HIV breakthrough stalled by red tape barriers in India


Dimapur, (MExN): India faces a critical moment in its effort to end AIDS nationally and globally as regulatory delays and patent-related barriers threaten access to lenacapavir, a groundbreaking long-acting HIV prevention medicine, health experts and activists warned today.

A press release from LEN-LA for All Coalition and MSF said that Lenacapavir confers virtually 100% protection against HIV infection and has been widely recognised by UNAIDS, WHO, and other technical normative agencies as a significant advance that can bring new infections under control. However, regulatory hurdles in India and patent filings by Gilead Sciences risk obstructing timely access for marginalised communities most affected by HIV, including sex workers, transgender persons, gay men and other men who have sex with men, people who use drugs, and young women and girls.

Key populations account for a disproportionate share of new HIV infections. Globally, outside sub-Saharan Africa, two out of three new infections occur among key populations and their sexual partners. Overall, new HIV infections have remained virtually unchanged for the past three years, highlighting the urgent need for more effective prevention tools deployed at scale.

“Indian manufacturers can reduce the price of generic lenacapavir to US$25–40 (Rs. 2,225 - 3,560) per person per year, which would be a game changer for countries such as South Africa, which has the highest number of new HIV infections in the world. Unnecessary regulatory delays will mean India cannot supply generic lenacapavir in 2026, weakening its role in supplying affordable HIV medicines for the world,” said Fatima Hassan of South Africa's Health Justice Initiative. “This will have a devastating effect across low- and middle-income countries that depend on Indian generics, and especially countries like ours that are being targeted by the Trump administration by arbitrary exclusion from the Gilead / PEPFAR global rollout program. We need generics urgently to save lives.”

Under India’s New Drugs and Clinical Trials Rules (NDCTR) 2019, companies may seek a waiver of the requirement to conduct local clinical trials if a medicine has been approved by the drug regulatory authorities of the US (USFDA), European Union (EMA), or other specified countries and offers a “significant therapeutic advance.” Lenacapavir has met these criteria. Without such a waiver, the timely introduction of Indian generics globally could be substantially hindered.

“Few medical interventions demonstrate such remarkable efficacy. In clinical trials, lenacapavir has shown 100% effectiveness in preventing HIV among cisgender women and girls, and a 96% reduction in HIV risk within a gender-diverse group that includes cisgender men, transgender men, and non-binary individuals. Now we need the policies that will allow us to deliver this superior protection tool to all who need it, including a waiver of India’s requirement for national clinical trials,” said Dr Antonio Flores, Senior HIV/TB Advisor, MSF.

Community networks said that delays could have immediate and severe consequences. “Access to more effective HIV prevention tools like lenacapavir from the HIV programme free of cost is vital because our exposure to HIV through sex work is a daily worry for us,” said Dr Protim Ray, representative of Kolkata-based, sex worker–led collective Durbar Mahila Samanwaya Committee. “When revolutionary prevention tools like lenacapavir are delayed or locked behind red tape, it’s not just policy — it’s our lives at stake.”

In addition to regulatory barriers, health groups including the Third World Network have raised concerns about Gilead’s patent filings in India, arguing that the claims may lack sufficient novelty. If granted, the patents could restrict open competition among generic manufacturers producing active pharmaceutical ingredients (API) and finished formulations, undermining India’s capacity to manufacture and supply affordable generics. Although Gilead has granted royalty-free, non-exclusive licenses to six generic manufacturers, including four Indian companies, to supply lenacapavir to 120 low- and lower-middle-income countries and territories, key regions with high HIV incidence among key populations, including parts of Latin America, are excluded. This undermines equitable global access and restricts local production.

Granted patents in India will prevent Indian generic companies that have not been licensed by Gilead from supplying locally or to countries excluded from Gilead's list of 120 eligible countries. Advocates say Gilead’s multiple patent claims must be expeditiously rejected.“A decisive action is urgently needed. Regulatory authorities, patent offices, and global partners must work together to ensure that long-acting HIV prevention becomes accessible without delay, and that communities most at risk are not once again left behind,” said Eldred Tellis of the global LEN-LA for All Coalition. This coalition includes Health GAP (Global), the Health Justice Initiative (South Africa), Sankalp Rehabilitation Trust (India), Just Treatment (UK), and ABIA (Brazil). HIV breakthrough stalled by red tape barriers in India | MorungExpress | morungexpress.com
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Rupee crashes to record low beyond 90 per dollar


(AI Image/IANS)

New Delhi, (IANS) The Indian rupee fell sharply on Wednesday, slipping past the crucial 90-per-dollar level for the first time ever.

