Understanding laws, regulations and acts in drug approval is essential for B.Pharm students preparing for careers in regulatory affairs, quality assurance, clinical research and pharmacovigilance. This overview covers important statutes like the Drugs and Cosmetics Act, regulatory authorities such as CDSCO and FDA, and core processes including IND and clinical trials, NDA/ANDA submissions, Common Technical Document (CTD), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), bioequivalence, pharmacovigilance and post-marketing surveillance. The focus is on approval pathways, documentation, ethics committee oversight, safety reporting and compliance to protect patients and ensure product quality. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a New Drug Application (NDA)?
- To register a generic drug for market approval
- To request marketing approval for a new chemical entity or new formulation
- To seek permission to import a finished drug product
- To report adverse drug reactions to the regulator
Correct Answer: To request marketing approval for a new chemical entity or new formulation
Q2. Which Indian law principally governs manufacture, sale and distribution of drugs and cosmetics?
- The Food Safety and Standards Act
- The Drugs and Cosmetics Act, 1940
- The Patent Act
- The Clinical Establishments Act
Correct Answer: The Drugs and Cosmetics Act, 1940
Q3. CDSCO stands for which of the following?
- Central Drug Safety and Control Organization
- Central Drugs Standard Control Organization
- Chief Directorate of Scientific and Clinical Oversight
- Central Directorate for Standards and Compliance of Organs
Correct Answer: Central Drugs Standard Control Organization
Q4. Which document format harmonizes regulatory submissions across regions and is commonly used for CTD dossiers?
- ICH Common Technical Document (CTD)
- Good Laboratory Practice Manual
- Schedule Y Checklist
- GMP Inspection Template
Correct Answer: ICH Common Technical Document (CTD)
Q5. What is the primary role of an Institutional Ethics Committee (IEC) or IRB in clinical trials?
- To manufacture the investigational product
- To review and approve the scientific and ethical aspects of the trial, including informed consent
- To market the drug after approval
- To grant marketing exclusivity
Correct Answer: To review and approve the scientific and ethical aspects of the trial, including informed consent
Q6. Which regulatory pathway is generally used in the US to gain approval for a generic version of an approved drug?
- New Drug Application (NDA)
- Investigational New Drug (IND)
- Abbreviated New Drug Application (ANDA)
- Biologics License Application (BLA)
Correct Answer: Abbreviated New Drug Application (ANDA)
Q7. Schedule Y in Indian regulations is mainly associated with which topic?
- GMP requirements for manufacturing facilities
- Regulatory requirements for clinical trials and approval of new drugs
- Labeling requirements for cosmetics
- Import tariffs on pharmaceutical raw materials
Correct Answer: Regulatory requirements for clinical trials and approval of new drugs
Q8. What does pharmacovigilance primarily focus on?
- Drug discovery and design
- Monitoring, detecting and preventing adverse drug reactions after marketing
- Optimizing manufacturing yield
- Drug pricing and reimbursement
Correct Answer: Monitoring, detecting and preventing adverse drug reactions after marketing
Q9. Which guideline set provides internationally accepted principles for designing and conducting clinical trials?
- ICH E6 Good Clinical Practice (GCP)
- WHO GMP Guidelines
- GLP Principles for Animal Studies
- Schedule M Manufacturing Rules
Correct Answer: ICH E6 Good Clinical Practice (GCP)
Q10. An Investigational New Drug (IND) application is submitted to obtain permission to:
- Market a generic drug
- Conduct clinical trials in humans with a new investigational product
- Export a drug without registration
- Change a product label
Correct Answer: Conduct clinical trials in humans with a new investigational product
Q11. Which of the following is a key objective of Good Manufacturing Practice (GMP)?
- To ensure the safety, quality and purity of manufactured pharmaceutical products
- To design clinical trial protocols
- To investigate preclinical toxicology only
- To manage regulatory inspections scheduling
Correct Answer: To ensure the safety, quality and purity of manufactured pharmaceutical products
Q12. What is the Orphan Drug Act designed to encourage?
- Development of standard painkillers
- Research and development of treatments for rare diseases
- Production of over-the-counter supplements
- Generic competition for blockbuster drugs
Correct Answer: Research and development of treatments for rare diseases
Q13. Which regulatory dossier section contains clinical study reports and trial data?
- Module 1: Administrative information
- Module 3: Quality (CMC) information
- Module 4: Nonclinical study reports
- Module 5: Clinical study reports
Correct Answer: Module 5: Clinical study reports
Q14. Bioequivalence studies are primarily required for:
- Innovator new chemical entities seeking first approval
- Generic versions of immediate-release oral formulations to demonstrate comparable rate and extent of absorption
- Vaccine potency testing
- Manufacturing site validation
Correct Answer: Generic versions of immediate-release oral formulations to demonstrate comparable rate and extent of absorption
Q15. Which authority in India grants final approval for marketing a new drug?
