Regulatory authorities in India – ASU DTAB and ASU DCC MCQs With Answer

Regulatory authorities in India – ASU DTAB and ASU DCC MCQs With Answer

Understanding regulatory authorities in India is essential for B. Pharm students, especially the roles of ASU DTAB and ASU DCC in Ayurveda, Siddha and Unani (ASU) drug governance. This introduction covers legal framework, advisory functions, coordination between central and state drug control bodies, standards for manufacturing, quality control, clinical trial oversight, registration and pharmacovigilance specific to ASU drugs. Familiarity with Central Drugs Standard Control Organization (CDSCO), Drug Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC) helps future pharmacists navigate drug approval, licensing and compliance. Clear knowledge of these bodies strengthens safe, effective practice in traditional and modern pharmaceutical contexts. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does ASU stand for in the context of Indian drug regulation?

• Allopathic, Surgical, and Urgent care
• Ayurveda, Siddha and Unani
• Administrative, Scientific, and Utility
• Authority for Standardized Usage

Correct Answer: Ayurveda, Siddha and Unani

Q2. Which central body primarily coordinates drug regulation and approval in India for modern medicines?

• ASU DTAB
• State Drug Control Organization
• Central Drugs Standard Control Organization (CDSCO)
• Drug Consultative Committee (DCC)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. What is the main function of the Drug Technical Advisory Board (DTAB)?

• Execute inspections of manufacturing units
• Provide technical advice to the central government on drug matters
• Grant manufacturing licenses directly
• Manage hospital pharmacy operations

Correct Answer: Provide technical advice to the central government on drug matters

Q4. What does the Drug Consultative Committee (DCC) primarily facilitate?

• International trade agreements for drugs
• Coordination between central and state drug regulatory authorities
• Clinical training for pharmacists
• Advertising approvals for medicines

Correct Answer: Coordination between central and state drug regulatory authorities

Q5. ASU DTAB is focused on regulatory guidance for which category of medicines?

• Synthetic chemical drugs only
• Ayurveda, Siddha and Unani medicines
• Veterinary vaccines exclusively
• Homeopathic preparations only

Correct Answer: Ayurveda, Siddha and Unani medicines

Q6. Which legal act forms the backbone of drug regulation in India, covering both modern and traditional drugs?

• The Pharmacy Act, 1948
• The Drugs and Cosmetics Act, 1940
• The Indian Medical Council Act, 1956
• The AYUSH Practice Act, 1996

Correct Answer: The Drugs and Cosmetics Act, 1940

Q7. Which of the following is a typical role of ASU DCC?

• Conducting clinical trials single-handedly
• Standardizing coordination and policies between states for ASU drugs
• Manufacturing ASU medicines
• Granting patents for herbal formulations

Correct Answer: Standardizing coordination and policies between states for ASU drugs

Q8. Who benefits directly from clear guidelines issued by DTAB and DCC?

• Only international manufacturers
• Pharmacists, manufacturers, regulators and patients
• Only traditional healers
• Only clinical trial volunteers

Correct Answer: Pharmacists, manufacturers, regulators and patients

Q9. Which activity is commonly overseen by regulatory authorities for ASU drugs?

• Setting tuition fees for Ayurvedic colleges
• Establishing quality standards and monographs
• Designing marketing logos
• Providing clinical care in hospitals

Correct Answer: Establishing quality standards and monographs

Q10. What is pharmacovigilance in the context of ASU and conventional drugs?

• Promotion of drug sales
• Monitoring and reporting adverse drug reactions
• Manufacturing process optimization
• Label design and printing

Correct Answer: Monitoring and reporting adverse drug reactions

Q11. Which body typically issues guidelines for clinical trials of drugs in India?

• Local hospital administration
• Central Drugs Standard Control Organization (CDSCO)
• Private pharmaceutical retailers
• National Medical Commission

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q12. A primary difference between DTAB and DCC is that DTAB is mainly:

• An operational inspection wing
• A technical advisory board offering expert recommendations
• A manufacturing consortium
• A marketing regulatory cell

Correct Answer: A technical advisory board offering expert recommendations

Q13. The DCC usually includes representatives from which entities?

• Only central ministries
• State drug controllers and central regulatory authorities
• Private pharmaceutical companies exclusively
• International health organizations only

Correct Answer: State drug controllers and central regulatory authorities

Q14. Why is standardization important for ASU medicines?

