GS Analyst
Daily Current Affairs

The Centre reiterated its “humble request” to the Supreme Court not to rewrite the Special Marriage Act (SMA) for legal validation of same-sex marriages, claiming the LGBTQ++ community was an unidentified class of persons and legalising a marital relationship between members of this group could potentially create hurdles in the implementation of other statutes.

Arguments made by the Centre

• The subject of extending legal recognition to same-sex marriages should “better be left to the choice of the Parliament”.
• Marriage was not an absolute right, even between heterosexual couples.
• The right to marry does not include the right to compel the State to create a new definition of marriage.

What are absolute rights?

• Absolute rights cannot be limited for any reason. No circumstance justifies a qualification or limitation of absolute rights. Absolute rights cannot be suspended or restricted, even during a declared state of emergency.

The Union Cabinet approved the National Medical Devices Policy, in 2023.

The current state of the medical device sector in India

• The medical devices sector in India is a sunrise sector which is growing at a fast pace.
• The market size of the medical devices sector in India is estimated to be $11 billion (approximately, Rs 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
• What is the National Devices Policy, 2023?
• The National Medical Devices Policy, of 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation.
• Salient Features of National Medical Devices Policy, 2023:
• Vision: Accelerated growth path with a patient-centric approach and emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years.  The Policy is expected to help the Medical Devices Sector grow from the present $11 Bn to $50 Bn by 2030.
• Mission: The policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

Strategies to Promote Medical Device Sector:

The medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions:

• Regulatory Streamlining: In order to enhance ease of doing research and business and further balance patient safety with product innovation measures such as the creation of a Single Window Clearance System' for Licensing of Medical Devices coopting all the stakeholder departments/organizations such as AERB, MeitY, DAHD, etc, enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation, will be followed.
• Enabling Infrastructure: The establishment and strengthening of large medical device parks, and clusters equipped with world-class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti, would be pursued with the State Governments and Industry for better convergence and backward integration with medical device industry
• Facilitating R&D and Innovation: The policy envisages promoting Research & Development in India and complements the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India. It also aims at establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups.
• Attracting Investments in the Sector: Along with recent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, and Start-up mission, the policy encourages private investments, a series of funding from Venture Capitalists, and also Public-Private Partnership (PPP).
• Human Resources Development: The scheme aims to have a steady supply of skilled workforce across the value chain such as scientists, regulators, health experts, managers, technicians, etc.
• Brand Positioning and Awareness Creation: The policy envisages the creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issues.

Significance of the policy

• Strengthening the industry: The policy is expected to provide the required support and directions to strengthen the medical devices industry into a competitive, self-reliant, resilient and innovative industry that caters to the healthcare needs of not only India but also of the world.
• Patient-centric approach: The National Medical Devices Policy, 2023 aims to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients.

Government schemes & interventions

• The Government of India has already initiated the implementation of the PLI Scheme for medical devices and support for the setting up of 4 Medical device Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
  • Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs.1206 Cr and out of this, so far, an investment of Rs.714 Cr has been achieved.
  • Under the PLI scheme, a total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammograms, C-Arm, MRI Coils, high-end X-ray tubes, etc. The remaining 12 products will be commissioned in the near future.
  • Five projects out of a total of 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products/product components.

The issues regarding India’s nuclear liability law continue to hold up the more than a decade-old plan to build six nuclear power reactors in Maharashtra’s Jaitapur, the world’s biggest nuclear power generation site under consideration at present.

What is the law governing nuclear liability in India?

