Why in News?

Recently, important issues of Medical Technology (MedTech) Industry were taken-up at the first meeting of the reconstituted National Medical Device Promotion Council (NMDPC).

What were the Key Highlights of the Meeting?

• Agenda:
  • Central Drugs Standards and Control Organisation (CDSCO) and the State Licensing Authorities (SLAs) provided updates for the smooth transition to licensing of Class A and B Medical Devices w.e.f 1st October 2022.
    • Medical devices under Medical Devices Rules, 2017 are classified as:
      • Class A (low risk): E.g., absorbent cotton balls, alcohol swabs.
      • Class B (low moderate risk): E.g., thermometer, BP monitoring device.
      • Class C (moderate high risk): E.g., implants.
      • Class D (high risk): E.g., heart valves.

  • Department of Pharmaceuticals provided the latest status of the various initiatives such as 100% Foreign direct Investment (FDI) in MedTech Sector on automatic route, Production-Linked Incentive Scheme (PLI) scheme for Medical Devices, Medical Devices Parks in four States (Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh), etc.
  • The discussion regarding the requirement of National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation of In-House labs of the manufacturers of specific Medical Devices was taken-up during the meeting.

• Concerns Highlighted:
  • There is a regulatory burden of labelling requirements of Medical Devices.
  • There are only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO and that is grossly insufficient keeping in view the size of the country.
  • Indian Medical Devices Industry presently lacks research ecosystem and infrastructure for manufacturing of high tech, advanced medical devices (Class C&D).

What were the Key Recommendations made by the NMDPC?

• Harmonize the Labelling Provisions:
  • There is a need to move forward to harmonize the provisions of labeling of Medical Devices under the Legal Metrology (Packaged Commodity) Rules, 2011 into Medical Device Rules, 2017, for licensed medical devices.

• Investment in the Medical Devices Park:
  • The Medical Devices Industry Associations representatives were encouraged to actively engage with states, which were sanctioned Medical Devices Parks by the Department for creating common infrastructure facilities and come forward to invest in the proposed parks to boost domestic manufacturing.

• Active Participation in the National MedTech Expo, 2022:
  • The industry’s support was also asked for the proposed National MedTech Expo, 2022 to showcase the strengths and capabilities of Indian Medical Devices Industry.

• Need of More Certified Medical Devices Testing Laboratories:
  • An adequate common infrastructure including accredited laboratories in various regions of the country for standard testing should be in place.

• Post-market Surveillance system and Medical Device Registry:
  • There must be a robust IT enabled feedback driven post-market surveillance system and medical device registry, particularly for implants to ensure traceability of patient who has received the implant in order to assess the performance of the implant.

• New Legislation for a New Regulator:
  • The Committee has recommended that the new legislation should set up a new set of regulators at different levels for regulating the medical devices industry.
    
  • Medical device regulations must be dispensed with by qualified and well-trained Medical Device Officers to give a boost to the Medical Device industry in the country.

• Research Linked Incentive (RLI) Scheme:
  • The Committee recommended the Department to start a RLI Scheme in Line with the PLI scheme.

• Upskilling of the Medical Device Officers:
  • The Ministry should work in synergy with State governments and impart the necessary skills to the local medical device officers.

• A Single Window Clearing Platform:
  • A single window clearing platform for application of license for manufacturing, export, import must be set up that shall also integrate all these bodies involved in the regulation of medical devices.
    

Source: TH

Why in News?

Recently, the Union Ministry of Rural Development has come up with penalties for any further delay in completing the flagship rural household scheme — Pradhan Mantri Awas Yojana (Gramin).

Why is the Need for Imposing Penalties?

• About:
  • The penalty would be levied on the state government. If the sanction of the house is delayed for more than one month from the date of issue of the target, the State government will be penalised Rs 10 per house for the first month of delay and Rs 20 per house for each subsequent month of delay.
  • Similarly, if the first instalment due to the beneficiary is delayed for more than seven days from the date of sanction, then the State governments will have to pay Rs 10 per house per week of delay.
  • No penalty would be imposed if the central funds are not available with the State.

