Date : 11/12/2023

Relevance: GS Paper 2- Social Justice - Health

Keywords: fixed-dose combinations (FDCs), Antibacterial microbial resistance (AMR), Drugs Controller General of India (DCGI), Antibiotic Mismanagement, Pseudo-innovation

Context-

• In a recent study published in the Journal of Pharmaceutical Policy and Practice (2023), a consortium of researchers from India, Qatar, and the United Kingdom shed light on the alarming prevalence of unapproved and banned fixed-dose combinations (FDCs) of antibiotics in India.
• The study, based on pharmaceutical industry sales data from 2020, reveals that a staggering 60.5% of antibiotic FDCs (comprising 239 formulations) were unapproved, while an additional 9.9% (39 formulations) were being sold despite being banned.
• This concerning trend raises significant public health issues, especially given the escalating problem of antibacterial microbial resistance (AMR) in India.

Understanding Fixed Dose Combinations (FDCs)

• FDCs are combinations of two or more known drugs, often designed to improve patient compliance by consolidating multiple medications into a single tablet or syrup.
• While this approach has proven effective in certain diseases like AIDS, the formulation of FDCs is a nuanced process.
• The challenge lies in potential interactions between active ingredients or even excipients, which may impact the efficacy or safety of each drug.

Pharmaceutical Industry's Love for FDCs

• The pharmaceutical industry in India has capitalized on FDCs as a means to circumvent regulatory frameworks and pricing controls.
• One such regulation is the Drugs Prices Control Order (DPCO), which allows the government to fix the prices of individual drugs. Since drug combinations were historically not covered under the DPCO, pharmaceutical companies found creating FDCs to be a strategic way to avoid price controls.
• Driven by market interests rather than public health concerns, the industry introduced a multitude of FDCs lacking medical rationale.
• This included perplexing combinations like anti-inflammatory drugs with vitamins, anti-histamines with anti-diarrhoeal agents, and penicillin with sulphonamides – formulations unseen in other countries.

Regulatory Gaps and Exploitation

• The regulatory framework surrounding FDCs has been a cause for concern since 1978 when the first government committee recognized the issue.
• Amendments in 1982 granted the central government the power to prohibit the manufacture of drugs lacking therapeutic value, while subsequent changes in 1988 mandated manufacturers to submit proof of safety and efficacy to the Drugs Controller General of India (DCGI) for all "new drugs," including FDCs.
• However, despite clear legal provisions, state drug controllers have routinely flouted the law by issuing manufacturing licenses for unapproved FDCs.
• The Ministry of Health, instead of pursuing criminal prosecutions, has resorted to a reactive approach, invoking its powers under Section 26A to prohibit the manufacture of specific FDCs. Since 1983, 444 such orders have been issued, resulting in a convoluted legal landscape with inconsistent court decisions.

Public Health Implications

• The gravity of the situation becomes apparent when considering the academic study's revelation of 239 unapproved FDCs being sold in 2020 in just one category, highlighting a 42-year-long failure of the regulatory framework.
• The lack of oversight not only compromises patient safety but also contributes to the growing problem of AMR in India.

The Unseen Threat: Antibiotic Mismanagement

• One of the most alarming aspects is that a significant portion of these unapproved or banned FDCs contain antibiotics. In a country grappling with the rise of antibacterial microbial resistance, the proliferation of such formulations poses a severe threat.
• The misuse and overuse of antibiotics can exacerbate the development of drug-resistant bacteria, making infections harder to treat and posing a substantial risk to public health.

Root Causes: Market Logic Over Public Health

• The pharmaceutical industry's motivation to exploit FDCs lies in their ability to charge higher prices while avoiding stringent regulations. By creating a seemingly innovative product by combining drugs, companies can claim uniqueness and charge premium prices until competitors introduce similar products.
• This pseudo-innovation is further incentivized by a regulatory structure that rewards market maneuvering rather than genuine pharmaceutical innovation.

Doctor's Role in the Prescription Dilemma

• While it might be tempting to attribute the blame solely to pharmaceutical companies, the study acknowledges that many doctors unknowingly contribute to the problem.
• Due to a misplaced trust in the drug regulatory system, doctors often assume that a product on the market has undergone thorough scrutiny.
• This underscores the need for increased awareness and education within the medical community regarding the nuances of FDCs and the potential risks associated with their use.

Regulatory Shortcomings and Whack-a-Mole Approach

• The regulatory failures are evident in the continuous issuance of manufacturing licenses for unapproved FDCs.
• Instead of taking a proactive stance, the Ministry of Health resorts to a reactive "whack-a-mole" approach, issuing prohibitory orders after the fact.
• This not only creates a legal quagmire but also fails to address the root cause – the unchecked issuance of manufacturing licenses for dubious FDCs.

International Perspectives and Collaborative Solutions

• Addressing the FDC problem requires a multi-faceted approach involving international collaboration.
• Learning from best practices in other countries, especially those with robust regulatory frameworks, can provide insights into how to effectively manage FDCs.
• Collaborative efforts with global health organizations and pharmaceutical regulatory bodies can contribute to establishing comprehensive guidelines for the approval and monitoring of FDCs.

The Urgency of Immediate Action

• Given the implications for public health, the Ministry of Health must take swift and decisive action.
• The unbridled proliferation of unapproved and banned FDCs, particularly those containing antibiotics, poses a significant threat to the nation's health.
• Immediate steps should include stringent enforcement of existing regulations, enhanced oversight of state drug controllers, and a comprehensive review of the regulatory framework governing FDCs

Conclusion

In conclusion, the issue of unapproved and banned FDCs in India, especially in the realm of antibiotics, demands urgent attention and systemic reform. The regulatory framework must evolve to address the complexities of the pharmaceutical landscape, and the industry should prioritize public health over profit motives. Collaborative efforts between regulatory bodies, the medical community, and international stakeholders are crucial to stemming the tide of unchecked FDC proliferation and safeguarding the well-being of the Indian population. Only through a concerted and comprehensive approach can India hope to mitigate the looming threat of antibiotic mismanagement and the associated risks of antibacterial microbial resistance.

Source- The Hindu