<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<rss xmlns:atom="http://www.w3.org/2005/Atom" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:dc="http://purl.org/dc/elements/1.1/" version="2.0">
<channel>
<title><![CDATA[IndiaSpend: Data journalism, analysis on Indian economy, education, healthcare, agriculture, politics]]></title>
<description><![CDATA[IndiaSpend: Data journalism, analysis on Indian economy, education, healthcare, agriculture, politics]]></description>
<link>https://www.indiaspend.com</link>
<image>
<url>https://www.indiaspend.com/images/logo.png</url>
<title>IndiaSpend: Data journalism, analysis on Indian economy, education, healthcare, agriculture, politics</title>
<link>https://www.indiaspend.com</link>
</image>
<generator>Hocalwire</generator>
<atom:link href="https://www.indiaspend.com/feeds.xml" rel="self" type="application/rss+xml"/>
<lastBuildDate>Fri, 10 Apr 2026 15:32:40 GMT</lastBuildDate>
<pubDate>Fri, 10 Apr 2026 15:32:40 GMT</pubDate>
<copyright><![CDATA[Indiaspend]]></copyright>
<language><![CDATA[en]]></language>
<managingEditor><![CDATA[editor@indiaspend.com (IndiaSpend)]]></managingEditor>
<ttl>1</ttl>
<item>
<title><![CDATA[What’s Ailing India’s Green Credit Programme?]]></title>
<description><![CDATA[Internal documents suggest evictions, possible violations of the Forest Rights Act, procedural lapses, selection of unsuitable sites and delays]]></description>
<content:encoded><![CDATA[<p><b>New Delhi: </b>Subhan Mondol has had his home, family and livelihood uprooted twice in the past two decades.</p><div class="pasted-from-word-wrapper"><p dir="ltr">First, in 2004 when the Brahmaputra river breached its banks and swallowed whole his home and farmland in Assam’s Goalpara district. Overnight, he was rendered homeless. With few options left, he and others from the inundated village pitched makeshift houses in a government land close to his village. Brick by brick, a settlement grew: homes, farms, a mosque, even an anganwadi. The Mondals rebuilt their life on a one-acre land. </p><p dir="ltr">Then, just as suddenly as the floods did, the forest department arrived with bulldozers in early 2025. Overnight, 1,040 people were evicted and displaced. “First they buried our paddy fields under soil. Then they planted bamboo," said Mondal. “Now the land is fenced off, and we are no longer allowed near our own land,” he added. </p><p dir="ltr">A few days later on March 24, 2025, the district forest department <a href="https://x.com/GoalparaForest/status/1904212759182819629?s=20"><u>posted on social media</u></a>: “GCP [Green Credit Program] monitoring team visits evicted site in Lakhipur, Goalpara! New beginnings: Plantation drive to revive elephant habitat to commence soon!”</p><p dir="ltr">The <a href="https://www.moefcc-gcp.in/"><u>GCP programme</u></a> was started in October 2023 by the Ministry of Environment, Forests and Climate Change (MoEF&amp;CC) to “encourage voluntary plantations” among corporations and industries. State forest departments provide a list of “degraded lands” which are then afforested using “green credits” bought by companies. </p><p dir="ltr">Internal documents accessed through the Right to Information Act show that in numerous “restoration” sites, locals—like the Mondals—have been evicted in the name of ecological restoration.</p><p dir="ltr">Furthermore, in some sites, lands claimed by forest-dwelling communities under the Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act or <a href="https://www.indiacode.nic.in/bitstream/123456789/8311/1/a2007-02.pdf"><u>Forest Rights Act</u></a> have been fenced off and listed for afforestation.</p><p dir="ltr">The documents also show the rocky path to the implementation of the afforestation programme. Environment officials and funding companies have raised concerns of financial irregularities, of local authorities deviating from approved eco-restoration plans by raising monoculture plantations or planting lower densities of trees, or choosing sites where plantations would be difficult to sustain. </p><p dir="ltr">For experts and policy analysts, these instances have added to the skepticism of the programme which they say would violate international norms, particularly on mandates of social justice and involvement of local communities, for market-linked environmental action. </p><p dir="ltr"><b>IndiaSpend</b> has written to MoEFCC for comment on safeguards to assess eligible land, steps taken to address irregularities, and concerns around dilution of intent of compensatory afforestation. We will update this story when we receive a response.</p><p dir="ltr"><br></p><p dir="ltr"><b><span style="font-size: 24px;">Expanding the scope of Green Credits</span></b></p><p dir="ltr">The Green Credit Programme (GCP) came into effect with the notification of the <a href="https://ankurykftgupta.s3.cyfuture.cloud/gcc/dev/green-credit-program-notification-closdct3600050pzj8wdrcth8.pdf"><u>Green Credit Rules</u></a> on October 12, 2023 under the Environment Protection Act, 1986.</p><p dir="ltr">The rules created a record of degraded land that can be used to promote voluntary plantation activities and eco-restoration projects across the country by awarding “green credits”. One Green Credit is equivalent to one tree planted. These credits, to be bought by individuals, communities and private companies, <a href="https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1967476&amp;reg=3&amp;lang=2"><u>can be traded</u></a> domestically. </p><p dir="ltr">While the scheme <a href="https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1967476&amp;reg=3&amp;lang=2"><u>hoped</u></a> to enrol individuals and private sector industries, until now, it has attracted investments from only state-run oil, coal and power companies. Seventeen public sector units—including, Indian Oil Corporation and other petrochemical corporations, Coal India Limited and its subsidiaries, National Thermal Power Plant Corporation—have bought green credits.