Kazhuveli Bird Sanctuary is one of the newest additions to India's Ramsar sites, further elevating Tamil Nadu's status as a key conservation region. With the inclusion of Kazhuveli and Nanjarayan, Tamil Nadu now has 18 Ramsar sites, the highest number in India, underscoring the state's commitment to wetland conservation.

Key Features

• Location: Kazhuveli Bird Sanctuary is located in Tamil Nadu and houses the second-largest brackish lake in southern India, making it a vital ecological zone.
• Ramsar Site Designation: Recognized under the Ramsar Convention for its international ecological importance, the sanctuary plays a crucial role in the conservation of migratory birds and wetland ecosystems.

Biodiversity

• Migratory Birds: The sanctuary serves as a critical habitat for migratory birds, with notable species such as:
• Black-headed Ibis: Known for its distinctive appearance and migratory patterns.
• Greater Flamingo: A large migratory bird that uses the sanctuary as a stopover.
• East Asian-Australasian Flyway: The sanctuary is a significant stopover point along this migratory route, which extends from East Asia to Australasia, allowing many bird species to rest and feed during long migrations.

Ecological Importance

• Flood Control and Groundwater Recharge: Kazhuveli Bird Sanctuary plays a key role in water storage, which helps control floods during heavy rainfall and recharges groundwater, contributing to the stability of the region's water table.
• Brackish Lake Ecosystem: As one of the largest brackish lakes in southern India, Kazhuveli supports a unique ecosystem, blending both freshwater and saltwater species, and providing a habitat for various flora and fauna.

Conservation Significance

• Wetland Preservation: The sanctuary’s Ramsar status highlights its importance as a critical wetland ecosystem, promoting efforts to conserve both the biodiversity and the ecological functions of the area.
• Sustainable Water Management: By acting as a natural reservoir, Kazhuveli helps in water management, particularly in controlling floods and enhancing groundwater recharge, which are crucial for both the local ecosystem and human populations.

The Himachal Pradesh Assembly has passed the Prohibition of Child Marriage (Himachal Pradesh Amendment) Bill, 2024, proposing a significant legal change by raising the minimum marriage age for women from 18 to 21 years. The Bill modifies the existing Prohibition of Child Marriage (PCM) Act, 2006, reflecting the state's intention to bring gender parity to the legal age of marriage and further align with ongoing discussions on enhancing women's empowerment and welfare.

Key Provisions of the Bill:

• Definition of "Child": The Bill redefines a "child" as any individual below 21 years, irrespective of gender, giving this age limit overriding authority over any other law or cultural practice that allows for earlier marriage.
• Extended Annulment Period: The Bill also extends the period to file a petition for annulling a child marriage. Under the amendment, individuals have up to five years from reaching the age of majority (18), meaning they can file annulment petitions until they turn 23.

Key Challenges:

• Difference Between Age of Majority and Marriage:
• The Bill raises the minimum age of marriage for women to 21, aligning it with the minimum age for men.
• However, under the Majority Act of 1875, individuals attain legal adulthood at 18, which raises concerns about the rights and responsibilities of young adults (ages 18 to 21). These individuals can vote, enter contracts, and be tried as adults, yet the Bill restricts their right to marry before 21.
• Inconsistencies with Supreme Court Judgments:
• The Supreme Court has affirmed that the right to marry is a fundamental right under Article 21 (right to life and personal liberty). In 2018, the Court ruled that consensual adult relationships, including marriage, are protected under Articles 19 and 21.
• The Bill, by prohibiting marriage before 21, imposes a restriction on the fundamental right to marry, raising questions about its constitutionality. For restrictions on fundamental rights, the law must meet three conditions:
• Public Purpose: The law must serve a public interest.
• Nexus with Purpose: There should be a clear connection between the restriction and the intended public purpose.
• Less Intrusive Means: There should be no less intrusive way to achieve the desired purpose.
• Critics argue that the restriction for those between 18 and 21 years may not satisfy these criteria.
• Implementation Challenges:
• Despite existing laws prohibiting child marriages, enforcement has been limited. In 2020, only 785 cases were registered under the 2006 PCM Act, suggesting low detection rates for child marriages.
• It remains uncertain whether increasing the legal age of marriage will significantly reduce child marriages, particularly in rural and underdeveloped regions, where enforcement and societal acceptance remain hurdles.

