Fixed Dose Combination (FDC) Drugs Regulation
Social Justice & Development
- PYQs7
- Articles1
Background
Understanding government's role in public health and drug safety, evidence-based policy-making, consumer protection in healthcare, and the challenges of pharmaceutical regulation in India.
Fixed Dose Combination (FDC) drugs contain two or more active pharmacological ingredients in a single dosage, designed to improve treatment compliance and sometimes therapeutic effectiveness. However, irrational FDCs, lacking therapeutic justification, can be ineffective, harmful, and contribute to public health issues like antimicrobial resistance.
Facts & tables
- Definition
- Drug with two or more active ingredients in a fixed ratio in a single dosage.
- Purpose (when rational)
- Improve treatment compliance (reduce pill burden), enhance therapeutic effectiveness.
- Risks of irrational FDCs
- Ineffectiveness, harm, unclear allergy source, unnecessary side effects, antimicrobial resistance.
- Regulatory action
- Health Ministry bans irrational FDCs based on scientific review.
| Type | Reference |
|---|---|
| Conceptual area | Public Health |
| Conceptual area | Pharmaceutical Regulation |
| Body | Role |
|---|---|
| Ministry of Health and Family Welfare | Formulates and implements drug policies, issues bans |
| State Drug Controllers | Ensures strict implementation and compliance at state level |
Prelims angle
Prelims angle: Conceptual understanding
Prelims angle: Terminology-based question
- FDCs combine multiple active ingredients.
- Rational FDCs improve compliance; irrational ones are unsafe.
- Health Ministry bans FDCs based on scientific evidence.
- Irrational antibiotic FDCs contribute to AMR.
- Effective implementation requires strong monitoring.
| Year | Framing tags |
|---|---|
| 2026 | Multi-statement analysis, Factual recall |
| 2026 | Conceptual understanding, Terminology-based question |
| 2026 | Statement-based questions, Factual recall |
| 2025 | Statement-based questions, Purpose or function of a policy tool |
| 2023 | Statement-based questions, Multi-statement analysis |
| 2020 | Multi-statement analysis, Conceptual understanding |
| 2017 | Statement-based questions, Factual recall |
Timeline
-
Public Health
Conceptual area
-
Pharmaceutical Regulation
Conceptual area
-
Prelims 2017
Statement-based questions, Factual recall
-
Prelims 2020
Multi-statement analysis, Conceptual understanding
-
Prelims 2023
Statement-based questions, Multi-statement analysis
-
Prelims 2025
Statement-based questions, Purpose or function of a policy tool
-
Prelims 2026
Multi-statement analysis, Factual recall
-
Prelims 2026
Conceptual understanding, Terminology-based question
-
Prelims 2026
Statement-based questions, Factual recall
-
Stay with the evidence: On the ban on Fixed Dose Combination drugs
FDCs combine multiple drugs; while beneficial when rational, irrational FDCs pose significant health risks, leading to government bans and strict regulatory oversight to ensure public safety and combat issues like AMR.
See also
Past papers
2017–2026 · 7 questions
In the news
Stay with the evidence: On the ban on Fixed Dose Combination drugs
FDCs combine multiple drugs; while beneficial when rational, irrational FDCs pose significant health risks, leading to government bans and strict regulatory oversight to ensure public safety and combat issues like AMR.
Try these PYQs
Mr. X, a senior officer, was overseeing a critical vaccination programme during a pandemic. He found that a private service provider responsible for vaccine distribution was compromising on quality to make profits. Despite immense pressure to manage the issue due to vested interests, he raised his voice based on the principles of public administration which he learnt during various training programmes attended across his career. He reported the issue to the appropriate vigilance authority and halted the contract to ensure citizen welfare.
Which one among the following principles of public administration was most strongly demonstrated by Mr. X's actions?
Accountability is the obligation of public officials to take responsibility for their actions, ensure transparency, and answer to oversight bodies (such as vigilance authorities). It involves actively protecting the public interest, reporting misconduct, and ensuring that private contractors utilizing public funds adhere to strict quality and ethical standards. By reporting the compromised vaccine distribution to the vigilance authority and halting the contract despite immense pressure, Mr. X demonstrated a high degree of accountability towards citizen welfare. Esprit de corps is a classical management principle that emphasizes building team spirit, unity, harmony, and mutual trust among personnel within an organization. It is not the primary principle demonstrated in this scenario. Equity refers to the principle of fairness, justice, and impartiality in administration, ensuring that public services and resources are distributed without bias. While his actions were just, the specific act of reporting to vigilance and taking responsibility highlights accountability rather than equity. Delegation is the administrative process of transferring authority and responsibility for specific tasks from a superior to a subordinate or a third-party service provider. Mr. X's actions were about holding the delegated party accountable, not the act of delegation itself. Therefore, the correct option is C.
What is the importance of using Pneumococcal Conjugate Vaccines in India?
1. These vaccines are effective against pneumonia as well as meningitis and sepsis.
2. Dependence on antibiotics that are not effective against drug-resistant bacteria can be reduced.
3. These vaccines have no side effects and cause no allergic reactions.
Select the correct answer using the code given below:
Statement 1 is correct. Pneumococcal Conjugate Vaccines (PCVs) are effective in preventing several serious diseases caused by Streptococcus pneumoniae bacteria. This includes pneumonia, meningitis (inflammation of the meninges surrounding the brain and spinal cord), and sepsis (a life-threatening blood infection). Statement 2 is also correct. The growing prevalence of antibiotic-resistant strains of Streptococcus pneumoniae is a major concern. PCV vaccination helps reduce dependence on antibiotics, particularly for these resistant strains. This lowers the risk of antibiotic overuse and emergence of further resistance. Statement 3 is incorrect. While most people experience no serious side effects with PCV vaccines, there can be mild reactions like redness, swelling, or soreness at the injection site. Serious allergic reactions are rare.