</p><p dir="ltr">Since its launch, eco-restoration has begun in 225 sites across 12 states covering 48.53 sq.km. of “degraded land”, show data from the MoEF&amp;CC.</p></div><div class="hocal-draggable" draggable="true"><div class="h-embed" contenteditable="false"><div class="h-embed-wrapper desktop-only-embed"><iframe src="https://flo.uri.sh/visualisation/28386116/embed" title="Interactive or visual content" class="flourish-embed-iframe" frameborder="0" scrolling="no" style="width:100%;height:600px;" sandbox="allow-same-origin allow-forms allow-scripts allow-downloads allow-popups allow-popups-to-escape-sandbox allow-top-navigation-by-user-activation"></iframe></div></div></div><div class="pasted-from-word-wrapper"><p dir="ltr"><br></p></div><div class="hocal-draggable" draggable="true"><div class="h-embed" contenteditable="false"><div class="h-embed-wrapper mobile-only-embed"><iframe src="https://flo.uri.sh/visualisation/28386116/embed" title="Interactive or visual content" class="flourish-embed-iframe" frameborder="0" scrolling="no" style="width:100%;height:600px;" sandbox="allow-same-origin allow-forms allow-scripts allow-downloads allow-popups allow-popups-to-escape-sandbox allow-top-navigation-by-user-activation"></iframe></div></div></div><div class="pasted-from-word-wrapper"><p dir="ltr"><b><span style="font-size: 24px;">Plantations after evictions and displacements</span></b></p><p dir="ltr">Internal documents accessed from the Indian Council of Forestry Research and Education (<a href="https://icfre.gov.in/hi/"><u>ICFRE</u></a>), a government body supervising the programme, through the RTI Act, show that GCP is being carried out in multiple sites where local communities have been evicted.</p><p dir="ltr">The <a href="https://www.indiaspend.com/h-library/annexure-1-minutes-of-meeting-06032025-and-07032025.pdf"><u>documents</u></a> include inspection reports conducted by ICFRE and PSU representatives in 169 GCP sites across 10 states. These sites are spread over 3,530 hectares (35.30 sq.km.) of forest involving Rs 117 crore worth of green credits.</p><p dir="ltr">In Bihar, during March 2025, an ICFRE inspection team <a href="https://www.indiaspend.com/h-library/annexure-2-review-of-progress-bihar.pdf"><u>found</u></a> mud huts and “agricultural activities” in 50 hectares and 55 hectares of degraded forest in Rohatas and Nawada districts, respectively. “Necessary action must be taken to remove the encroachments,” stated a <a href="https://www.indiaspend.com/h-library/annexure-3-letter-to-hoff-bihar.pdf"><u>letter</u></a> dated April 29, 2025 to the Forest department, adding that protection against grazing should be in place.</p><p dir="ltr">In Assam, five sites spanning 214 hectares were cleared of homes, farmlands, tea plantations and even two schools. One of them “will be used as a camp hut for plantation and one forest battalion will be placed there to stop any further encroachment,” said the ICFRE inspection <a href="https://www.indiaspend.com/h-library/annexure-10-review-of-progress-assam.pdf"><u>report</u></a> from March 2025. </p><p dir="ltr">Assam has seen an uptick in anti-encroachment drives in recent years, particularly in forest land. <a href="https://www.landconflictwatch.org/"><u>Land Conflict Watch</u></a>, an organisation that documents ongoing land and resource conflicts in India, <a href="https://www.landconflictwatch.org/all-conflicts"><u>estimates</u></a> that 15,684 people were affected by evictions in forest lands in Assam. </p><p dir="ltr">In another 84-hectare site, the ICFRE team—which included officials from Coal India Limited which is funding the eco-restoration—observed that while major portions of encroachments were cleared the previous year, “a significant portion” remained which “must be cleared before the commencement of ecorestoration activities”.</p><p dir="ltr">“While large-scale eviction drives were successfully carried out at several sites, one location continues to face issues of residual encroachment. These must be fully cleared before plantation activities can begin to ensure sustainability and avoid future land conflicts,” said a <a href="https://www.indiaspend.com/h-library/annexure-11-letter-to-hoff-assam.pdf"><u>letter</u></a> dated April 15, 2025. </p><p dir="ltr">However, Ajay Kumar from Green Credit Cell, ICFRE, told <b>IndiaSpend</b> that eviction drives were not linked to the programme. “We have given no such direction. This is the state's law and order problem. We try to refrain from taking such lands. All states have to give undertaking that people were not displaced from the land for plantations,” he said.</p><p dir="ltr">He said the Green Credit Cell verifies the status of the land through satellite imagery to ensure that it did not have local communities. In Assam’s case, the sites were chosen after clarifications and assurances from the state Forest department, he said.