Drug Regulation and Quality Control in India
India's drug regulation faces systemic challenges in quality control, enforcement, and infrastructure, highlighted by recent contamination incidents, necessi...
The article critically analyzes the Indian government's new policy requiring a doctor's prescription for syrup-based medicines, a measure introduced to restore confidence in India's pharmaceutical supply chain following over 300 child deaths globally due to ethylene glycol (EG) and diethylene glycol (DEG) contamination in India-made cough syrups. While the Union Health Ministry removed 'syrup' from Schedule K of the Drugs Rules 1945 to enforce this, the article argues it's a defensive rather than reformist solution. It highlights that the core issue is manufacturing quality control failures, inadequate raw material testing, and chronic understaffing of State drug controllers, rather than consumer access. The policy may reduce inappropriate use but won't prevent contaminated products from entering the market, as the government continues to tolerate the pharmaceutical lobby's resistance to stringent testing.
Durable syllabus ideas for revision — not article memory.
India's drug regulation faces systemic challenges in quality control, enforcement, and infrastructure, highlighted by recent contamination incidents, necessi...
Previous year Prelims questions on overlapping themes and topics.
Consider the following statements:
1. The India Sanitation Coalition is a platform to promote sustainable sanitation and is funded by the Government of India and the World Health Organization.
2. The National Institute of Urban Affairs is an apex body of the Minister of Housing and Urban Affairs in Government
of India and provides innovative solutions to address the challenges of Urban India.
Which of the statements given above is/are correct?
Statement 1 is incorrect. The India Sanitation Coalition was launched on June 25, 2015, at FICCI, New Delhi. ISC is a multi-stakeholder platform that brings together the private sector, government, financial institutions, civil society groups, media, donors/bilateral/multilateral, experts, etc., to work in the sanitation space to drive sustainable sanitation through a partnership model. It is not funded by WHO. Statement 2 is incorrect. The National Institute of Urban Affairs (NIUA) is India’s premier urban think tank, shaping the urban narrative since its establishment in 1976, it not an apex body. It is an autonomous body under the Societies Registration Act.
What is/are the purpose of ‘District Mineral Foundations” in India?
1. Promoting mineral explorative activities in mineral-rich districts
2. Protecting the interests of the persons affected by mining operations
3. Authorizing State Governments to issue licenses for mineral exploration
Select the correct answer using the code given below:
District Mineral Foundations (DMFs) were established in India under the Mines and Minerals (Development and Regulation) Amendment Act, 2015. Statement 1 is Incorrect: Promoting mineral exploration activities in mineral-rich districts is not a stated objective of DMFs. Statement 2 is Correct: The primary purpose of DMFs is to work for the welfare and benefit of areas and individuals affected by mining-related operations. This includes protecting the interests of the persons affected by mining operations. Statement 3 is Incorrect: However, DMFs do not have the authority to issue licenses for mineral exploration, as this is the responsibility of the State Governments. Their focus is more on the welfare of the affected persons and areas. Hence, option B is the correct answer.
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.
With reference to the National Legal Services Authority, consider the following statements :
1. Its objective is to provide free and competent legal services to the weaker sections of the society on the basis of equal opportunity.
2. It issues guidelines for the State Legal Services Authorities to implement the legal programs and schemes throughout the country.
Which of the statements given above is/are correct?
Both statements are correct. The National Legal Services Authority (NALSA) plays a crucial role in ensuring equal access to justice for all in India. Statement 1 is correct: NALSA's primary objective is to offer free and competent legal services to the underprivileged sections of society. This empowers them to navigate the legal system and fight for their rights, regardless of their financial background. Statement 2 is correct: NALSA functions as the apex body, setting guidelines and frameworks for State Legal Services Authorities (SLSAs) to implement legal aid programs and initiatives throughout the country. These SLSAs operate at the state level to deliver legal services to the public.
Consider the following statements about the provisions pertaining to the Scheduled Castes and the Scheduled Tribes in India :
1. Provisions regarding the administration of the Tribal Areas in the States of Assam, Meghalaya, Tripura and Mizoram are given in the Fifth Schedule of the Constitution of India.
2. Some tribes of India are entitled to exemption from paying Income Tax on certain incomes.
3. The Constitution of India provides for reservation of seats in Panchayats for women belonging to the Scheduled Castes and the Scheduled Tribes.
