Overview of regulatory authorities in India (CDSCO) MCQs With Answer

Overview of regulatory authorities in India (CDSCO) MCQs With Answer

Understanding the Central Drugs Standard Control Organization (CDSCO) is essential for B. Pharm students preparing for careers in pharmaceuticals, regulatory affairs, and clinical research. This introduction explains CDSCO’s role under the Drugs and Cosmetics Act, core functions such as approval of new drugs, medical device regulation, clinical trial oversight, good manufacturing practices (Schedule M), and pharmacovigilance. It also clarifies relationships with the DCGI, State Drug Authorities, ethics committees, and national safety programs. Focused knowledge of these topics helps students navigate drug approval, licensing, post-marketing surveillance, and compliance — key areas in pharmacy practice and regulatory science. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the Central Drugs Standard Control Organization (CDSCO)?

• India’s central regulatory authority for drugs, medical devices and cosmetics
• A private pharmaceutical industry association
• A clinical trial sponsor organization
• A state-level licensing office

Correct Answer: India’s central regulatory authority for drugs, medical devices and cosmetics

Q2. Who is the head of CDSCO responsible for technical and regulatory decisions?

• Drug Enforcement Officer
• Drugs Controller General of India (DCGI)
• Chief Medical Officer
• Director General of Health Services

Correct Answer: Drugs Controller General of India (DCGI)

Q3. Which law primarily empowers CDSCO to regulate drugs and cosmetics in India?

• Pharmacy Act, 1948
• Food Safety and Standards Act, 2006
• Drugs and Cosmetics Act, 1940
• Clinical Establishments Act, 2010

Correct Answer: Drugs and Cosmetics Act, 1940

Q4. Which rules complement the Drugs and Cosmetics Act for detailed procedures?

• Clinical Trials Rules, 2019
• Drugs and Cosmetics Rules, 1945
• Medical Device Regulations, 2020
• Pharmacovigilance Guidelines, 2015

Correct Answer: Drugs and Cosmetics Rules, 1945

Q5. Which schedule of the Drugs and Cosmetics Rules deals primarily with clinical trial requirements in India?

• Schedule M
• Schedule Y
• Schedule D
• Schedule H

Correct Answer: Schedule Y

Q6. Which schedule provides Good Manufacturing Practices (GMP) requirements for pharmaceutical manufacturing in India?

• Schedule H
• Schedule M
• Schedule X
• Schedule L

Correct Answer: Schedule M

Q7. Which of the following is a core function of CDSCO?

• Issuing medical degrees
• Approving new drugs and regulating clinical trials
• Setting retail drug prices exclusively
• Manufacturing medicines

Correct Answer: Approving new drugs and regulating clinical trials

Q8. Which authority typically issues manufacturing licenses for most pharmaceutical factories operating within a state?

• Central Drugs Standard Control Organization (CDSCO)
• State Licensing Authority/State Drug Controller
• World Health Organization
• Clinical Trials Registry-India

Correct Answer: State Licensing Authority/State Drug Controller

Q9. Under Indian rules, which provision covers registration of Ethics Committees that oversee clinical trials?

• Rule 122A
• Rule 122DD
• Rule 18B
• Rule 45C

Correct Answer: Rule 122DD

Q10. Which international guideline represents global standards for Good Clinical Practice that India refers to?

• ICH-GCP (International Council for Harmonisation — Good Clinical Practice)
• WHO Food Code
• FDA Part 11
• ISO 9001

Correct Answer: ICH-GCP (International Council for Harmonisation — Good Clinical Practice)

Q11. Which body in India coordinates the national pharmacovigilance program (PvPI)?

• Central Drugs Laboratory
• Indian Pharmacopoeia Commission (IPC)
• National Medical Commission
• Clinical Trials Registry-India

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q12. What is the primary objective of pharmacovigilance?

• Increase drug sales
• Detect, assess and prevent adverse drug reactions and ensure patient safety
• Register clinical trial sites
• Standardize drug packaging

Correct Answer: Detect, assess and prevent adverse drug reactions and ensure patient safety

Q13. Where must all clinical trials in India be registered before participant enrollment?

• Clinical Trials Registry-India (CTRI)
• WHO Global Database only
• State Drug Authority local registry
• Company internal registry

Correct Answer: Clinical Trials Registry-India (CTRI)

Q14. Which authority is responsible for granting marketing authorization for a new drug in India?

• Local hospital ethics committee
• Central licensing authority (CDSCO/DCGI)
• Pharmaceutical distributor
• World Health Organization

Correct Answer: Central licensing authority (CDSCO/DCGI)

Q15. Which regulation specifically brought medical devices under CDSCO oversight in recent years?