</p><p dir="ltr">When contacted, Tejas Maraswamy, Divisional Forest Officer (DFO), Goalpara district, said the evictions were done only after a survey revealed that the residents were not eligible for claims under the Forest Rights Act. </p><p dir="ltr">“The evictions were conducted because the area is a reserve forest and a protected area. It was not done for the purpose of plantations,” he said, and added: “It was good we got the opportunity later for plantation and the revival of habitat through the (GCP) programme. We had to prevent encroachment because it degrades the land.”</p><p dir="ltr"><br></p><p dir="ltr"><b><span style="font-size: 24px;">A grey zone with few safeguards</span></b></p><p dir="ltr">The Green Credit Programme currently lacks explicit safeguards for indigenous and local communities. In contrast, internationally traded carbon credit programmes are increasingly attempting to incorporate ethical standards and safeguards to prevent human rights violations.</p><p dir="ltr">In a <a href="https://www.pib.gov.in/PressReleseDetailm.aspx?PRID=2162981&amp;reg=3&amp;lang=2"><u>bid to attract</u></a> private investment, the Union government, in August 2025, expanded the scope of the GCP to allow the credits to be <a href="https://dghindia.gov.in/assets/downloads/68cbcedd8db7anotice.pdf"><u>utilised</u></a> for compensatory afforestation. Prior to this, if a company wanted to acquire forest lands to set up an industry, they would have to “compensate” for the forest loss by <a href="https://forestsclearance.nic.in/writereaddata/Addinfo/0_0_6111512271291CAguidelines.pdf"><u>paying for afforestation</u></a> primarily in alternative non-forest land. But, now, companies could just buy green credits which will pay for afforestation in existing forest lands.  </p><p dir="ltr">“These degraded forest lands could have anyway been regenerated using existing public funds,” said Prakriti Shrivastava, a former Indian Forest Service (IFS) officer. “Instead, companies have been allowed an easy route out through these credits,” she said. </p><p dir="ltr">In March 2025, Shrivastava and other members of environmental groups, People for Aravalli and Rainbow Warriors, <a href="https://timesofindia.indiatimes.com/city/gurgaon/environmentalists-move-sc-to-revise-green-credit-norms-say-they-may-cause-more-harm-than-good/articleshow/118858127.cms"><u>filed</u></a> a writ petition in the Supreme Court questioning the criteria for determining credits or “degraded” lands. The PIL is yet to be heard. </p><p dir="ltr">The August notification also dilutes the stated intention of the Green Credit mechanism. “I have not been too comfortable with the Carbon Credit System since it reflects “wrong doer’s penance” in monetary terms. There is a need to develop a more positive approach,” said Prime Minister Narendra Modi <a href="https://www.moefcc-gcp.in/"><u>about</u></a> GCP’s objectives, quoted prominently on the website. </p><p dir="ltr">"There is a significant shift in logic from restitution of forest harm to market-mediated compliance. This fundamentally weakens the legal safeguards of the Compensatory Afforestation regime and normalises forest loss through market instruments," said Meenal Tatpati, independent lawyer and researcher, who has closely studied the green credit mechanism.</p><p dir="ltr">The programme also escapes scrutiny of international guidelines. </p><p dir="ltr">The United Nations Framework Convention on Climate Change (<a href="https://unfccc.int/"><u>UNFCCC</u></a>), which is the primary international treaty for coordinating the global response to climate change, had placed “mandatory environmental and human rights” <a href="https://unfccc.int/news/mandatory-environmental-and-human-rights-safeguards-agreed-for-un-carbon-market"><u>safeguards</u></a> while <a href="https://unfccc.int/process-and-meetings/the-paris-agreement/article-64-mechanism"><u>introducing</u></a> the concept of carbon credits. </p><p dir="ltr">Policy observers point to the <a href="https://unfccc.int/sites/default/files/resource/parisagreement_publication.pdf"><u>preamble</u></a> to the 2015 Paris Agreement where 194 countries (and the European Union) agreed to recognise that climate action must be grounded in justice, human rights, including the “the rights of indigenous peoples (and) local communities”.</p><p dir="ltr">The UN body responsible for establishing the carbon market has finalised a <a href="https://unfccc.int/sites/default/files/resource/a64-sb011-a03.pdf"><u>grievance and appeals procedure</u></a> for anyone affected by the carbon credit market. More <a href="https://unfccc.int/sites/default/files/resource/a64-sb011.pdf"><u>safeguards</u></a> are expected to be put in place to empower vulnerable communities and individuals.</p><p dir="ltr">“However, GCP does not need to adhere to these standards because it is not traded internationally under the Paris Agreement,” said Trishant Dev, deputy programme manager specialising in climate, trade and green industrial policy at the Centre for Science and Environment (<a href="https://www.cseindia.org/"><u>CSE</u></a>). “If India were to make these credits tradable internationally under the agreement, they may fall short of the standards laid down in the agreement,” he said.</p><p dir="ltr"><br></p><p dir="ltr"><b><span style="font-size: 24px;">When GCP runs contradictory to Forest Rights Act</span> </b></p><p dir="ltr">The accessed internal documents show possible violations of the country’s forest legislations aimed to protect indigenous communities. At Nana Baval village in Sabarkanta district of Gujarat, the site has been fenced off, while borewells and earthen check dams were being built, photographs dated March 26, 2025 from the <a href="https://www.indiaspend.com/h-library/annexure-6-review-of-progress-gujarat.pdf"><u>inspection report</u></a> show. Actual tree plantation had not started, residents say, but official reports show activities such as laying “thorny bushes”, creation of concrete walls, and appointment of watchmen is under way. </p><p dir="ltr">During the fencing of the land, villagers had been told vaguely that the land was being protected for “development activity” that will benefit the village.