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1 Jan 2026·Source: The Indian Express
2 min
Social IssuesPolity & GovernanceScience & TechnologyNEWS

Nimesulide Above 100mg Banned, Cough Syrup OTC Sales Under Review

Government bans Nimesulide above 100mg, considers restricting cough syrup over-the-counter sales.

Nimesulide Above 100mg Banned, Cough Syrup OTC Sales Under Review

Photo by Emily Bernal

In a significant public health measure, the government has banned the manufacture, sale, and distribution of Nimesulide in oral 'immediate release' formulations exceeding 100 mg, citing potential health risks. Simultaneously, the Ministry of Health and Family Welfare has issued a draft notification proposing to remove cough syrups from the list of over-the-counter (OTC) medicines, meaning they would require a prescription.

These decisions underscore the government's commitment to drug safety and rational use of medicines. This topic is highly relevant for UPSC GS2 (Polity & Governance - health policy) and GS3 (Science & Technology - drug regulation) as it impacts public health, pharmaceutical policy, and consumer safety.

Key Facts

1.

Nimesulide (oral, immediate release, above 100 mg) banned

2.

Draft notification to remove cough syrups from Schedule K (OTC list)

UPSC Exam Angles

1.

Role and functions of drug regulatory bodies (CDSCO, DTAB, DCGI).

2.

Provisions of the Drugs and Cosmetics Act, 1940, and its amendments.

3.

Public health policy and the right to health (Article 21, DPSP Article 47).

4.

Rational drug use, patient safety, and pharmacovigilance.

5.

Challenges in drug regulation: balancing access, affordability, and safety.

6.

Impact on pharmaceutical industry and consumer behavior.

Visual Insights

Evolution of Drug Regulation & Public Health Policy in India

This timeline highlights key legislative and policy milestones in India's drug regulation and public health landscape, leading up to the recent Nimesulide ban and the review of cough syrup OTC sales. It demonstrates the government's continuous efforts to enhance drug safety and rational use.

India's drug regulation journey began with the Drugs and Cosmetics Act of 1940, evolving through various policies and programs like PvPI and NHP 2017. This continuous refinement, marked by periodic bans on irrational drugs and a focus on public health, has culminated in recent stringent measures like the Nimesulide ban and OTC cough syrup review, reflecting a commitment to patient safety and rational drug use.

  • 1940Drugs and Cosmetics Act enacted (Foundational legal framework)
  • 1945Drugs and Cosmetics Rules formulated
  • 2002National Drug Policy (revised) to ensure availability, affordability, and quality of drugs
  • 2010Launch of Pharmacovigilance Programme of India (PvPI) for drug safety monitoring
  • 2016Major ban on Fixed-Dose Combinations (FDCs) deemed irrational or unsafe
  • 2017National Health Policy 2017 released, targeting 2.5% of GDP public health spending by 2025
  • 2018Launch of Ayushman Bharat (PMJAY & Health and Wellness Centers)
  • 2020-2022COVID-19 Pandemic: Highlighted critical need for robust public health infrastructure and drug supply chain
  • 2023Further bans on several FDCs and irrational drugs based on expert committee recommendations
  • 2024Draft of new Drugs, Medical Devices and Cosmetics Bill under active discussion to replace 1940 Act
  • 2025Continued strengthening of e-pharmacy regulations and digital health initiatives (Ayushman Bharat Digital Mission)
  • 2026 (Jan)Nimesulide in oral 'immediate release' formulations exceeding 100 mg banned; Cough Syrup OTC sales under review (CURRENT NEWS)
More Information

Background

India's drug regulatory framework, primarily governed by the Drugs and Cosmetics Act, 1940, and Rules, 1945, aims to ensure the quality, safety, and efficacy of drugs. Historically, India has faced challenges with irrational drug combinations, misuse of antibiotics, and inadequate pharmacovigilance, leading to various government interventions and bans, notably on Fixed Dose Combinations (FDCs). The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare is the principal regulatory body.