• Need:
  • To Reorient Focus: Due to Covid-19, there was sluggishness in the implementation of the scheme, therefore by imposing penalties the central government is ensuring that the States pay more attention to the programme.
  • Issues with State Government: West Bengal, Chhattisgarh and Odisha along Assam are the leading four laggard States who are far behind their targets.
    • Further, the West Bengal government repackaged the scheme as “Bangla Awas Yojana” and due to this reason, the central government withheld funds meant for the scheme.

What do we Know about Pradhan Mantri Awas Yojna Gramin?

• Ministry Involved: Ministry of Rural development.
• Aim: To provide a pucca house with basic amenities to all rural families, who are homeless or living in kutcha or dilapidated houses by the end of March 2022.
  • To help rural people Below the Poverty Line (BPL) in construction of dwelling units and upgradation of existing unserviceable kutcha houses by providing assistance in the form of a full grant.

• Beneficiaries: People belonging to SCs/STs, freed bonded labourers and non-SC/ST categories, widows or next-of-kin of defence personnel killed in action, ex-servicemen and retired members of the paramilitary forces, disabled persons and minorities.
• Selection of Beneficiaries: Through a three-stage validation – Socio-Economic Caste Census 2011, Gram Sabha, and geo-tagging.
• Cost Sharing: The cost of unit assistance is shared between Central and State Governments in the ratio of 60:40 in plain areas and 90:10 for North Eastern and hilly states.
• Features:
  • The unit assistance has been increased from Rs. 70,000 to Rs. 1.20 lakh in plain and from Rs. 75,000 to Rs. 1.30 lakh in hilly states.
  • The assistance for construction of toilets shall be leveraged through convergence with Swachh Bharat Mission-Gramin (SBM-G), MGNREGS or any other dedicated source of funding.

• Performance:
  • Under the scheme, the government has set the target of 2.95 crore houses and by August 2022, 2.02 crore houses have been constructed.

Source: TH

Why in News?

The Shanghai Cooperation Organisation (SCO) summit 2022 was held recently in Samarkand, Uzbekistan.

• Samarkand declaration was signed by the member states.
• India takes over Presidency of the SCO for 2023.

What are the Key Highlights of the Summit?

• The Samarkand declaration advocated “commitment to peaceful settlement of differences and disputes between countries through dialogue and consultation”.
• They stress that the principles of mutual respect for sovereignty, independence, territorial integrity of States, equality, mutual benefit, non- interference in internal affairs, and non-use or threat of use of force are the basis for sustainable development of international relations.
• The member countries are planning to develop common principles and approaches to form a unified list of terrorists, separatist and extremist organizations whose activities are prohibited on the territories of the SCO member states.
• Russia is also looking at more customers for its gas as Western countries look to cut their dependence on it.
• Russia suggested that the organisation should think about holding its own big athletic event.
• Indian Perspective:
  • Connectivity: India urged Shanghai Cooperation Organisation member states to give each other full right to transit, as it would enhance connectivity and help in establishing reliable and resilient supply chains in the region.
  • Food Security: As the whole world is facing an unprecedented energy and food crisis, India emphasised the initiative to promote millet and address issues related to food security.
    • In this context, India is trying to popularise millets, as SCO can play a big role in marking 2023 as the International Year of Millets.

  • Working Group on Traditional Medicine: World Health Organisation (WHO) opened its Global Center for Traditional Medicines in Gujarat in April 2022.
    • This was the first and only worldwide centre for conventional medicine established by the WHO.