</p><p dir="ltr">“We have been cultivating this land for nearly 45 years. We earn around Rs 70,000-80,000 annually from it. Even now, we don’t know what will happen to our crop,” said Laxman Bumbadiya (35), a farmer from the Dungri Bhil community, a Scheduled Tribe community <a href="https://repository.tribal.gov.in/bitstream/123456789/75555/1/Sons_of_the_Aravallis_The_Garasiyas.pdf"><u>indigenous</u></a> to the Aravali landscape.</p><p dir="ltr">Villagers have filed applications over this land under the Forest Rights Act, which identifies historical rights over forest lands for tribal communities. “We’ve lost track of the number of times we’ve gone to the Collector’s office to check on the status of FRA claims,” he said. </p><p dir="ltr">Their applications have remained pending, they said. Across India, there are nearly 750,000 claims <a href="https://dashboard.tribal.gov.in/"><u>pending</u></a> under the FRA. Under the Act, claimants cannot be evicted or displaced <a href="https://tribal.nic.in/FRA/data/FRARulesBook.pdf"><u>until</u></a> the process of verification is complete. </p><p dir="ltr">“Nearly all GCP sites are on potential Community Forest Rights lands. The risk of communities losing their right over forests increases under GCP,” said Gautam Aredath, a policy analyst at Ashoka Trust for Research in Ecology and the Environment (<a href="https://www.atree.org/"><u>ATREE</u></a>)’s <a href="https://cfr.atree.org/"><u>CFR Central India Initiative</u></a>, which promotes decentralised and democratic forest governance for conservation and livelihoods. </p><p dir="ltr">ICFRE’s <a href="https://www.indiaspend.com/h-library/annexure-10-review-of-progress-assam.pdf"><u>inspection reports</u></a> show that in one site spanning 16 hectare in Kamrup West district of Assam, which was planned to be restored through credits bought by Oil India Limited for Rs 1 crore, the local community had already obtained rights under the Forest Rights Act. The sites were chosen in June 2024, and the funding companies were <a href="https://www.indiaspend.com/h-library/annexure-11-letter-to-hoff-assam.pdf"><u>informed</u></a> of the Forest Rights applications only in March 2025 during their inspection. </p><p dir="ltr">Aredath believed that GCP’s “top-down” approach to restoration can be exclusionary. “Restoration must deliver both local livelihood and wider environmental benefits. This will be best achieved by using the funds through GCP to allow local communities to lead restoration,” he said.</p><p dir="ltr">Pia Sethi, senior fellow at the Centre for Ecology Development and Research, said these plantations should account for local incomes, aspirations and dependence on the land. “Ideally, these projects should work closely with pastoralist communities in the restoration of ecosystems and protection of their ancestral grazing grounds, because they have historically been given short shrift,” she added.</p><p dir="ltr"><br></p><p dir="ltr"><b><span style="font-size: 24px;">Implementation on rocky ground</span></b></p><p dir="ltr">Two years into the scheme, inspection reports and letters of correspondence between ICFRE and forest departments have listed non-compliance, irregularities and procedural lapses in choosing of lands and in means of restorations.</p><p dir="ltr">For instance, in five sites in Assam’s Goalpara district, officials from ICFRE as well as the companies funding the green credits <a href="https://www.indiaspend.com/h-library/annexure-11-letter-to-hoff-assam.pdf"><u>found</u></a> that the forest department had deviated from plans by cutting costs. The original approved plan was for an <a href="https://www.fao.org/forestry/our-focus/forest-management/assisted-natural-regeneration/en"><u>Assisted Regeneration</u></a> plantation with 2,500 saplings per hectare. Local forest officials however <a href="https://drive.google.com/drive/folders/1p92RUimo27_yaz3tSpSrKM2_YwSpjdz6"><u>planted</u></a> bamboo at 625 saplings per hectare.</p><p dir="ltr">“...such changes are not permissible…,” said ICFRE in a <a href="https://www.indiaspend.com/h-library/annexure-11-letter-to-hoff-assam.pdf"><u>letter</u></a> to the Principal Chief Conservator of Forest, Assam. “This raises serious concerns regarding financial integrity and compliance with GCP guidelines.”</p><p dir="ltr">In <a href="https://www.indiaspend.com/h-library/annexure-12-review-of-progress-chhattisgarh.pdf"><u>Chhattisgarh</u></a>, the monitoring team <a href="https://www.indiaspend.com/h-library/annexure-13-letter-to-hoff-chhattisgarh.pdf"><u>observed</u></a> a “mismatch” between species listed in cost estimates and those being raised in nurseries. In Uttar Pradesh, officials <a href="https://www.indiaspend.com/h-library/annexure-9-letter-to-hoff-up.pdf"><u>found</u></a> that plantation was being done in areas adjacent to the chosen site. </p><p dir="ltr">In at least eight sites, officials found the chosen site unsuitable for eco-restoration. In Keonjhar in Odisha, for instance, officials <a href="https://www.indiaspend.com/h-library/annexure-15-letter-to-hoff-odisha.pdf"><u>found</u></a> that the site had a “dense canopy” of trees already. In Telangana, the site was an existing mature <a href="https://www.indiaspend.com/h-library/annexure-1-minutes-of-meeting-06032025-and-07032025.pdf"><u>eucalyptus</u></a> plantation. In several sites across states, the site selected was too rocky to plant trees.