The Hindu Editorial • June 23, 2026 • Read Original

Stay with the evidence: On the ban on Fixed Dose Combination drugs

Better monitoring of sale of banned drugs is essential

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The Hindu Read Original

12 min read

Analysis of editorial from The Hindu newspaper on June 23, 2026

Stay with the evidence: On the ban on Fixed Dose Combination drugs

Better monitoring of sale of banned drugs is essential

Fixed Dose Combination DrugsFDC BanMinistry of Health and Family WelfareAntimicrobial ResistanceDrug Regulation in IndiaState Drug Controllers

Sentences

Sentence 1 of 13

English Original

The character of science leans to openness: to new evidence and emerging facts.

Sentence Breakdown

Part 1

The character of science

The fundamental nature and behavior of scientific study

Part 2

leans

tends to favor or move in a particular direction

Part 3

to : to new evidence and facts

towards being willing to accept new scientific proofs and newly discovered details

Sentence 2 of 13

English Original

Its ability to be agile to pivot and shift to newer guidelines is therefore absolutely crucial.

Sentence Breakdown

Part 1

Its ability to be to and shift to newer

The capacity of science to adapt quickly and change its direction according to new rules

Part 2

exists as / represents

Part 3

therefore

as a result of what was previously stated

Part 4

absolutely

extremely important or completely necessary

Sentence 3 of 13

English Original

The Health Ministry’s recent ban on 16 Fixed Dose Combination (FDC) drugs comes on the evidence that these drug combinations lack therapeutic justification, are ‘deemed irrational or unsafe’ and might pose risks to patients.

Sentence Breakdown

Part 1

The Health Ministry’s recent ban on 16 drugs

The official order by the health department stopping 16 combination medicines

Part 2

comes

is based on / originates from

Part 3

on the evidence that these drug combinations lack , are ‘ or unsafe’ and might to patients

based on the proof that these mixtures have no medical reason to exist, are considered unscientific or dangerous, and could harm people

Context and Background

Union Health Ministry

Under Section 26A of the Drugs and Cosmetics Act, 1940, the Union Health Ministry in June 2026 banned 16 Fixed Dose Combination (FDC) drugs following a review by the Drugs Technical Advisory Board (DTAB). The advisory board’s expert committee declared these formulations irrational, meaning they lacked scientific justification, offered no therapeutic benefits, and posed potential health risks to patients.

Sentence 4 of 13

English Original

The drugs include dermatological drugs, analgesics and antispasmodics, and antibiotic-based formulations.

Sentence Breakdown

Part 1

The drugs

The 16 banned Fixed Dose Combination medicines

Part 2

include

contain or consist of

Part 3

drugs, and , and

skin creams, painkillers, muscle cramp relievers, and medicine mixtures containing antibiotics

Sentence 5 of 13

English Original

An FDC is a drug containing two or more active pharmacological ingredients, combined in a fixed ratio in a single dosage.

Sentence Breakdown

Part 1

An FDC

A Fixed Dose Combination medicine

Part 2

exists as / is defined as

Part 3

a drug containing two or more active , combined in a fixed in a single

a single medicine pill or liquid that mixes two or more active drugs in pre-measured amounts

Sentence 6 of 13

English Original

These were meant to improve treatment compliance in chronic conditions (such as Tuberculosis) by reducing the pill burden and, sometimes, by improved therapeutic effectiveness.

Sentence Breakdown

Part 1

These

These Fixed Dose Combination drugs

Part 2

were meant

were designed or intended

Part 3

to improve treatment in conditions (such as Tuberculosis)

to help patients take their long-term medicine properly and regularly (for diseases like TB)

Part 4

by reducing the and, sometimes, by improved therapeutic

by making patients take fewer pills and occasionally making the treatment work better

Context and Background

FDCs in Tuberculosis Treatment

Fixed Dose Combinations (FDCs) are a cornerstone in the treatment of Tuberculosis (TB) under the World Health Organization’s DOTS (Directly Observed Treatment, Short-course) strategy. By combining multiple anti-TB drugs like Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol into a single daily tablet, FDCs dramatically reduce the number of pills a patient needs to swallow, preventing partial compliance and the development of drug-resistant TB strains.

Sentence 7 of 13

English Original

In chronic diseases, many patients might find it difficult to keep track of multiple pills that have to be taken at different times of the day.

