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Archives for : Health Care

Evidence confirms contamination of Groundwater by Vedanta Ltd’s Sterlite Copper in Thoothukudi

By Nityanand Jayaraman

Vedanta has claimed that there is no evidence of water contamination. When evidence of water contamination was provided, it claimed that the contamination is not recent, and that groundwater sources in Thoothukudi were already contaminated even before Sterlite commenced operations. Sterlite has argued that it is not sufficient to demonstrate that contaminant levels are in violation of regulatory limits. Rather they have demanded proof that current contaminant levels are higher than earlier contaminant levels in the groundwater sources.

In the charts below, we present a comparison between the 2018 annual average for various contaminants (Total Dissolved Solids (TDS), Fluoride, Iron, Sulphates, Calcium, Lead, Nickel and Iron) taken from TNPCB’s measurements for the year and baseline values from 1996, 2003, and 2005 as provided in a 2017 study sponsored by Vedanta Ltd.

Nickel is a marker chemical and a known pollutant from copper smelters. The International Agency for Research on Cancer (IARC) has determined that some nickel compounds are carcinogenic to humans and that metallic nickel may possibly be carcinogenic to humans. The EPA has determined that nickel refinery dust and nickel subsulfide are human carcinogens.

The International Agency for Research on Cancer (IARC) has determined that inorganic lead is probably carcinogenic to humans.

Excess iron gets deposited in the liver, heart and pancreas, where it can cause cirrhosis, liver cancer, cardiac arrhythmias and diabetes.

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The water quality from 22 groundwater sources located inside (14 locations) and outside the factory (8 locations) were compared with baseline values furnished the Vedanta-sponsored report. The comparison revealed that:

GROUNDWATER CONTAMINATION IN NEARBY VILLAGES
1. In 2018, TDS levels were between 2 and 10 times higher than 1996 baseline value in ground water from Madathur, Meelavittan, Pandarampatti, Silverpuram, Therkuveerapandiapuram (TV Puram) and Kayaloorani. In Kumareddiapuram, TDS level was nearly double the 2010 baseline value cited in the Vedanta-sponsored report.

Except for TV Puram, where TDS levels were above “acceptable” limits but within permissible limits, the levels of TDS in all other locations was above the permissile limit of 2000 milligram/Litre (mg/L).

  1. In 2018, Sulphate levels were up to 3.5 times higher than the 1996 baseline value in groundwater from Madathur, Pandarampatti, Silverpuram, TV Puram and Kayaloorani. Levels in all locations were above the “acceptable” limit of 200 mg/L, with levels in Kayaloorani and Silverpuram exceeding even the “permissible” limit of 400 mg/L.

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  1. Lead levels in Madathur, TV Puram, Kayaloorani, and Kumareddiapuram have increased from levels at or below the permissible levels during the baseline year to well above dangerous levels in 2018. Levels in all these locations make the water toxic for human and animal consumption.

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  1. 2018 Nickel levels in Pandarampatti, Silverpuram, TV Puram, Kayaloorani and Kumareddiapuram were between 1.07 to 16.5 times higher than 2011 and 2014 baseline values reported in the NEERI report of 2011 and TNPCB measurements of 2014 respectively. The Vedanta-sponsored report did not include Nickel measurements. Nickel levels in all locations were higher than permissible levels, making the water too toxic for human and animal consumption.

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  1. 2018 Calcium levels in Madathur, Meelavittan, Pandarampatti, Silverpuram, TV Puram and Kayaloorani had increased from 1996 baseline values by between 1.3 and 6 times. Calcium levels in Silverpuram, Madathur and Meelavittan were beyond “permissible” limits making the water too toxic for consumption.

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  1. 2018 Iron levels in Madathur, Meelavittan, Pandarampatti, Silverpuram, TV Puram, Kumareddiapuram and Kayaloorani had all increased from their respective baseline values in 1996, 2005 and 2014. Levels in all locations except Kumareddiapuram increased from acceptable levels to well above dangerous limits during the comparison period. Iron levels at all locations make the water too toxic for human and animal consumption.