</p><p dir="ltr">GCP <a href="https://www.moefcc-gcp.in/green-credits/how-to-generate"><u>promises</u></a> its investors that the forest department will finish the plantations within two years. But, internal reports show persistent issues of delays and slow progress. Just 28% of the pledged funds had been used, with ICFRE noting bureaucratic delays in disbursing funds from nodal offices in state forest departments to local forest authorities.</p><p dir="ltr">When asked about these irregularities and concerns, Ajay Kumar from the Green Credit Cell at ICFRE, said: “We are monitoring the situation regularly and addressing if there are any issues. It’s our responsibility to ensure there are no financial irregularities and the scheme is successfully implemented.”</p><p><i>We welcome feedback. Please write to <a href="mailto:respond@indiaspend.org" target="_blank" rel="nofollow">respond@indiaspend.org</a>. We reserve the right to edit responses for language and grammar.</i></p></div>]]></content:encoded>
<link>https://www.indiaspend.com/forest-rights/whats-ailing-indias-green-credit-programme-982904</link>
<guid isPermaLink="true">https://www.indiaspend.com/forest-rights/whats-ailing-indias-green-credit-programme-982904</guid>
<category><![CDATA[Climate Change,Development,Governance,Latest news,Environment,Forest Rights]]></category>
<dc:creator><![CDATA[Sukriti Vats]]></dc:creator>
<pubDate>Tue, 07 Apr 2026 00:30:17 GMT</pubDate>
<enclosure length="0" type="image/*" url="https://www.indiaspend.com/h-upload/2026/04/06/1757514-india-green-credit-scheme-1500.webp"/>
</item>
<item>
<title><![CDATA[India Wants 1,000 New Clinical Trial Sites. Patients Are Still Being Left In The Dark.]]></title>
<description><![CDATA[Experts warn that scaling up trial sites without fixing consent failures, financial oversight, and ethics committee lapses will put vulnerable patients at greater risk]]></description>
<content:encoded><![CDATA[<p><b>Mount Abu, Rajasthan:</b> Thirty-five-year-old Ritu Bhalla was twice diagnosed with blood cancer, at the ages of four and 11. She developed chronic hepatitis B as a long-term side-effect after cancer treatment.</p><div class="pasted-from-word-wrapper"><p dir="ltr">Three years ago, while waiting for a follow up consultation in a hospital in Delhi, a woman who was not part of the hospital staff approached Bhalla—she asked her to provide a blood sample and sign a consent sheet to take part in a gastrointestinal clinical trial. But she did not explain why.</p><p dir="ltr">Bhalla asked for the information sheet or details of the study, but that only annoyed the woman, who she assumed was a trial coordinator, she said. Since no one came forward to explain the study, she refused to participate. </p><p dir="ltr">Experts say Bhalla’s experience isn’t a one-off occurrence. This is even as India’s regulatory framework covering clinical trials was significantly strengthened after the Supreme Court’s <a href="https://api.sci.gov.in/jonew/bosir/orderpdfold/1646467.pdf"><u>intervention</u></a> in 2013, and <a href="https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/NEW%20DRUGS%20ANDctrS%20RULE,%202019.pdf"><u>subsequent amendments</u></a> were made to the Drugs &amp; Cosmetics Rules.</p><p dir="ltr">New rules include provisions for compensation to trial participants, and recording consent on video, especially among vulnerable populations. These, and mandatory registration of ethics committees with the central licensing authority (<a href="https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/Ethics-Committee/"><u>CDSCO</u></a>) have improved safeguards for participants, said Poonam Bagai, founder and chairman, <a href="https://cankidsindia.org/"><u>CanKids…KidsCan</u></a>, which also hosts the Pediatric Cancer Research Institute (pCRI), an initiative focused on patient-centred paediatric oncology research.</p><p dir="ltr">However, “the video recording of the consent process of vulnerable trial participants isn’t happening,” said Amulya Nidhi of the <a href="https://en.wikipedia.org/wiki/Swasthya_Adhikar_Manch"><u>Swasthya Adhikar Manch</u></a>, a not-for-profit working in the clinical trials space.</p><p dir="ltr">Bagai said the consent process still often lacks true comprehensibility, limiting informed decision-making. “Consent forms may exist, but the key question is whether patients and families genuinely understand what participation means,” she said, noting that low health literacy remains a significant barrier in India. “Consent or assent for paediatric populations is another important area to address.”</p><p dir="ltr">Studies such as <a href="https://www.sciencedirect.com/science/article/pii/S2213398424000289"><u>this</u></a> conducted among rural adolescents and <a href="https://journals.lww.com/ijph/fulltext/2023/67030/role_of_health_literacy_and_primary_health_care.17.aspx"><u>this</u></a> among hypertensive adults show that anywhere between 60% and 75% of the population is insufficiently informed.</p><p dir="ltr">“Many patients who participate in clinical trials in India aren’t aware that they could suffer an adverse drug reaction, contrary to getting better, nor are they aware of their rights in such an eventuality,” said Nidhi.