Pharmacy education, industry and organization in India MCQs With Answer

Introduction

Pharmacy education, industry, and organization in India integrate regulatory science, practice standards, and manufacturing excellence. B.Pharm, D.Pharm, and Pharm.D programs are governed by the Pharmacy Council of India (PCI), with AICTE overseeing technical institution norms. The pharmaceutical industry is regulated by CDSCO led by DCGI, adhering to GMP (Schedule M), GLP (Schedule L-1), and New Drugs and Clinical Trials Rules, 2019. Pricing and access are shaped by DPCO and NPPA, guided by the NLEM. Practice frameworks include Pharmacy Practice Regulations, 2015, hospital and community pharmacy standards, and pharmacovigilance under IPC. Professional bodies like IPA, IDMA, OPPI, and APTI support growth and ethics. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which statutory body regulates pharmacy education and the profession in India?

• Pharmacy Council of India (PCI)
• All India Council for Technical Education (AICTE)
• Central Drugs Standard Control Organization (CDSCO)
• National Pharmaceutical Pricing Authority (NPPA)

Correct Answer: Pharmacy Council of India (PCI)

Q2. What is the primary role of AICTE in the context of pharmacy colleges?

• Approving technical institutions and ensuring infrastructure and faculty norms
• Granting marketing approval for new drugs
• Registering pharmacists under the Pharmacy Act
• Fixing ceiling prices of essential medicines

Correct Answer: Approving technical institutions and ensuring infrastructure and faculty norms

Q3. Which is the minimum entry-level qualification that makes one eligible for registration as a pharmacist in India?

• Diploma in Pharmacy (D.Pharm) from a PCI-approved institute
• Bachelor of Science (B.Sc.)
• Master of Pharmacy (M.Pharm) only
• Certificate in Health Assistant

Correct Answer: Diploma in Pharmacy (D.Pharm) from a PCI-approved institute

Q4. The Pharm.D program in India has a duration of:

• 6 years including 1-year internship
• 4 years with no internship
• 5 years including 6-month internship
• 3 years post-12th

Correct Answer: 6 years including 1-year internship

Q5. Who grants marketing authorization for new drugs at the national level in India?

• Drug Controller General of India (DCGI) under CDSCO
• Pharmacy Council of India (PCI)
• National Board of Accreditation (NBA)
• State Pharmacy Council

Correct Answer: Drug Controller General of India (DCGI) under CDSCO

Q6. Which Schedule of the Drugs and Cosmetics Rules prescribes Good Manufacturing Practices (GMP) for pharmaceuticals?

• Schedule M
• Schedule H
• Schedule X
• Schedule Y

Correct Answer: Schedule M

Q7. The basis for price control under DPCO in India is primarily the:

• National List of Essential Medicines (NLEM)
• Indian Pharmacopoeia
• WHO Essential Medicines List only
• Central List of Controlled Substances

Correct Answer: National List of Essential Medicines (NLEM)

Q8. The Drug Prices Control Order (DPCO) 2013 is issued under which Act?

• Essential Commodities Act, 1955
• Drugs and Cosmetics Act, 1940
• Pharmacy Act, 1948
• NDPS Act, 1985

Correct Answer: Essential Commodities Act, 1955

Q9. In a pharmaceutical company, which department is responsible for batch release decisions?

• Quality Assurance (QA)
• Quality Control (QC) only
• Production
• Marketing

Correct Answer: Quality Assurance (QA)

Q10. The National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) is located at:

• Indian Pharmacopoeia Commission (IPC), Ghaziabad
• Central Drugs Laboratory (CDL), Kolkata
• National Institute of Pharmaceutical Education and Research (NIPER), Mohali
• AIIMS, New Delhi

Correct Answer: Indian Pharmacopoeia Commission (IPC), Ghaziabad

Q11. Schedule H1 mandates which of the following?

• Prescription-only sale with mandatory record-keeping for specified antibiotics
• Over-the-counter sale with pharmacist advice
• Prohibition of sale in rural areas
• Exclusive sale through government hospitals

Correct Answer: Prescription-only sale with mandatory record-keeping for specified antibiotics

Q12. Which is a core clinical service provided by hospital pharmacists?

• Medication reconciliation at transitions of care
• Final diagnosis of disease
• Surgical procedure scheduling
• Health insurance underwriting

Correct Answer: Medication reconciliation at transitions of care

Q13. What additional requirement applies to the retail sale of Schedule X drugs?

