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The Hindu Editorial • January 30, 2026 • Read Original

Quick pill: On amendments to drug rules

Removal of some pharma regulations should not come at the cost of quality

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The Hindu Read Original
8 min read

Analysis of editorial from The Hindu newspaper on January 30, 2026

Quick pill: On amendments to drug rules

Removal of some pharma regulations should not come at the cost of quality

Drug RulesPharmaceutical SectorEase of Doing BusinessCDSCOQuality Control
Sentences
Sentence 1 of 17
English Original

The government’s move to scrap the traditional, mandatory test licences required to manufacture small quantities of drugs for research is an effort to remove the sometimes-crippling regulatory hurdles in the pharmaceutical sector.

Simple Present S + V + C Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
The government’s move to scrap the traditional, mandatory test licences required to manufacture small quantities of drugs for research
The government’s decision to stop requiring old, compulsory permits for making small amounts of medicine for testing
Verb What is happening
is
Represents a state or fact
Complement Completes meaning
an effort to remove the sometimes-crippling regulatory hurdles in the pharmaceutical sector
A step to get rid of difficult rules and paperwork that slow down the medicine industry
Context and Background
Simplifying Drug Manufacturing Permits

Previously, Indian drug makers needed a ‘Form 29’ license from state authorities to manufacture even small quantities of drugs for research. This manual process was often slow, taking weeks or months, which delayed the early stages of drug development.

Sentence 2 of 17
English Original

This decision aligns with the national goal of facilitating ease of doing business.

Simple Present S + V + Adjunct Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
This decision
The government’s new rule mentioned in the previous sentence
Verb What is happening
aligns
Matches or agrees with
Adjunct Additional info
with the national goal of facilitating ease of doing business
With the country’s plan to make starting and running a company much easier
Sentence 3 of 17
English Original

The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism.

Simple Present S + V + C Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019
The most important part of the changes made to the 2019 medicine research laws
Verb What is happening
is
Represents the identity of the main part
Complement Completes meaning
replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism
Changing the rule from “must get a permit first” to “just inform us first” for making research medicines
Context and Background
The NDCT Rules, 2019

The New Drugs and Clinical Trials (NDCT) Rules were introduced in 2019 to speed up the approval process for new drugs and clinical trials in India. They aim to make India a global hub for clinical research by reducing bureaucratic delays while maintaining safety standards.

Sentence 4 of 17
English Original

Developers can now manufacture small quantities of drugs for research, testing, and analysis after intimating the Central Drugs Standard Control Organisation via its SUGAM Portal, online.

Simple Present S + V + O + Adjunct Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
Developers
People or companies that create new medicines
Verb What is happening
can now manufacture
Are finally allowed to produce
Object What receives action
small quantities of drugs for research, testing, and analysis
Low amounts of medicine used only for laboratory work and not for sale
Adjunct Additional info
after intimating the Central Drugs Standard Control Organisation via its SUGAM Portal, online
After telling the national drug regulator using their online computer system
Context and Background
What is the CDSCO?

The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, conducting clinical trials, and setting standards for drug quality across the country.

Sentence 5 of 17
English Original

Once a ‘notice of intent’ is acknowledged online, a company is free to go ahead with drug synthesis, strictly for research.

Simple Present Adjunct + S + V + C Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Adjunct Additional info
Once a ‘notice of intent’ is acknowledged online
As soon as the government’s computer system confirms receiving the company’s plan
Subject Who/What
a company
The drug manufacturing firm
Verb What is happening
is
Becomes or exists in a state
Complement Completes meaning
free to go ahead with drug synthesis, strictly for research
Allowed to start making the chemical medicine, but only for testing purposes
Sentence 6 of 17
English Original

In a post-COVID world, where speed of delivery for end use has gained virtue, the government anticipates that removal of this licencing factor will fast-track the timeline of drug development by at least three months.

