Regulation of medical devices
(GS-II: Issues related to the social sector involving healthcare, schemes for vulnerable sections of society etc)
The Union Health Ministry has released the new draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’ that separately defines medical devices.
The government has sought comments, objections, and suggestions on the draft Bill over the next 45 days.
Separate expert group: It has provision for the constitution of a separate expert group on medical devices.
Central and state testing laboratories: It calls for the setting up of central and state medical device-testing laboratories on the lines of the network of drug-testing laboratories.
Rules for online pharmacy: The draft Bill also suggests that the Central government formulate rules for regulating online pharmacies.
Separate definitions for medical devices: The draft Bill has a separate definition for medical devices that bring under its ambit diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits.
The previous 1940 Act regulated medical devices as one of the four categories of “drugs”.
‘Medical devices technical advisory board’: It makes provision for the creation of a ‘medical devices technical advisory board’ on the lines of the existing drugs technical advisory board.
This board will include medical professionals and also people with technical knowledge of the devices.
Other than officials from the Health ministry, the board will also include people from:
Drugs and Cosmetics Act, 1940:
The Act regulates the import, manufacture, and distribution of drugs in India.
The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
Section 3 of the Drugs and Cosmetics Act, 1940:
The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in human beings or animals as drugs.
IPBES Assessment Report on wild species
(GS-III: Conservation, environmental pollution and degradation, environmental impact assessment)
Intergovernmental Science-policy platform on Biodiversity and Ecosystem Service (IPBES) released its report on the sustainable use of wild species of plants, animals, fungi and algae around the world.
Findings of the Report:
Impact on the biodiversity and wild species ecosystem: Major impact is through Climate change, landscape and seascape changes, pollution and invasive alien species impact
It is the main threat to wild species in marine ecosystems and the second greatest threat to those in terrestrial and freshwater ecosystems.
Unsustainable hunting is the main threat to wild mammal species.
Unsustainable logging and gathering are one of the main threats for several plant groups, notably cacti, cycads, and orchids as well as other plants and fungi harvested for medicinal purposes.
On livelihood: Small-scale fisheries support over 90% of the 120 million people and about half of the people involved in small-scale fisheries are women.
The report finds that 34% of marine wildlife is overfished.
50,000 wild species globally can meet the needs of billions of people.
70 per cent of the world’s poor population was directly dependent on wild species.
On indigenous people: Sustainable use of wild species is central to its identity, existence and livelihood
Empower indigenous communities: The report noted that indigenous people and local communities used local knowledge, practices and spirituality for the sustainable use of wild species. They respected nature and only took what they needed.
Robust fisheries management:g. The Atlantic bluefin tuna population has been rebuilt and is now fished within sustainable levels
Effective regulations: Without them, unsustainable use and trade would increase, leading to population collapse.
Sustainable use of wild species can meet the needs of billions
Other measures needed to save wild species: integration of diverse value systems, equitable distribution of costs and benefits, changes in cultural norms and social values and effective institutions and governance systems would facilitate the sustainable use of wild species in future.
What is IPBES?
It is an independent intergovernmental body, established by member States in 2012, with the objective to strengthen the research, evidence-based policy making for the conservation and sustainable use of biodiversity.
The work of IPBES works include: – Assessments, Policy Support, Building Capacity & Knowledge
Secretariat: Bonn, Germany.
(GS-I: Important Geophysical phenomena such as earthquakes, tsunamis, Volcanic activity, cyclones etc.)
Sudden, “highly-localised rains” in Amarnath, Jammu and Kashmir, caused flooding and led to the deaths of at least 16 people and injuries to more than 20 others.
What is a cloudburst?
A cloudburst refers to an extreme amount of rain that happens in a short period, sometimes accompanied by hail and thunder, and this has a precise definition.
The India Meteorological Department (IMD) defines it as unexpected precipitation exceeding 100mm (or 10 cm) per hour over a geographical region of approximately 20 to 30 square km
Where do they occur?
They are more likely to occur in mountainous zones mainly because of terrain and elevation.
A cloudburst occurs when moisture-carrying air moves up a hilly terrain, forming a vertical column of clouds known as ‘cumulonimbus’ clouds.
Such clouds usually cause rain, thunder and lightning. This upward motion of the clouds is known as an ‘orographic lift’.
These unstable clouds cause an intense rainstorm over a small area after becoming heavy enough and locked in the ridges and valleys between the hills.
The energy necessary for the cloudburst comes from the upward motion of air. Cloudbursts mostly occur at elevations between 1,000-2,500 metres above sea level.
SDG report 2022 released by the UN
(GS-II: Important international policies and institutions, issues related to the development of the social sector, India’s SDG targets and its achievements, SDG etc)
A recent UN SDG index says, all 17 SDGs, are in jeopardy due to the climate crisis, the COVID-19 pandemic and an increase in the number of conflicts across the world.
The 2022 SDG Index is topped by three Nordic countries – Finland, Denmark and Sweden – and all top 10 countries are European countries.
India ranked at 121.
No improvement in performance: Performance on SDG 1 (No Poverty) and SDG 8 (Decent Work and Economic Growth) remain below pre-pandemic levels in many low-income countries (LICs) and lower-middle-income countries (LMICs).
Slow progress on climate and biodiversity: Progress on climate and biodiversity goals is also too slow, especially in rich countries.
Rise in Greenhouse gas: Greenhouse gas emissions are set to rise 14 per cent over a decade.
Antithetical to the Paris Agreement plan: A 2025 peak followed by a 43 per cent decline by 2030 and Net 2050.
Pandemic as a threat: The pandemic itself has emerged as one of the biggest threats to several SDGs, pointing at 15 million “excess deaths” directly or indirectly due to the novel coronavirus by 2021.
Health emergency: Economic shocks due to the worldwide health emergency pushed 93 million into poverty in 2020 alone, undoing “more than four years” work at alleviating poverty. It also affected the education and healthcare services for millions.
Immunization, for example, has dropped for the first time in a decade even as deaths from malaria and TB have risen.
Lowering of global economic growth: The pandemic and the Russia-Ukraine war have already led to a lowering of global economic growth projections by 0.9 percentage points, the statement highlighted, flagging the conflict for harming in more ways than one: