Schedule Y – details and significance MCQs With Answer

Schedule Y – details and significance MCQs With Answer is an essential introduction for B. Pharm students studying Indian drug regulation and clinical trial governance. This concise guide explains Schedule Y provisions on clinical trial approval, phase-wise trial design, investigator and sponsor responsibilities, informed consent, Institutional Ethics Committee (IEC) review, bioavailability/bioequivalence (BA/BE) studies, and pharmacovigilance. Emphasis on Good Clinical Practice (GCP), documentation (case report forms, investigator’s brochure), and clinical data needed for marketing authorisation helps students link regulatory expectations to drug development and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is Schedule Y?

• A part of the Drugs and Cosmetics Rules that defines clinical trial requirements
• A World Health Organization guideline for trials
• An Indian Pharmacopoeia chapter on formulations
• An ICH safety guideline

Correct Answer: A part of the Drugs and Cosmetics Rules that defines clinical trial requirements

Q2. Which regulatory organisation is primarily responsible for implementing Schedule Y in India?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Council of Medical Research (ICMR)
• Pharmacy Council of India (PCI)
• World Health Organization (WHO)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. What is the main scope of Schedule Y?

• Guidance for clinical trial conduct and clinical data required for drug approval
• Manufacturing site inspections only
• Pharmacopoeial monograph development
• Drug pricing regulations

Correct Answer: Guidance for clinical trial conduct and clinical data required for drug approval

Q4. Which trial phases are defined under Schedule Y?

• Phase I, Phase II, Phase III and Phase IV
• Preclinical only
• Phase I and II only
• Phase III and Phase IV only

Correct Answer: Phase I, Phase II, Phase III and Phase IV

Q5. Approval from which body is required at the trial site according to Schedule Y?

• Institutional Ethics Committee (IEC)
• Local hospital administration only
• State Medical Council
• Drug manufacturer’s legal team

Correct Answer: Institutional Ethics Committee (IEC)

Q6. Schedule Y mandates compliance with which set of standards for trial conduct?

• Good Clinical Practice (GCP)
• Good Manufacturing Practice (GMP) only
• Good Laboratory Practice (GLP) only
• No external standards

Correct Answer: Good Clinical Practice (GCP)

Q7. Does Schedule Y provide guidance for bioavailability and bioequivalence (BA/BE) studies?

• Yes, it includes BA/BE study requirements
• No, BA/BE is outside its scope
• Only for veterinary medicines
• Only for biological products

Correct Answer: Yes, it includes BA/BE study requirements

Q8. Who is primarily responsible for the conduct of a clinical trial at a site?

• The Investigator
• The Marketing Authorisation Holder only
• The IEC Chairperson only
• The Ethics Committee Secretary only

Correct Answer: The Investigator

Q9. Which document should the sponsor prepare to summarize clinical and nonclinical information for investigators?

• Investigator’s Brochure
• Manufacturing batch record
• Drug master file
• Patient prescription leaflet

Correct Answer: Investigator’s Brochure

Q10. Schedule Y requires which key ethical process before enrolment of trial subjects?

• Informed consent
• Insurance premium payment
• Final product pricing approval
• Marketing approval

Correct Answer: Informed consent

Q11. For a new chemical entity, Schedule Y expects data from which stages before human trials?

• Preclinical safety studies and toxicology
• Only stability testing
• Only marketing surveys
• Only manufacturing validation

Correct Answer: Preclinical safety studies and toxicology

Q12. Which document contains the detailed plan for a clinical trial as envisaged under Schedule Y?

• Clinical trial protocol
• Product monograph for patients
• Manufacturing SOP
• Regulatory fee receipt

Correct Answer: Clinical trial protocol

Q13. Schedule Y is used to support which regulatory action after trial completion?

• Marketing authorisation (drug approval)
• Tax exemption for manufacturers
• Hospital accreditation
• Education curriculum approval

Correct Answer: Marketing authorisation (drug approval)

Q14. According to Schedule Y guidance, bioequivalence studies are commonly conducted in which population?