The currency dropped to a new record low of 90.13 against the US dollar, breaking its previous all-time low of 89.9475 touched just a day earlier.

The decline in the rupee came amid weak trade and portfolio flows, along with growing uncertainty over the India-US trade deal.

These factors kept the currency under continuous pressure throughout the session.

The sharp fall in the rupee also weighed on domestic equity markets. The Nifty index slipped below the 26,000 mark -- reflecting cautious sentiment among investors.

The Sensex also dropped nearly 200 points in early trade as the weakening currency raised concerns about inflation and foreign investor activity.

Analysts said that the market mood remained tense as traders watched for signs of stability in the rupee and clarity on trade negotiations between India and the United States.

“The rupee depreciation will halt and even reverse when the India-US trade deal materialises. This is likely this month. A lot, however, will depend on the details of the tariffs to be imposed on India as part of the deal,” analysts stated.

Meanwhile, the Indian stock market opened on a quiet note on Wednesday, with both benchmark indices showing minimal movement in early trade.

The Sensex inched up by just 12 points to 85,151, while the Nifty slipped 18 points to 26,014.

At the opening bell, shares of HUL, Titan, Tata Motors PV, NTPC, BEL, Trent, Bajaj Finserv, Kotak Bank, Ultratech Cement, Maruti Suzuki, L&T, Power Grid, and ITC were among the top losers in the morning session.

“A real concern now, which has contributed to the slow drifting down of the market, is the continued depreciation in the rupee and fears of further depreciation since the RBI is not intervening to support the rupee,” analysts stated.“This concern is forcing the FIIs to sell despite the improving fundamentals of rising corporate earnings and strong rebound in GDP growth,” they added. Rupee crashes to record low beyond 90 per dollar | MorungExpress | morungexpress.com
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The world’s carbon emissions continue to rise. But 35 countries show progress in cutting carbon

Global fossil fuel emissions are projected to rise in 2025 to a new all-time high, with all sources – coal, gas, and oil – contributing to the increase.

At the same time, our new global snapshot of carbon dioxide emissions and carbon sinks shows at least 35 countries have a plan to decarbonise. Australia, Germany, New Zealand and many others have shown statistically significant declines in fossil carbon emissions during the past decade, while their economies have continued to grow. China’s emissions have also been been growing at a much slower pace than recent trends and might even be flat by year’s end.

As world leaders and delegates meet in Brazil for the United Nations’ global climate summit, COP30, many countries that have submitted new emissions commitments to 2035 have shown increased ambition.

But unless these efforts are scaled up substantially, current global temperature trends are projected to significantly exceed the Paris Agreement target that aims to keep warming well below 2°C.

These 35 countries are now emitting less carbon dioxide even as their economies grow. Global Carbon Project 2025, CC BY-NC-ND

Fossil fuel emissions up again in 2025

Together with colleagues from 102 research institutions worldwide, the Global Carbon Project today releases the Global Carbon Budget 2025. This is an annual stocktake of the sources and sinks of carbon dioxide worldwide.

We also publish the major scientific advances enabling us to pinpoint the global human and natural sources and sinks of carbon dioxide with higher confidence. Carbon sinks are natural or artificial systems such as forests which absorb more carbon dioxide from the atmosphere than they release.

Global CO₂ emissions from the use of fossil fuels continue to increase. They are set to rise by 1.1% in 2025, on top of a similar rise in 2024. All fossil fuels are contributing to the rise. Emissions from natural gas grew 1.3%, followed by oil (up 1.0%) and coal (up 0.8%). Altogether, fossil fuels produced 38.1 billion tonnes of CO₂ in 2025.

Not all the news is bad. Our research finds emissions from the top emitter, China (32% of global CO₂ emissions) will increase significantly more slowly below its growth over the past decade, with a modest 0.4% increase. Emissions from India (8% of global) are projected to increase by 1.4%, also below recent trends.

However, emissions from the United States (13% of global) and the European Union (6% of global) are expected to grow above recent trends. For the US, a projected growth of 1.9% is driven by a colder start to the year, increased liquefied natural gas (LNG) exports, increased coal use, and higher demand for electricity.

EU emissions are expected to grow 0.4%, linked to lower hydropower and wind output due to weather. This led to increased electricity generation from LNG. Uncertainties in currently available data also include the possibility of no growth or a small decline.