Simple Present Adjunct + S + V + O Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Adjunct Additional info
In a post-COVID world, where speed of delivery for end use has gained virtue
After the COVID-19 pandemic, where being fast in delivering medicines is now seen as very important
Subject Who/What
the government
The central authorities of India
Verb What is happening
anticipates
Expects or hopes
Object What receives action
that removal of this licencing factor will fast-track the timeline of drug development by at least three months
That getting rid of this permit rule will speed up medicine creation by 3 months or more
Sentence 7 of 17
English Original

Specific low-risk bioavailability and bioequivalence studies can also commence after an online intimation on the portal.

Simple Present S + V + Adjunct Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
Specific low-risk bioavailability and bioequivalence studies
Certain safe types of research that test how a medicine is absorbed in the human body
Verb What is happening
can also commence
Are also allowed to start
Adjunct Additional info
after an online intimation on the portal
After informing the government through their website
Context and Background
BA/BE Studies

Bioavailability (BA) and Bioequivalence (BE) studies are essential clinical tests, especially for generic drugs. They prove that a new generic medicine works exactly like the original brand-name version by showing that the body absorbs them in the same way.

Sentence 8 of 17
English Original

In addition, even for categories in which a licence is still required, such as for high-risk psychotropic or narcotic drugs, the statutory processing time will be reduced from 90 days to 45.

Simple Future Adjunct + Adjunct + S + V + Adjunct Main Clause Complex Sentence
Phrase Breakdown
Adjunct Additional info
In addition
Furthermore or also
Adjunct Additional info
even for categories in which a licence is still required, such as for high-risk psychotropic or narcotic drugs
Even for dangerous drugs like strong painkillers or mood-altering medicines that still need a permit
Subject Who/What
the statutory processing time
The maximum time allowed by law for the government to finish checking an application
Verb What is happening
will be reduced
Will be made shorter
Adjunct Additional info
from 90 days to 45
To half the previous time (from 3 months to 1.5 months)
Context and Background
Regulating Narcotic Drugs

Narcotic and psychotropic drugs are strictly controlled under the Narcotic Drugs and Psychotropic Substances (NDPS) Act in India. High-risk drugs in these categories will still require human oversight and a formal license, but the government is now promising to finish that review in half the time.

Sentence 9 of 17
English Original

All manufacturers are required to meticulously document and file processes as per rules.

Simple Present S + V + C Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
All manufacturers
Every company that makes medicine in India
Verb What is happening
are required
Must (it is a legal rule)
Complement Completes meaning
to meticulously document and file processes as per rules
To very carefully record and submit their work steps exactly as the law says
Sentence 10 of 17
English Original

The abolishment of a ‘licence raj’ is always good news.

Simple Present S + V + C Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
The abolishment of a ‘licence raj’
Ending the system where every business step needs a slow government permit
Verb What is happening
is
Represents a fact or state
Complement Completes meaning
always good news
Always something positive for progress
Context and Background
What was the

The ‘Licence Raj’ refers to the period between 1947 and 1990 in India when the government had strict control over the economy. Businesses needed licenses for almost everything (from starting a factory to importing equipment). This often led to bureaucracy, delays, and slower economic growth until the 1991 reforms.

Sentence 11 of 17
English Original

The dismantling of hurdles in pharma research and development bodes well for a country that is aspiring to position itself as the pharmacy of the world.

Simple Present S + V + Adjunct + Adjunct Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Subject Who/What
The dismantling of hurdles in pharma research and development
Getting rid of obstacles and difficulties in the medicine discovery and testing process
Verb What is happening
bodes
Is a sign of
Adjunct Additional info
well
In a positive way
Adjunct Additional info
for a country that is aspiring to position itself as the pharmacy of the world
For India, which wants to be known as the main global supplier of high-quality medicines
Sentence 12 of 17
English Original

The paperless, prior intimation mechanism will no doubt reduce the time spent twiddling thumbs, waiting for a physical copy of the licence.