Sentence Breakdown

Part 1

In chronic diseases

For illnesses that last a long time

Part 2

many patients

a large number of sick people

Part 3

might find

could feel or experience

Part 4

this situation (placeholder for the real action of tracking pills)

Part 5

difficult

hard or challenging

Part 6

to pills that have to be taken at different times of the day

remembering to take several different medicines at morning, noon, or night

Sentence 8 of 13

English Original

But irrational drug combinations can be counter-productive, ineffective and harmful.

Sentence Breakdown

Part 1

But

However (connective showing contrast)

Part 2

drug combinations

medicine cocktails that lack scientific reasoning

Part 3

can be

have the potential to be

Part 4

, and

having the opposite of the desired effect, not working at all, and causing physical damage

Context and Background

Why Irrational FDCs are Dangerous

Irrational FDCs pose several clinical risks: (1) Difficulty in dose titration: If a doctor needs to adjust the dose of only one drug, they are forced to increase the dose of both, leading to potential toxicity. (2) Masking of side effects: If a patient develops an allergic reaction, it is difficult to identify which specific drug caused it. (3) Reduced effectiveness: Combining drugs without scientific backing can lead to chemical interactions that make the individual components less effective.

Sentence 9 of 13

English Original

If a patient suffers from an adverse reaction, it is difficult to isolate which of the active ingredients is the culprit, meaning that all have to be withdrawn, causing clinical confusion.

Sentence Breakdown

Part 1

If a patient suffers from an

If someone takes a drug and experiences a bad side effect

Part 2

this situation (placeholder for the real action of isolating the ingredient)

Part 3

exists as / behaves as

Part 4

difficult

hard or complex

Part 5

to which of the active ingredients is the , meaning that all have to be , causing

to find out exactly which drug in the mixture caused the reaction, so doctors must stop all of them, leading to medical uncertainty

Sentence 10 of 13

English Original

In the case of antibiotics, the issue of antimicrobial resistance is another factor that is particularly concerning in India.

Sentence Breakdown

Part 1

In the case of antibiotics

Regarding medications used to fight bacterial infections

Part 2

the issue of

the problem where bacteria adapt and stop responding to drugs

Part 3

stands as / represents

Part 4

another factor that is particularly in India

one more reason that causes great worry in India specifically

Context and Background

Antimicrobial Resistance (AMR) in India

Antimicrobial Resistance (AMR) is a global health crisis, and India is one of the worst-affected countries. The widespread and unregulated use of Fixed Dose Combinations (FDCs) containing antibiotics, often prescribed for viral infections where they are useless, accelerates the survival of resistant bacteria. This renders standard life-saving antibiotics ineffective, making common infections treatable only with stronger, more expensive, and highly toxic last-resort drugs.

Sentence 11 of 13

English Original

The Health Ministry had set up a committee to look into the issue and, based on its recommendations and those of the Drugs Technical Advisory Board, the decision was taken.

Sentence Breakdown

Part 1

The Health Ministry

The department of health in the government

Part 2

had

had established or created

Part 3

a committee

a group of chosen experts

Part 4

to the issue

to investigate the problem

Part 5

and, based on its and those of the Drugs Technical Advisory Board, the decision was taken

and the final choice was made after looking at the suggestions of this committee and the DTAB

Context and Background

Drugs Technical Advisory Board (DTAB)

The Drugs Technical Advisory Board (DTAB) is the highest statutory advisory body in India on technical matters related to drug regulations. Established under the Drugs and Cosmetics Act, 1940, it functions under the Central Drugs Standard Control Organization (CDSCO). The board consists of ex-officio, nominated, and elected members, and is chaired by the Director General of Health Services (DGHS). Its recommendations are critical for policy formulation, drug approvals, and banning irrational medicines in India.

Sentence 12 of 13

English Original

Yet, it is a well-known fact that several drugs that are banned elsewhere are easily available in India, and the issue is really with enforcement and supervision.

Sentence Breakdown

Part 1

Yet

However (contrastive conjunction)

Part 2

this fact (placeholder for the clause that follows)

Part 3

exists as / represents

Part 4

a fact that several drugs that are banned elsewhere are easily available in India

something that everybody knows: that many medicines prohibited in other countries can buy easily in India

Part 5

and the issue is really with and

and the actual problem lies in how rules are enforced and how sales are monitored

Context and Background

Dual Drug Regulation System in India

India’s drug regulation follows a dual system: the central agency (CDSCO) approves ‘New Drugs’ (including FDCs), while State Licensing Authorities (SLAs) issue manufacturing licenses. However, a major enforcement gap arises when SLAs issue licenses for FDCs without obtaining prior CDSCO clearance. This lack of coordination has led to thousands of unscientific or banned drug cocktails circulating in the market, highlighting the need for centralized oversight and uniform enforcement.

