The Central Drugs Standard Control Organization (CDSCO) is India’s central drug regulatory authority responsible for drug approval, device regulation, clinical trial oversight, licensing, and pharmacovigilance. Understanding CDSCO organization and responsibilities is essential for B. Pharm students because it links regulatory policy with pharmacy practice, drug safety, quality control, and compliance. This topic covers CDSCO structure, key divisions, functions such as approvals, inspections, import/export control, clinical trial regulation, post-marketing surveillance, and standard setting. These MCQs emphasize practical regulatory scenarios, major rules, inspection roles, and reporting duties to build competency in drug regulation and public health protection. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the role of the Drugs Controller General of India (DCGI) within CDSCO?
- Chief scientific advisor to the Indian Pharmacopoeia Commission
- Head of CDSCO responsible for approval of new drugs and clinical trial oversight
- State-level licensing officer for drug manufacturing
- Head of the Central Bureau of Narcotics
Correct Answer: Head of CDSCO responsible for approval of new drugs and clinical trial oversight
Q2. Which legislation primarily empowers CDSCO to regulate drugs and cosmetics in India?
- The Pharmacy Act, 1948
- The Drugs and Cosmetics Act, 1940 and Rules, 1945
- The Medical Council Act, 1956
- The Food Safety and Standards Act, 2006
Correct Answer: The Drugs and Cosmetics Act, 1940 and Rules, 1945
Q3. Which of the following is a central responsibility of CDSCO related to clinical research?
- Issuing manufacturing licences to all drug manufacturers
- Granting permission for conduct of clinical trials for new drugs
- Regulating retail pharmacy operations in states
- Conducting independent clinical trials for every new drug
Correct Answer: Granting permission for conduct of clinical trials for new drugs
Q4. Which regulatory function is typically handled by State Drug Control Authorities rather than CDSCO?
- Granting import licences for pharmaceuticals
- Issuing manufacturing licences for most domestic drug manufacturers
- Approval of new drug marketing applications
- Central oversight of clinical trial ethics committees
Correct Answer: Issuing manufacturing licences for most domestic drug manufacturers
Q5. What is Schedule Y mainly concerned with in Indian regulations?
- Standards for cosmetics and toiletries
- Clinical trial requirements and approval process for new drugs
- Import tariff classification for pharmaceuticals
- Packaging and labeling of medical devices
Correct Answer: Clinical trial requirements and approval process for new drugs
Q6. Which CDSCO activity directly supports drug safety monitoring after a product is marketed?
- Issuing GMP certificates to manufacturers
- Post-marketing surveillance and pharmacovigilance coordination
- Granting import licences for solvents
- Training pharmacists for retail sales
Correct Answer: Post-marketing surveillance and pharmacovigilance coordination
Q7. Which division within CDSCO is primarily responsible for evaluation of clinical trial data and new drug applications?
- Metrology Division
- New Drugs and Clinical Trials Division
- Food Safety Division
- Pharmacy Practice Division
Correct Answer: New Drugs and Clinical Trials Division
Q8. What authority does CDSCO have regarding import of pharmaceutical products?
- It sets import tariffs for raw materials
- It grants or denies import licences and reviews imported drug quality
- It manages customs clearance documentation for all imports
- It issues retail trade permits for imported drugs
Correct Answer: It grants or denies import licences and reviews imported drug quality
Q9. Which program is linked with CDSCO for national pharmacovigilance efforts?
- National Vector Control Programme
- Pharmacovigilance Programme of India (PvPI)
- National Rural Health Mission
- Essential Medicines Initiative
Correct Answer: Pharmacovigilance Programme of India (PvPI)
Q10. CDSCO inspects manufacturing facilities primarily to ensure compliance with which of the following?
- Good Manufacturing Practices (GMP)
- Consumer Protection Act
- Clinical practice guidelines
- Wholesale pricing regulations
Correct Answer: Good Manufacturing Practices (GMP)
Q11. Who coordinates with CDSCO for state-level drug regulation and enforcement?
- State Drug Control Authorities
- District Health Societies
- Central Pollution Control Board
- Indian Pharmacopoeia Commission
Correct Answer: State Drug Control Authorities
Q12. What is one key CDSCO responsibility related to medical devices?
- Licensing of retail stores selling medical devices
- Regulation and registration of certain categories of medical devices and overseeing their safety
- Manufacturing of all medical devices centrally
- Price fixation for implantable devices
Correct Answer: Regulation and registration of certain categories of medical devices and overseeing their safety
Q13. For a B. Pharm student, why is knowledge of CDSCO responsibilities important?
- It replaces the need to learn pharmaceutics
- It helps understand regulatory compliance, drug approval pathways, and safety monitoring relevant to pharmacy practice
- It is only relevant for legal professionals
- It guarantees automatic employment in CDSCO
Correct Answer: It helps understand regulatory compliance, drug approval pathways, and safety monitoring relevant to pharmacy practice
Q14. Which activity below is an example of CDSCO’s role in quality control?
- Conducting nationwide vaccination campaigns
- Issuing standards and overseeing testing for drug quality and impurities
- Providing hospital pharmacy services
- Regulating food adulteration inspections
Correct Answer: Issuing standards and overseeing testing for drug quality and impurities
Q15. What action can CDSCO take if a drug in the market is found unsafe?
