MCQ with answers
New Drugs and Clinical Trials Rules, 2019
10 explained questions below · 15 on this instrument in the practice banks · Rules as amended; they supersede the clinical-trial provisions formerly under Schedule Y for new drugs.
The New Drugs and Clinical Trials Rules, 2019 replaced the older clinical-trial provisions of the 1945 Rules with a self-contained code for how a new drug reaches the Indian market: what counts as a new drug or an investigational new drug, who the Central Licensing Authority is, how an ethics committee is registered and what it must do, how permission to conduct a trial is obtained, and what a sponsor owes a participant who is injured. Coaching material still routinely describes clinical trials under Schedule Y; the exam expects the 2019 Rules.
The provisions that recur are the definitions, the registration and composition of ethics committees, the permission and timeline architecture for trials and for import or manufacture of new drugs, the compensation provisions, the conditions under which trial data from outside India is accepted, and the post-approval obligations such as safety reporting. Questions are structural — which authority, which stage, which timeline — rather than pharmacological.
The questions below are served from the reviewed bank; the badge on each item states whether its explanation quotes the rule or was independently fact-checked.
What the exams keep asking
- ▸Definitions — new drug, investigational new drug, clinical trial, bioavailability and bioequivalence study
- ▸The Central Licensing Authority and the stages of permission
- ▸Ethics committees — registration, composition and responsibilities
- ▸Timelines for review and the concept of deemed approval
- ▸Compensation for injury or death during a clinical trial
- ▸Post-approval obligations — safety reporting and post-marketing requirements
10 practice questions, each explained
Attempt first, then open the answer. Every explanation says why the right option is right — and, where the bank holds it, quotes the provision.
- Question 1EASY
What is the primary objective of Pharmacovigilance in the pharmaceutical regulatory system?
- A)To promote the sale of older drugs instead of new ones
- B)To prevent drug prices from increasing
- C)To detect, assess, understand, and prevent adverse drug reactions and drug-related problems
- D)To replace clinical trials in drug development
Show answer & explanation
Answer: C) To detect, assess, understand, and prevent adverse drug reactions and drug-related problems
Pharmacovigilance is the science of ongoing safety monitoring of approved drugs.
Why the others fail
- A) Pharmacovigilance is impartial; it monitors all drugs
- B) Pharmacovigilance focuses on safety, not pricing
- D) Pharmacovigilance is postmarket; clinical trials are premarket
Source: Pharmacovigilance framework and NDCT Rules, Pharmacovigilance procedures
AI fact-checkedfrom the Drug Inspector bank - Question 2MEDIUM
Which committee advises the DCGI on approval of new chemical entities and clinical trial applications?
- A)State Drugs Standards Authority
- B)Indian Pharmacopoeia Commission
- C)National Pharmaceutical Pricing Authority (NPPA)
- D)Drug Technical Advisory Board (DTAB)
Show answer & explanation
Answer: D) Drug Technical Advisory Board (DTAB)
The DTAB is the supreme technical advisory body to the DCGI for new drug approvals and clinical trials.
Why the others fail
- A) State bodies implement law; DTAB is the national technical advisory body
- B) IP Commission sets standards; DTAB advises on regulatory approvals
- C) NPPA advises on pricing; DTAB advises on clinical matters
Source: D&C Act and NDCT Rules, Committee structures for drug approval
AI fact-checkedfrom the Drug Inspector bank - Question 3MEDIUM
Under the D&C Act, when a manufacturer seeks to launch a new drug, at what stage does the NDAC (New Drugs Advisory Committee) provide its recommendation?
- A)After market launch based on post-market safety data
- B)Before approval, during review of safety and efficacy data from trials
- C)Only if the drug is imported from another country
- D)After the drug receives approval from at least two developed countries
Show answer & explanation
Answer: B) Before approval, during review of safety and efficacy data from trials
NDAC reviews new drug applications before approval, evaluating safety and efficacy data from preclinical and clinical studies. NDAC recommendations to CDSCO guide approval decisions.
Why the others fail
- A) NDAC review is pre-approval, not post-market.
- C) NDAC review applies to all new drugs regardless of origin.
- D) Indian approval is independent; international approvals support but don't trigger NDAC review.
Source: New Drugs & Clinical Trials Rules, 2019; NDAC Procedure
AI fact-checkedfrom the Drug Inspector bank - Question 4MEDIUM
Under the NDCT Rules 2019, what is the role of an Institutional Ethics Committee (IEC) in clinical trials?
- A)To conduct the actual drug testing on patients
- B)To approve any dose increase without participant consent
- C)Only to check if funding is adequate
- D)To ensure ethical standards, informed consent, and participant safety are maintained
Show answer & explanation
Answer: D) To ensure ethical standards, informed consent, and participant safety are maintained
NDCT Rules 2019 require IEC approval for all clinical trials. The IEC's role is to review protocols, ensure informed consent, monitor safety, and protect participant rights throughout the trial.
Why the others fail
- A) Ethics committees oversee, not conduct trials.
- B) IEC ensures consent is maintained throughout.
- C) Ethics committees focus on ethics and safety, not funding.
Source: New Drugs & Clinical Trials Rules, 2019; IEC Requirements
AI fact-checkedfrom the Drug Inspector bank - Question 5MEDIUM
Under the NDPT Rules 2019, what is the maximum permissible duration for a clinical trial Phase II study?