Sentence 13 of 13

English Original

Unless there is an audit of what is being manufactured and sold, and the findings are used to enforce a ban, patients will continue to be at risk.

Sentence Breakdown

Part 1

Unless there is an of what is being manufactured and sold, and the are used to a ban

If the government does not inspect what medicines are made and sold, and use that information to stop them

Part 2

patients

sick people taking these medicines

Part 3

will continue

will go on / will keep on

Part 4

to be

being in danger of suffering harm

Context and Background

Pharmacovigilance Programme of India (PvPI)

The Pharmacovigilance Programme of India (PvPI) was launched in July 2010 by the Ministry of Health and Family Welfare to monitor and analyze Adverse Drug Reactions (ADRs) in the country. It is coordinated by the Indian Pharmacopoeia Commission (IPC), Ghaziabad. PvPI serves as a crucial regulatory support system for the CDSCO, collecting safety data from hospitals nationwide to ensure that the clinical benefits of marketed medicines outweigh their risks.

Sentence 1 of 13

Sentences Breakdown

Editorial Summary

5-Point Summary

1 The Union Health Ministry has banned 16 Fixed Dose Combination (FDC) drugs because they lack therapeutic justification, are deemed irrational or unsafe, and pose risks to patients.
2 Fixed Dose Combinations, which combine two or more active ingredients in a single dosage, are designed to improve treatment compliance in chronic conditions by reducing the number of pills a patient must take.
3 However, irrational combinations are not only ineffective but can also be counter-productive, making it difficult to adjust individual doses and identify the source of allergic reactions.
4 A major concern is the contribution of irrational antibiotic FDCs to India’s rising crisis of antimicrobial resistance (AMR), which makes standard infections harder to treat.
5 While the ban is a positive step, the government must actively monitor the market and ensure strict enforcement to prevent banned drugs from continuing to be sold in local pharmacies.

Tone of the Editorial

Analytical

Why this tone?

The editorial objectively evaluates the Health Ministry’s decision to ban 16 Fixed Dose Combination (FDC) drugs. It details both the medical rationale for FDCs (like improving treatment compliance) and their inherent clinical risks (such as dose titration issues and antimicrobial resistance), while pointing out past execution gaps to advocate for stronger regulatory monitoring.

Sentence 1 of 13

The character of science leans to openness: to new evidence and emerging facts.

Sentence Breakdown

Part 1

The character of science

The fundamental nature and behavior of scientific study

Part 2

leans

tends to favor or move in a particular direction

Part 3

to openness: to new evidence and emerging facts

towards being willing to accept new scientific proofs and newly discovered details

Sentence 2 of 13

Its ability to be agile to pivot and shift to newer guidelines is therefore absolutely crucial.

Sentence Breakdown

Part 1

Its ability to be agile to pivot and shift to newer guidelines

The capacity of science to adapt quickly and change its direction according to new rules

Part 2

exists as / represents

Part 3

therefore

as a result of what was previously stated

Part 4

absolutely crucial

extremely important or completely necessary

Sentence 3 of 13

Sentence Breakdown

Part 1

The Health Ministry’s recent ban on 16 Fixed Dose Combination (FDC) drugs

The official order by the health department stopping 16 combination medicines

Part 2

comes

is based on / originates from

Part 3

on the evidence that these drug combinations lack therapeutic justification, are ‘deemed irrational or unsafe’ and might pose risks to patients

based on the proof that these mixtures have no medical reason to exist, are considered unscientific or dangerous, and could harm people

Sentence 4 of 13

The drugs include dermatological drugs, analgesics and antispasmodics, and antibiotic-based formulations.

Sentence Breakdown

Part 1

The drugs

The 16 banned Fixed Dose Combination medicines

Part 2

include

contain or consist of

Part 3

dermatological drugs, analgesics and antispasmodics, and antibiotic-based formulations

skin creams, painkillers, muscle cramp relievers, and medicine mixtures containing antibiotics

Sentence 5 of 13

An FDC is a drug containing two or more active pharmacological ingredients, combined in a fixed ratio in a single dosage.

Sentence Breakdown

Part 1

An FDC

A Fixed Dose Combination medicine

Part 2

exists as / is defined as

Part 3

a drug containing two or more active pharmacological ingredients, combined in a fixed ratio in a single dosage

a single medicine pill or liquid that mixes two or more active drugs in pre-measured amounts

Sentence 6 of 13

These were meant to improve treatment compliance in chronic conditions (such as Tuberculosis) by reducing the pill burden and, sometimes, by improved therapeutic effectiveness.

