Introduction: Regulatory requirements for new drug approval in India cover legal frameworks, clinical trial approvals, documentation, and post‑marketing surveillance. B. Pharm students must understand key terms and authorities such as CDSCO, DCGI, NDCTR‑2019, Schedule Y, CTRI, GCP, CTD dossier, GMP certification, stability studies, bioavailability/bioequivalence, ethics committee approval, informed consent, and pharmacovigilance. Practical knowledge includes clinical trial phases, investigator responsibilities, sponsor obligations, safety reporting, and submission pathways for marketing authorization. A clear grasp of these topics helps ensure patient safety, data quality, and compliance during drug development and approval in India. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which is the primary national regulatory authority responsible for drug approval in India?
- Central Drugs Standard Control Organization (CDSCO)
- Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Indian Council of Medical Research (ICMR)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q2. Who is the head official responsible for granting permissions for clinical trials and new drugs in India?
- Drug Controller General of India (DCGI)
- Director General of Health Services (DGHS)
- Chairperson of ICMR
- Secretary, Ministry of Science
Correct Answer: Drug Controller General of India (DCGI)
Q3. Which regulation specifically governs clinical trials and new drug approvals introduced in 2019?
- New Drugs and Clinical Trials Rules, 2019 (NDCTR)
- Schedule M of Drugs Rules
- Pharmacy Act, 1948
- National Pharmaceutical Policy, 2012
Correct Answer: New Drugs and Clinical Trials Rules, 2019 (NDCTR)
Q4. Where must all clinical trials conducted in India be prospectively registered?
- Clinical Trials Registry – India (CTRI)
- US ClinicalTrials.gov
- World Health Organization (WHO) database only
- Indian Patent Office
Correct Answer: Clinical Trials Registry – India (CTRI)
Q5. Which core document provides investigators with preclinical and clinical information about an investigational product?
- Investigator’s Brochure
- Certificate of Pharmaceutical Product (CPP)
- Market Authorization Label
- Pharmacopoeial Monograph
Correct Answer: Investigator’s Brochure
Q6. What dossier format is commonly used for regulatory submissions of new drugs in India?
- Common Technical Document (CTD)
- Biologic License Application (BLA)
- New Drug Application (NDA) only in US
- Abbreviated New Drug Application (ANDA)
Correct Answer: Common Technical Document (CTD)
Q7. Which certificate is essential to show a manufacturing site meets quality and hygiene standards?
- Good Manufacturing Practices (GMP) certificate
- ISO 9001 certificate
- Good Clinical Practice (GCP) certificate
- Biosafety Level (BSL) certificate
Correct Answer: Good Manufacturing Practices (GMP) certificate
Q8. Which sequence correctly lists the standard clinical trial phases?
- Phase I, Phase II, Phase III, Phase IV
- Phase IV, Phase III, Phase II, Phase I
- Phase II, Phase I, Phase III, Phase IV
- Phase III, Phase II, Phase I, Phase IV
Correct Answer: Phase I, Phase II, Phase III, Phase IV
Q9. Which committee must approve a clinical trial protocol before a study begins at an institution?
- Institutional Ethics Committee (IEC)
- Central Drugs Review Panel
- State Health Board
- Pharmacy Council
Correct Answer: Institutional Ethics Committee (IEC)
Q10. What is mandatory for ethics committees reviewing clinical trials in India?
- Registration of Ethics Committee with CDSCO
- Certification by WHO only
- Registration with US FDA
- No formal registration required
Correct Answer: Registration of Ethics Committee with CDSCO
Q11. What is the primary objective of a Phase I clinical trial?
- Assess safety and tolerability in humans
- Confirm large‑scale efficacy
- Post‑marketing surveillance
- Compare two marketed products
Correct Answer: Assess safety and tolerability in humans
Q12. Pharmacovigilance primarily focuses on what activity after a drug is marketed?
- Monitoring and reporting adverse drug reactions
- Conducting Phase I trials
- Manufacturing process validation only
- Drug pricing regulation
Correct Answer: Monitoring and reporting adverse drug reactions
Q13. Which studies are required to establish shelf life and recommended storage for a new drug?
- Stability studies as per ICH guidelines
- Bioequivalence studies only
- Only preclinical toxicology studies
- Marketing surveillance studies
Correct Answer: Stability studies as per ICH guidelines
Q14. Which application is submitted to CDSCO for permission to manufacture and market a new drug in India?
