Hindu Editorial Analysis : 20-June-2023

India, known as “The Pharmacy of the World,” has been a major player in the global pharmaceutical industry. However, recent reports have raised concerns about the safety of drugs manufactured in India, as they have been linked to severe harm and even patient deaths across the world.

Anaesthetic Drugs: Tragedy in Sri Lanka

One of the latest incidents involved the deaths of two patients in Sri Lanka who were administered Indian-made anaesthetic drugs. This shocking event has raised questions about the safety and quality of pharmaceutical products coming from India.

Eye Drops: Blindness in Sri Lanka and the United States

In another case, eye drops manufactured in India caused eye infections in approximately 30 patients and even led to blindness in 10 individuals in Sri Lanka. A few months prior to this, a similar incident occurred in the United States, where eye drops produced in India were found to be contaminated with a highly drug-resistant bacteria, resulting in severe health consequences.

Cough Syrups: A Deadly Culprit

The series of adverse reports began with cough syrups manufactured in India. The World Health Organization (WHO) linked the deaths of at least 70 children in Gambia to cough syrups containing diethylene glycol and ethylene glycol – chemicals that should never have been present in medicines. Subsequently, 18 children lost their lives in Uzbekistan after consuming cough syrups with the same deadly chemicals. Furthermore, contaminated cough syrups from India were also identified in the Marshall Islands and Micronesia, prompting concerns about the quality control processes in the Indian pharmaceutical industry.

Indian Pharmaceutical Industry: A Global Powerhouse

The Indian pharmaceutical industry has established itself as a global powerhouse, ranking third in the world by volume. India’s ability to export pharmaceuticals worth Rs 175,040 crore in the financial year 2021-22, including Bulk Drugs/Drug Intermediates, has contributed to its reputation as “The Pharmacy of the World.” Additionally, India’s massive talent pool of trained pharmaceutical professionals and its vast manufacturing capabilities have enabled the industry to develop generic drugs at significantly lower costs.

Potential Growth and Challenges:

According to the Indian Economic Survey 2021, the pharmaceutical industry in India is projected to reach USD 120-130 Billion by 2030. However, the industry faces challenges that need to be addressed to ensure continued growth and maintain its reputation:

Safety of Drugs: The Indian drug regulator must institute robust measures to ensure the safety of drugs produced in India for both domestic use and export. Addressing concerns about the quality of drugs is crucial to maintaining confidence in Indian pharmaceutical products.

Costs of Production: While India’s production costs are 50 percent lower than those of developed nations, they are still 18 percent higher than China. Higher costs in areas like raw materials, electricity, and logistics need to be addressed to maintain the industry’s competitive edge.

Regulatory Framework: The Drugs and Cosmetics Act, 1940, governs drug importation, production, and distribution in India. The proposed New Drugs, Medical Devices, and Cosmetics Bill, 2022, aims to modernize regulations and ensure compliance with evolving standards. Ensuring effective implementation of this new bill will be essential for maintaining the industry’s global reputation.

Why In News

Reports of drugs manufactured in India causing severe harm and dozens of patient deaths from across the world continue to trickle in, raising concerns about the quality and safety standards of the pharmaceutical industry in the country. Urgent measures need to be implemented to address this growing crisis and restore confidence in the Indian drug manufacturing sector, ensuring the well-being and safety of patients worldwide.

MCQs about Challenges and Growth Potential of India’s Pharmaceutical Industry

  1. Which concern regarding drugs manufactured in India?
    A. Lack of availability in the global market
    B. High production costs compared to developed nations
    C. Reports of severe harm and patient deaths
    D. Insufficient talent pool in the pharmaceutical industry
    Correct Answer: C. Reports of severe harm and patient deaths
    Explanation: The concerning incidents of drugs manufactured in India causing severe harm and even resulting in patient deaths across different countries.
  2. What has earned India the reputation of being “The Pharmacy of the World”?
    A. High production costs and quality standards
    B. Extensive talent pool in the pharmaceutical industry
    C. Superior infrastructure and manufacturing capabilities
    D. Exporting pharmaceuticals and generic drugs at a reduced price
    Correct Answer: D. Exporting pharmaceuticals and generic drugs at a reduced price
    Explanation: India’s ability to export pharmaceuticals, including generic drugs, at lower costs has contributed to its reputation as “The Pharmacy of the World.”
  3. What are some challenges faced by India’s pharmaceutical industry?
    A. Safety of drugs and compliance with quality standards
    B. Insufficient talent pool and limited manufacturing capabilities
    C. High production costs compared to China
    D. Lack of availability and accessibility of drugs in the domestic market
    Correct Answer: A. safety and quality of drugs produced in India and emphasizes the need for robust measures to ensure their safety and compliance with international standards.
  4. Which regulatory body is responsible for overseeing the pharmaceutical industry in India?
    A. World Health Organization (WHO)
    B. Central Drugs Standard Control Organization (CDSCO)
    C. Ministry of Health and Family Welfare
    D. Drugs Controller General of India (DCGI)
    Correct Answer: B. Central Drugs Standard Control Organization (CDSCO)
    Explanation: CDSCO is the apex regulatory body responsible for overseeing Indian pharmaceuticals and medical devices, operating under the Ministry of Health and Family Welfare.

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