Which one of the following conclusions based on the above statements is correct ?
Statement 1 is Incorrect: The Sixth Schedule (Article 244(2)) of the Indian Constitution specifically governs the administration of Tribal Areas in the four northeastern states of Assam, Meghalaya, Tripura, and Mizoram. The Fifth Schedule (Article 244(1)) applies to the administration and control of Scheduled Areas and Scheduled Tribes in states other than these four. Statement 2 is Correct: Under Section 10(26) of the Income Tax Act, 1961, members of Scheduled Tribes residing in specified regions (including Tripura, Mizoram, Manipur, Nagaland, Arunachal Pradesh, and Ladakh) are exempt from paying income tax on income generated from sources within those areas, as well as on dividends or interest on securities. Statement 3 is Correct: Article 243D of the Constitution mandates the reservation of seats in Panchayats for Scheduled Castes (SCs) and Scheduled Tribes (STs). Furthermore, Article 243D(2) explicitly requires that not less than one-third of the seats reserved for SCs and STs must be reserved for women belonging to the Scheduled Castes or Scheduled Tribes. Since Statements 2 and 3 are correct, there are exactly two correct statements, which include Statement 2. Therefore, the correct conclusion is that there are two correct statements, that include statement 2.
Which of the following statements with respect to the Revamped Rashtriya Gram Swaraj Abhiyan (RGSA) is/are correct ?
1. The period of its implementation is 1st April, 2021 to 31st March, 2026.
2. The key objective of the Revamped RGSA is to develop the governance capabilities of the Panchayati Raj Institutions to deliver on the Sustainable Development Goals.
3. The share of the Central funding for the Revamped RGSA is 100% for all States and Union Territories.
Select the answer using the code given below :
Statement 1 is Incorrect: The Revamped Rashtriya Gram Swaraj Abhiyan (RGSA) was approved by the Cabinet Committee on Economic Affairs for implementation from 1st April 2022 to 31st March 2026 (co-terminus with the 15th Finance Commission period), not from 1st April 2021. Statement 2 is Correct: The primary objective of the revamped scheme is to develop and enhance the governance capabilities of Panchayati Raj Institutions (PRIs) so they can effectively deliver on the Sustainable Development Goals (SDGs). It focuses on the localization of SDGs at the grassroots level through inclusive local governance. Statement 3 is Incorrect: The Revamped RGSA is a Centrally Sponsored Scheme, meaning the funding is shared between the Centre and the States. It is not 100% centrally funded for all States and UTs. The sharing pattern is 60:40 (Centre:State) for general category States, and 90:10 for North-Eastern States, Hilly States, and the Union Territory of Jammu & Kashmir. 100% Central funding applies only to other Union Territories and specific Central components of the scheme. Therefore, option B is the correct answer.
Consider the following statements :
1. As per the Right to Education (RTE) Act, to be eligible for appointment as a teacher in a State, a person would be required to possess the minimum qualifications laid down by the concerned State Council of Teacher Education.
2. As per the RTE Act, for teaching primary classes, a candidate is required to pass a Teacher Eligibility Test conducted in accordance with the National Council of Teacher Education guidelines.
3. In India, more than 90% of teacher education institutions are directly under the State Governments.
Which of the statements given above is/are correct?
Statement 1 is incorrect: As per the RTE Act, the minimum qualification for teachers is set by the National Council for Teacher Education (NCTE), not the state council. Statement 2 is correct: The RTE Act mandates that candidates must pass the Teacher Eligibility Test (TET) to qualify for teaching primary classes. The NCTE sets the guidelines for conducting this test. Statement 3 is incorrect: According to the All India Survey on Higher Education (AISHE) 2019-20, approximately 67% of teacher education institutions in India are privately managed, while only around 33% are government-run. Hence, the correct answer is option (b) 2 only.
In India, Legal Services Authorities provide free legal services to which of the following type of citizens?