Simple Future S + V + O Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
The paperless, prior intimation mechanism
The new digital system where companies inform the government online beforehand
Verb What is happening
will no doubt reduce
Will certainly decrease
Object What receives action
the time spent twiddling thumbs, waiting for a physical copy of the licence
The time wasted doing nothing while waiting for a printed permit to arrive in the mail
Sentence 13 of 17
English Original

And time saved is, naturally, money and lives saved.

Simple Present S + V + C Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
time saved
The extra time gained by using faster processes
Verb What is happening
is
Means or equals
Adjunct Additional info
naturally
Of course or obviously
Complement Completes meaning
money and lives saved
Financial savings and protection of human life
Sentence 14 of 17
English Original

Reducing the time a drug takes from the lab to the bedside for practical use can save countless lives and reduce morbidity in many more.

Simple Present S + V + O + V + O Main Clause Simple Sentence
Phrase Breakdown
Subject Who/What
Reducing the time a drug takes from the lab to the bedside for practical use
Shortening the time it takes for a new medicine to move from a research room to being used on a patient
Verb What is happening
can save
Is able to protect
Object What receives action
countless lives
Large numbers of people’s lives
Verb What is happening
reduce
Lessen or decrease
Object What receives action
morbidity in many more
The state of being ill for many other people
Sentence 15 of 17
English Original

However, the government would do well to circumvent the danger of a drop in quality control by initiating a mechanism, after intimation, to ensure that all good manufacturing practices are strictly adhered to.

Conditional Adjunct + S + V + Adjunct + Adjunct Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Adjunct Additional info
However
But or on the other hand
Subject Who/What
the government
The central authorities
Verb What is happening
would do
Ought to or should
Adjunct Additional info
well
Beneficially or wisely
Adjunct Additional info
to circumvent the danger of a drop in quality control by initiating a mechanism, after intimation, to ensure that all good manufacturing practices are strictly adhered to
To avoid the risk of bad quality by creating a system to make sure all safety rules are followed after they are informed
Context and Background
What is GMP?

Good Manufacturing Practices (GMP) are the minimum requirements that a manufacturer must meet to ensure their products are consistently high in quality and safe for human use. In India, these are listed under Schedule M of the Drugs and Cosmetics Rules.

Sentence 16 of 17
English Original

No drug, however speedily produced, is worth the blister it is packaged in if it comes with quality lapses.

Simple Present S + Adjunct + V + C + Adjunct Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Subject Who/What
No drug
No medicine at all
Adjunct Additional info
however speedily produced
No matter how fast it was made
Verb What is happening
is
Represents its value
Complement Completes meaning
worth the blister it is packaged in
Useful or valuable even for its basic plastic packaging
Adjunct Additional info
if it comes with quality lapses
If it has mistakes in how it was made or if it is not safe
Sentence 17 of 17
English Original

Poor pharmaceutical oversight, as recent cough syrup-related deaths showed, can be fatal.

Simple Present S + Adjunct + V + C Main Clause + Subordinate Clause Complex Sentence
Phrase Breakdown
Subject Who/What
Poor pharmaceutical oversight
Weak government supervision of medicine manufacturing
Adjunct Additional info
as recent cough syrup-related deaths showed
Just like we saw with the recent deaths caused by bad cough medicine
Verb What is happening
can be
Has the ability to be
Complement Completes meaning
fatal
Causing death
Context and Background
Cough Syrup Incidents

In recent years, several children abroad died after consuming contaminated cough syrups made by some Indian firms. These tragic events raised global concerns about the quality control standards in India’s pharmaceutical industry and led to stricter testing requirements for exported medicines.