- A)No specific duration limit; determined by efficacy endpoints
- B)Maximum 6 months for any Phase II study
- C)Phase II typically extends over 1-3 years depending on drug and disease
- D)Phase II must not exceed 1 year, with mandatory extension to Phase III
Show answer & explanation
Answer: C) Phase II typically extends over 1-3 years depending on drug and disease
Phase II clinical trials typically run 1-3 years depending on the drug class, disease, and efficacy outcomes being evaluated. Duration is determined by protocol requirements, not arbitrary time limits.
Why the others fail
- A) While flexible, trials typically have planned durations.
- B) Phase II studies are typically longer.
- D) Duration is not fixed by year; depends on endpoints.
Source: New Drugs & Clinical Trials Rules, 2019; Clinical Trial Phases
AI fact-checkedfrom the Drug Inspector bank - Question 6MEDIUM
Under the NDPT Rules 2019, which authority maintains the registry of clinical trials?
- A)Individual hospitals maintain separate registries without coordination
- B)CDSCO maintains the Clinical Trials Registry - India (CTRI)
- C)Individual manufacturers maintain their own trial registries privately
- D)Only international registries like ClinicalTrials.gov are recognized
Show answer & explanation
Answer: B) CDSCO maintains the Clinical Trials Registry - India (CTRI)
CDSCO maintains the Clinical Trials Registry - India (CTRI), a public registry where all clinical trials must be registered before participant enrollment. This ensures transparency and prevents selective reporting.
Why the others fail
- A) A centralized national registry is maintained.
- C) Public registry ensures transparency.
- D) India has its own national registry.
Source: New Drugs & Clinical Trials Rules, 2019; CTRI Registration
AI fact-checkedfrom the Drug Inspector bank - Question 7MEDIUM
Under the NDCT Rules 2019, what is the primary purpose of conducting bioavailability and bioequivalence (BA/BE) studies?
- A)To determine if a generic drug is therapeutically equivalent to the innovator product
- B)Only to satisfy international WHO requirements, not for Indian registration
- C)To test if the drug is toxic to laboratory animals
- D)To establish that a drug has no side effects
Show answer & explanation
Answer: A) To determine if a generic drug is therapeutically equivalent to the innovator product
BA/BE studies (conducted under NDCT Rules) compare the bioavailability of a generic drug with the innovator formulation in healthy volunteers. This ensures that generic drugs perform equivalent therapeutically to reference products.
Why the others fail
- B) BA/BE is essential for Indian drug approvals.
- C) BA/BE studies are human studies, not animal toxicity tests.
- D) BA/BE assesses absorption and equivalence, not safety broadly.
Source: New Drugs & Clinical Trials Rules, 2019; BA/BE Study Requirements
AI fact-checkedfrom the Drug Inspector bank - Question 8MEDIUM
Under the New Drugs & Clinical Trials Rules (NDCT), 2019, what is the primary authority that reviews and approves new drug applications?
- A)The World Health Organization directly approves drugs for use in India
- B)Any notified private laboratory can approve new drugs
- C)The Central Government (CDSCO) through the New Drugs Advisory Committee
- D)The drug manufacturer's own research committee
Show answer & explanation
Answer: C) The Central Government (CDSCO) through the New Drugs Advisory Committee
Under NDCT Rules 2019, the Central Government (CDSCO) reviews new drug applications through the New Drugs Advisory Committee. This committee evaluates safety, efficacy, and quality data before granting approval for clinical trials and eventual marketing.
Why the others fail
- A) WHO provides guidance; Indian regulatory authority makes final approval decisions.
- B) Only government regulatory authority can approve.
- D) Independent regulatory review is required, not just manufacturer review.
Source: New Drugs & Clinical Trials Rules, 2019
AI fact-checkedfrom the Drug Inspector bank - Question 9HARD
According to New Drugs and Clinical Trials Rules, 2019, the sponsor is required to forward his report on a serious adverse event of death, after due analysis, to the licensing authority and the head of the institution where the trial was conducted, within how many days of the occurrence of the event?
- A)Within 1 day
- B)Within 7 days
- C)Within 14 days
- D)Within 30 days
Show answer & explanation
Answer: C) Within 14 days
Under NDCT Rules 2019, the sponsor must forward the analysed report of a serious adverse event of death to the licensing authority and institutional head within 14 days of the event's occurrence.
Why the others fail
- A) This is shorter than the sponsor's analysed-report submission timeline (an initial urgent notification may be required sooner, but this is the analysed report deadline).
- B) This does not match the statutory timeline for the sponsor's analysed death report.
- D) This does not match the statutory timeline for the sponsor's analysed death report.
Source: New Drugs and Clinical Trials Rules, 2019, SAE-death sponsor reporting timeline
AI fact-checkedfrom the Drug Inspector bank - Question 10HARD
The expert committee shall examine the report of a serious event of death and give its recommendation to the licensing authority for the purpose of arriving at the cause of the adverse event within how many days of the occurrence of the adverse event?
- A)150 days
- B)30 days
- C)90 days
- D)105 days
Show answer & explanation
Answer: B) 30 days
Under India's clinical trial SAE-death investigation framework, the expert committee is required to examine the report and give its recommendation within 30 days of the adverse event.
Why the others fail
- A) This exceeds the statutory examination timeline.
- C) This exceeds the statutory examination timeline for this specific step.
- D) This exceeds the statutory examination timeline for this specific step.
Source: New Drugs and Clinical Trials Rules, 2019, SAE-death investigation timeline
AI fact-checkedfrom the Drug Inspector bank
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