1. Person with an annual income of less than Rs 1,00,000
2. Transgender with an annual income of less than Rs 2,00,000
3. Member of Other Backward Classes (OBC) with an annual income of less than Rs 3,00,000
4. All Senior Citizens
Statement 1 is correct. The persons eligible for getting free legal services include - Women and children - Members of SC/ST - Industrial workmen - Victims of mass disaster, violence, flood, drought, earthquake, industrial disaster - Disabled persons - Persons in custody - Persons whose annual income does not exceed 1 lakh - Victims of trafficking in human beings or begar . Statement 2 is correct. There is provision for free legal aid to transgenders up to 2 lakhs in Delhi. (But it is yet to be implemented at an all India level) Statement 3 is not correct. There is free aid to members of SC and ST community but not for OBCs. Statement 4 is not correct. Senior citizens eligibility for free legal aid depends on the Rules framed by the respective State Governments in this regard. In Delhi, for example, senior citizens are eligible for free legal aid subject to a prescribed ceiling of annual income. Therefore, all senior citizens are not eligible for free aid. Hence, A seems to be the most appropriate option among the given list.
Consider the following statements:
1. National Development Council is an organ of the Planning Commission.
2. The Economic and Social Planning is kept in the Concurrent List in the Constitution of India.
3. The Constitution of India prescribes that Panchayats should be assigned the task of preparation of plans for economic development and social justice.
Which of the statements given above is/are correct?
Statement 1 is incorrect: The National Development Council (NDC) is not an organ of the Planning Commission. It's an independent advisory body headed by the Prime Minister and includes Chief Ministers of all states, Union Cabinet Ministers, and members of the NITI Aayog (successor to the Planning Commission). It was set up on 6 August 1952. Statement 2 is correct: Economic and Social Planning is listed in the Concurrent List (List III) of the Seventh Schedule of the Indian Constitution. Statement 3 is correct: The Constitution (Article 243G) empowers Panchayats (local village governments) to prepare plans for economic development and social justice at the village level. This promotes decentralized planning and community participation. Hence, statement one is incorrect and statements two and three are correct. _Note: While the NDC was proposed to be abolished, it has not been formally dissolved, although its powers have largely been transferred to the NITI Aayog's Governing Council._
The Government enacted the Panchayat Extension to Scheduled Areas (PESA) Act in 1996. Which one of the following is not identified as its objective?
* PESA doesn't deal with the creation of autonomous regions in tribal areas. * The Sixth Schedule provides for the administration of certain tribal areas as autonomous entities. The provisions of the sixth schedule are provided under Articles 244(2) and 275(1) of the Indian Constitution.
Previous year Mains questions mapped to overlapping GS syllabus topics.
Does tribal development in India centre around two axes, those of displacement and of rehabilitation? Give your opinion.
Achieving sustainable growth with emphasis on environmental protection could come into conflict with poor people’s needs in a country like India – Comment.
How do you account for the growing fast food industries given that there are increased health concerns in modern society? Illustrate your answer with the Indian experience.
Discuss the distribution and density of population in the Ganga River Basin with special reference to land, soil and water resources.
Mahatma Jotirao Phule’s writings and efforts of social reforms touched issues of almost all subaltern classes. Discuss.
Do you think that globalization results in only an aggressive consumer culture? Justify your answer.
The article explicitly states: 'The Union Health Ministry has removed the term “syrup” from Schedule K of the Drugs Rules 1945, a change it had signalled when it issued the draft notification in December 2025, thus requiring cough syrups to be sold only with a prescription, through licensed pharmacies.'
The article states: 'The fundamental issue is that the government continues to tolerate the pharmaceutical lobby’s argument that high-end testing requirements — for stronger quality control and ultimately better drugs — will bankrupt smaller manufacturers.' While other options are related issues, the article identifies the pharmaceutical lobby's resistance as the 'fundamental issue' the government tolerates.
The article clearly states: 'These products were singled out after ethylene glycol (EG) and diethylene glycol (DEG) contamination in India-made cough syrups killed over 300 children across several countries since 2022.'
Introduce the policy and its stated aim. Critically analyze its limitations as highlighted in the article (e.g., doesn't address root causes like manufacturing quality, raw material testing, regulatory oversight, pharma lobby). Propose comprehensive reforms focusing on strengthening regulatory bodies, increasing inspectorate, enforcing stringent quality control, and addressing industry lobbying.
Explain the context of contamination. Detail how understaffing of drug controllers leads to inadequate enforcement and oversight. Discuss how the pharmaceutical lobby's resistance to stringent testing requirements weakens quality control. Conclude with the implications for public health and India's global reputation.