Sentence 1 of 17
Sentence 1 of 17
The government’s move to scrap the traditional, mandatory test licences required to manufacture small quantities of drugs for research is an effort to remove the sometimes-crippling regulatory hurdles in the pharmaceutical sector.
Phrase Breakdown
Subject
The government’s move to scrap the traditional, mandatory test licences required to manufacture small quantities of drugs for research
The government’s decision to stop requiring old, compulsory permits for making small amounts of medicine for testing
Verb
is
Represents a state or fact
Complement
an effort to remove the sometimes-crippling regulatory hurdles in the pharmaceutical sector
A step to get rid of difficult rules and paperwork that slow down the medicine industry
Sentence 2 of 17
This decision aligns with the national goal of facilitating ease of doing business.
Phrase Breakdown
Subject
This decision
The government’s new rule mentioned in the previous sentence
Verb
aligns
Matches or agrees with
Adjunct
with the national goal of facilitating ease of doing business
With the country’s plan to make starting and running a company much easier
Sentence 3 of 17
The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism.
Phrase Breakdown
Subject
The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019
The most important part of the changes made to the 2019 medicine research laws
Verb
is
Represents the identity of the main part
Complement
replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism
Changing the rule from “must get a permit first” to “just inform us first” for making research medicines
Sentence 4 of 17
Developers can now manufacture small quantities of drugs for research, testing, and analysis after intimating the Central Drugs Standard Control Organisation via its SUGAM Portal, online.
Phrase Breakdown
Subject
Developers
People or companies that create new medicines
Verb
can now manufacture
Are finally allowed to produce
Object
small quantities of drugs for research, testing, and analysis
Low amounts of medicine used only for laboratory work and not for sale
Adjunct
after intimating the Central Drugs Standard Control Organisation via its SUGAM Portal, online
After telling the national drug regulator using their online computer system
Sentence 5 of 17
Once a ‘notice of intent’ is acknowledged online, a company is free to go ahead with drug synthesis, strictly for research.
Phrase Breakdown
Adjunct
Once a ‘notice of intent’ is acknowledged online
As soon as the government’s computer system confirms receiving the company’s plan
Subject
a company
The drug manufacturing firm
Verb
is
Becomes or exists in a state
Complement
free to go ahead with drug synthesis, strictly for research
Allowed to start making the chemical medicine, but only for testing purposes
Sentence 6 of 17
In a post-COVID world, where speed of delivery for end use has gained virtue, the government anticipates that removal of this licencing factor will fast-track the timeline of drug development by at least three months.
Phrase Breakdown
Adjunct
In a post-COVID world, where speed of delivery for end use has gained virtue
After the COVID-19 pandemic, where being fast in delivering medicines is now seen as very important
Subject
the government
The central authorities of India
Verb
anticipates
Expects or hopes
Object
that removal of this licencing factor will fast-track the timeline of drug development by at least three months
That getting rid of this permit rule will speed up medicine creation by 3 months or more
Sentence 7 of 17
Specific low-risk bioavailability and bioequivalence studies can also commence after an online intimation on the portal.
Phrase Breakdown
Subject
Specific low-risk bioavailability and bioequivalence studies
Certain safe types of research that test how a medicine is absorbed in the human body
Verb
can also commence
Are also allowed to start
Adjunct
after an online intimation on the portal
After informing the government through their website
Sentence 8 of 17
In addition, even for categories in which a licence is still required, such as for high-risk psychotropic or narcotic drugs, the statutory processing time will be reduced from 90 days to 45.
Phrase Breakdown
Adjunct
In addition
Furthermore or also
Adjunct
even for categories in which a licence is still required, such as for high-risk psychotropic or narcotic drugs
Even for dangerous drugs like strong painkillers or mood-altering medicines that still need a permit
Subject
the statutory processing time
The maximum time allowed by law for the government to finish checking an application
Verb
will be reduced
Will be made shorter