</p><p dir="ltr">Further, “the Supreme Court has recommended the establishment of an apex committee to approve new clinical trials, and for those approvals to be based on a risk-benefit-analysis, on the innovation quotient of the new therapy and its usefulness versus existing therapies, and on the unmet medical needs of the country. Still, no such apex committee meeting has happened; and trials are being independently approved,” said Nidhi.</p><p dir="ltr">As India moves to expand clinical trials, with the 2026-27 <a href="https://www.indiabudget.gov.in/doc/Budget_Speech.pdf"><u>budget</u></a> allocating Rs 10,000 crore over five years to strengthen biopharma and establish 1,000 accredited new clinical trial sites, there is a pressing need to improve patient awareness and ensure their rights are upheld.</p><p dir="ltr">To successfully scale clinical trials, a mindset shift from ‘guinea pig’ to ‘aware patient’ and the promotion of active patient participation is key, said Pooja Sharma, CEO, APAR Health, an organisation working to promote patient-centric research.</p><p dir="ltr"><b><br></b></p><p dir="ltr"><b><span style="font-size: 24px;">Awareness must to eliminate vulnerability among potential participants</span></b></p><p dir="ltr">Low health literacy can make families more vulnerable, especially at emotionally difficult moments such as a serious diagnosis like cancer, Bagai said.</p><p dir="ltr">“At the same time, limited understanding may also prevent families from considering participation in legitimate research that could offer meaningful treatment opportunities,” she added.</p><p dir="ltr">National level policies and programmes are seen as the best way to promote health literacy but so far these have failed in delivering health information to underserved populations, according to an <a href="https://impact.economist.com/projects/health-inclusivity-index/country-insights/india/roadmap?country=india&amp;topic=healthcare-access"><u>analysis of health inclusivity</u></a> by the <i>Economist</i>.</p><p dir="ltr">“The need of the hour is widespread public awareness initiatives in urban as well as rural India, something like the Reserve Bank of India (RBI) does to create awareness in the financial sector,” said Alishan Naqvee, one of India’s leading healthcare lawyers.</p><p dir="ltr">“Such campaigns need to be carefully crafted, as we are a large population with a huge disease burden,” said Naqvee. “A campaign shall not discourage participation in clinical trials, just as the RBI’s campaigns do not discourage people from opening bank accounts.”</p><p dir="ltr">In particular, awareness campaigns must target the most vulnerable people. For instance, “many trials are conducted in tribal areas, where there is a lack of health facilities and services, among less educated people,” said Vinod Shende, a health rights activist from Pune, Maharashtra. “Investigators organise free treatment camps, and illiterate, poor people get taken in.”</p><p dir="ltr">Alongside potential participant awareness, Sharma said there is a need for more aware researchers, who must understand “patient centricity”, and more aware clinicians who must be “aware of research as a care option”.</p><p dir="ltr"><b><br></b></p><p dir="ltr"><b><span style="font-size: 24px;">Subject recruitment still a grey area</span></b></p><p dir="ltr">India’s regulatory framework still doesn’t lay down clear guidelines for the recruitment process. “In India,” Nidhi said, “patients are usually enrolled from hospital out-patient clinics, unlike in the West where the trial is advertised and details such as the ethics committee members and other bits of information are clearly stated.”</p><p dir="ltr">Greater transparency in recruitment extends to informed consent. “Patients must be informed of the possibility of an adverse drug reaction, and that they have the right to pull out of the trial and be compensated for a loss,” said Nidhi, stressing that “this still doesn’t happen as it should.”</p><p dir="ltr">In the case of early phase clinical trials, unexpected adverse effects or even benefits are unknown at the time of designing the trial, and hence not mentioned in the consent documents. But patients must be made to understand this. </p><p dir="ltr">In <a href="https://www.deccanchronicle.com/southern-states/telangana/clinic-trials-put-volunteers-lives-at-risk-in-telangana-1900441"><u>August 2025</u></a>, a participant of a trial for cardiac failure drugs who was promised Rs 20,000 for partaking was allegedly threatened by the company conducting the trial in Hyderabad, when he complained of severe chest pain and enormous worry because a fellow participant had succumbed to similar complaints a few days previously. Contrary to being treated, the participant was given Rs 500 and referred to a government hospital.</p><p dir="ltr">“It’s important to observe how consent functions on the ground,” said Preetisha Choudhury, a scholar researching the regulation of informed consent in clinical trials at the Department of Law, North-Eastern Hill University in Meghalaya’s Shillong. “In many instances, patients may have signed a consent form but not truly understood the purpose of the trial, the risks involved, and their right to withdraw.”</p><p dir="ltr">“Socio-economic vulnerability and therapeutic misconceptions can affect [a] patient’s understanding of a trial,” she added.