Legislative and Constitutional Implications:

• Concurrent List: Marriage falls under the Concurrent List of the Constitution, meaning both the central and state governments have the authority to legislate on the subject.
• Article 254(1) and 254(2): If the state law contradicts the central law, Article 254(1) renders the conflicting state law void unless the President provides assent under Article 254(2).
• Therefore, the Governor of Himachal Pradesh must forward the Bill for President's consideration. If approved, the Bill will become law, similar to the process seen with Uttarakhand's Uniform Civil Code (UCC) Bill.

Broader Implications:

• Debate on Women's Empowerment: Supporters of the Bill argue that raising the marriage age could delay early marriages and provide women more time for education and personal development. Critics, however, question whether a legal change without addressing societal and cultural norms will be sufficient to effect real change.
• Child Marriage Prevalence: Despite the legal framework, child marriage continues in many parts of India due to socio-economic factors, cultural traditions, and lack of enforcement. While raising the marriage age is a positive step, it must be accompanied by robust public awareness campaigns, stricter enforcement, and support systems for vulnerable communities.

In conclusion, the Himachal Pradesh Amendment Bill, 2024 is a legislative effort to combat child marriage by aligning the marriageable age for women with that of men and extending protection mechanisms. However, its effectiveness will depend on resolving constitutional challenges, addressing societal norms, and ensuring proper implementation.

India has successfully proposed names for three geographical structures located along the Southwest Indian Ridge in the Indian Ocean. These names have been approved by the International Hydrographic Organization (IHO) and UNESCO’s Intergovernmental Oceanographic Commission (IOC).

Newly Named Structures

• Ashoka Seamount:
• Named after the rulers of the Mauryan dynasty.
• Discovered in 2012 by the Russian vessel Akademik Nikolay Strakhov.
• Chandragupt Ridge:
• Also named after Mauryan rulers.
• Discovered in 2020 by the Indian vessel MGS Sagar.
• Kalpataru Ridge:
• Discovered in 2012 by the same Russian vessel, Akademik Nikolay Strakhov.

Previously Named Indian Structures

• Raman Ridge
• Panikkar Seamount
• Sagar Kanya Seamount
• DN Wadia Guyot

About the Organizations

International Hydrographic Organization (IHO)

• Location: Monaco
• Established: 1921
• Purpose: An intergovernmental body focused on ensuring safe navigation and protecting the marine environment.
• Membership: Comprises 100 member states, including India.
• UN Status: IHO holds observer status at the United Nations and is recognized as the competent authority on hydrographic surveying and nautical charting.

UNESCO Intergovernmental Oceanographic Commission (IOC)

• Headquarters: Paris, France
• Purpose: Promotes international cooperation in marine sciences and improves the management of oceans, coasts, and marine resources.
• Membership: Encompasses 150 member states; India has been a member since 1946.
• Current Initiative: Coordinates the United Nations Decade of Ocean Science for Sustainable Development (2021-2030), known as the “Ocean Decade.”

Conclusion

The naming of the Ashoka Seamount, Chandragupt Ridge, and Kalpataru Ridge reflects India's growing contributions to oceanic research and its commitment to preserving maritime heritage. These initiatives also highlight the collaboration between India and international organizations in advancing marine science and sustainable development.

Why in the News?

The Ministry of Health and Family Welfare in India has recently prohibited the manufacture, sale, or distribution of 156 fixed-dose combination (FDC) medicines. This action is aligned with the powers granted under the Drugs and Cosmetics Act of 1940.

