NEW DRUGS & CLINICAL TRIAL(NDCT) RULES, 2019

About

These are the rules for approval of new drugs and conduct of clinical trials in the country.

It aims to promote clinical research in India by providing for a transparent, predictable  and effective regulation for clinical trials and ensure accessibility of new drugs to the Indian population.

Nodal Authority

The Drugs Controller of India, appointed by the Union Government is designated as the Central Licensing Authority to act as the nodal entity for licensing and approvals.

Applicability 

The NDCT Rules are applicable to:

• All new drugs, 
• Investigational new drugs for human use, 
• Clinical trials, 
• Bioequivalence studies, 
• Bioavailability studies and 
• Ethics Committees.

Definition of New Drug

Rule 2(w) defines a “new drug” to include the following:

A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent’,

‘a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims’,

‘a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio’,

‘a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority’, or

‘a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug’.

Stem cell based products are, therefore, also deemed to be “new drugs” under the NDCT Rules.

Adverse event

Adverse event has been defined under Rule 2(d) to mean any unfortunate medical occurrence during treatment with an investigational drug or a trial of pharmaceutical product in a patient or a trial subject.

Compensation is payable to the trial subject/ patient in such cases.

Ethics Committee

Ethics Committee is required to be set up and registered by whoever intends to conduct clinical trials or bioavailability studies or bioequivalence studies.

Deemed Approval

Under Rule 23, if a drug is discovered or developed in India and is proposed for manufacture and marketing there, the Central Licensing Authority must process the clinical trial application within 30 working days. 

If no communication is received at that time, approval is deemed granted.

Manufacture of New Drugs for Clinical Trials

Approval from the Central Licensing Authority is required to manufacture a new drug for clinical trials. This permission is valid for three years.

Import of New Drugs for Clinical Trials

A licence from the Central Licensing Authority is necessary to import new drugs for clinical trials. 

This license is also valid for three years.

Bioavailability

Bioequivalence studies

Bioavailability is a measurement of the extent of a therapeutically active medicine that reaches the systemic circulation and is therefore available at the site of action.

The comparison of the bioavailability of two formulations of the same drug to determine if they have similar efficacy.

It concentrates on the absorption of a drug from its dosage form into systemic circulation.

It focuses on comparing two different formulations (e.g., brand vs. generic).

It is assessed by measuring drug concentration in the bloodstream over time.

It is evaluated by comparing pharmacokinetic parameters (e.g., Cmax, Tmax, AUC) between the formulations.

Its purpose is to understand how much of a drug is available for therapeutic effect.

It is to ensure that different formulations provide the same therapeutic effect.

PRACTICE QUESTION

Q.Consider the following statements about the New Drugs and Clinical Trial (NDCT) Rules, 2019 : 

1. They pertain to approval of new drugs and conduct of clinical trials in the country.
2. There is provision for compensation payable to the trial subject/ patient in case of adverse events during trial.
3. If a drug is discovered or developed in India, the Central Licensing Authority must process the clinical trial application within 90 working days. 

Which of the above  statements are correct? 

A. 1 and 2 only

B. 2 and 3 only

C. 1, 2 and 3 only

D. None

Answer: A

Explanation:

Statement 1 is correct: 

These are the rules for approval of new drugs and conduct of clinical trials in the country.

It aims to promote clinical research in India by providing for a transparent, predictable  and effective regulation for clinical trials and ensure accessibility of new drugs to the Indian population.

The Rules have come into force from 19th march 2019, except for Chapter IV, which will come into force 180 days after publication in the Gazette.

Statement 2 is correct: 

Adverse event has been defined under Rule 2(d) to mean any unfortunate medical occurrence during treatment with an investigational drug or a trial of pharmaceutical product in a patient or a trial subject.

Compensation is payable to the trial subject/ patient in such cases.

Statement 3 is incorrect: 

Under Rule 23, if a drug is discovered or developed in India and is proposed for manufacture and marketing there, the Central Licensing Authority must process the clinical trial application within 30 working days. 

If no communication is received at that time, approval is deemed granted.