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GROUNDWATER CONTAMINATION INSIDE STERLITE PREMISES
1. TDS levels in 9 sample locations out of 14 have increased above the baseline. Levels in all 9 locations are above permissible levels.
2. Sulphate levels in 8 sample locations out of 14 have increased above the baseline. Levels in all 8 locations are above permissible levels.
3. Fluoride levels in four out of 14 locations have increased above the baseline. Level in 1 location is above permissible level, and in 1 location is above desirable level.
4. Lead levels in 11 out of 14 locations have increased above the baseline. Levels in all 11 locations are above permissible level.
5. Nickel levels in 8 out of 14 locations have increased above the baseline. Levels in 5 locations are above permissible level.
6. Calcium levels in 3 out of 14 locations have increased above the baseline. Levels in 2 locations are above permissible level. Level in 1 location is above desirable level.
7. Iron levels in 2 out of 14 locations have increased above the baseline. Level in 1 location is above permissible level.

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Aadhaar glitches badly hit flood relief distribution

DECCAN CHRONICLE. | ARJUN RAGHUNATH

According to sources, the option of searching Aadhaar using bio-metric identification like finger print was affected.
The adalats being held by the state government at flood affected areas were now using this facility.

 The adalats being held by the state government at flood affected areas were now using this facility.

Thiruvananthapuram: The recent concerns regarding security of Aadhaar has slightly affected the state government’s single window facility to issues various certificates lost by people in the floods.

According to sources, the option of searching Aadhaar using bio-metric identification like finger print was affected. It was learnt that the Unique Identification Authority of India has temporarily frozen the provision owing to the security concerns.

 

However, the UIDAI has provided a facility to search Aadhaar details using multiple parametres like name and date of birth.

The adalats being held by the state government at flood affected areas were now using this facility.

IT secretary M Sivasankar said that though there was an issue a solution was worked out. Hence the adalats were progressing. He also said that about 336 certificates could be issued at the adalat at Green Park auditorium in Aluva on Tuesday.

It was learnt that a senior official from Unique Identification Authority of India  had also come down to Thiruvananthapuram the other day to sort out the issue. Senior officials from state IT department would be also going to Unique Identification Authority of India  office in Bengaluru soon in this regard.

Various certificates like ration card, SSLC book, driving licence, vehicle registration certificates, birth, marriage and death certificate and various certificates issued by the revenue department through the e-District facility could be issued on the spot at the single window facility.

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ArcelorMittal backtracks after accusing Vedanta of environmental lapses #WTFnews

ArcelorMittal said it had mailed the September 15 letter “inadvertently” to Essar Steel’s resolution professional.

Prince Mathews Thomas

A day after ArcelorMittal wrote to the Essar Steel resolution professional accusing Vedanta Ltd of environmental and human rights violations, the Lakshmi Mittal-led company now claims that the mail was shared “inadvertently”.

Both companies, along with Numetal, placed bids for Essar Steel.

In the letter dated September 16, and addressed to Satish Kumar Gupta, the resolution professional overseeing the auction, ArcelorMittal’s Sanjay Sharma said: “We refer to the letter dated September 15, 2018 in relation to Vedanta Limited. An internal draft of such letter was inadvertently shared with you. Please ignore the communication for now. We regret any inconvenience caused to you. Note that we hereby reserve all our rights in relation to the matters referenced therein.”

In a September 15 letter, ArcelorMittal had over six pages of material alleging violations committed by Vedanta.

“We believe that one of the cornerstones of the IBC process is full and complete disclosure of all material facts necessary for the Committee of Creditors to assess the eligibility of the resolution applicants as well as the feasibility and viability of any resolution plan submitted by such applicants,” ArcelorMittal had said.

It then listed the alleged violations under: “(a) environmental law violations committed in India (specifically, Tuticorin and Lanjigarh), Zambia as well as other jurisdictions, (b) illegal mining, (c) disregard for safety standards, and (d) human rights violations.”

Responding to the first ArcelorMittal letter, a Vedanta spokesperson told PTI: “…highly disappointed that such baseless and irrelevant issues are being raised and unfounded allegations are being made with the objective to malign competitors.”

On the second letter, the Vedanta spokesperson declined to comment.

“The way the second letter is worded, shows that ArcelorMittal may use the arguments later on,” said an executive from the sector.

When contacted, ArcelorMittal declined to comment.

The Essar Steel auction is at present being fought in courts, with the Supreme Court expected to resume hearing on September 18. ArcelorMittal had moved the court against an NCLAT order asking it to clear dues to become eligible for the bid.

The dues pertain to that of Uttam Galva Steels and KSS Petron, in which ArcelorMittal had significant stakes. The dues amount to approximately Rs 7,000 crore.