</p><p dir="ltr">Therapeutic misconceptions refer to patients anticipating better care through the trial than existing treatment, and being attracted to participate in trials because of the promise of free treatment. Intense patient counselling is crucial to minimise ‘therapeutic misconceptions’, concluded this Tata Memorial Centre <a href="https://nmji.in/quality-of-informed-consent-in-cancer-clinical-trials-in-india-a-cross-sectional-survey/"><u>study</u></a> of cancer trials.</p><p dir="ltr"><b><br></b></p><p dir="ltr"><b><span style="font-size: 24px;">Finance administration missing from regulatory framework</span></b></p><p dir="ltr"><span style="background-color: rgb(255, 255, 255); -webkit-text-size-adjust: 100%;">An additional affidavit to a public interest litigation first filed in the Supreme Court in February 2012, by the Swasthya Adhikar Manch in April 2025</span><span style="-webkit-text-size-adjust: 100%;">, alleging investigator impropriety at the </span><a href="https://ahmedabadcity.gov.in/SP/MunicipalHospitals" style="background-color: rgb(249, 249, 249); -webkit-text-size-adjust: 100%;"><u>Sheth VS General Hospital, Ahmedabad</u></a><span style="-webkit-text-size-adjust: 100%;">, a municipal-run hospital, prompted a probe by the Drugs Controller General of India (DCGI).</span><br></p></div><div class="pasted-from-word-wrapper"><p dir="ltr">A preliminary report by a five-member team of the Ahmedabad Municipal Corporation (AMC) confirmed financial irregularities in <a href="https://medicaldialogues.in/news/industry/pharma/58-unauthorised-clinical-trials-spark-dcgi-ban-on-vs-hospital-doctors-pharma-giants-under-fire-150599"><u>58 clinical trials</u></a> being conducted in the hospital, involving more than <a href="https://medicaldialogues.in/news/industry/pharma/58-unauthorised-clinical-trials-spark-dcgi-ban-on-vs-hospital-doctors-pharma-giants-under-fire-150599"><u>500 patients</u></a>.</p><p dir="ltr">About 15 doctors including the hospital’s medical superintendent were found to have <a href="https://indianexpress.com/article/cities/ahmedabad/gujarat-hospital-doctors-diverted-rs-1-87-crore-to-own-bank-accounts-from-clinical-trials-probe-10098477/"><u>diverted Rs 1.87 crore</u></a> to their personal accounts over the previous four years.</p><p dir="ltr">Eight contractual doctors were dismissed and one faculty member was suspended.</p><p dir="ltr">A member of the AMC’s investigating team, on the condition of anonymity, told <b>IndiaSpend</b> that he blamed gaps in the regulatory framework for this scandal.</p><p dir="ltr">“Our existing regulatory framework adequately addresses the clinical aspects but it omits the financial and administrative aspects of a trial,” he said. “We need a policy covering the disbursements of funds, essentially, which stipulates how the trial budget should be disbursed—how much the principal investigator will get, how much the co-investigator will get, how much the hospital will get, and so on.” </p><p dir="ltr">“We studied the agreements of 62 clinical trials being conducted at the Sheth VS General Hospital, and insofar as the patients-related part was concerned, everything was in order,” he continued. “But the disbursements under different expenditure heads varied for each, which isn’t appropriate. We need a standard, fair policy for clinical trial budget disbursements across India.”</p><p dir="ltr">“Disbursements to the hospital supporting the trial, to cover the overheads, must also be clearly mentioned in the policy; it shouldn’t be left to the discretion of the institution,” said the investigating team member, adding that “Sheth VS General Hospital’s share hadn’t been disbursed.”</p><p dir="ltr">A senior officer of the AMC <a href="https://health.economictimes.indiatimes.com/news/hospitals/dcgi-begins-probe-into-illegal-clinical-trials-at-vs-hospital/120953957"><u>reportedly</u></a> told the <i>Times of India</i> in 2025 that the investigating DCGI team didn’t recall “conducting routine inspections at the VS Hospital clinical trial site over the past four years”.</p><p dir="ltr">“It appears that the DCGI is short of regulators to monitor trials across the country,” said Nidhi.</p><p dir="ltr">As 1,000 new accredited trial sites come online, Bagai pointed out that the government will need to strengthen monitoring. “Oversight should be risk-based and enabling, ensuring ethical standards without discouraging responsible research.”</p><p dir="ltr">“Expansion is not inherently problematic,” said Choudhury. “But without careful monitoring, public trust may suffer.”</p><p dir="ltr"><b>IndiaSpend</b> has reached out to the health ministry and the AMC for comment on financial irregularities and trial monitoring lapses. The AMC directed us to individual officers but has not provided a response on record. The health ministry did not respond to queries at the time of publishing. We will update this story when we receive responses.</p><p dir="ltr"><b><br></b></p><p dir="ltr"><b><span style="font-size: 24px;">Ethics committee lapses bear adversely upon trials</span></b></p><p dir="ltr">Every institution conducting trials must have an <a href="https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/NEW%20DRUGS%20ANDctrS%20RULE,%202019.pdf"><u>ethics committee</u></a> in place to review consent documents, monitor the conduct of clinical trials and even halt their progress if irregularities are identified in their conduct, and safeguard participant’s rights.</p><p dir="ltr">Ideally, the institution should appoint a third-party autonomous ethics committee composed of institutional representatives, community representatives, local health not-for-profits and public health experts.