• Previous Actions: Earlier in 2023, the ministry had banned 14 FDCs due to similar concerns.
• Reasons for Ban: The banned FDCs were determined to pose risks to human health, with safer alternatives available. An expert committee, along with the Drugs Technical Advisory Board (DTAB), concluded that there is no therapeutic justification for the ingredients in these FDCs.
• Examples of Banned FDCs: The list includes various medicines, such as antibiotics, painkillers, and multivitamins, with specific examples like Aceclofenac and Paracetamol.

What are Fixed Dose Combinations (FDCs)?

• Definition: FDCs are pharmaceutical products that contain two or more active ingredients (often referred to as "cocktail drugs") intended for a specific medical indication. This definition is in accordance with the Drugs & Cosmetics Rules of 1945.
• Active Ingredients: An active ingredient is the biologically active component of a drug (such as a tablet, capsule, cream, or injectable) responsible for producing the intended therapeutic effects.
• Regulatory Status: According to the Drugs and Cosmetics Act of 1940, FDCs are classified as New Drugs. Approval for these combinations is granted by the Central Drugs Standard Control Organization (CDSCO).
• Common Combinations: FDCs are frequently found in formulations targeting cough, cold, and fever; antimicrobials; as well as vitamins and minerals.

Implications of the Ban

This ban reflects the Indian government's commitment to ensuring the safety and efficacy of pharmaceutical products. By removing potentially harmful FDCs from the market, the ministry aims to protect public health and promote the use of safer alternatives. The move also emphasizes the importance of rigorous evaluation of drug combinations before they are approved for use.

Rationale for the Usage of Fixed Dose Combination Drugs (FDCs)

Fixed Dose Combination (FDC) drugs are increasingly utilized in modern medicine for several compelling reasons.

1. Enhanced Efficacy

• Better Therapeutic Outcomes: FDCs can provide improved therapeutic effects compared to using individual medications. By combining drugs that work synergistically, healthcare providers can target multiple pathways in disease management, often leading to more effective treatment.

2. Cost-Effectiveness

• Affordability: FDCs are generally more cost-effective than purchasing individual medications separately. This can significantly reduce the financial burden on patients, especially for chronic conditions requiring long-term treatment.

3. Reduced Pill Burden

• Convenience and Compliance: FDCs simplify treatment regimens by reducing the number of pills patients need to take. This convenience can lead to improved patient adherence to prescribed therapies, which is crucial for achieving optimal health outcomes.

4. Pharmacokinetic Advantage

• Optimized Absorption and Metabolism: FDCs can offer pharmacokinetic advantages by improving the absorption, distribution, metabolism, and excretion (ADME) of the drugs involved. This can enhance the overall effectiveness of the treatment and minimize potential side effects. For example:
• Synergistic Effects: When two drugs are combined, they may enhance each other's absorption or metabolic pathways, leading to better overall bioavailability.
• Streamlined Metabolism: Combining medications can help in synchronizing their metabolic profiles, allowing for more consistent therapeutic levels in the bloodstream.

Issues Associated with Fixed Dose Combination Drugs (FDCs)

While Fixed Dose Combination (FDC) drugs offer several advantages, they also present significant issues that can impact patient safety and public health.

1. Lack of Individual Dose Flexibility

• Fixed Dosage Limitations: FDCs contain a predetermined dosage of each active ingredient, which may not be suitable for all patients. Individual variations in response to medication, including differences in weight, age, and co-existing medical conditions, can make fixed doses problematic. This lack of flexibility can lead to suboptimal treatment outcomes or increased side effects for certain patients.

2. Unapproved and Banned FDCs

• Hazards of Unlicensed Products: The availability of untested and unlicensed FDCs, particularly in countries like India, raises significant public health concerns. Such FDCs may lack rigorous testing for safety and efficacy, putting patients at risk of adverse effects or ineffective treatment. The ease of access to these medications can lead to their widespread use without proper medical supervision.

3. Increased Risk of Antimicrobial Resistance (AMR)

• Overuse of Antibiotics: The combination of multiple antimicrobial agents in FDCs can lead to potential overuse and misuse, contributing to the rise of antimicrobial resistance. Inappropriate prescribing or self-medication with FDCs containing antibiotics may promote resistance, complicating the treatment of infections and threatening public health.