• Special drug license and maintenance of a separate Schedule X register
• Only a pharmacist on duty
• No invoice needed
• Open sale without prescription

Correct Answer: Special drug license and maintenance of a separate Schedule X register

Q14. The Association of Pharmaceutical Teachers of India (APTI) primarily represents:

• Pharmacy teachers and academia
• Drug inspectors
• Hospital administrators
• Medical doctors

Correct Answer: Pharmacy teachers and academia

Q15. IDMA is a trade body that primarily represents:

• Indian-owned pharmaceutical manufacturers
• Physicians
• Pharmacovigilance centers
• State regulators

Correct Answer: Indian-owned pharmaceutical manufacturers

Q16. The Indian Pharmaceutical Association (IPA) is best described as:

• The professional body representing pharmacists across practice, industry and academia in India
• A government regulator
• A trade body of API importers
• A hospital chain

Correct Answer: The professional body representing pharmacists across practice, industry and academia in India

Q17. The New Drugs and Clinical Trials Rules in India were notified in:

• 2019
• 2014
• 2005
• 2021

Correct Answer: 2019

Q18. Who publishes the Indian Pharmacopoeia (IP)?

• Indian Pharmacopoeia Commission (IPC)
• Pharmacy Council of India (PCI)
• Bureau of Indian Standards (BIS)
• National Institute of Nutrition (NIN)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q19. Which body prescribes the B.Pharm syllabus and course regulations nationwide?

• Pharmacy Council of India (PCI)
• AICTE only
• Medical Council of India (now NMC)
• NPPA

Correct Answer: Pharmacy Council of India (PCI)

Q20. As per PCI, the minimum industrial/hospital training required in B.Pharm is:

• At least 150 hours (4 weeks) during the final year/semester
• Exactly 1 year internship
• No training required
• 6 months full-time

Correct Answer: At least 150 hours (4 weeks) during the final year/semester

Q21. Schedule L-1 of the Drugs and Cosmetics Rules relates to:

• Good Laboratory Practices (GLP) for pharmaceutical testing
• List of prescription drugs
• Requirements for medical devices
• Pharmacovigilance reporting forms

Correct Answer: Good Laboratory Practices (GLP) for pharmaceutical testing

Q22. Which sequence correctly represents the typical pharmaceutical supply chain in India?

• Manufacturer → Carrying & Forwarding (C&F) agent → Distributor/Stockist → Retailer → Patient
• Manufacturer → Retailer → Distributor → Patient
• Manufacturer → Patient directly in all cases
• Distributor → Manufacturer → Retailer → Patient

Correct Answer: Manufacturer → Carrying & Forwarding (C&F) agent → Distributor/Stockist → Retailer → Patient

Q23. The primary mandate of the National Pharmaceutical Pricing Authority (NPPA) is to:

• Fix and monitor ceiling prices of scheduled medicines and ensure availability
• Approve new drug clinical trials
• Accredit pharmacy colleges
• Conduct national health surveys

Correct Answer: Fix and monitor ceiling prices of scheduled medicines and ensure availability

Q24. Schedule H of the Drugs and Cosmetics Rules lists:

• Prescription-only medicines to be sold on the prescription of a registered medical practitioner
• Narcotics requiring triplicate prescription
• Over-the-counter medicines
• Ayurvedic formulations only

Correct Answer: Prescription-only medicines to be sold on the prescription of a registered medical practitioner

Q25. Under the Drugs and Cosmetics Rules, Schedule X covers:

• Certain narcotic and psychotropic substances requiring special handling and records
• Vaccines for children
• Cosmetics only
• Homeopathic drugs

Correct Answer: Certain narcotic and psychotropic substances requiring special handling and records

Q26. A key function of State Pharmacy Councils is:

• Registration and renewal of pharmacists and enforcement of professional conduct
• Grant of new drug marketing approvals
• Fixation of drug prices
• Setting industrial tax policy

Correct Answer: Registration and renewal of pharmacists and enforcement of professional conduct

Q27. The Pharmacy Practice Regulations, 2015 emphasize:

• Patient-centered pharmacy services such as counseling, documentation, and prescription audit
• Exclusive focus on product compounding only
• Elimination of pharmacist role in community pharmacies
• Outsourcing of all clinical services

Correct Answer: Patient-centered pharmacy services such as counseling, documentation, and prescription audit

Q28. Which document provides the complete history of each manufactured batch as per GMP?

• Batch Manufacturing Record (BMR)/Batch Production Record (BPR)
• Material Safety Data Sheet (MSDS)
• Product Monograph
• Annual Product Review

Correct Answer: Batch Manufacturing Record (BMR)/Batch Production Record (BPR)

Q29. Baddi, a major pharmaceutical manufacturing hub in India, is located in:

• Himachal Pradesh (Solan district)
• Gujarat (Anand district)
• Telangana (Ranga Reddy district)
• Tamil Nadu (Coimbatore district)

Correct Answer: Himachal Pradesh (Solan district)

Q30. Clinical trials in India are approved and overseen by the:

• Central Licensing Authority (DCGI) under CDSCO
• State Pharmacy Council
• Indian Pharmaceutical Association
• National Pharmaceutical Pricing Authority

Correct Answer: Central Licensing Authority (DCGI) under CDSCO

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