  • Tourism: Varanasi was declared as the SCO Tourism and Cultural Capital for 2022-2023 to promote the rich cultural and historical heritage of the people and the tourism potential of SCO member states.
    • Further, it will promote tourism, cultural and humanitarian exchanges between India and the SCO member Countries.
    • It also underlines India’s ancient civilizational links with the Member States of SCO, especially the Central Asian Republics.
    • Under the framework of this major cultural outreach program, a number of events will be hosted in Varanasi during 2022-23.

Source: IE

Why in News?

Recently, Jean-Luc Godard, one of the legends of French New Wave cinema, died by assisted suicide at the age of 91.

What is Assisted Suicide?

• About:
  • Assisted suicide and euthanasia both are practices under which a person intentionally ends their life with active assistance from others.
  • Several European nations, some states in Australia and Colombia in South America allow assisted suicide and euthanasia under certain circumstances.

• Types:
  • Active:
    • Active euthanasia, which is legal in only a few countries, entails the use of substances to end the life of the patient.

  • Passive:
    • It involves simply stopping lifesaving treatment or medical intervention with the consent of the patient or a family member or a close friend representing the patient.

What are the Arguments for and against Assisted Suicide?

• Arguments for:
  • Freedom of Choice:
    • Advocates argue that the person should be able to make their own choice.

  • Quality of Life:
    • Only the individual really knows how they feel, and how the physical and emotional pain of illness and prolonged death impacts their quality of life.

  • Dignity:
    • Every individual should be able to die with dignity.

  • Resources:
    • It makes more sense to channel the resources of highly skilled staff, equipment, hospital beds, and medications toward lifesaving treatments for those who wish to live, rather than those who do not.

  • Humane:
    • It is more humane to allow a person with intractable suffering to be allowed to choose to end that suffering.

  • Loved ones:
    • It can help to shorten the grief and suffering of loved ones.

• Arguments Against:
  • Moral and Religious Arguments:
    • Several faiths see euthanasia as a form of murder and morally unacceptable. Suicide, too, is “illegal” in some religions. Morally, there is an argument that euthanasia will weaken society’s respect for the sanctity of life.

  • Patient Competence:
    • Euthanasia is only voluntary if the patient is mentally competent, with a lucid understanding of available options and consequences, and the ability to express that understanding and their wish to terminate their own life. Determining or defining competence is not straightforward.

  • Guilt:
    • Patients may feel they are a burden on resources and are psychologically pressured into consenting. They may feel that the financial, emotional, and mental burden on their family is too great.

  • Slippery slope:
    • There is a risk that physician-assisted suicide will start with those who are terminally ill and wish to die because of intractable suffering, but then begin to include other individuals.

  • Regulation: Euthanasia cannot be properly regulated.

Source: IE

Why in News?

Recently, the United Nations Environmental Programme (UNEP), along with the UK-based charity Reef-World Foundation, launched the Green Fins Hub.

• Green Fins Hub is a global digital platform for diving and snorkelling operators worldwide.

What is Green Fins Hub?

• About:
  • The Green Fins Hub is the first-ever global marine tourism industry platform.
  • It would give sustainable marine tourism a ‘major boost’.
  • It is expected to scale up to reach a potential 30,000 operators worldwide from about 700 operators across 14 countries.

• Significance:
  • It is intended to catalyse a seismic shift towards sustainability in the marine tourism sector through Green Fins membership.
  • Coral reefs are home to at least 25% of marine life, are the mecca for marine-related tourism, contributing up to 40% or more of the gross domestic product in some island nations. However, they are a most vulnerable ecosystem, especially to climate change with the difference between a global temperature rise of 1.5 or 20C being existential for reefs.
    • Increasing accessibility of best practice, knowledge and citizen science through the Green Fins Hub could be a game changer in ensuring a future for coral reefs and other fragile marine ecosystems.

  • The platform will help diving and snorkelling operators worldwide to make simple, cost-efficient changes to their daily practices by utilising tried and tested solutions.
    • It would also help them keep track of their annual improvements and communicate with their communities and customers.

What is Sustainable Coastal and Marine Tourism?

