The Indian regulatory framework for pharmaceuticals is anchored in the Drugs and Cosmetics Act, 1940 and Rules, 1945, with the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLAs) sharing responsibilities. CDSCO (headed by the DCGI) oversees new drug approvals, clinical trial permissions, import licensing, pharmacovigilance and national standards, while SLAs handle state-level manufacturing, wholesale and retail drug licensing, inspections and GMP compliance. Understanding CDSCO processes, Schedule M (GMP), Schedule Y (clinical trials), drug registration, licensing pathways, and adverse drug reaction reporting is essential for B.Pharm students preparing for careers in regulatory affairs, quality assurance and pharmaceutical manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which legislation is the primary legal framework for drug regulation in India?
- Food Safety and Standards Act
- Drugs and Cosmetics Act, 1940
- Pharmacy Act
- Medical Council Act
Correct Answer: Drugs and Cosmetics Act, 1940
Q2. What is the central regulatory body responsible for approval of new drugs and clinical trials in India?
- Pharmacy Council of India
- Central Drugs Standard Control Organization (CDSCO)
- State Licensing Authority
- National Institute of Health
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q3. Who is the head of CDSCO commonly referred to as?
- Chief Medical Officer
- Director General of Health Services
- Drugs Controller General of India (DCGI)
- Chairman, National Drug Authority
Correct Answer: Drugs Controller General of India (DCGI)
Q4. Which authority issues state-level manufacturing and retail drug licenses?
- CDSCO
- Pharmacovigilance Programme of India
- State Licensing Authority (SLA)
- National Institute of Pharmaceutical Education
Correct Answer: State Licensing Authority (SLA)
Q5. Which Schedule of the Drugs and Cosmetics Rules specifies Good Manufacturing Practices (GMP) for pharmaceutical manufacturing?
- Schedule H
- Schedule M
- Schedule Y
- Schedule X
Correct Answer: Schedule M
Q6. Which Schedule provides regulatory guidance for clinical trials and requirements for new drugs in India?
- Schedule M
- Schedule H
- Schedule Y
- Schedule K
Correct Answer: Schedule Y
Q7. Which of the following is a primary responsibility of CDSCO?
- Issuing retail drug licenses within a district
- Approving new drug applications and clinical trial permissions
- Running hospital pharmacies
- Conducting routine dispensing at community pharmacies
Correct Answer: Approving new drug applications and clinical trial permissions
Q8. Which of the following tasks is typically handled by State Licensing Authorities?
- Granting import licenses for drugs manufactured abroad
- Approval of new molecular entities
- Issuing licences for manufacture, sale and distribution at state level
- Setting national pharmacopoeial standards
Correct Answer: Issuing licences for manufacture, sale and distribution at state level
Q9. What are the standard phases of clinical trials?
- Preclinical only
- Phase I, II, III and IV
- Screening and Marketing
- Laboratory and Field trials
Correct Answer: Phase I, II, III and IV
Q10. Before initiating a clinical trial at an institution, approval must be obtained from which body?
- Local Pharmacy Committee
- Institutional Ethics Committee (IEC)
- State Pollution Control Board
- National Clinical Trial Registry only
Correct Answer: Institutional Ethics Committee (IEC)
Q11. What does PvPI stand for?
- Pharmacovigilance Programme of India
- Public Vaccine Programme of India
- Pharmaceutical Validation Program India
- Policy for Veterinary Products of India
Correct Answer: Pharmacovigilance Programme of India
Q12. Which schedule contains the list of drugs that must be sold only on prescription?
- Schedule M
- Schedule H
- Schedule Y
- Schedule D
Correct Answer: Schedule H
Q13. Which schedule requires strict record-keeping and retention for certain controlled drugs?
- Schedule H
- Schedule X
- Schedule M
- Schedule Y
Correct Answer: Schedule X
Q14. Who is responsible for granting marketing authorization for a genuine new drug or new molecular entity in India?
- State Licensing Authority
- Central Drugs Standard Control Organization / DCGI
- Pharmacy Council of India
- World Health Organization
Correct Answer: Central Drugs Standard Control Organization / DCGI
Q15. Bioequivalence studies are primarily used to demonstrate which of the following?
- Safety of a novel molecule
- Equivalence of a generic formulation to an innovator product
- Taste masking effectiveness
- Stability under accelerated conditions
Correct Answer: Equivalence of a generic formulation to an innovator product
Q16. Which authorities conduct GMP inspections of pharmaceutical manufacturing sites in India?
- Only State Licensing Authorities
- Only CDSCO inspectors
- Both CDSCO and State Licensing Authority inspectors
- Pharmaceutical trade associations
Correct Answer: Both CDSCO and State Licensing Authority inspectors
Q17. Import of pharmaceutical products into India requires prior permission from which authority?
- State Licensing Authority
- Central Drugs Standard Control Organization (CDSCO)
- Customs only, no drug authority
- Pharmacy Council of India
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q18. Adverse drug reactions (ADRs) from marketed products in India should be reported to which program?
- National Clinical Registry
- Pharmacovigilance Programme of India (PvPI)
- Central Bureau of Health Intelligence
- State Pollution Control Board
Correct Answer: Pharmacovigilance Programme of India (PvPI)
Q19. Licensing and inspection of blood banks in India generally fall under which authority?
- Municipal Corporation only
- State Licensing Authority under the Drugs and Cosmetics Rules
- CDSCO exclusively
- Food Safety and Standards Authority
Correct Answer: State Licensing Authority under the Drugs and Cosmetics Rules
Q20. Which of the following best describes the role of the Drugs Controller General of India (DCGI)?
- Manages hospital pharmacies nationwide
- Approves national drug policies, new drugs and oversees clinical trial approvals
- Issues retail drug licenses in districts
- Conducts community health awareness programs only
Correct Answer: Approves national drug policies, new drugs and oversees clinical trial approvals
Q21. Schedule M primarily applies to which aspect of pharmaceuticals?
- Marketing and advertising rules
- Good Manufacturing Practice requirements for drug manufacturing
- Clinical trial compensation rules
- Import tariffs and duties
Correct Answer: Good Manufacturing Practice requirements for drug manufacturing
Q22. Which of the following is a central function of national pharmacopoeial standards and monographs?
- To set global pricing for drugs
- To provide authoritative quality standards for identity, purity and strength of medicines
- To license retail pharmacies
- To approve hospital clinical protocols
Correct Answer: To provide authoritative quality standards for identity, purity and strength of medicines
Q23. For a fixed-dose combination (FDC) intended to be marketed nationally, which approval is essential?
- Local municipal approval only
- Central regulatory approval from CDSCO
- No approval if components are already marketed separately
- Approval by Pharmacy Council
Correct Answer: Central regulatory approval from CDSCO
Q24. Renewal of a state-issued manufacturing licence is primarily processed by which authority?
- CDSCO
- State Licensing Authority
- Pharmacovigilance Programme of India
- Food Safety Department
Correct Answer: State Licensing Authority
Q25. Which law in India specifically prohibits misleading advertisements about drugs and remedies?
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
- Pharmacy Act, 1948
- Clinical Trials Regulation Act
- Consumer Protection Act only
Correct Answer: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Q26. Which authority plays a key role in organizing national pharmacovigilance activities and ADR data collection?
- State Licensing Authority
- Pharmacovigilance Programme of India coordinated with CDSCO
- Medical Council of India
- Department of Agriculture
Correct Answer: Pharmacovigilance Programme of India coordinated with CDSCO
Q27. In case of a major safety concern with a marketed drug, who can order a recall in India?
- Only the manufacturer
- CDSCO in coordination with State Authorities
- Local pharmacies collectively
- Pharmacy Council of India
Correct Answer: CDSCO in coordination with State Authorities
Q28. Which of the following is a mandatory element on a finished pharmaceutical product label in India?
- Manufacturer’s internal batch code only for records
- Expiry date
- Name of the wholesaler only
- Clinical trial registry number
Correct Answer: Expiry date
Q29. What is an orphan drug as per common regulatory definitions?
- A drug for pediatric use only
- A drug intended to treat a rare disease or condition with limited market potential
- A drug that is no longer under patent but widely used
- A drug intended only for veterinary use
Correct Answer: A drug intended to treat a rare disease or condition with limited market potential
Q30. Pharmacovigilance primarily involves which of the following activities?
- Manufacturing sterile products
- Monitoring, detection, assessment and prevention of adverse drug reactions
- Setting retail pharmacy opening hours
- Conducting marketing surveys for new drugs
Correct Answer: Monitoring, detection, assessment and prevention of adverse drug reactions
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