• UGI USER
  • Mar 07, 2024
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THE TALE OF ‘HAVE MONEY, BUY MIRACLE DRUG’

Syllabus:

GS 2:

  • Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.
Sources:- Hindu

Focus:

  • Miraculous weight loss injections featuring a drug known as Semaglutide.
  • In recent months, the Indian media has been awash with stories of miraculous weight loss injections featuring a drug known as Semaglutide. Originally intended for Type 2 diabetes treatment, its weight loss benefits have caught public attention. However, beneath the surface of these promising reports lie serious regulatory, ethical, and healthrelated concerns.

The Semaglutide Phenomenon

  • Background: Semaglutide, gaining fame as a ‘magic injection’ for weight loss, is initially approved for managing Type 2 diabetes but has shown significant weight loss results.
  • Media Coverage: Articles frequently highlight the drug’s benefits without mentioning its lack of approval for weight loss in India, creating a misleading narrative of its safety and efficacy.

Regulatory and Health Concerns

  • Unapproved Status in India: Despite its popularity, Semaglutide has not received approval for weight loss treatment in India, leading to its administration mainly to affluent patients by some healthcare providers.
  • Lack of Clinical Trials in India: There’s a concerning absence of localized clinical trials, raising questions about the drug’s safety and effectiveness for the Indian population, especially those with preexisting conditions.
  • Side Effects and Historical Precedents: The enthusiastic promotion of Semaglutide overlooks potential side effects and echoes past controversies with weight loss drugs like Rimonabant and FenPhen in the U.S., which resulted in significant legal settlements.
Drugs and Cosmetics Act, 1940

·    Objective: To ensure the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

·    Regulation of Manufacture and Sale: Controls the manufacture and sale of drugs and cosmetics to prevent substandard products.

·    Licensing: Mandates that manufacturing, selling, or distribution of drugs and cosmetics can only be done with a valid license.

·    Standards: Establishes standards for drugs and cosmetics to ensure consumer safety.

·    Banning of Drugs and Cosmetics: Provides provisions for the prohibition of certain drugs and cosmetics harmful to humans.

·    Adulteration and Misbranding: Addresses penalties for the adulteration and misbranding of drugs and cosmetics.

Drugs Rules, 1945

·    Implementation of the Act: Provides detailed guidelines for the enforcement of the Drugs and Cosmetics Act, 1940.

·    Licensing Procedure: Elaborates on the process for obtaining licenses for the manufacture, sale, and distribution of drugs.

·    Quality Control: Specifies the standards and quality requirements for drugs.

·    Import and Export: Regulates the import and export of drugs, ensuring they meet the required standards.

·    Pricing: May include provisions related to the control of prices for certain drugs.

Medical Devices Rules, 2017

·    Regulatory Framework: Establishes a comprehensive framework for the regulation of medical devices separate from drugs.

·    Classification of Devices: Categorizes medical devices based on their risk level (low to high).

·    Manufacturing and Import Licensing: Outlines the licensing requirements for the manufacture, import, and sale of medical devices in India.

·    Clinical Investigations: Sets guidelines for the conduct of clinical investigations for medical devices.

·    Quality and Safety Standards: Ensures that medical devices meet specified quality and safety standards before they are marketed.

New Drugs and Clinical Trial Rules, 2019

·    Expedited Approval: Introduces provisions for expedited approval of new drugs and vaccines.

·    Clinical Trials: Streamlines the approval process for clinical trials, ensuring safety and ethical considerations.

·    Compensation: Establishes rules for compensation in case of injury or death during a clinical trial.

·    Regulatory Timelines: Specifies timelines for the review and approval of new drugs and clinical trial applications.

·    Global Clinical Trials: Facilitates the conduct of global clinical trials and the approval of new drugs tested outside India.

Cosmetic Rules, 2019

·    Regulation and Standards: Establishes standards for the manufacture, sale, and import of cosmetics.

·    Licensing: Details the licensing requirements for manufacturing and importing cosmetics.

·    Safety and Compliance: Ensures that cosmetics are safe for use and comply with prescribed safety standards.

·    Prohibition of Certain Substances: Lists substances that are prohibited in cosmetics due to safety concerns.

·    Labeling and Packaging: Specifies requirements for the labeling and packaging of cosmetics to ensure consumer safety and information transparency.

 Ethical and Legal Implications

  • Doctor Patient Dynamics: The eagerness to use these unapproved drugs raises ethical questions about doctor recommendations, patient demands influenced by media, and the overall duty of healthcare professionals.
  • Risk of Counterfeits: The reliance on imported, unapproved drugs heightens the risk of administering counterfeit medications, exemplified by the spurious Adcetris scandal.

Government and Regulatory Oversight

  • Import Controls and Legal Accountability: The government and drug regulators face challenges in controlling the import of unapproved drugs, with calls for stricter enforcement and potential legal consequences for noncompliance.
  • Public Health Priorities: The issue underscores a broader debate on healthcare priorities, questioning the attention given to affluent individuals’ access to expensive, unapproved treatments while overlooking broader public health concerns.

Societal Perspective

  • A Question of Priorities: The focus on highcost, unapproved drugs for weight loss is critiqued as a concern primarily affecting the wealthy, drawing parallels to luxury goods and questioning societal and governmental priorities in healthcare.
  • Reflections on Inequality and Responsibility: The situation invites reflections on healthcare equity, regulatory responsibility, and the ethical obligations of the medical community towards all segments of society, not just the affluent.

The tale of Semaglutide in India is a multifaceted issue encompassing regulatory, ethical, and health dimensions. It serves as a cautionary narrative about the complexities of introducing unapproved medical treatments into the market, especially when influenced by media portrayal and societal pressures. As India grapples with these challenges, the need for stringent regulatory oversight, ethical medical practices, and a balanced approach to healthcare priorities becomes ever more apparent.

CDSCO

·   Regulatory Authority: CDSCO, part of the Directorate General of Health Services under the Ministry of Health & Family Welfare, serves as India’s National Regulatory Authority (NRA).

·   Legislative Foundation: Operates under the Drugs & Cosmetics Act, 1940, and Rules, 1945, guiding drug and cosmetic regulation alongside state counterparts.

·   Mission: Aims for uniform enforcement of its governing act and rules to protect patient safety, rights, and wellbeing through drug and cosmetic regulation.

·   Objectives: Focuses on enhancing transparency, accountability, and uniformity to ensure the safety, efficacy, and quality of medical products in India.

Key Responsibilities:

·   Approval of new drugs and conduct of clinical trials.

·   Establishing drug standards and controlling the quality of imports.

·   Advising and coordinating with State Drug Control Organizations for consistent enforcement of laws.

·   Specialized Licensing: Collaborates with state regulators to license critical drug categories like blood products, IV fluids, and vaccines.

Source:

https://www.thehindu.com/opinion/op-ed/safeguarding-local-democracy/article67920485.ece

Mains Practice Question:

Critically examine the impact of social media on public discourse and democracy in India. Discuss how it has transformed political engagement and the challenges it poses to traditional forms of governance.