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JNTU Pharm. D III Year PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (April/May - 2019 - R08)

Pharm. D | III Year | III Year | R08 | April/May - 2019

Answer PaperPaper Code: 3.4Maximum Marks: 70Time: 3 hours

Answer any five questions. All questions carry equal marks.

Main

114 marks
a

Write briefly about ‘Drugs Enquiry Committee’.

7 marks

Answer

The Drugs Enquiry Committee, also known as the Chopra Committee, was appointed by the Government of India in 1930 under the chairmanship of Col. R.N. Chopra. Its primary objective was to investigate the state of the drug industry and the profession of pharmacy in India.

Key aspects of the committee include:

  • It conducted a comprehensive survey of the pharmaceutical industry, noting the prevalence of low-quality, spurious, and misbranded drugs in the market.
  • The committee highlighted the lack of uniform legislation to regulate the import, manufacture, and sale of drugs.
  • It recommended the establishment of a central laboratory for drug testing and the implementation of a system for the registration of pharmacists.
  • The report submitted in 1931 served as the foundational document for the drafting of the Drugs Act, 1940, which laid the groundwork for modern pharmaceutical regulation in India.
b

Write the background of pharmaceutical legislations in India.

7 marks

Answer

The history of pharmaceutical legislation in India is rooted in the need to protect public health from the unregulated trade of medicinal substances. Prior to the 20th century, there was no centralized control over the quality of drugs, leading to widespread adulteration.

The evolution of this legal framework occurred in several phases:

  • Pre-Independence Era: Following the recommendations of the Drugs Enquiry Committee (1930), the government enacted the Drugs Act, 1940. This was the first major step toward regulating the import, manufacture, distribution, and sale of drugs.
  • Post-Independence Development: The Pharmacy Act, 1948 was introduced to regulate the profession of pharmacy, ensuring that only qualified individuals could dispense medicines. This was followed by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, to curb misleading claims about drug efficacy.
  • Expansion of Controls: The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 was enacted to regulate alcohol-containing preparations. Subsequently, the Drugs and Cosmetics Act, 1940 underwent significant amendments, most notably the inclusion of the Drugs and Cosmetics Rules, 1945, which provided detailed technical standards for manufacturing and quality control.
  • Modern Era: Legislation continued to evolve with the Narcotic Drugs and Psychotropic Substances Act, 1985 and the Drug Price Control Orders (DPCO), ensuring that the pharmaceutical sector remains regulated in terms of safety, efficacy, professional standards, and affordability.
214 marks
a

Write the principle and significance of professional ethics with special reference to pharmaceutical ethics.

7 marks

Answer

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b

Write the objectives and legal definition of drugs and Cosmetics Act, 1940.

7 marks

Answer

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314 marks
a

Write about the essential requirements of building, space, equipment etc., outlined in schedule M for the manufacture of drugs.

7 marks

Answer

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b

What are the rules governing the labeling of drugs meant for export from India?

7 marks

Answer

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414 marks
a

Discuss the constitution, functions and power of DTAB.

7 marks

Answer

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b

What are the qualifications for appointment as a drugs inspector? Discuss the duties of the drugs inspector.

7 marks

Answer

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514 marks
a

Write the main features of the education regulations framed by pharmacy council of India.

7 marks

Answer

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b

How are the first and subsequent registers of pharmacists are prepared and maintained?

7 marks

Answer

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614 marks
a

Draw a neat sketch for a bonded laboratory in accordance with the provisions of the excise act and the rules.

7 marks

Answer

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b

Write about restricted and unrestricted preparations.

7 marks

Answer

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714 marks
a

Define the following according to act: i) Coca leaf ii) prepared opium iii) medicinal cannabis iv) manufactured drugs.

5 marks

Answer

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b

Define advertisement and magic remedies Act. What classes of advertisements are prohibited under this Act?

5 marks

Answer

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c

How are the experimental animals are handled before and after the experiments?

4 marks

Answer

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814 marks
a

How are the prices of drugs in bulk and of drug formulations calculated under the drugs (prices control) order 1987?

5 marks

Answer

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b

What are patents and designs? Give the salient features of patents and designs Act-1970?

5 marks

Answer

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c

With suitable examples, write prescription and non-prescription products.

4 marks

Answer

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