JNTU
JNTU Pharm. D III Year PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (October/November - 2019 - R08)
Answer any five questions. All questions carry equal marks.
Main
Define the following as per Drugs and Cosmetics Act: i) Drugs Allopathic ii) Misbranded drugs iii) Pharmacy iv) Manufacture
Answer
As per the Drugs and Cosmetics Act, 1940 and Rules, 1945:
- Drugs (Allopathic): Includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
- Misbranded Drugs: A drug is deemed misbranded if it is so colored, coated, powdered, or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or if it is not labeled in the prescribed manner; or if its label or container bears any statement, design, or device which is false or misleading in any particular.
- Pharmacy: Under the Pharmacy Act, 1948, pharmacy refers to the place where drugs are dispensed, compounded, or prepared, and where the practice of pharmacy is carried out by a registered pharmacist.
- Manufacture: In relation to any drug or cosmetic, this includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up, or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution.
Write the labeling requirements of Schedule X and G drugs giving suitable examples.
Answer
Labeling requirements for Schedule G and X drugs are as follows:
- Schedule G Drugs: These are substances that carry the risk of side effects and must be used under medical supervision. The label must bear the text: Caution: It is dangerous to take this preparation except under medical supervision.Examples include Metformin, Glibenclamide, and various hormones.
- Schedule X Drugs: These are habit-forming drugs with high abuse potential. The label must bear the symbol X in red on the left top corner of the label, and the text: Schedule X Drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.The container must be securely packed. Examples include Amphetamine, Secobarbital, and Nitrazepam.
Write the constitution and functions of Pharmacy Council of India.
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What is First Register of Pharmacist under Pharmacy Act and how it is prepared?
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What are the qualifications and duties of the Government Analyst and procedures to be followed for analysis of drugs?
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Give the constitution and functions of Drug Technical Advisory Board.
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Bring out the salient features of the Narcotic Drugs and Psychotropic Substances Act. Mention the offences and penalties under the Act.
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Write the salient features of Indian Patents and Design Act 1970 with reference to Drugs and Cosmetics?
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What are the objectives of Drugs Price Control Order? Explain the procedure for fixing the maximum ceiling price of formulations under DPCO 2013.
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Explain the construction and working of a bonded laboratory.
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What are the objectives of Drugs and Magic Remedies Act? Write about prohibited advertisements under this act.
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What is the need for following ethics in profession of pharmacy? Write about the ethics to be followed in trade and profession of pharmacy.
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Discuss the salient features of National Drug Policy.
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Write short notes on:
Prevention of Cruelty to Animals Act
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Drugs consultative committee
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Differentiate prescription and non prescription product.
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