Hindu Editorial Analysis : 16-January-2024

In a recent collaborative study involving academics from India, Qatar, and the UK, attention has been drawn to the concerning prevalence of unapproved and banned Fixed Dose Combination (FDC) antibiotics in the Indian pharmaceutical market.

Understanding Fixed Dose Combination (FDC):

FDC drugs are unique formulations containing two or more active pharmaceutical ingredients (APIs) in a fixed ratio. These combinations aim to enhance patient compliance by simplifying complex treatment regimens.

Benefits of FDC Therapies:
  • Simplification of treatment regimens for improved patient compliance.
  • Greater efficacy compared to higher dose monotherapy.
  • Reduced risk of adverse reactions.
  • Lower overall costs for patients.
  • Improved medication concordance for better treatment outcomes, particularly in diseases like AIDS.
Issues and Concerns Surrounding FDCs:

The Indian pharmaceutical industry, in its pursuit of innovation, introduced a multitude of FDCs lacking medical rationale. Key concerns include:

  • Lack of standards for quality testing by regulatory bodies.
  • Misuse by pharmaceutical companies to avoid legal liabilities and charge higher prices.
  • Potential interactions and side effects due to combined formulations.
Study Findings:

In 2020, a staggering 60.5% of FDCs of antibiotics were found to be unapproved, with an additional 9.9% being sold despite being banned in the country.

Government Initiatives:

Recognizing the need for regulatory control, the central government amended rules in 1988, mandating manufacturers to submit proof of safety and efficacy for all “new drugs,” including FDCs. State drug controllers were prohibited from granting manufacturing licenses for unapproved drugs. The government has also banned 14 FDC drugs, citing “no therapeutic justification” and potential risks under the Drugs and Cosmetics Act, 1940.

Why In News

A collaborative effort involving academics from India, Qatar, and the UK has yielded a groundbreaking study on the alarming prevalence of unapproved and banned Fixed Dose Combination (FDC) antibiotics in the Indian market, shedding light on the urgent need for regulatory intervention and global cooperation to address this critical issue.

MCQs about Challenges and Solutions in India’s FDC Antibiotics Landscape

  1. What is the primary purpose of Fixed Dose Combination (FDC) drugs?
    A. To increase manufacturing costs
    B. To simplify complex treatment regimens
    C. To complicate patient compliance
    D. To minimize medication concordance
    Correct Answer: B. To simplify complex treatment regimens
    Explanation: FDC drugs aim to simplify complex treatment regimens, enhancing patient compliance by combining multiple medications into a single formulation.
  2. What percentage of FDC antibiotics in India were unapproved in the year 2020?
    A. 40.1%
    B. 60.5%
    C. 75.0%
    D. 90.2%
    Correct Answer: B. 60.5%
    Explanation: 60.5% of FDC antibiotics in India were unapproved in the year 2020.
  3. What is a key concern associated with the introduction of FDCs in the Indian pharmaceutical industry?
    A. Improved patient compliance
    B. Lack of standards for quality testing
    C. Reduced medication concordance
    D. Lower overall treatment costs
    Correct Answer: B. Lack of standards for quality testing
    Explanation: The lack of standards for quality testing by regulatory bodies as a key concern associated with FDCs.
  4. In 1988, what amendment was introduced by the central government regarding FDCs?
    A. Banning all FDC drugs
    B. Allowing unrestricted manufacturing licenses
    C. Mandating proof of safety and efficacy for “new drugs”
    D. Encouraging pharmaceutical companies to charge higher prices
    Correct Answer: C. Mandating proof of safety and efficacy for “new drugs”
    Explanation: In 1988, the central government amended rules to mandate manufacturers to submit proof of safety and efficacy for all “new drugs,” including FDCs.

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