UPSC Prelims Practice Questions — Health Ministry eases drug trial norms; cuts licence requirement

Question 1

Which one of the following is the apex national authority that processes test licence applications and receives prior intimations under the New Drugs and Clinical Trials Rules, 2019 (as amended in 2026)?

Accepted Answer

Central Drugs Standard Control Organisation (CDSCO)

Answer

National Pharmaceutical Pricing Authority (NPPA)

Answer

Indian Council of Medical Research (ICMR)

Answer

National Institute of Pharmaceutical Education and Research (NIPER)

Question 2

Under the 2026 amendments to the New Drugs and Clinical Trials Rules, 2019, how many categories of drugs continue to mandatorily require a test licence and are excluded from the new prior-intimation mechanism for non-commercial manufacture?

Accepted Answer

Three

Answer

Two

Answer

Four

Answer

Five

Question 3

In the context of the 2026 NDCT Rules amendments, the term 'BA/BE study', for which prior approval has been replaced with online intimation, refers to which one of the following?

Accepted Answer

A bio-availability and bio-equivalence study comparing rate and extent of drug absorption, used principally for approval of generic formulations

Answer

A bio-augmentation and bio-enhancement study to improve the potency of cytotoxic anti-cancer molecules

Answer

A bacterial-assay and biofilm-elimination study mandated for all new antibiotics before Phase-III trials

Answer

A biosimilar-authentication and batch-equivalence study undertaken only for recombinant DNA-based vaccines

Question 4

The New Drugs and Clinical Trials (Amendment) Rules notified in January 2026, which replace test licences with a prior-intimation system, were issued under the administrative authority of which one of the following Union Ministries?

Accepted Answer

Ministry of Health and Family Welfare

Answer

Ministry of Chemicals and Fertilizers

Answer

Ministry of Science and Technology

Answer

Ministry of AYUSH

UPSC Prelims Practice Questions — Health Ministry eases drug trial norms; cuts licence requirement

Q1. Which one of the following is the apex national authority that processes test licence applications and receives prior intimations under the New Drugs and Clinical Trials Rules, 2019 (as amended in 2026)?

Q2. Under the 2026 amendments to the New Drugs and Clinical Trials Rules, 2019, how many categories of drugs continue to mandatorily require a test licence and are excluded from the new prior-intimation mechanism for non-commercial manufacture?

Q3. In the context of the 2026 NDCT Rules amendments, the term 'BA/BE study', for which prior approval has been replaced with online intimation, refers to which one of the following?

Q4. The New Drugs and Clinical Trials (Amendment) Rules notified in January 2026, which replace test licences with a prior-intimation system, were issued under the administrative authority of which one of the following Union Ministries?