Adjunct
from 90 days to 45
To half the previous time (from 3 months to 1.5 months)
Sentence 9 of 17
All manufacturers are required to meticulously document and file processes as per rules.
Phrase Breakdown
Subject
All manufacturers
Every company that makes medicine in India
Verb
are required
Must (it is a legal rule)
Complement
to meticulously document and file processes as per rules
To very carefully record and submit their work steps exactly as the law says
Sentence 10 of 17
The abolishment of a ‘licence raj’ is always good news.
Phrase Breakdown
Subject
The abolishment of a ‘licence raj’
Ending the system where every business step needs a slow government permit
Verb
is
Represents a fact or state
Complement
always good news
Always something positive for progress
Sentence 11 of 17
The dismantling of hurdles in pharma research and development bodes well for a country that is aspiring to position itself as the pharmacy of the world.
Phrase Breakdown
Subject
The dismantling of hurdles in pharma research and development
Getting rid of obstacles and difficulties in the medicine discovery and testing process
Verb
bodes
Is a sign of
Adjunct
well
In a positive way
Adjunct
for a country that is aspiring to position itself as the pharmacy of the world
For India, which wants to be known as the main global supplier of high-quality medicines
Sentence 12 of 17
The paperless, prior intimation mechanism will no doubt reduce the time spent twiddling thumbs, waiting for a physical copy of the licence.
Phrase Breakdown
Subject
The paperless, prior intimation mechanism
The new digital system where companies inform the government online beforehand
Verb
will no doubt reduce
Will certainly decrease
Object
the time spent twiddling thumbs, waiting for a physical copy of the licence
The time wasted doing nothing while waiting for a printed permit to arrive in the mail
Sentence 13 of 17
And time saved is, naturally, money and lives saved.
Phrase Breakdown
Subject
time saved
The extra time gained by using faster processes
Verb
is
Means or equals
Adjunct
naturally
Of course or obviously
Complement
money and lives saved
Financial savings and protection of human life
Sentence 14 of 17
Reducing the time a drug takes from the lab to the bedside for practical use can save countless lives and reduce morbidity in many more.
Phrase Breakdown
Subject
Reducing the time a drug takes from the lab to the bedside for practical use
Shortening the time it takes for a new medicine to move from a research room to being used on a patient
Verb
can save
Is able to protect
Object
countless lives
Large numbers of people’s lives
Verb
reduce
Lessen or decrease
Object
morbidity in many more
The state of being ill for many other people
Sentence 15 of 17
However, the government would do well to circumvent the danger of a drop in quality control by initiating a mechanism, after intimation, to ensure that all good manufacturing practices are strictly adhered to.
Phrase Breakdown
Adjunct
However
But or on the other hand
Subject
the government
The central authorities
Verb
would do
Ought to or should
Adjunct
well
Beneficially or wisely
Adjunct
to circumvent the danger of a drop in quality control by initiating a mechanism, after intimation, to ensure that all good manufacturing practices are strictly adhered to
To avoid the risk of bad quality by creating a system to make sure all safety rules are followed after they are informed
Sentence 16 of 17
No drug, however speedily produced, is worth the blister it is packaged in if it comes with quality lapses.
Phrase Breakdown
Subject
No drug
No medicine at all
Adjunct
however speedily produced
No matter how fast it was made
Verb
is
Represents its value
Complement
worth the blister it is packaged in
Useful or valuable even for its basic plastic packaging
Adjunct
if it comes with quality lapses
If it has mistakes in how it was made or if it is not safe
Sentence 17 of 17
Poor pharmaceutical oversight, as recent cough syrup-related deaths showed, can be fatal.
Phrase Breakdown
Subject
Poor pharmaceutical oversight
Weak government supervision of medicine manufacturing
Adjunct
as recent cough syrup-related deaths showed
Just like we saw with the recent deaths caused by bad cough medicine
Verb
can be
Has the ability to be
Complement
fatal
Causing death

Reading Comprehension

Practice questions based on this editorial

Reading Comprehension - Drug Rule Amendments

Practice reading comprehension questions based on the editorial about Indian government's move to simplify drug manufacturing rules for research.

5 Questions Passing: 70%

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