Exam Details

Subject Drugs Regulatory affairs
Paper
Exam / Course Post Graduate Diploma in Pharmaceutical sales Management (PGDPSM)
Department School of Vocational Education and Training (SOVET)
Organization indira gandhi national open university
Position
Exam Date June, 2016
City, State new delhi,


Question Paper

Give the full forms of any five

DGTD

IPI

NDP

OTC

CRAMS

IPA

UNISEF

What are Over the Counter Medicines

Give an overview of the governing body of the Indian Council of Medical Research (ICMR).

Discuss the role and responsibility of CDSCO.

What is carcinogenicity and teratogenicity

What is acute toxicity study

Define informed consent..

4. Discuss any two in brief:

What is the process of approval of vaccines?

Discuss the role and constitution of State Biotechnology Co-ordination Committee (SBCC).

Discuss the structure of IBSC committee.

5. Explain anyone in detail:

What are the different phases of clinical trials and what is their importance?

Give the functions of National Pharmaceutical Pricing Authority.

Discuss various drugs legislations during the British Rule.

Discuss the genesis of drugs act 1940.

Discuss the salient features of adulterated drugs.

Discuss the various storage conditions of medicines.

8. Explain any two

Narcotic Drugs and Psychotropic Substances (NDPS) Act.

Medical Termination of Pregnancy Act, 1971.

Drug Price Control Order.


Departments

  • Centre for Corporate Education, Training & Consultancy (CCETC)
  • Centre for Corporate Education, Training & Consultancy (CCETC)
  • National Centre for Disability Studies (NCDS)
  • School of Agriculture (SOA)
  • School of Computer and Information Sciences (SOCIS)
  • School of Continuing Education (SOCE)
  • School of Education (SOE)
  • School of Engineering & Technology (SOET)
  • School of Extension and Development Studies (SOEDS)
  • School of Foreign Languages (SOFL)
  • School of Gender Development Studies(SOGDS)
  • School of Health Science (SOHS)
  • School of Humanities (SOH)
  • School of Interdisciplinary and Trans-Disciplinary Studies (SOITDS)
  • School of Journalism and New Media Studies (SOJNMS)
  • School of Law (SOL)
  • School of Management Studies (SOMS)
  • School of Performing Arts and Visual Arts (SOPVA)
  • School of Performing Arts and Visual Arts(SOPVA)
  • School of Sciences (SOS)
  • School of Social Sciences (SOSS)
  • School of Social Work (SOSW)
  • School of Tourism & Hospitality Service Sectoral SOMS (SOTHSM)
  • School of Tourism &Hospitality Service Sectoral SOMS (SOTHSSM)
  • School of Translation Studies and Training (SOTST)
  • School of Vocational Education and Training (SOVET)
  • Staff Training & Research in Distance Education (STRIDE)

Subjects

  • Drugs Regulatory affairs
  • Introduction to Anatomy, Physiology and Pharmaceutical Chemistry
  • Introduction To Management
  • Pharmaceutics
  • Pharmacology and Toxicology
  • Sales management