Fossil fuel emissions hit a new high in 2025, but the growth rate is slowing and there are encouraging signs from countries cutting emissions. Global Carbon Project 2025, CC BY-NC-ND

Drop in land use emissions

In positive news, net carbon emissions from changes to land use such as deforestation, degradation and reforestation have declined over the past decade. They are expected to produce 4.1 billion tonnes of carbon dioxide in 2025 down from the annual average of 5 billion tonnes over the past decade. Permanent deforestation remains the largest source of emissions. This figure also takes into account the 2.2 billion tonnes of carbon soaked up by human-driven reforestation annually.

Three countries – Brazil, Indonesia and the Democratic Republic of the Congo – contribute 57% of global net land-use change CO₂ emissions.

When we combine the net emissions from land-use change and fossil fuels, we find total global human-caused emissions will reach 42.2 billion tonnes of carbon dioxide in 2025. This total has grown 0.3% annually over the past decade, compared with 1.9% in the previous one (2005–14).

Carbon sinks largely stagnant

Natural carbon sinks in the ocean and terrestrial ecosystems remove about half of all human-caused carbon emissions. But our new data suggests these sinks are not growing as we would expect.

The ocean carbon sink has been relatively stagnant since 2016, largely because of climate variability and impacts from ocean heatwaves.

The land CO₂ sink has been relatively stagnant since 2000, with a significant decline in 2024 due to warmer El Niño conditions on top of record global warming. Preliminary estimates for 2025 show a recovery of this sink to pre-El Niño levels.

Since 1960, the negative effects of climate change on the natural carbon sinks, particularly on the land sink, have suppressed a fraction of the full sink potential. This has left more CO₂ in the atmosphere, with an increase in the CO₂ concentration by an additional 8 parts per million. This year, atmospheric CO₂ levels are expected to reach just above 425 ppm.

Tracking global progress

Despite the continued global rise of carbon emissions, there are clear signs of progress towards lower-carbon energy and land use in our data.

There are now 35 countries that have reduced their fossil carbon emissions over the past decade, while still growing their economy. Many more, including China, are shifting to cleaner energy production. This has led to a significant slowdown of emissions growth.

Existing policies supporting national emissions cuts under the Paris Agreement are projected to lead to global warming of 2.8°C above preindustrial levels by the end of this century.

This is an improvement over the previous assessment of 3.1°C, although methodological changes also contributed to the lower warming projection. New emissions cut commitments to 2035, for those countries that have submitted them, show increased mitigation ambition.

This level of expected mitigation falls still far short of what is needed to meet the Paris Agreement goal of keeping warming well below 2°C.

At current levels of emissions, we calculate that the remaining global carbon budget – the carbon dioxide still able to be emitted before reaching specific global temperatures (averaged over multiple years) – will be used up in four years for 1.5°C (170 gigatonnes remaining), 12 years for 1.7°C (525 Gt) and 25 years for 2°C (1,055 Gt).

Falling short

Our improved and updated global carbon budget shows the relentless global increase of fossil fuel CO₂ emissions. But it also shows detectable and measurable progress towards decarbonisation in many countries.

The recovery of the natural CO₂ sinks is a positive finding. But large year-to-year variability shows the high sensitivity of these sinks to heat and drought.

Overall, this year’s carbon report card shows we have fallen short, again, of reaching a global peak in fossil fuel use. We are yet to begin the rapid decline in carbon emissions needed to stabilise the climate.The Conversation

Pep Canadell, Chief Research Scientist, CSIRO Environment; Executive Director, Global Carbon Project, CSIRO; Clemens Schwingshackl, Senior Researcher in Climate Science, Ludwig Maximilian University of Munich; Corinne Le Quéré, Royal Society Research Professor of Climate Change Science, University of East Anglia; Glen Peters, Senior Researcher, Center for International Climate and Environment Research - Oslo; Judith Hauck, Helmholtz Young Investigator group leader and deputy head, Marine Biogeosciences section at the Alfred Wegener Institute, Universität Bremen; Julia Pongratz, Professor of Physical Geography and Land Use Systems, Department of Geography, Ludwig Maximilian University of Munich; Mike O'Sullivan, Lecturer in Mathematics and Statistics, University of Exeter; Pierre Friedlingstein, Chair, Mathematical Modelling of Climate, University of Exeter, and Robbie Andrew, Senior Researcher, Center for International Climate and Environment Research - Oslo

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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