Overview of Acts and Rules governing drugs, cosmetics, medical devices, biologicals, herbals, food & nutraceuticals in India MCQs With Answer

Overview of Acts and Rules governing drugs, cosmetics, medical devices, biologicals, herbals, food & nutraceuticals in India MCQs With Answer

This quiz collection is designed for M.Pharm students to deepen understanding of India’s regulatory framework for drugs, cosmetics, medical devices, biologicals, herbals and nutraceuticals. The questions cover primary statutes (Drugs & Cosmetics Act, Food Safety Act), key rules (Medical Devices Rules, New Drugs & Clinical Trials Rules), schedules (M, Y, H, H1, X), regulatory authorities (CDSCO, DCGI, FSSAI, State Licensing Authorities), and practical compliance topics such as licensing, GMP, clinical trial responsibilities, pharmacovigilance and patents. These MCQs are meant to reinforce classroom learning, test interpretation of regulations, and prepare students for regulatory roles in industry, quality assurance, regulatory affairs and research.

Q1. Which statute is the principal law governing manufacture, sale and import of drugs and cosmetics in India?

• The Food Safety and Standards Act, 2006
• The Drugs and Cosmetics Act, 1940
• The Medical Devices Rules, 2017
• The Indian Patents Act, 1970

Correct Answer: The Drugs and Cosmetics Act, 1940

Q2. Which authority is primarily responsible for approval of new drugs and clinical trial permissions in India?

• Food Safety and Standards Authority of India (FSSAI)
• State Licensing Authority
• Central Drugs Standard Control Organization / DCGI
• Indian Pharmacopoeia Commission

Correct Answer: Central Drugs Standard Control Organization / DCGI

Q3. Schedule M in the Drugs and Cosmetics Rules mainly addresses which aspect of pharmaceutical regulation?

• Clinical trial ethical requirements
• Good Manufacturing Practices for manufacturers
• Labeling and advertising of drugs
• Import-export documentation

Correct Answer: Good Manufacturing Practices for manufacturers

Q4. Which schedule contains drugs that are to be sold only on prescription with conditions, and includes many potent APIs?

• Schedule X
• Schedule M
• Schedule H
• Schedule Y

Correct Answer: Schedule H

Q5. Which set of rules specifically governs regulation, classification, and registration of medical devices in India?

• New Drugs and Clinical Trials Rules, 2019
• Medical Devices Rules, 2017
• Cosmetic Rules, 2020
• Food Safety and Standards Regulations, 2016

Correct Answer: Medical Devices Rules, 2017

Q6. Under Indian Medical Devices Rules, which device class represents the highest risk category?

• Class A
• Class B
• Class C
• Class D

Correct Answer: Class D

Q7. Which authority normally issues manufacturing licences for most formulation manufacturing units (non-biological drugs) in India?

• Central Licensing Authority (CDSCO)
• State Licensing Authority / State Drug Controller
• Food Safety and Standards Authority of India
• Indian Patent Office

Correct Answer: State Licensing Authority / State Drug Controller

Q8. Which rules introduced a consolidated framework for approval of new drugs, clinical trial permissions, and post-approval obligations in India in 2019?

• Medical Devices Rules, 2017
• Drugs and Cosmetics Rules, 1945 (unchanged)
• New Drugs and Clinical Trials Rules, 2019
• Food Safety and Standards Regulations, 2016

Correct Answer: New Drugs and Clinical Trials Rules, 2019

Q9. Which authority regulates nutraceuticals, functional foods and health supplements in India?

• Central Drugs Standard Control Organization (CDSCO)
• Department of AYUSH
• Food Safety and Standards Authority of India (FSSAI)
• Indian Council of Medical Research (ICMR)

Correct Answer: Food Safety and Standards Authority of India (FSSAI)

Q10. The specific FSSAI regulation dealing with health supplements, foods for special dietary uses, functional foods and novel foods was issued in which year?

• 2006
• 2016
• 2019
• 2012

Correct Answer: 2016

Q11. Which schedule of the Drugs and Cosmetics Rules provides detailed requirements and guidance on clinical trials, investigator responsibilities and approval pathways for new drugs?

• Schedule M
• Schedule Y
• Schedule H1
• Schedule X

Correct Answer: Schedule Y

Q12. For approval of a Fixed Dose Combination (FDC) of existing drugs where both components are approved separately, which authority’s approval is required?

• State Licensing Authority only
• Central Licensing Authority (CDSCO/DCGI)
• FSSAI
• No approval is required if individual drugs are approved

Correct Answer: Central Licensing Authority (CDSCO/DCGI)

Q13. Import of pharmaceutical drugs into India requires an import licence issued by which authority?

• State Drug Controller
• Central Drugs Standard Control Organization / DCGI
• FSSAI
• Customs alone, no licence required

Correct Answer: Central Drugs Standard Control Organization / DCGI

Q14. Which schedule contains a list of drugs that require special prescription and strict record-keeping because they are potentially habit-forming or subject to abuse?

• Schedule H1
• Schedule M
• Schedule X
• Schedule G

Correct Answer: Schedule X

Q15. The Pharmacovigilance Programme of India (PvPI) is coordinated by which organization?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Council of Medical Research (ICMR)
• Indian Pharmacopoeia Commission (IPC)
• All India Institute of Medical Sciences (AIIMS)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q16. Cosmetics in India are regulated under which legal framework?

• Food Safety and Standards Act, 2006
• Drugs and Cosmetics Act, 1940 and Cosmetic Rules
• Medical Devices Rules, 2017
• Indian Patents Act, 1970

Correct Answer: Drugs and Cosmetics Act, 1940 and Cosmetic Rules

Q17. Who is primarily liable to pay compensation for injury or death occurring to a subject during a registered clinical trial in India?

• The investigator
• The Ethics Committee
• The Sponsor of the clinical trial
• The State Licensing Authority

Correct Answer: The Sponsor of the clinical trial

Q18. Which of the following is a mandatory requirement under Schedule M for pharmaceutical manufacturing buildings?

• Presence of a clinical trial unit within the premises
• Separate and documented area for quarantine and sampling of raw materials
• No requirement for controlled environment or HVAC
• On-site retail pharmacy for distribution

Correct Answer: Separate and documented area for quarantine and sampling of raw materials

Q19. Traditional herbal (AYUSH) products are regulated in India primarily by which department or authority for manufacturing and quality standards?

• Central Drugs Standard Control Organization (CDSCO)
• Department of AYUSH and respective licensing authorities under Drugs & Cosmetics Act (where applicable)
• FSSAI only
• Indian Patent Office

Correct Answer: Department of AYUSH and respective licensing authorities under Drugs & Cosmetics Act (where applicable)

Q20. Under the Indian Patents Act, what is the standard term (duration) of a granted patent for pharmaceutical inventions?

• 10 years from grant date
• 14 years from priority date
• 20 years from the date of filing
• 7 years renewable annually

Correct Answer: 20 years from the date of filing

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