- Application to CDSCO for manufacturing and marketing permission
- Clinical Trial Exemption Notice
- Importer Registration Form only
- Pharmacopoeia Monograph Submission
Correct Answer: Application to CDSCO for manufacturing and marketing permission
Q15. CTRI, an important registry for trials in India, stands for which of the following?
- Clinical Trials Registry – India
- Central Therapeutics Review Institute
- Clinical Testing Regulatory Initiative
- Committee for Trial Registration International
Correct Answer: Clinical Trials Registry – India
Q16. Who is primarily responsible for reporting serious adverse events (SAEs) during a clinical trial?
- The sponsor
- The trial participant only
- The manufacturing unit only
- The national parliament
Correct Answer: The sponsor
Q17. Which international guideline is commonly referenced in India for Good Clinical Practice?
- ICH‑GCP (International Council for Harmonisation – Good Clinical Practice)
- OECD GLP only
- WHO GMP exclusively
- ISO Clinical Standard 14000
Correct Answer: ICH‑GCP (International Council for Harmonisation – Good Clinical Practice)
Q18. For approval of a generic product in India, which type of study is most commonly required?
- Bioequivalence study
- Phase III efficacy trial
- Long‑term carcinogenicity study
- Whole new preclinical package
Correct Answer: Bioequivalence study
Q19. Which part of Indian regulations traditionally defined the term “new drug” and clinical trial requirements before NDCTR?
- Schedule Y of Drugs and Cosmetics Rules
- Schedule M of Drugs Rules
- Pharmacy Act Schedule A
- Indian Penal Code
Correct Answer: Schedule Y of Drugs and Cosmetics Rules
Q20. What does the abbreviation DCGI represent?
- Drug Controller General of India
- Director Clinical Governance Institute
- Drug Compliance Group International
- Department of Clinical Growth and Innovation
Correct Answer: Drug Controller General of India
Q21. Which authority oversees compensation and regulatory compliance for clinical trial injuries in India?
- Central Drugs Standard Control Organization (CDSCO)
- State Pharmacy Council only
- World Health Organization exclusively
- Local municipal corporation
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q22. What is a mandatory element of informed consent for clinical trial participants in India?
- Information provided in a language understood by the participant
- Consent only by verbal agreement without documentation
- Consent form in English only
- No requirement to explain risks
Correct Answer: Information provided in a language understood by the participant
Q23. Which international guideline family is typically followed for stability testing and quality assessment?
- ICH guidelines
- HIPAA regulations
- WTO trade rules
- UNICEF clinical standards
Correct Answer: ICH guidelines
Q24. What is the main purpose of a Phase IV clinical study?
- Post‑marketing surveillance and long‑term safety monitoring
- First‑in‑human safety testing
- Preclinical toxicology assessment
- Initial dose finding in healthy volunteers
Correct Answer: Post‑marketing surveillance and long‑term safety monitoring
Q25. Which document must be submitted to both the IEC and regulator before trial initiation?
- Clinical trial protocol
- Marketing brochure
- Patient prescription labels only
- Annual financial statement
Correct Answer: Clinical trial protocol
Q26. What is required to legally import an investigational medicinal product into India for clinical research?
- Import license/permission from CDSCO
- Only a courier airway bill
- Approval from local police
- Registration with state education board
Correct Answer: Import license/permission from CDSCO
Q27. In the CTD format, what does Module 3 primarily cover?
- Quality (Chemistry, Manufacturing and Controls)
- Nonclinical study reports
- Clinical study reports
- Administrative forms
Correct Answer: Quality (Chemistry, Manufacturing and Controls)
Q28. Which statement best describes data exclusivity in India?
- India does not provide prolonged formal data exclusivity like some other jurisdictions
- India guarantees 10 years of data exclusivity for all drugs
- India provides perpetual exclusivity to innovators
- Data exclusivity is decided by state governments
Correct Answer: India does not provide prolonged formal data exclusivity like some other jurisdictions
Q29. Which clinical trial phase is primarily designed to provide confirmatory evidence of efficacy and safety for regulatory approval?
- Phase III
- Phase I
- Phase IV
- Pilot Phase
Correct Answer: Phase III
Q30. When must a clinical trial be registered in the CTRI relative to participant enrollment?
- Prospectively, before enrolling the first participant
- After the trial is completed only
- After first patient is enrolled only
- Registration is optional
Correct Answer: Prospectively, before enrolling the first participant
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.
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