The court will also hear Numetal, which had appealed against NCLAT’s order giving ArcelorMittal three days to clear the dues.

Interestingly, ArcelorMittal hasn’t cleared the dues, but has instead reiterated its commitment to pay. Meanwhile, it has raised its bid for Essar Steel to Rs 42,000 crore. Numetal is said to have bid Rs 37,000 crore, and Vedanta’s bid is approximately Rs 32,000 crore.

https://www.moneycontrol.com/news/business/companies/arcelormittal-backtracks-after-accusing-vedanta-of-environmental-lapses-2958871.html

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The Kerala model can be implemented across India with the same secular and gender-sensitive spirit

The power of Kudumbashree

Brinda Karat

Kumari died on September 1. She had contracted leptospirosis while doing relief work in Kerala after the floods, away from her own home which had not been affected.

 She was a health volunteer and prominent member of the Kudumbashree Mission in her panchayat in Ernakulum district. Kumari’s work and life symbolises the spirit of Kerala reflected in the inspirational way in which the people of the State have faced the worst disaster in a century.

 United in relief work

Among the heroic stories of selfless community service are those of the Kudumbashree women, who have perhaps not got the attention they deserve. The attention is necessary not just to accord women relief helpers like Kumari recognition and appreciation, but also to understand how such an enormous, effective and well-planned intervention could be made across the State by women through their own initiatives.

 

One got a glimpse of the process at a district-level informal review meeting of around 60 key coordinators of Kudumbashree in Kozhikode, which suffered landslides and heavy rain. 

Women from working class families, women from the lower middle class and middle class, Muslim women and Dalit women were present. They were a microcosm of the 2.43 lakh groups functioning across the State.

Within a day or two of the deluge, the Kudumbashree members started contacting each other to discuss what they should do. They divided themselves into squads of five to six members and started relief work. They were helped by the district coordination team of five women, who were on deputation to the Kudumbashree Mission from the government.

 Within a short span of time, there were 7,000 women volunteers engaged in various tasks. When the situation in their district improved, some of them set out to neighbouring districts like Thrissur and Wayanad to help.

 Many of these women have family responsibilities, but they convinced their families of the urgency of the work at hand and set off with all the equipment required for cleaning which they themselves had collected through sponsorships. Some of them went to relief camps to distribute relief material; others went to tribal areas which had been badly affected by landslides.

 

Volunteers Zarina and Sudha said: “We saw mounds of foul-smelling black mud piled outside the houses blocking the entrances and, in some cases, partially covering the houses.

There were dead animals too. At first we were looked at with suspicion. But when we started working, we saw relief on the tribal women’s faces.

We all worked together. We stood, sometimes knee-deep, in the filthy mud and began removing it. It was difficult work and one group could clean only a few houses in a day. We knew we could fall ill or be stung by poisonous insects or snakes, but we were not afraid.

Tribal women and members of Kudumbashree from nearby areas also joined us.”

 Like Zarina and Sudha, around 4,00,000 women of Kudumbashree self-mobilised across the State to do relief work, including collecting, packing and distributing relief material, cleaning up public spaces and private homes, and counselling affected families and putting them in touch with concerned authorities.

The Kudumbashree State Mission estimates that Kudumbashree groups cleaned up 11,300 public places including schools, hospitals, panchayat buildings, and anganwadi centres, and two lakh houses.

Around 40,000 affected families received counselling and information assistance from Kudumbashree groups. To provide shelter to families rendered homeless by the floods, 38,000 Kudumbashree members opened up their own homes. 

Kudumbashree members also donated 7.4 crore to the Chief Ministers Distress Relief Fund. This scale of voluntary relief work by women is quite unprecedented by any standard.

 

A unique model

How were these women motivated? The Kudumbashree model may provide some answers. Started in 1998 by the CPI(M)-led government, it was envisioned as a part of the People’s Plan Campaign and local self-governance, with women at the centre of it.

 In its conceptualisation, it was markedly different from the self-help group (SHG) movements in many parts of India. While the commonality with other States was in the thrift and credit activities at the grassroots level through the formations of saving groups, the structures differed.

Kudumbashree has a three-tier structure. The first is the basic unit — the neighbourhood groups (NGs). There could be several such units within a ward and they are networked through the area development societies (ADS).

 All ADSs are federated through the community development societies (CDS). There are core committees of elected coordinators at all three levels — at least five in each NG; seven or more at the ADS level, depending on the number of NGs; and around 21 at the CDS level.