- State Drug Inspector
- Drugs Controller General of India (DCGI) / CDSCO at central level
- Local Municipal Corporation
- Department of Biotechnology
Correct Answer: Drugs Controller General of India (DCGI) / CDSCO at central level
Q16. Which document outlines safety updates required periodically after marketing authorization?
- Manufacturing Batch Record
- Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
- Clinical Trial Protocol
- Investigator’s Brochure
Correct Answer: Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Q17. Which of the following best describes “accelerated approval” pathways?
- Approval without any clinical data
- Faster approval based on surrogate endpoints for serious conditions with unmet medical need, with post-approval confirmatory trials
- Only applicable to veterinary products
- Approval that bypasses manufacturing controls
Correct Answer: Faster approval based on surrogate endpoints for serious conditions with unmet medical need, with post-approval confirmatory trials
Q18. What is the key purpose of Good Laboratory Practice (GLP) regulations?
- To control advertising claims
- To ensure integrity, reproducibility and quality of non-clinical safety study data
- To approve marketing authorizations
- To certify clinical research organizations
Correct Answer: To ensure integrity, reproducibility and quality of non-clinical safety study data
Q19. Which term describes approval for a biosimilar in many regulatory frameworks?
- ANDA application
- Biosimilar application or similar biologic marketing authorization
- Over-the-counter monograph
- Investigational Device Exemption
Correct Answer: Biosimilar application or similar biologic marketing authorization
Q20. In regulatory submissions, what does CMC stand for?
- Clinical Monitoring Committee
- Chemistry, Manufacturing and Controls
- Committee for Medical Certification
- Compliance, Marketing and Certification
Correct Answer: Chemistry, Manufacturing and Controls
Q21. Which regulator issues guidance and enforces the Food, Drug, and Cosmetic Act in the United States?
- European Medicines Agency (EMA)
- Central Drugs Standard Control Organization (CDSCO)
- U.S. Food and Drug Administration (FDA)
- World Health Organization (WHO)
Correct Answer: U.S. Food and Drug Administration (FDA)
Q22. What is an Investigator’s Brochure (IB)?
- A marketing plan for the product
- A compilation of clinical and nonclinical data on an investigational product relevant to the study of humans
- A GMP batch release certificate
- An ethics committee approval form
Correct Answer: A compilation of clinical and nonclinical data on an investigational product relevant to the study of humans
Q23. Which activity is a responsibility of the marketing authorization holder (MAH) post-approval?
- Conducting all preclinical toxicology studies only
- Maintaining pharmacovigilance system, reporting safety signals and ensuring product quality
- Licensing clinical investigators
- Setting international patent law
Correct Answer: Maintaining pharmacovigilance system, reporting safety signals and ensuring product quality
Q24. What is the principal aim of bioequivalence testing for generics?
- To show identical excipients to the innovator
- To demonstrate comparable rate and extent of absorption to the reference product
- To validate manufacturing machinery
- To assess market demand
Correct Answer: To demonstrate comparable rate and extent of absorption to the reference product
Q25. Which international body issues GMP guides commonly used worldwide?
- IMDRF
- International Council for Harmonisation (ICH)
- European Directorate for the Quality of Medicines
- World Health Organization (WHO)
Correct Answer: World Health Organization (WHO)
Q26. What does Informed Consent ensure in a clinical trial?
- That the sponsor will fund the trial
- That participants are aware of trial purpose, risks, benefits and their rights and voluntarily agree to participate
- That the product will be approved after trial completion
- That the investigator owns the data
Correct Answer: That participants are aware of trial purpose, risks, benefits and their rights and voluntarily agree to participate
Q27. Which of the following best describes post-marketing surveillance?
- Testing product stability before first release
- Ongoing monitoring of safety and effectiveness once a product is available to the public
- Preclinical animal toxicology studies
- Clinical trial randomization methods
Correct Answer: Ongoing monitoring of safety and effectiveness once a product is available to the public
Q28. What is a common regulatory requirement before starting a clinical trial in humans?
- Marketing authorization for the drug
- Approval from ethics committee/IRB and regulatory authority (where applicable)
- Commercial sales contract
- Publication of trial results in a journal
Correct Answer: Approval from ethics committee/IRB and regulatory authority (where applicable)
Q29. Which regulatory concept links patent status with marketing approval and can affect generic entry in some jurisdictions?
- Regulatory exclusivity and patent linkage
- Good Clinical Practice
- Bioavailability indexing
- Investigator compensation rules
Correct Answer: Regulatory exclusivity and patent linkage
Q30. What is the main regulatory concern for labeling and packaging of pharmaceuticals?
- Maximizing shelf space
- Providing accurate product identity, directions, safety information and storage conditions to ensure safe use
- Minimizing production costs
- Preventing patent infringement
Correct Answer: Providing accurate product identity, directions, safety information and storage conditions to ensure safe use
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