4. Ethical Concerns

Regulatory Discrepancies: Although the Indian government has imposed bans on certain FDCs due to safety concerns, ethical dilemmas arise when the same drugs are permitted for export to African or SAARC (South Asian Association for Regional Cooperation) countries. This inconsistency raises questions about the responsibility of pharmaceutical companies and regulatory bodies in ensuring the safety of medicines available in both domestic and international markets. The potential exploitation of less stringent regulations in other countries poses a risk to vulnerable populations.

Issues in the Regulation of Fixed Dose Combination Drugs (FDCs) in India

The regulation of Fixed Dose Combination (FDC) drugs in India faces several significant challenges that can compromise patient safety and public health. Here are some key issues:

1. Reformulation of Drugs

• Evasion of Price Control: Some pharmaceutical companies reformulate individual drugs into FDCs to circumvent price control regulations. This practice can lead to the introduction of medications that may not provide additional therapeutic benefits while increasing costs for consumers.

2. Compromised Quality

• Lax Regulatory Oversight: After a four-year period, other manufacturers can produce new FDCs by obtaining licenses from State Licensing Authorities (SLAs) without undergoing rigorous checks related to pharmacological studies. This lack of stringent quality control can result in substandard medications entering the market.

3. Approval Process

• Regulatory Gaps: The Parliamentary Standing Committee on Health and Family Welfare's 59th report highlighted that some SLAs have issued manufacturing licenses for FDCs without prior clearance from the Central Drugs Standard Control Organization (CDSCO). This oversight can lead to the circulation of unsafe or ineffective medications.

4. Other Concerns

• Poor Adverse Drug Reaction Reporting: India has a suboptimal system for reporting adverse drug reactions, which hampers the identification and management of safety concerns associated with FDCs.
• Lack of Comprehensive Data: There is no precise database tracking the currently available FDCs in the market, including their sales turnover and usage patterns. This lack of data makes it difficult to assess the impact of FDCs on public health effectively.

Steps Taken by India for Regulation of FDCs

To address these issues, India has implemented several regulatory measures:

• Drugs & Cosmetics (Amendment) Act, 2008:
• Introduces stringent penalties for manufacturers of spurious and adulterated drugs. Certain offenses related to drug quality have also been made cognizable and non-bailable.
• Strengthening Testing Capacities:
• The Central Drugs Testing Laboratories under the CDSCO are continuously enhancing their testing capabilities to expedite the analysis of drug samples in the country.
• Amendment of Drugs and Cosmetics Rules (2017):
• Requires applicants to submit bioequivalence study results along with applications for manufacturing licenses for oral dosage forms of drugs, enhancing the scrutiny of FDCs.

Suggestions to Improve Regulation of FDCs

To further strengthen the regulation of FDCs in India, the following measures are suggested:

• Periodic Surveys:
• Conduct regular surveys of drug manufacturers and wholesale/retail outlets to gain insights into the existing challenges in the sector and ensure compliance with regulatory standards.
• Establishment of a National Drug Authority (NDA):
• Create a National Drug Authority through an Act of Parliament, as recommended by the Hathi Committee and outlined in the Drug Policy of 1994, to oversee drug quality and safety.
• Strong Punitive Actions:
• Implement robust punitive measures against individuals involved in drug-related corruption, as suggested by the Mashelkar Committee. For instance, consider escalating the penalties for manufacturing or selling spurious drugs from life imprisonment to a death penalty as a deterrent.
• Multistep Approach:
• Adopt a multistep approach involving all stakeholders—consumers, physicians, regulatory authorities, industry representatives, and academia—to address the irrational use of FDCs effectively. Collaborative efforts can enhance awareness, improve practices, and promote safer use of medications.

Conclusion

Regulating FDCs in India requires comprehensive measures to address existing challenges and improve drug safety and efficacy. By implementing the suggested steps, India can enhance its regulatory framework, ensuring that FDCs are both safe and effective for patients.