Unlike in other States, all the coordinators are elected in Kerala. Each Kudumbashree member has a vote. Direct elections for the NG coordinators are held every three years.

These people, in turn, elect the coordinators of the ADS who elect the members of the CDS. A majority of the members of the coordinator groups have to belong to women below the poverty line or from comparatively poorer sections.

There is reservation for Dalit and Adivasi women. At the district and State levels, employees/officers of the government are appointed on deputation to help the Kudumbashree groups. Thus, there is a socially representative leadership.

This secular composition acts as a facilitator for the secularisation of public spaces. In other States, SHGs came to be dominated by women from better-off families or from powerful castes.

 This led to unhealthy hierarchies in which poorer women and Dalit women were denied decision-making powers. Over the years, as women dropped out from these sections for a number of reasons, the social potential of the SHGs to challenge dominant structures of gender bias at the local level weakened.

 

The micro-enterprises undertaken by the women NGs in Kerala also strengthen community bonds. These include organic vegetable growing, poultry and dairy, catering and tailoring.

The concepts and practices have expanded over the years. Today the community farms run by Kudumbashree groups are acknowledged as a critical avenue for the rejuvenation of agricultural production in Kerala.

 Kudumbashree training courses are quite comprehensive and include women’s rights, knowledge of constitutional and legal provisions, training in banking practices, and training in skills to set up micro-enterprises.

 

The Kudumbashree groups are therefore often seen as a threat by those who would like women to adhere to socially conformist roles.

 In earlier years, women of the Kudumbashree groups had to organise protests when the Congress-led government drastically cut the budgetary allocation of funds and floated a parallel Janashree project. The BJP and RSS have also floated parallel groups, but so far these groups have not been able to make much headway.

Although conceived, initiated and helped by the Left Front governments and supported by Left-oriented organisations, the Kudumbashree groups are not affiliated to any political party. This ‘Made in Kerala’ model can be implemented across India, if it is done with the same secular and gender-sensitive spirit.

Brinda Karat is a member of the CPI(M) Polit Bureau and a former Rajya Sabha MP.

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MP- Six Disabled Inmates of Shelter Home ‘raped, sodomised’ for yrs

Bhopal:

What makes this case even more horrifying is that Awasthi was accused of the same crimes by some minors of a Hoshangabad shelter last year, but was allowed to run his home in Bhopal, where he allegedly continued to prey on children as young as 10.

Congress took the youngsters to the party office for a press conference before they even had a chance to speak with police. Till late Friday night, police were still trying to take down statements and had not yet filed an FIR.

On Friday afternoon, 40 deaf and mute teenagers trooped in, accusing Awasthi of rape. The teens — who covered their faces — let out their sufferings through translator Shraddha Shukla. State Congress spokesperson Shobha Oza spoke in support of the survivors, and said, “Officials are not heeding their grievances. Why wasn’t Awasthi punished if he was found guilty in the Hoshangbad case last year? Why did the government allow him to run the Bhopal shelter?”

The six complainants alleged that Awasthi repeatedly raped them and would beat them mercilessly if they resisted. The teenagers submitted a signed complaint listing Awasthi’s horrendous and sickening act

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Maharashtra – Protest against Government Move to Deprive Poor off Affordable Foodgrains

 

A State wide mass agitation will be held on Sept 21st to protest against the recent directive issued by the Maharashtra Government to deny the poor foodgrains from ration shops guaranteed under the Food Security Act, 2013.

Maharashtra Government had announced a decision on 21st August through the issuance of a GR to start a pilot project in Mumbai, replacing pds with direct benefits transfer. Now money will be deposited directly in the bank accounts of the poor instead of giving foodgrains through ration shops. Now the money will be deposited directly in the bank accounts of the poor instead of giving foodgrains through ration shops.

This has amounted to diluting the Food Security guaranteed to the poor after a long agitation. This is clearly a step towards dismantling the PDS system.    Anna Adhikar Abhiyan, Maharashtra strongly condemns this decision and plan to agitate at taluka and district level across Maharashtra on 21st September 2018 to remind the Government of its Food Security commitment to the Poor.

Various organisations and progressive political parties in the nation had compelled the UPA Government in 2013 to bring the Food Security Act giving the poor people right to get foodgrains at cheaper rate from the ration shops.