Sentence Breakdown

Part 1

These

These Fixed Dose Combination drugs

Part 2

were meant

were designed or intended

Part 3

to improve treatment compliance in chronic conditions (such as Tuberculosis)

to help patients take their long-term medicine properly and regularly (for diseases like TB)

Part 4

by reducing the pill burden and, sometimes, by improved therapeutic effectiveness

by making patients take fewer pills and occasionally making the treatment work better

Sentence 7 of 13

In chronic diseases, many patients might find it difficult to keep track of multiple pills that have to be taken at different times of the day.

Sentence Breakdown

Part 1

In chronic diseases

For illnesses that last a long time

Part 2

many patients

a large number of sick people

Part 3

might find

could feel or experience

Part 4

this situation (placeholder for the real action of tracking pills)

Part 5

difficult

hard or challenging

Part 6

to keep track of multiple pills that have to be taken at different times of the day

remembering to take several different medicines at morning, noon, or night

Sentence 8 of 13

But irrational drug combinations can be counter-productive, ineffective and harmful.

Sentence Breakdown

Part 1

But

However (connective showing contrast)

Part 2

irrational drug combinations

medicine cocktails that lack scientific reasoning

Part 3

can be

have the potential to be

Part 4

counter-productive, ineffective and harmful

having the opposite of the desired effect, not working at all, and causing physical damage

Sentence 9 of 13

If a patient suffers from an adverse reaction, it is difficult to isolate which of the active ingredients is the culprit, meaning that all have to be withdrawn, causing clinical confusion.

Sentence Breakdown

Part 1

If a patient suffers from an adverse reaction

If someone takes a drug and experiences a bad side effect

Part 2

this situation (placeholder for the real action of isolating the ingredient)

Part 3

exists as / behaves as

Part 4

difficult

hard or complex

Part 5

to isolate which of the active ingredients is the culprit, meaning that all have to be withdrawn, causing clinical confusion

to find out exactly which drug in the mixture caused the reaction, so doctors must stop all of them, leading to medical uncertainty

Sentence 10 of 13

In the case of antibiotics, the issue of antimicrobial resistance is another factor that is particularly concerning in India.

Sentence Breakdown

Part 1

In the case of antibiotics

Regarding medications used to fight bacterial infections

Part 2

the issue of antimicrobial resistance

the problem where bacteria adapt and stop responding to drugs

Part 3

stands as / represents

Part 4

another factor that is particularly concerning in India

one more reason that causes great worry in India specifically

Sentence 11 of 13

The Health Ministry had set up a committee to look into the issue and, based on its recommendations and those of the Drugs Technical Advisory Board, the decision was taken.

Sentence Breakdown

Part 1

The Health Ministry

The department of health in the government

Part 2

had set up

had established or created

Part 3

a committee

a group of chosen experts

Part 4

to look into the issue

to investigate the problem

Part 5

and, based on its recommendations and those of the Drugs Technical Advisory Board, the decision was taken

and the final choice was made after looking at the suggestions of this committee and the DTAB

Sentence 12 of 13

Yet, it is a well-known fact that several drugs that are banned elsewhere are easily available in India, and the issue is really with enforcement and supervision.

Sentence Breakdown

Part 1

Yet

However (contrastive conjunction)

Part 2

this fact (placeholder for the clause that follows)

Part 3

exists as / represents

Part 4

a well-known fact that several drugs that are banned elsewhere are easily available in India

something that everybody knows: that many medicines prohibited in other countries can buy easily in India

Part 5

and the issue is really with enforcement and supervision

and the actual problem lies in how rules are enforced and how sales are monitored

Sentence 13 of 13

Unless there is an audit of what is being manufactured and sold, and the findings are used to enforce a ban, patients will continue to be at risk.

Sentence Breakdown

Part 1

Unless there is an audit of what is being manufactured and sold, and the findings are used to enforce a ban

If the government does not inspect what medicines are made and sold, and use that information to stop them

Part 2

patients

sick people taking these medicines

Part 3

will continue

will go on / will keep on

Part 4

to be at risk

being in danger of suffering harm

Reading Comprehension

Practice questions based on this editorial

Reading Comprehension - FDC Ban

Practice reading comprehension questions based on the editorial about the ban on Fixed Dose Combination (FDC) drugs.

5 Questions Passing: 70%

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Stay with the evidence: On the ban on Fixed Dose Combination drugs

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