• Sustainable Tourism refers to sustainable practices in and by the tourism industry. It refers to addressing the issues of a greener tourism sector both on the demand as well as supply side.
  • According to the UN, sustainable tourism should incorporate the following:
    • Make optimal use of environmental resources that constitute a key element in tourism development, maintaining essential ecological processes and helping to conserve natural heritage and biodiversity.
    • Respect the socio-cultural authenticity of host communities, conserve their built and living cultural heritage and traditional values, and contribute to inter-cultural understanding and tolerance.
    • Ensure viable, long-term economic operations, providing socio-economic benefits to all stakeholders that are fairly distributed, including stable employment and income-earning opportunities and social services to host communities, and contributing to poverty alleviation.

• Coastal and Marine Tourism (CMT) represents at least 50% of total global tourism. It constitutes the largest economic sector for most Small Island Developing States (SIDS) and many coastal states.
  • With anticipated global growth rates of more than 3.5%, coastal and marine tourism is projected to be the largest value-adding segment of the ocean economy by 2030, at 26%.

What are the Challenges Associated with CMT?

• Continued Depletion and Degradation of Natural Assets is putting the sustainability and viability of the industry, along with the local communities that rely on it, at risk.
• Covid-19 Pandemic Caused a Major Disruption in the tourism industry. The World Travel and Tourism Council has projected around 75 million job losses and a tourism-induced GDP reduction of more than $2 trillion globally.
• Climate Change will Affect Strongly the Coastal Areas with high anthropic vulnerability, through temperature increase, more frequent environmental events, water scarcity and sea level rise (SLR).

What are the Other Initiatives Towards Coastal and Marine Tourism?

• Global Initiatives:
  • Global Sustainable Tourism Council (GSTC) and World Wild Fund (WWF) are partnering with hotels, cruise ships, tour operators and the industry to create nature-positive tourism where all supply chain actors converge to create value for people, nature and businesses.
  • Sustainable Blue Economy Finance Initiative is a UN-convened global community focused on the intersection between private finance and ocean health, supporting the implementation of the Sustainable Blue Economy Finance Principles.
    • The Sustainable Blue Economy Finance Principles are the foundational keystone to invest in the ocean economy. Launched in 2018, they are the world’s first global guiding framework for banks, insurers and investors to finance a sustainable blue economy. They promote the implementation of SDG 14 (Life Below Water), and set out ocean-specific standards.

  • Ocean Recovery Alliance has become a signatory of the Global Tourism Plastics Initiative, led by the UNEP and World Tourism Organization, in collaboration with the Ellen MacArthur Foundation.
    • The Global Tourism Plastics Initiative has the objective to tackle plastic pollution by promoting a shift towards circular economy of plastics in tourism operations where plastics never become waste, rather than to completely eliminate plastics from all tourism operations.

• Indian Initiatives:
  

Source: DTE

Why in News?

Recently, The Central Board for Direct Taxes (CBDT) has accused the makers of the Dolo-650 tablet of spending Rs 1,000 crore to distribute freebies to doctors for prescribing the medicine.

What do we need to know about Freebies in Drug Marketing?

• About:
  • Drug manufacturing companies have been observed practicing ‘Gift-giving’: offering freebies ranging from free dinners and drug samples to promotional merchandise to doctors for their product marketing.
    • In order to promote their products, pharma companies allegedly arrange accommodation in five-star hotels, local sight-seeing, etc. in conferences conducted by doctors.

  • This is a well-oiled racket that sees pharmaceutical (pharma) companies ‘gifting’ doctors to push their respective drugs under the guise of marketing.

• Pharma Company’s Stand:
  • Drug firms would offer branded souvenirs like pen stands, calendars, diaries or sanitizers to doctors.
    • The idea is to ensure top-of-the-mind recall of their brands.
    • The Indian market is price-controlled. Therefore, the differentiator here is the brands and this is common practice.