The G.R. issued on 21st August has clearly gone against this right guaranteed to the Poor since it will force the poor to buy foodgrains from the market and leave them vulnerable to wide fluctuations in the market. The experience in several states has shown that large scale diversion of funds has happened consequent to the new Aadhar linked DBT system.

This step will dismantle the current foodgrains procurement and distribution system in which the Government was a major stakeholder. With Government absolving itself of the interventionist role in buying and distributing foodgrains, the agrarian economy will fall in the hands of monopoly food aggregating companies furthering corporate interests.

A false narrative has been build that by directly depositing amount in the bank account of the Poor beneficiaries, there will be no scope for corruption. This narrative runs contrary to socio-cultural ground reality is different. According to one of the study, 91% of people in Andhra Pradesh, 88% in Orissa, 90% in Chhattisgarh, and 81% in Himachal Pradesh want only food grain.  It is revealing to note that among those giving priority to cash, most are males. (Infochangeindia.org/agriculture/analysis/the-case-against-cash-transfers.html).

 

While taking this decision, the govt. did not engage other stakeholders such as farmer’s bodies and organizations working at the grassroots and the people’s representatives but has signed a MoU with a US based company/NGO Abdul Latif Poverty Action Lab.  Claiming to be transparent, nationalist and patriot the government of  Maharashtra on the contrary has given in to the hands of foreign NGO  in a very dictatorial manner.

This has clearly been under the pressure of WTO which wants US based aggregating companies to procure foodgrains and sell it at market determined prices. The experience of similar system in several other countries has shown that it has helped the foodgrains aggregating companies and US farmers who are already highly subsidized while creating disadvantages for small farmers, consumers and poor dependent on the PDS to save them from the shock of so called price discovery of food aggregators.

 

Ulka Mahajan (9868232478), Mukta Srivastava (9969530060), Chandrkant Yadav

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India accounted for 37% of global suicide deaths among women, 24% among men in 2016

PTI | Sep 12, 2018, 17:56 IST

Representative Image Representative Image

NEW DELHI: India accounted for 37 per cent of global suicide deaths among women and 24 per cent among men in 2016, according to a study published on Wednesday.

The Global Burden of Disease Study 1990-2016 published in the Lancet Public Health journal said 63 per cent of all suicide deaths reported in India were in the 15-39 age group.

Suicide ranked first in India as the cause of death compared to its third rank globally in this age group, it said.

There was an increase of 40 per cent in the number of suicide deaths between 1990 and 2016, with an estimated 2,30,314 deaths in 2016 indicating that “disproportionately high suicide deaths in India are a public health crisis”, according to the lead author of the study, Professor Rakhi Dandona from Public Health Foundation of India.

“Having said that, the suicide death rate (SDR) has reduced by 15 per cent from 1990 to 2016,” she said.

The study found wide variations in suicide death rate across states in India.

Karnataka, Tamil Nadu, Andhra Pradesh, Telangana, West Bengal and Tripura had high suicide death rates for both men and women, in addition to Kerala and Chhattisgarh which had high suicide death rates for men.

The suicide death rate for women in India is 15 per one lakh women, double that of the global suicide rate for women in 2016, which is 7 per one lakh women.

Married women account for the high proportion of suicide deaths in India, the study stated.

Marriage is known to be less protective against suicide for women because of arranged and early marriage, young motherhood, low social status, domestic violence, and economic dependence.

“The trends in SDR in women in this study suggest the need to further assess the complex relationships between gender and suicidal behaviour to facilitate women-specific suicide prevention strategies,” Dandona said.

At the same time, she stressed the high SDR among men in India has not changed over time and needs immediate attention.

For suicide among men in India, it appears young adults are a vulnerable group, and marriage does not seem to be protective for them either.

Personal and social reasons, financial problems, poor health are known as major reasons of suicide in India and the most-used means of suicide are poisoning, drug overdose and hanging, as known from previous research, Dandona said.

The study found that the suicide death rate is increasing in the elderly, especially among those above the age of 80 years, which will pose additional challenges.

For the elderly, social isolation, depression, functional disability, and the feeling of being a burden on their family have been cited as reasons for suicides globally, however, not much is known about reasons for suicides in the elderly in India, Dandona said.

With their increasing proportion in the population, the reasons for suicide and mental health issues in the elderly need to be explored urgently within the National Programme for Health Care of the Elderly in India to address the increasing suicide deaths in this age group, Dandona stated.

