CDSCO and State Licensing Authority – organization and responsibilities MCQs With Answer

Introduction

CDSCO and State Licensing Authority – organization and responsibilities MCQs With Answer is a focused question set designed for M.Pharm students preparing for exams and regulatory discussions. The quiz explains the structure and functions of the Central Drugs Standard Control Organization (CDSCO) and the State Licensing Authorities, clarifying roles such as new drug approvals, clinical trial permissions, import controls, licensing, inspections and post‑marketing surveillance. These MCQs emphasize practical regulatory responsibilities, relevant schedules and the coordination between central and state regulators. This resource helps students deepen their understanding of how India’s drug and device regulatory system operates and prepares them for professional or academic regulatory tasks.

Q1. Who is the head of the Central Drugs Standard Control Organization (CDSCO)?

• Drugs Controller General of India (DCGI)
• Director General of Health Services (DGHS)
• Secretary, Ministry of Health & Family Welfare
• Chairperson, Central Drug Authority

Correct Answer: Drugs Controller General of India (DCGI)

Q2. Which primary legislation governs drugs and cosmetics regulation in India?

• Food Safety and Standards Act, 2006
• Indian Medical Council Act, 1956
• Drugs and Cosmetics Act, 1940
• Pharmacy Act, 1948

Correct Answer: Drugs and Cosmetics Act, 1940

Q3. Where is the headquarters of CDSCO located?

• Mumbai
• Kolkata
• New Delhi
• Chennai

Correct Answer: New Delhi

Q4. Which of the following is a core responsibility of CDSCO?

• Issuing retail drug sale licences within a state
• Approval of new drugs and clinical trial permissions
• Collecting state excise on pharmaceuticals
• Running private hospital accreditations

Correct Answer: Approval of new drugs and clinical trial permissions

Q5. Which authority primarily issues manufacturing licences for most finished pharmaceutical products for sale within a state?

• Central Drugs Standard Control Organization (CDSCO)
• State Licensing Authority (State Drug Controller)
• Indian Pharmacopoeia Commission
• National Pharmaceutical Pricing Authority (NPPA)

Correct Answer: State Licensing Authority (State Drug Controller)

Q6. Who is responsible for granting permission to import pharmaceutical products into India?

• State Licensing Authority
• Food Safety and Standards Authority of India (FSSAI)
• Central Drugs Standard Control Organization (CDSCO)
• Reserve Bank of India (RBI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q7. Which schedule of the Drugs and Cosmetics Rules specifies Good Manufacturing Practices and requirements for drug manufacturing premises?

• Schedule Y
• Schedule M
• Schedule P
• Schedule V

Correct Answer: Schedule M

Q8. How are medical devices classified under the Medical Devices Rules, 2017?

• Two classes: Standard and Non‑standard
• Four classes based on risk: A, B, C, D
• By manufacturer country of origin
• By intended user: professional or consumer only

Correct Answer: Four classes based on risk: A, B, C, D

Q9. Which authority grants permission to conduct a clinical trial for a new drug in India?

• Institutional Ethics Committee only
• State Licensing Authority
• Drugs Controller General of India (DCGI) under CDSCO
• Central Bureau of Investigation (CBI)

Correct Answer: Drugs Controller General of India (DCGI) under CDSCO

Q10. Central Drugs Testing Laboratories (CDTLs) and referral testing infrastructure operate under which organization?

• Indian Council of Medical Research (ICMR)
• Central Drugs Standard Control Organization (CDSCO)
• National Accreditation Board for Testing and Calibration Laboratories (NABL)
• State Health Departments

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q11. Which authority is primarily responsible for issuing retail and wholesale drug licences within a state?

• Central Drugs Standard Control Organization (CDSCO)
• State Licensing Authority (State Drug Controller)
• Pharmacy Council of India
• Ministry of Commerce

Correct Answer: State Licensing Authority (State Drug Controller)

Q12. At the national level, which body coordinates approvals and regulatory oversight for post‑marketing drug safety and surveillance?

• State Licensing Authority
• Central Drugs Standard Control Organization (CDSCO)
• National Drug Distribution Federation
• Medical Council of India

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q13. Which schedules of the Drugs and Cosmetics Rules are principally concerned with biologicals (vaccines, sera, toxins)?

• Schedule X and XA
• Schedule C and C(1)
• Schedule D and D(1)
• Schedule S and S1

Correct Answer: Schedule C and C(1)

Q14. Which body is responsible for coordinating training, policy harmonization and technical support between the Centre and State drug controllers?

• Local Municipal Corporations
• Central Drugs Standard Control Organization (CDSCO)
• National Pharmaceutical Association
• Ministry of Finance

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q15. Under the Medical Devices Rules, which authority typically handles approval/registration and regulatory oversight for high‑risk (Class C and D) medical devices?

• State Licensing Authority
• Central Drugs Standard Control Organization (CDSCO)
• Pharmaceutical Export Promotion Council
• Department of Biotechnology

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q16. Who normally initiates prosecution and enforcement actions for offences under the Drugs and Cosmetics Act within a state?

• Central Bureau of Investigation (CBI)
• State Licensing Authority / State Drug Control Organization
• World Health Organization (WHO)
• National Human Rights Commission

Correct Answer: State Licensing Authority / State Drug Control Organization

Q17. What are key responsibilities of a State Licensing Authority regarding retail drug outlets?

• Issuing, renewing, suspending licences and conducting inspections of retail outlets
• Approving new drug molecules for market
• Setting central drug prices nationwide
• Granting import licences for active pharmaceutical ingredients

Correct Answer: Issuing, renewing, suspending licences and conducting inspections of retail outlets

Q18. When an investigator needs to import investigational medicinal product for a clinical trial, which authority’s permission is required?

• Local Municipal Health Officer
• State Licensing Authority
• Central Drugs Standard Control Organization (CDSCO)
• Export Promotion Council

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q19. Who maintains and updates the register of licensed manufacturers, wholesalers and retailers within a state?

• Central Drugs Standard Control Organization (CDSCO)
• State Licensing Authority (State Drug Controller)
• Indian Pharmacopoeia Commission
• National Accreditation Board

Correct Answer: State Licensing Authority (State Drug Controller)

Q20. Which authority is empowered to make rules and notify amendments under the Drugs and Cosmetics Act at the national level?

• State Governments independently
• Central Government (Ministry of Health & Family Welfare)
• World Health Organization (WHO)
• National Consumer Disputes Redressal Commission

Correct Answer: Central Government (Ministry of Health & Family Welfare)

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