from Pharmaceutical Jurisprudence and Pharmacy Law and Ethics and MCQs related to them for
RRB Pharmacist Recruitment Exam
KGMU Pharmacist Recruitment Exam
KSSSCI Pharmacist Recruitment Exam
MPESB Pharmacist Recruitment Exam
Drugs Inspector Exams
Drugs Controller Exams
GPAT
DPEE
D.Pharm, B.Pharm, and Pharm.D.
1. Registered pharmacist: Means a person whose name for the time being is entered in the register of the pharmacists of the state in which he is for the time being residing or carrying on his profession or business of pharmacy.
2. New Drug: (I) A new substance of chemical, biological or biotechnological origin in bulk or prepared dosage form used for prevention, diagnosis, or treatment of disease in man or animals, which except during local clinical trials has not been used in the country to any significant extent and has not been recognised as effective and safe by the licensing authority; OR
(II) A drug already approved by the Licensing Authority (CDSCO) for certain claims, which is now proposed to be marketed with modified or new claims namely indications dosage, dosage form; OR (III) A fixed dose combination of two or more drugs individually approved earlier for certain claims which are now proposed to be combined for the first time in a ratio; OR
(IV) The ratio of ingredients in an already marketed combination is proposed to be changed with certain claims; OR
(V) A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; OR
(VI) A vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.
(Note: Points (V) and (VI) in the above description of New Drug are as per given in the New Drugs and Clinical Trials Rules, 2019).
3. Misbranded drug: A drug shall be deemed to be misbranded if:
(I) it is so colored, coated, powdered or polished that, damage is concealed; OR
(II) it is made to appear of better or greater therapeutic value than it really is; OR
(III) it is not labeled in the prescribed manner; OR
(IV) its label or container or anything accompanying the drugs bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
4. Adulterated drug: A drug shall be deemed to be adulterated if:
(I) it consists, in whole or in part, of any filthy, putrid or decomposed substance; OR
(II) it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; OR
(III) its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; OR
(IV) it bears or contains, a colour other than prescribed which may be used for the purpose of colouring only; OR
(V) it contains any harmful or toxic substance which may render it injurious to health; OR
(VI) any substance mixed with it so as to reduce its quality or strength.
5. Spurious drug: A drug shall be deemed to be spurious if:
(I) it is imported under a name which belongs to another drug; OR
(II) It is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; OR
(III) the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; OR
(IV) it has been substituted wholly or in part by another drug or substance; OR
(V) it purports to be the product of a manufacturer of whom it is not truly a product.
6. Illicit traffic in relation to narcotic drugs and psychotropic substances:
(i) Cultivating any coca plant or gathering any portion of coca plant;
(ii) Cultivating the opium poppy or any cannabis plant;
(iii) Engaging in the production, manufacture, possession, sale, purchase, transportation, warehousing, concealment, use or consumption, import inter-state, export inter-state, import into India, export from India or transhipment, of narcotic drugs or psychotropic substances;
(iv) Handling or letting out any premises for the carrying on of any of the activities referred to in sub-clauses above, other than those permitted under this Act.
It also includes:
I. Financing, directly or indirectly, any of the afore-mentioned activities;
II. Abetting or conspiring in the furtherance of or in support of doing any of the afore-mentioned activities; and
III. Harbouring persons engaged in any of the afore-mentioned activities.
7. Magic remedy: It includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals.
8. Animal: Any living creature other than a human being. (Prevention of Cruelty to Animals Act, 1960)
9. Ceiling price: A price fixed by the Government for Scheduled formulations in accordance with the provisions of this Order (DPCO, 2013).
10. Clinical trial: Clinical trial in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its (i) clinical or; (ii) pharmacological including pharmacodynamics, pharmacokinetics or; (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.
MCQs
1. If a drug contains a colour which is not prescribed is called ______.
(a) Misbranded
(b) Spurious drug
(c) Adulterated drug
(d) New drug
2. If a product purporting to be the product of a manufacturer of whom its not true product means a substance is ______.
(a) Adulterated
(b) Spurious
(c) Misbranded
(d) Deterioated
3. The drug which is clinically not recognized safe by the licensing authority is known as ______.
(a) Imported drug
(b) Patented drug
(c) Misbranded drug
(d) New drug
4. As per the definition in Prevention of Cruelty to Animals Act, 1960 Animal means any living creature EXCEPT:
(a) Microorganisms
(b) Butterflies
(c) Human beings
(d) Insects
5. Magic remedies include ______.
(a) Modern medicines
(b) Ayurvedic medicines
(c) Homeopathic medicines
(d) Mantras and Kavachas
6. Any drug described as filthy, putrid or decomposed substance in whole or in part is termed as ___.
(a) substandard drug
(b) spurious drug
(c) adulterated drug
(d) misbranded drug
7. A label of drug that is not in prescribed manner is known as ______.
(a) Misbranded
(b) Spurious
(c) Adulterated
(d) New Drug
8. What is Ceiling Price?
(a) Maximum price fixed by government on Scheduled formulations
(b) Maximum price fixed by government on Non-Scheduled formulations
(c) Minimum price fixed by government on Scheduled formulations
(d) Maximum price fixed by the manufacturer
Check your answers below:
Recommended book for the preparation of GPAT and Drugs Inspector Exams, "ESSENTIAL PHARMACY REVIEW FOR DRUGS INSPECTOR EXAMS", NIRALI PRAKASHAN, PUNE
To know more about the book:
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Recommended book for the preparation of Pharmacist Exams, "PHARMACIST RECRUITMENT EXAM", NIRALI PRAKASHAN, PUNE
To know more about the book:
Click here
Check your Answers:
1. (c)
2. (b)
3. (d)
4. (c)
5. (d)
6. (c)
7. (a)
8. (a)
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