There is an urgent need for a national suicide prevention strategy, that is data-driven, gender-specific and takes the state variations into account.

https://timesofindia.indiatimes.com/india/india-accounted-for-37-of-global-suicide-deaths-among-women-24-among-men-in-2016/articleshow/65784986.cms

 

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Churu Drug Trials: 4 Months On, Dalit Victims Report Severe Damage To Health And Caste-Based Harassment

By NEHA DIXIT | 

It was mid April, the onset of the heat wave in Rajasthan. Twenty-one-year-old Mamta had spent three consecutive days lying on her bed next to a mud wall in her round, thatched hut. That day she gave her husband, 24-year-old Oma Ram, an ultimatum: either he finds work outside their village or she would leave.

When Oma Ram was 13 years old, his father died. Since then, he had been fending for himself by alternating as a shepherd for the village cattle and as a farm labourer during the four-month farming season each year. Like most young men from his community—Meghwals, enlisted as a Scheduled Caste in Rajasthan—he owns a small patch of farm land, two beeghas that yield abysmal harvests from millets and barley. Depending on it for livelihood is not possible. In the last two years, since his marriage, the lack of money had marred his household more than ever. With increasingly dismal rainfall each year, chances of finding work on farms closer home had grown bleak. According to the local doctor, Mamta had contracted jaundice due to regular bouts of starvation and hunger.

Digaria, Oma Ram and Mamta’s village in Rajasthan’s Churu district, is occupied primarily by the Meghwals. The gram pradhan Umed Singh said that it has a voting population of 1,600, and is clubbed with four other villages under the Ghantiyal Badi panchayat. Untouchability is rampantly practised. Dalits are not allowed entry into the district’s famous Babosa Balaji Maharaj temple. They can only draw water from designated wells, and regularly face thrashing if found sitting on cots in the presence of the Rajput and Brahmin landowners whose farms they work in. Traditionally, the Meghwals worked as weavers and wood carvers, but over the years, working as farm labourers has become their primary occupation. Several people I met said that for a 12-hour shift, they are paid Rs 200.

On the day of Mamta’s ultimatum, Oma Ram went to the village square to look for leads for potential employment. Sher Singh, a Rajput truck driver from Palasa village, part of the same gram panchayat as Digaria, was recruiting daily-wagers to work at a week-long medical camp in Jaipur. The job, as Singh described to those interested, was to set up the tents, serve food and refreshments to incoming patients, keep the surroundings clean and help the medical personnel. The promised daily wage was Rs 500, alongside free food and lodging.

The next morning, on 18 April, Oma Ram and 20 other men from his village—all young Meghwals—left with Singh for Jaipur. After a five-hour drive, they reached the isolated Malpani Hospital and were lodged in its basement. The basement had seven other people from Bharatpur and Jaipur, who had come for the same work. The hospital workers told the men that the camp doctors will come two days later, and that until then they should not leave the basement at any cost. “The basement was filthy with mounds of medical trash in several corners. On one side, there were a couple of hospital beds and we were asked to rest there,” Sohan Lal, a 19-year-old student who had come to work so he could earn his college fee, told me.

On 19 April, around 10 am, they were provided with a meal. Several of the men recounted that Rahul Saini, a hospital doctor, gave all 28 of them small, white round tablets to swallow after they had eaten. “He said that we should take the tablets to get rid of any fatigue, indigestion or body pain,” Moora Ram, a 40-year-old farm labourer from Digaria, said. Saini said that the tablets “will help us relax and sleep better,” he added. “Once we take the tablets, we will also be eligible for free examination by the doctors.”

Within an hour of taking the tablets, 17 of the men fell unconscious. Seeing this effect, four others refused to take the tablet and escaped to Digaria. “They informed our family members of what was happening in the hospital,” Shammamal, a 25-year-old mason who had been administered the tablet, said.

“We could hardly get up from the bed the next day. Some had muscle cramps, skin allergies and fever. Others felt nauseous, got diarrhea.” Sohan Lal said. By then, their relatives from Digaria had arrived. “The hospital staff informed us that they conducted a medical prashikshan”—a clinical trial—“on us.”

When the Digaria residents who had gathered at Malpani Hospital learnt what had happened, they began protesting, and insisted that the hospital staff give them details of the trial. The staff gave in. It was then that Oma Ram and the others found out that they had been made to undergo a Phase 2 trial for GRC 27864, a drug manufactured by the pharmaceutical giant Glenmark. The drug is intended to treat hip- or knee-osteoarthritis pain on patients between the ages 40 and 60. Phase 2 trials are usually conducted on mid-sized groups, to assess how well the drug in question is performing.