- Issue a manufacturing licence
- Initiate recall, suspend marketing approval, and issue safety advisories
- Award certification to the product
- Decrease the tax on the product
Correct Answer: Initiate recall, suspend marketing approval, and issue safety advisories
Q16. Which document or requirement is commonly reviewed by CDSCO during new drug approval?
- Clinical trial data demonstrating safety and efficacy
- Retail sales data of similar drugs
- Employee training manuals from the manufacturer
- Patient satisfaction surveys
Correct Answer: Clinical trial data demonstrating safety and efficacy
Q17. How does CDSCO interact with international regulatory agencies?
- It isolates Indian regulations and does not engage internationally
- Through collaboration, harmonization efforts, and information exchange on safety and regulatory science
- By outsourcing approvals to foreign agencies
- By adopting international prices for drugs
Correct Answer: Through collaboration, harmonization efforts, and information exchange on safety and regulatory science
Q18. Which of the following best describes CDSCO’s role in controlling advertising and claims for drugs?
- It has no role; advertising is unregulated
- It monitors and can act against misleading or unapproved therapeutic claims
- It approves all marketing slogans before release
- It handles only television advertisements for food products
Correct Answer: It monitors and can act against misleading or unapproved therapeutic claims
Q19. Which process would a pharmaceutical company approach CDSCO for when seeking to market a novel vaccine in India?
- Registration of trademark only
- New drug/vaccine approval and clinical trial permissions as applicable
- Local municipal clearance for distribution
- Approval from state police department
Correct Answer: New drug/vaccine approval and clinical trial permissions as applicable
Q20. CDSCO issues which type of licences that are especially relevant for imported drugs?
- Retail shop licences
- Import licences and registration certificates for importers and products
- Wholesale trade licences for food items
- Driving licences for courier drivers
Correct Answer: Import licences and registration certificates for importers and products
Q21. What is the significance of Good Clinical Practice (GCP) in CDSCO-regulated trials?
- GCP is irrelevant for regulatory review
- GCP ensures ethical conduct, participant safety, and data integrity in clinical trials
- GCP mandates marketing strategies post-approval
- GCP focuses only on manufacturing procedures
Correct Answer: GCP ensures ethical conduct, participant safety, and data integrity in clinical trials
Q22. Which entity is responsible for publishing the official standards for drug substances and formulations that CDSCO may reference?
- Indian Pharmacopoeia Commission (IPC)
- Reserve Bank of India
- National Health Mission
- Department of Agriculture
Correct Answer: Indian Pharmacopoeia Commission (IPC)
Q23. What is a common regulatory requirement CDSCO enforces for clinical trial investigators?
- Investigators must be registered medical practitioners and have requisite training and ethics approvals
- Investigators must be pharmacists only
- Investigators should fund the trial personally
- Investigators must be employed by CDSCO
Correct Answer: Investigators must be registered medical practitioners and have requisite training and ethics approvals
Q24. Which of the following best reflects CDSCO’s role in emergency use authorization or expedited approvals?
- CDSCO has mechanisms to consider expedited pathways during public health emergencies
- CDSCO never expedites any approvals under any circumstance
- CDSCO delegates emergency approvals to state drug inspectors
- CDSCO only expedites approvals for cosmetics
Correct Answer: CDSCO has mechanisms to consider expedited pathways during public health emergencies
Q25. What is an important documentation submission to CDSCO for post-approval changes in a marketed product?
- Change control and variation application describing the modification and supporting data
- Only a verbal request to local post office
- A sales forecast for the next five years
- An advertisement plan for the product
Correct Answer: Change control and variation application describing the modification and supporting data
Q26. In the context of CDSCO, what does pharmacovigilance primarily aim to achieve?
- Maximize a drug’s market price
- Detect, assess, understand, and prevent adverse drug reactions and ensure safe use
- Train sales representatives in marketing techniques
- Develop packaging innovations
Correct Answer: Detect, assess, understand, and prevent adverse drug reactions and ensure safe use
Q27. Which of the following is true about CDSCO’s authority to recall drugs?
- Only manufacturers can recall without CDSCO involvement
- CDSCO can coordinate or order a recall when safety or quality concerns are identified
- Drugs cannot be recalled once marketed
- Recalls are managed exclusively by state pharmacies
Correct Answer: CDSCO can coordinate or order a recall when safety or quality concerns are identified
Q28. How does CDSCO contribute to setting national standards for drug quality?
- By developing and enforcing standards, sometimes in coordination with pharmacopoeial bodies and expert committees
- By controlling retail prices of drugs nationwide
- By manufacturing all essential medicines centrally
- By issuing patents for new molecules
Correct Answer: By developing and enforcing standards, sometimes in coordination with pharmacopoeial bodies and expert committees
Q29. Which stakeholders typically interact with CDSCO during the lifecycle of a pharmaceutical product?
- Manufacturers, importers, clinical investigators, ethics committees, and state regulators
- Only retail customers and pharmacists
- Only the Ministry of Finance
- Only international shipping companies
Correct Answer: Manufacturers, importers, clinical investigators, ethics committees, and state regulators
Q30. For B. Pharm students preparing for regulatory roles, which skillset is most relevant in relation to CDSCO functions?
- Understanding of regulatory frameworks, quality systems, clinical trial processes, and pharmacovigilance
- Ability to design hospital interiors
- Expertise in vegetable cultivation
- Proficiency in automobile repair
Correct Answer: Understanding of regulatory frameworks, quality systems, clinical trial processes, and pharmacovigilance
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