• Healthy adult volunteers
• Pediatric patients only
• Terminally ill patients only
• Pregnant women

Correct Answer: Healthy adult volunteers

Q15. The primary objective of Phase I trials under Schedule Y is to assess:

• Safety and tolerability in humans
• Long-term postmarketing risks
• Comparison with alternative marketed products
• Large-scale efficacy in diverse populations

Correct Answer: Safety and tolerability in humans

Q16. Phase II trials primarily focus on:

• Preliminary efficacy and dose selection
• Manufacturing process validation
• Post-marketing surveillance
• Pharmacoeconomics

Correct Answer: Preliminary efficacy and dose selection

Q17. The main goal of Phase III trials as per Schedule Y is to:

• Demonstrate confirmatory efficacy and monitor safety in larger populations
• Conduct animal toxicology studies
• Test only formulation stability
• Perform initial human dosing

Correct Answer: Demonstrate confirmatory efficacy and monitor safety in larger populations

Q18. Phase IV trials are intended for:

• Post-marketing surveillance and long-term safety monitoring
• Initial human safety only
• Preclinical pharmacology
• Random laboratory testing

Correct Answer: Post-marketing surveillance and long-term safety monitoring

Q19. Which action is mandatory before recruiting a subject into a trial according to Schedule Y?

• Obtaining voluntary informed consent
• Paying a trial enrolment fee
• Advertising recruitment on national TV
• Issuing a drug coupon

Correct Answer: Obtaining voluntary informed consent

Q20. Who is expected to apply to the regulatory authority for permission to conduct a clinical trial?

• The Sponsor
• The trial subject
• The hospital billing department
• The media representative

Correct Answer: The Sponsor

Q21. Schedule Y requires maintenance of which trial records at site?

• Case Report Forms (CRFs) and source documents
• Only marketing brochures
• Only investigator personal notes without signatures
• Only drug promotional material

Correct Answer: Case Report Forms (CRFs) and source documents

Q22. How does Schedule Y address vulnerable populations (e.g., minors, incapacitated persons)?

• Requires special safeguards and additional ethical oversight
• Prohibits any research under all circumstances
• Allows enrolment without consent
• Mandates global advertising for recruitment

Correct Answer: Requires special safeguards and additional ethical oversight

Q23. Which study design is commonly recommended for BA/BE comparisons under Schedule Y guidance?

• Single or multiple dose crossover design
• Open-label uncontrolled cohort only
• Case series without controls
• Ecological study design

Correct Answer: Single or multiple dose crossover design

Q24. In Schedule Y terminology, SAE stands for:

• Serious Adverse Event
• Scheduled Assessment Event
• Stable Active Element
• Site Approval Exemption

Correct Answer: Serious Adverse Event

Q25. Which document compiles information necessary for investigator reference about the investigational product?

• Investigator’s Brochure
• Clinical trial registration number
• Patient satisfaction survey
• Marketing plan

Correct Answer: Investigator’s Brochure

Q26. For fixed-dose combination products, Schedule Y requires demonstration of:

• Safety and efficacy of the combination
• Only the combined packaging aesthetics
• Only single component stability
• Marketing cost analysis only

Correct Answer: Safety and efficacy of the combination

Q27. Which institutional body assesses both scientific and ethical aspects of a trial protocol at the site?

• Institutional Ethics Committee (IEC)
• State Police Department
• Pharmacy retail association
• Consumer forum

Correct Answer: Institutional Ethics Committee (IEC)

Q28. Which responsibility is primarily assigned to the sponsor under Schedule Y?

• Overall trial conduct oversight, monitoring and safety reporting
• Only printing patient information leaflets
• Only hiring clinical staff
• Only hospital facility maintenance

Correct Answer: Overall trial conduct oversight, monitoring and safety reporting

Q29. What is the fundamental aim of Schedule Y in regulating clinical trials?

• To protect participant safety and ensure reliable clinical data for regulatory decisions
• To increase drug prices
• To discourage research in India
• To limit international collaborations only

Correct Answer: To protect participant safety and ensure reliable clinical data for regulatory decisions

Q30. Schedule Y is a regulatory schedule applicable to which country?

• India
• United States
• United Kingdom
• Australia

Correct Answer: India

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com