Under the law, it is mandatory to get written consent from the clinical-trial participant. Each victim I spoke to said that they were not informed of the trial, nor were any others present in the basement. Further, the trial was conducted on healthy men who were far younger than the target age for the drug. Shammalal said, “We had gone to earn a living, we ended up losing all our strength to do that in the days to come.”

 

*

According to an RTI response from the Director General of Health Services in India to a query filed by the Swasthya Adhikar Manch, a public-health advocacy group, nearly 5,000 people lost their lives between 2005 and 2017 as a result of clinical trials in India, and 20,758 were reported to have faced severe adverse health consequences. Till date, compensation has been given in only 187 cases of death.

Data presented before the Supreme Court by the Rajasthan government states that between 2005 and 2013, 95 people in the state lost their lives due to clinical trials, and 361 patients continue to face adverse effects. In 2012, the Swasthya Adhikar Manch, the Drug Trial Peedit Sangh, Rajasthan Nagrik Manch, Bhopal Gas Peedit Mahila Udyog Sangathan and Jan Swasthya Abhiya—all civil-society organisations—filed a PIL in the Supreme Court to demand strict regulations for ethical clinical trials in India, adequate compensation for victims and action against guilty medical practitioners. Since then, the court has passed several orders in the case—including directions that the central government must discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. “Uncontrolled clinical trials are causing havoc to human life,” the court reportedly said. “There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.” The PIL is next slated for hearing on 12 September.

Despite the ongoing hearing, since 2015, the government has amended crucial rules concerning drug trials in India, walking back many of the progressive changes from previous years. On the eve of the PIL’s hearing, the ordeal undergone by the men from Churu and what has followed since the case was first reported in April are sobering reminders of the reality of clinical drug trials in India.

In the days following the illegal trial in April, several local and mainstream media outlets reported the story. Three days later, on 23 April, the Swasthya Adhikar Manch, the chief petitioner in the PIL before the court, filed a complaint with the National Human Rights Commission. Referring to the media reports regarding the illegal trial, the complaint requested that “the matter be investigated and that action be taken against the hospital and medical practitioners involved in the incident.”

Meanwhile, Sohan Lal and several other victims decided to file a police complaint against Sher Singh and the hospital staff. A group of them visited the Vishwakarma police station in Jaipur, under which Malpani Hospital falls. “We had to do a sit-in protest outside the police station for two weeks to get the complaint filed,” he said. In the FIR filed on 29 May, Sohan Lal’s statement said, “Since the trial, we have developed skin allergies, chest pain, weakness, nausea and diarrhea … many of those who were with me and I are still under treatment for the effects of the trial at the government hospital in Sandwa, Sujangarh and Bidasar.” He added, “The effects of the drug are impacting our minds and bodies even today.”

On 2 May 2018, the Office of the Drugs Controller General of India, which falls under the Central Drugs Standard Control Organization, issued a notice to Glenmark Pharmaceutical Limited. The DGI’s notice stated that, taking cognisance of the media reports regarding the trial, an investigation team constituted by the CDSCO had looked into the trial and discovered multiple violations. The team found that, as per Malpani Hospital’s records, only three people were officially enrolled for the Phase 2 clinical trial of GRC 27864 tablets. While looking into the records of the three persons, the CDSCO team found that the identities of all the three people were falsified in all accounts—their address, phone numbers and their signatures on the consent forms. The report also mentioned that around 25 people were recruited as volunteers without following the procedure for ethical trials, or without seeking their prior approval.

The CDSCO investigators also found that the clinical-trial room was “not adequate,” as it did not have any ventilation, washrooms or proper spacing between beds. They also found that neither the procedures for recruiting the 25 or so subjects nor the procedure for the trial was reviewed by the Ethics Committee—under Schedule Y of the Drugs and Cosmetics Rules, 1945, approval from an ethics committee within the institute or an independent committee is mandatory.

According to the CDSCO, Malpani Hospital in Jaipur is conducting 18 drug trials at present. The hospital is one of 23 sites where Glenmark had initiated Phase 2 clinical trials for GRC 27864. Soon after the CDSCO notice, Glenmark issued a media statement: “As soon as we became aware of the alleged irregularities at Malpani Hospital, we suspended the trial at the site in the interest of patient safety. Further, we have all the requisite approvals in place for the trial at the site and have submitted all supporting documents of our approvals to the regulator.”