• To increase advertising reach
• To ensure consistent quality, safety and efficacy
• To reduce packaging costs
• To restrict market access

Correct Answer: To ensure consistent quality, safety and efficacy

Q15. Which process is under central jurisdiction for new drug approvals in India?

• Local retail pricing approval
• Clinical trial approval and new drug licensing by CDSCO
• Village-level licensing
• Advertising campaign approval by DCC

Correct Answer: Clinical trial approval and new drug licensing by CDSCO

Q16. How do DTAB recommendations typically reach formal policy?

• Direct implementation by manufacturers
• Adopted by the central government after evaluation
• Voted on by the general public
• Automatically enforced by states

Correct Answer: Adopted by the central government after evaluation

Q17. Which of the following best describes ASU regulatory focus areas?

• Only export documentation
• Quality control, monographs, safety, licensing and pharmacovigilance
• Hospital bed allocation
• Academic curriculum development only

Correct Answer: Quality control, monographs, safety, licensing and pharmacovigilance

Q18. Which document often contains official standards for herbal and ASU ingredients?

• Monographs and pharmacopoeias
• Promotional brochures
• Trade invoices
• Patent specifications only

Correct Answer: Monographs and pharmacopoeias

Q19. State drug control organizations are primarily responsible for which task?

• Formulating central drug policy
• Implementing licensing, inspections and enforcement at the state level
• Appointing CDSCO leadership
• International treaty negotiation

Correct Answer: Implementing licensing, inspections and enforcement at the state level

Q20. Which regulatory measure improves patient safety for ASU products?

• Unregulated traditional claims
• Mandatory safety reporting and standardized labeling
• Exclusive online sales
• Hidden ingredient lists

Correct Answer: Mandatory safety reporting and standardized labeling

Q21. Which organization would a B. Pharm student consult to learn about national drug safety alerts?

• Local gym association
• Central Drugs Standard Control Organization (CDSCO)
• Tourism department
• Chamber of commerce

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q22. What is a key output of DTAB relevant to pharmacists?

• Retail store designs
• Technical recommendations on drug standards and classification
• International shipping schedules
• Pharmacy staffing rosters

Correct Answer: Technical recommendations on drug standards and classification

Q23. How can DCC meetings support uniform regulation across India?

• By issuing local manufacturing permits
• By harmonizing policies and resolving state-central regulatory issues
• By funding private companies directly
• By conducting patient care services

Correct Answer: By harmonizing policies and resolving state-central regulatory issues

Q24. Which activity is NOT typically within the scope of DTAB?

• Advising on drug classification
• Recommending safety standards
• Directly enforcing state-level inspections
• Advising on labeling norms

Correct Answer: Directly enforcing state-level inspections

Q25. For ASU products, pharmacovigilance systems help to:

• Increase product prices
• Detect and manage adverse reactions to traditional medicines
• Limit scientific research
• Promote only export markets

Correct Answer: Detect and manage adverse reactions to traditional medicines

Q26. Which body is best placed to coordinate laboratory standards and testing methods nationwide?

• Local retailers association
• Central regulatory authorities with input from DTAB/DCC
• Individual manufacturers alone
• State tourism boards

Correct Answer: Central regulatory authorities with input from DTAB/DCC

Q27. Why should B. Pharm students study ASU DTAB and ASU DCC?

• To become herbal product marketers
• To understand regulatory frameworks affecting drug quality, safety and legal compliance
• To learn cooking techniques
• To design hospital buildings

Correct Answer: To understand regulatory frameworks affecting drug quality, safety and legal compliance

Q28. Which statement about ASU drug registration is generally correct?

• ASU drugs never require any registration
• They often require adherence to standards and appropriate registration under national laws
• They are only registered internationally
• Registration is handled by tourism departments

Correct Answer: They often require adherence to standards and appropriate registration under national laws

Q29. Effective coordination between DTAB, DCC and CDSCO helps to:

• Delay drug approvals indefinitely
• Ensure consistent regulatory decisions and protect public health
• Remove all manufacturing standards
• Limit academic research opportunities

Correct Answer: Ensure consistent regulatory decisions and protect public health

Q30. As future pharmacists, students should engage with regulatory topics because:

• Regulation is irrelevant to pharmacy practice
• Understanding regulations ensures safe dispensing, compliance and improved patient outcomes
• It helps avoid clinical responsibilities
• It only matters for marketing teams

Correct Answer: Understanding regulations ensures safe dispensing, compliance and improved patient outcomes

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