</p><p dir="ltr">Bagai added that patient and caregiver representation within ethics review and oversight processes is important, though structured participation remains limited in practice.</p><p dir="ltr">It’s also important that the ethics committee doesn’t report to the institution, said Nidhi. “Only then can it provide the right checks and balances.”</p><p dir="ltr">In the Sheth VS General Hospital, the trials were being overseen by an external private ethics committee.</p><p dir="ltr">Now that the budget has tabulated plans to increase infrastructure and accredited sites to strengthen research capacity, the focus must also be on growing ethical safeguards at the same pace, said Choudhury.</p><p dir="ltr">Accreditation for ethics committees on the lines of accreditation for hospitals (National Accreditation Board for Hospitals, or NABH domestically and the Joint Commission International, or JCI, globally), may be an appropriate safeguard. </p><p dir="ltr">“Our ethics committee (IEC-3, ACTREC, Tata Memorial Centre) is registered with the DCGI as well as the Department of Health Research and is one of the very few ethics committees in India to be accredited by international agencies such as Strategic Initiative for Developing Capacity for Ethical Review (SIDCER),” said Sachin Punatar, member secretary, IEC-3 (ethics committee), ACTREC, Tata Memorial Centre, Navi Mumbai.</p><p dir="ltr">With the planned expansion of clinical trial sites, Nidhi proposed that the government appoint a representative for each, possibly as a member of the ethics committee.</p><p dir="ltr">Punatar said that in order to maintain the highest standards, new trial sites and newly registered ethics committees should be closely monitored until they acquire adequate experience.</p><p dir="ltr"><b><br></b></p><p dir="ltr"><b><span style="font-size: 24px;">Recommendations for a healthier clinical trial scenario</span></b></p><p dir="ltr">Clinical trials are considered as one of the best ways to advance science and improve patient outcomes. “India needs more clinical trials, particularly in oncology where survival outcomes remain uneven across geographies and innovation is critical,” Bagai said. Incidentally, of thousands of registered clinical trials running in India, <a href="https://hrapl.in/clinical-trials-in-india-global-ranking-growth/"><u>oncology is among the fastest growing segments</u></a>. </p><p dir="ltr">In oncology, there has been a tremendous improvement in patient outcomes through decades of research, said Punatar. “Trials to test new medicinal products in patients who have exhausted all standard therapies may offer a ray of hope for patients who may not have any further treatment options.”</p><p dir="ltr">However, nothing has been said so far about the kind of trials to be run at the 1,000 new trial sites, nor the kinds of sites to be promoted, said Nidhi. </p><p dir="ltr">“Clarity would help patients’ rights groups mobilise adequate support,” he said. “Trials should take place in public institutions.”</p><p dir="ltr">To strengthen accountability, Shende underscored the need for a speedy, easily accessible grievance redressal mechanism, helpline and online portal for patients participating in the trial, and for action to be taken on these complaints within a specific timeframe.</p><p dir="ltr">“Faster and more accessible grievance mechanisms would strengthen accountability,” agreed Choudhury, while also underscoring the need for “a more contextual consent model that adapts communication to participants’ realities”. </p><p dir="ltr">Additionally, “if India is investing Rs 10,000 crore in research infrastructure, some of that investment should also support patient education and patient-advocacy capacity building,” said Bagai.</p><p dir="ltr">Global frameworks such as the US FDA’s Patient-Focused Drug Development <a href="https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development"><u>initiative</u></a> and the European Medicines Agency’s patient engagement <a href="https://www.ema.europa.eu/en/documents/other/engagement-framework-european-medicines-agency-and-patients-consumers-and-their-organisations_en.pdf"><u>framework</u></a> show that patient involvement improves trial design, retention and ethical robustness. So, “government engagement with initiatives such as PACER, which build the capacity of patient advocates to participate in research design, patient-led research, and public education, will be vital to creating a more ethical and patient-centred clinical research ecosystem,” Bagai said.</p><p dir="ltr">“For India to become a global clinical research hub, the focus must extend beyond laboratories and trial sites to building informed patients and informed communities.”</p><p><i>We welcome feedback. Please write to <a href="mailto:respond@indiaspend.org" target="_blank" rel="nofollow">respond@indiaspend.org</a>. We reserve the right to edit responses for language and grammar.</i></p></div>]]></content:encoded>
<link>https://www.indiaspend.com/health/india-wants-1000-new-clinical-trial-sites-patients-are-still-being-left-in-the-dark-982673</link>
<guid isPermaLink="true">https://www.indiaspend.com/health/india-wants-1000-new-clinical-trial-sites-patients-are-still-being-left-in-the-dark-982673</guid>
<category><![CDATA[Governance,Health,HealthCheck,Latest news]]></category>
<dc:creator><![CDATA[Charu Bahri]]></dc:creator>
<pubDate>Thu, 02 Apr 2026 00:30:35 GMT</pubDate>
<enclosure length="0" type="image/*" url="https://www.indiaspend.com/h-upload/2026/03/19/1756231-clinical-trials-1500.webp"/>
</item>
</channel>
</rss>