• Medical Device Rules, 2017
• Pharmacy Practice Regulations, 2015
• Food Safety Rules, 2011
• Clinical Trial Rules, 2000

Correct Answer: Medical Device Rules, 2017

Q16. Which statutory advisory board provides technical advice to the Government of India on drugs and related matters?

• Medical Council of India
• Drugs Technical Advisory Board (DTAB)
• National Institute of Virology
• Pharmaceutical Industry Council

Correct Answer: Drugs Technical Advisory Board (DTAB)

Q17. What is the main purpose of Schedule Y requirements for clinical trials?

• Define packaging standards for tablets
• Outline requirements for clinical trial conduct, safety reporting and approval
• Set tax rules for pharmaceutical companies
• Regulate pharmacy retail hours

Correct Answer: Outline requirements for clinical trial conduct, safety reporting and approval

Q18. Which of the following best describes a Phase I clinical trial?

• Large-scale efficacy trial in thousands of patients
• Post-marketing surveillance study
• Initial human study primarily assessing safety and tolerability
• Comparative cost-effectiveness study

Correct Answer: Initial human study primarily assessing safety and tolerability

Q19. What is the role of State Drug Controllers in India?

• Conduct international drug approvals
• Inspect and license manufacturing and wholesale within the state and enforce state-level provisions
• Run the national pharmacovigilance center
• Approve nationwide marketing authorizations

Correct Answer: Inspect and license manufacturing and wholesale within the state and enforce state-level provisions

Q20. Which entity is the primary registry for recording adverse drug reactions reported under PvPI?

• VigiFlow (WHO-hosted pharmacovigilance tool) used by PvPI
• Pharmacy College Alumni Registry
• State Commerce Department database
• Clinical Trials Registry-India

Correct Answer: VigiFlow (WHO-hosted pharmacovigilance tool) used by PvPI

Q21. What does a bioequivalence study establish for generic drug approval?

• Chemical synthesis route of the drug
• Equivalence in rate and extent of absorption between generic and reference product
• Marketing strategies for a drug
• Cost of manufacturing per tablet

Correct Answer: Equivalence in rate and extent of absorption between generic and reference product

Q22. Which of these is a central responsibility of the DCGI in clinical research?

• Designing hospital infrastructure
• Granting permission to conduct clinical trials of new drugs
• Issuing medical degrees to investigators
• Managing retail pharmacies

Correct Answer: Granting permission to conduct clinical trials of new drugs

Q23. Who is primarily responsible for ensuring informed consent is properly obtained in a clinical trial?

• Sponsor’s marketing team
• Principal Investigator (PI)
• Pharmacy dispenser
• State Drug Controller

Correct Answer: Principal Investigator (PI)

Q24. Which document or register must trials in India be made publicly available to improve transparency?

• Company internal memo
• Clinical Trials Registry-India (CTRI) entry
• Confidential investigator file only
• State court records

Correct Answer: Clinical Trials Registry-India (CTRI) entry

Q25. Which statement best describes post-marketing surveillance (Phase IV)?

• It is conducted before human exposure
• It monitors long-term safety, rare adverse events and real-world effectiveness after approval
• It is used only for veterinary drugs
• It replaces preclinical animal testing

Correct Answer: It monitors long-term safety, rare adverse events and real-world effectiveness after approval

Q26. Which body evaluates biological and biotech product dossiers at the central level?

• State Drug Authority
• CDSCO/DCGI expert committees for biologicals and vaccines
• Local hospital ethics committee
• National Pharmacy Council

Correct Answer: CDSCO/DCGI expert committees for biologicals and vaccines

Q27. Which of the following is NOT typically regulated by CDSCO?

• New chemical entities and biologics
• Medical devices listed under Medical Device Rules
• Over-the-counter botanical home remedies sold as foods not claiming therapeutic effect
• Clinical trial approvals and safety oversight

Correct Answer: Over-the-counter botanical home remedies sold as foods not claiming therapeutic effect

Q28. Which authority primarily issues import licenses for pharmaceutical products entering India?

• Local municipal corporation
• Central Drugs Standard Control Organization (CDSCO)
• Clinical Trials Registry-India
• National Institute of Nutrition

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q29. Which of the following responsibilities belongs to an Ethics Committee reviewing a clinical trial?

• Controlling drug pricing
• Assessing risk-benefit, consent process and participant protections
• Manufacturing the investigational product
• Registering the drug for marketing

Correct Answer: Assessing risk-benefit, consent process and participant protections

Q30. Why is understanding CDSCO procedures important for B. Pharm students pursuing regulatory affairs?

• It helps them design new synthesis routes for APIs only
• It equips them to ensure regulatory compliance, prepare dossiers, manage approvals and safeguard public health
• It lets them ignore post-marketing obligations
• It is irrelevant to pharmaceutical practice

Correct Answer: It equips them to ensure regulatory compliance, prepare dossiers, manage approvals and safeguard public health

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