Question 1

The Indian Council of Medical Research (ICMR) directly grants approvals and test licenses for new drugs and clinical trials in India.

Accepted Answer

The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), is the statutory Central Licensing Authority that grants approvals. ICMR only frames ethical guidelines for biomedical research.

Question 2

The 2026 amendment allows pharmaceutical companies to bypass clinical trials and sell new drugs faster.

Accepted Answer

The 'prior intimation' pathway strictly applies only to the manufacturing of small batches for 'analytical and non-clinical' (laboratory and animal) testing, NOT for commercial sale or human trials.

Question 3

Consider the following statements regarding the New Drugs and Clinical Trials (Amendment) Rules, 2026:
1. It introduces a prior intimation pathway that allows pharmaceutical companies to manufacture all categories of new drugs for human clinical trials upon generating an online acknowledgment.
2. The statutory processing timeline for test licenses requiring explicit Central Licensing Authority permission has been reduced from 90 to 45 days.
3. Stakeholders are required to submit their prior intimation applications for non-clinical testing exclusively through the National Single Window System (NSWS) portal.
How many of the above statements are correct?

Accepted Answer

(b) Only two — Statement 1 is incorrect: The prior intimation pathway applies strictly to analytical and non-clinical (pre-clinical) testing, NOT human clinical trials. Furthermore, it explicitly excludes high-risk categories like cytotoxics, sex hormones, and biologics with live microorganisms. Statements 2 and 3 are correct.

Question 4

Match the following regulatory bodies/terms with their corresponding functions under India's clinical trial framework:

List I
A. CDSCO
B. ICMR
C. NSWS
D. BA/BE Studies

List II
1. Government portal designated for submitting online prior intimation for drug manufacturing
2. Clinical trials assessing the rate and extent to which an active drug ingredient is absorbed into the bloodstream
3. Statutory authority that frames ethical guidelines for biomedical research on human participants
4. The Central Licensing Authority responsible for granting permission to manufacture and test new drugs

Accepted Answer

(a) A-4, B-3, C-1, D-2 — CDSCO (Central Drugs Standard Control Organisation) functions as the Central Licensing Authority (4). ICMR formulates the ethical guidelines for biomedical research (3). NSWS is the portal for 'prior intimation' submissions under the new rules (1). BA/BE (Bioavailability/Bioequivalence) studies measure drug absorption into the systemic circulation (2).

Question 5

Assertion (A): Under the NDCT Amendment Rules 2026, pharmaceutical companies can manufacture biologics containing live microorganisms for analytical testing through the new 'prior intimation' route without waiting for formal approval.
Reason (R): The government has adopted a risk-based regulatory framework to promote the Ease of Doing Business and reduce initial drug development timelines.
Select the correct answer from the codes given below:

Accepted Answer

(d) A is incorrect but R is correct. — Assertion (A) is incorrect because high-risk drugs—specifically biologics with live microorganisms, sex hormones, cytotoxic drugs, beta-lactams, and narcotics—are strictly excluded from the prior intimation pathway and still require formal prior permission. Reason (R) is correct, as the 2026 amendments implement a risk-based approach specifically designed to improve Ease of Doing Business by fast-tracking low-risk activities.