Latest Developments

The recent ban on Nimesulide (oral 'immediate release' formulations exceeding 100 mg) stems from concerns over its hepatotoxicity (liver damage) at higher doses, a long-standing issue debated globally. Simultaneously, the proposal to reclassify cough syrups from Over-the-Counter (OTC) to prescription-only status highlights concerns about their potential misuse, particularly in cases of substance abuse, and the need for medical supervision for appropriate diagnosis and treatment of underlying conditions. These decisions underscore the government's commitment to drug safety and rational use of medicines.

Practice Questions (MCQs)

1. Consider the following statements regarding drug regulation in India: 1. The recent ban on Nimesulide (oral 'immediate release' formulations exceeding 100 mg) was primarily due to concerns over its potential cardiotoxicity. 2. The Central Drugs Standard Control Organization (CDSCO) is responsible for the approval of new drugs and clinical trials in India. 3. The Drug Technical Advisory Board (DTAB) is the highest statutory decision-making body on technical matters related to drugs and cosmetics. Which of the statements given above is/are correct?

  • A.1 and 2 only
  • B.2 and 3 only
  • C.2 only
  • D.1, 2 and 3
Show Answer

Answer: B

Statement 1 is incorrect. The ban on Nimesulide was primarily due to concerns over its hepatotoxicity (liver damage), not cardiotoxicity. Statement 2 is correct. CDSCO, headed by the DCGI, is the national regulatory authority for Indian pharmaceuticals and medical devices, responsible for approval of new drugs, clinical trials, and setting standards. Statement 3 is correct. DTAB is constituted under the Drugs and Cosmetics Act, 1940, and advises the Central and State Governments on technical matters related to the Act.

2. In the context of drug classification and regulation in India, consider the following statements: 1. Over-the-Counter (OTC) medicines are those that can be sold directly to consumers without a prescription from a healthcare professional. 2. The reclassification of a drug from OTC to prescription-only status typically aims to enhance patient safety and promote rational drug use. 3. All drugs listed under Schedule H of the Drugs and Cosmetics Rules, 1945, are considered Over-the-Counter (OTC) medicines. Which of the statements given above is/are correct?

  • A.1 and 2 only
  • B.2 and 3 only
  • C.1 and 3 only
  • D.1, 2 and 3
Show Answer

Answer: A

Statement 1 is correct. This is the standard definition of OTC medicines. Statement 2 is correct. Requiring a prescription ensures medical supervision, proper diagnosis, and reduces misuse, thereby enhancing safety and promoting rational use. Statement 3 is incorrect. Schedule H drugs are 'Prescription Drugs' and must be sold only on the prescription of a registered medical practitioner. They are explicitly *not* OTC medicines.

3. Which of the following statements about the Drugs and Cosmetics Act, 1940, and its associated regulatory framework is NOT correct?

  • A.The Act provides for the regulation of import, manufacture, distribution, and sale of drugs and cosmetics in India.
  • B.State Drug Control Organizations are primarily responsible for the licensing of manufacturing establishments and sales premises within their respective states.
  • C.The Drug Controller General of India (DCGI) is the final authority for granting manufacturing licenses for all categories of drugs across India.
  • D.The Indian Pharmacopoeia Commission (IPC) sets standards for drugs manufactured and sold in India.
Show Answer

Answer: C

Statement A is correct. This is the core objective of the Drugs and Cosmetics Act, 1940. Statement B is correct. State Drug Control Organizations handle licensing at the state level, while CDSCO handles central approvals (e.g., new drugs, clinical trials). Statement C is incorrect. While DCGI is a key central authority, manufacturing licenses for most drugs are granted by State Drug Control Authorities. DCGI's role is more focused on new drug approvals, clinical trials, and overall coordination, not direct manufacturing licensing for all categories across India. Statement D is correct. IPC is an autonomous institution under the Ministry of Health & Family Welfare, responsible for updating and publishing the Indian Pharmacopoeia, which sets standards for drugs.

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