• Compensation for nuclear disaster: Laws on civil nuclear liability ensure that compensation is available to the victims for nuclear damage caused by a nuclear incident or disaster and set out who will be liable for those damages.
• International nuclear liability regime: The international nuclear liability regime consists of multiple treaties and was strengthened after the 1986 Chornobyl nuclear accident.
• Convention on Supplementary Compensation (CSC): The umbrella Convention on Supplementary Compensation (CSC) was adopted in 1997 with the aim of establishing a minimum national compensation amount.
  • The amount can further be increased through public funds, (to be made available by the contracting parties), should the national amount be insufficient to compensate for the damage caused by a nuclear incident.
  • Even though India was a signatory to the CSC, Parliament ratified the convention only in 2016.
• Civil Liability for Nuclear Damage Act (CLNDA): To keep in line with the international convention, India enacted the Civil Liability for Nuclear Damage Act (CLNDA) in 2010, to put in place a speedy compensation mechanism for victims of a nuclear accident.
  • The CLNDA provides for strict and no-fault liability on the operator of the nuclear plant, where it will be held liable for damage regardless of any fault on its part.
  • It also specifies the amount the operator will have to shell out in case of damage caused by an accident at Rs 1,500 crore and requires the operator to cover liability through insurance or other financial security.
  • In case the damage claims exceed Rs 1,500 crore, the CLNDA expects the government to step in and has limited the government liability amount to the rupee equivalent of 300 million Special Drawing Rights (SDRs) or about Rs 2,100 to Rs 2,300 crore.
  • The Act also specifies the limitations on the amount and time when an action for compensation can be brought against the operator.

What does the CLNDA say on supplier liability?

• The international legal framework on civil nuclear liability, including the annexe of the CSC is based on the central principle of exclusive liability of the operator of a nuclear installation and no other person.
• Making suppliers responsible would hinder growth: In the initial stages of the nuclear industry’s development, it was agreed that excessive liability claims against suppliers of nuclear equipment would make their business unviable and hinder the growth of nuclear energy.
• Shifting responsibility to the operator: It became an accepted practice for national laws of countries to channel nuclear liability to the operators of the plant with only some exceptions.
• Section 10 of the annexe of the CSC lays down “only” two conditions under which the national law of a country may provide the operator with the “right of recourse”, where they can extract liability from the supplier —
  • if it is expressly agreed upon in the contract
  • if the nuclear incident “results from an act or omission done with intent to cause damage”

Who introduced the concept of supplier liability (for the first time)?

• However, India, going beyond these two conditions, for the first time introduced the concept of supplier liability over and above that of the operators in its civil nuclear liability law, the CLNDA.
• The architects of the law recognised that defective parts were partly responsible for historical incidents such as the Bhopal gas tragedy in 1984 and added the clause on supplier liability.

Why is the supplier liability clause an issue in nuclear deals?

• Foreign suppliers of nuclear equipment from countries as well as domestic suppliers have been wary of operationalising nuclear deals with India as it has the only law where suppliers can be asked to pay damages.
• Sticking point for suppliers: Concerns about potentially getting exposed to unlimited liability under the CLNDA and ambiguity over how much insurance to set aside in case of damage claims have been sticking points for suppliers.

The Supreme Court modified its June 2022 order that ruled each national park and wildlife sanctuary must have an eco-sensitive zone (ESZ) of a minimum 1km, measured from the demarcated boundary of such protected forest, while also lifting a complete ban on development and construction activities within ESZs.

The reason behind the development

• SC stated that its 2022 order on uniform ESZs was not workable and that its directive prohibiting all development activities within such zones is “impossible to be implemented”.
  • The area to be declared as ESZ cannot be uniform and will be protected area specific.
  • In some cases, it may be 10km on one side and 500m on the other side. In certain cases, it may not be possible to have a uniform minimum area by virtue of interstate boundaries or a sea or a river beyond one side of the protected area.

What are Eco-Sensitive Zones?

• As per the National Wildlife Action Plan (2002-2016), issued by the Union Ministry of Environment, Forest and Climate Change, land within 10 km of the boundaries of national parks and wildlife sanctuaries is to be notified as eco-fragile zones or Eco-Sensitive Zones (ESZ).
  • While the 10-km rule is implemented as a general principle, the extent of its application can vary.
  • Areas beyond 10 km can also be notified by the Union government as ESZs if they hold larger ecologically important “sensitive corridors.
• According to the guidelines issued by the Environment Ministry in 2011, ESZs are created as “shock absorbers” for the protected areas, to minimize the negative impact on the “fragile ecosystems” by certain human activities taking place nearby.
  • Furthermore, these areas are meant to act as transition zone from areas requiring higher protection to those requiring lesser protection.