Consider the following statements :
Statement-I :India's public sector health care system largely focuses on curative care with limited preventive, promotive and rehabilitative care.
Statement-II: Under India's decentralized approach to health care delivery, the States are primarily responsible for organizing health services.
Which one of the following is correct in respect of the above statements?
* Statement I is correct: India's public healthcare system prioritises curative care, which focuses on treating existing illnesses. Preventive, promotive, and rehabilitative care, which aims to prevent diseases, promote good health, and help people recover from illness, receive less emphasis. * Statement II is correct: India's healthcare system follows a decentralised approach. The central government sets policies and provides financial assistance, but individual states are responsible for organising and delivering health services to their populations. This allows for flexibility based on local needs and contexts.
Therefore, the answer is Both Statement I and Statement II are correct.
Consider the following in respect of ‘National Career Service’:
1. National Career Service is an initiative of the Department of Personnel and Training, Government of India.
2. National Career Service has been launched in a Mission Mode to improve the employment opportunities to uneducated youth of the country.
Which of the above statements is/are correct?
Statement 1 is incorrect. The National Career Service is not an initiative of the Department of Personnel and Training, Government of India. It is actually implemented by the Directorate General of Employment, Ministry of Labour & Employment. Statement 2 is incorrect. The National Career Service has indeed been launched in a Mission Mode, but it is not specifically targeted at improving the employment opportunities for uneducated youth of the country. It is a comprehensive platform providing a wide array of employment and career related services to all citizens of India, aiming to bridge the gap between jobseekers and employers, candidates seeking training and career guidance, and agencies providing training and career counselling.
Consider the following statements about Multidimensional Poverty Index (MPI) :
1. MPI is calculated using Alkire-Foster methodology.
2. MPI calculated by NITI Aayog has a total of twelve indicators.
3. Maternal Health and Bank Account are common indicators in the MPI of NITI Aayog and MPI of United Nations Development Programme (UNDP).
Which of the statements given above is/are correct ?
Statement 1 is Correct: Both the Global Multidimensional Poverty Index (MPI) and India's National MPI are calculated using the Alkire-Foster (AF) methodology. This method measures acute poverty by counting the overlapping deprivations that individuals experience simultaneously. Statement 2 is Correct: India's National MPI, calculated by NITI Aayog, consists of 12 indicators. It retains the 10 standard indicators from the Global MPI and adds two new ones to better reflect India's specific development priorities. Statement 3 is Incorrect: The two additional indicators in the National MPI are Maternal Health (added to the Health dimension) and Bank Account (added to the Standard of Living dimension). Therefore, these two are exclusive to NITI Aayog's National MPI and are not present in the UNDP's Global MPI, which only has 10 indicators. Therefore, option A is the correct answer.
Show 2 more PYQs
Consider the following statements about the Rashtriya Gokul Mission:
I. It is important for the upliftment of rural poor as majority of low producing indigenous animals are with small and marginal farmers and landless labourers.
II. It was initiated to promote indigenous cattle and buffalo rearing and conservation in a scientific and holistic manner.
Which of the statements given above is/are correct?
✅ Statement I: Correct
*RGM aims to conserve indigenous breeds, benefiting small farmers and landless labourers by improving animal productivity.* ✅ Statement II: Correct
*Launched in December 2014, the mission promotes scientific breeding, genetic upgradation, and conservation of indigenous breeds.* Correct Answer: (C) Both Statements I and II are correct.
Which of the following statements with regard to the persons with disabilities in India is/are correct ?
1. The Rights of Persons with Disabilities Act, an Act passed by the Parliament of India in 2018, mandates reservation in education and employment, places a legal duty on Governments to ensure accessibility and non-discrimination.
2. The Sugamya Bharat Abhiyan focuses on achieving universal accessibility for Persons with Disabilities across three key domains — built infrastructure, transport systems and information and communication technology.
3. The National Divyangjan Finance and Development Corporation (NDFDC) is a public sector organisation set up by the Ministry of Corporate Affairs as a not-for-profit company to promote entrepreneurship among Persons with Disabilities (PwDs).
Select the answer using the code given below :
Statement 1 is Incorrect: The Rights of Persons with Disabilities (RPwD) Act was passed by the Parliament of India in 2016, not 2018. It aligns with the UN Convention on the Rights of Persons with Disabilities and places a legal obligation on governments to ensure non-discrimination and accessibility. It also mandates reservations for PwDs, such as increasing the quota to 4% in government employment and 5% in higher education. Statement 2 is Correct: The Sugamya Bharat Abhiyan (Accessible India Campaign) was launched in 2015 by the Department of Empowerment of Persons with Disabilities (DEPwD). It focuses on achieving universal accessibility for Persons with Disabilities across three key domains: built infrastructure (barrier-free public buildings), transport systems (accessible railways, airports, and roads), and information and communication technology (accessible government websites and digital ecosystems). Statement 3 is Incorrect: The National Divyangjan Finance and Development Corporation (NDFDC) is a Central Public Sector Undertaking registered as a not-for-profit company to provide concessional financial assistance to promote entrepreneurship, self-employment, and higher education among PwDs. However, it was set up under the aegis of the Ministry of Social Justice and Empowerment, not the Ministry of Corporate Affairs. Therefore, the correct option is B.