In the last four months, despite the fact that several investigations by the media as well as government-constituted teams have found that the drug trial was non-consensual and that the complainants continue to face adverse health effects, no officials have met the complainants. The ethics committee members and the principal investigators of the trial, who are responsible for the medical management of the victims, have not visited or met them either.

Baghu Ram, a 23-year old, has lost ten kgs since April. He told me that he was admitted in the Sandwa Community Health Centre for a lung infection and chest pain that he had had for over a month. He can no longer take up a labour-intensive job. “My parents lost all their savings in getting me treated. I used to work as a part-time mason. But I can hardly pick up more than two bricks at a time.”

Sohan Lal, the 19-year-old, said he had missed most classes this college semester. He complained of incessant breathlessness, headaches and poor eyesight. “In a government hospital, if you tell the doctor that you have a headache, they give you a tablet. If you say that you are restless, they again give you a tablet. That is the only medical treatment they know of,” he said. “No one is checking on us for the long-term impact of this trial on us. And we can’t afford to pay a private doctor to know on our own.”

Baghu Ram's prescription for treatment. Credit: Neha Dixit for The Caravan.
Baghu Ram’s prescription for treatment. Credit: Neha Dixit for The Caravan.

Post the trial, Oma Ram has suffered from restlessness and anxiety. “I feel like sleeping in the dark the whole day. I take up work but feel jittery. It happened four or five times, when I started working at a local construction site and could not concentrate,” he told me, “as if someone has kept a rock on my body.”

Meanwhile, the FIR filed by Sohan Lal and others against Sher Singh and Malpani hospital has resulted in the Dalits facing threats and harassment in the village. Sohan Lal told me that on 15 May, Sher Singh came to Digaria with goons in tow, attempting to scare them into withdrawing their police complaint against Malpani hospital. The Rajputs also threatened the Dalit labourers, saying that they will make sure that the complainants do not get work in the farmlands in the next cropping season.

“We have informed the police several times over but there has been no action. When Rajputs file a case against us even for asking our wages on time, the police do not even take a minute to take us into custody,” says Moora Ram.

Sohan Lal says that their fight is now for systemic change. “We don’t want compensation. We want dignity and justice.” Last month, a newly constructed Ambedkar shrine was vandalised for the third time since its construction. “We know the Rajputs. We have removed the Ambedkar statue for now. We will place it back once we get justice,” he said.

I contacted Rajiv Gupta, the principal investigator for the clinical trial at Malpani hospital. He refused to comment, saying that “the investigation is on.” NK Malpani, founder of Malpani hospital, declined to comment on the incident

*

Before 2005, clinical trials in India were only allowed on drug molecules discovered in the country. In 2005, Schedule Y of the Drugs and Cosmetics Act was modified to allow early-phase clinical trials to be conducted in the country. Soon after, global pharmaceutical companies began to project India as the preferred destination for global clinical trials.

Internationally, recruiting patients for clinical trials is a difficult and expensive task—the cost of standard of clinical care, mandatory health insurance, high documentation, counselling and training for a clinical-trial volunteer as mandated by law is high even in developed countries. Many trials that are conducted in India could not be conducted in these countries, as they rely on people’s lack of access to affordable, good-quality care.

With the arrival of global clinical trials in India, the Indian Council for Medical Research revised its first guidelines on “Ethical considerations involved in research on Human Subjects” in 2000, and again in 2006. There was a multifold increase in new trials from 2008 to 2012.

According to the Drugs and Cosmetics Act, each clinical trial needs the approval of an Institutional Ethics Committee that comprises 8 to 10 members. According to the Clinical Development Services Agency (CDSA) under the Ministry of Science and Technology in India, the responsibility of the Ethics Committee is to review studies that are to be conducted on humans. “The committee will make unbiased recommendations on all types of research proposals with a view to safeguard the dignity, rights, safety and well-being of all actual and potential research subjects. The goals of research, however important, should not be permitted to override the health and well-being of the research subjects,” the CDSA states. It adds that the committee shall also look into “the informed consent process, study/ protocol risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensation process, wherever required” and will “review the proposals before start of the study and monitor the research throughout the study until and after completion of the study through appropriate well documented procedures, for example … assessment of all Severe Adverse Events and advise for compensation to regulatory authority.”

But until 2012, any ten people sitting in any part of the country could approve a clinical trial. Instances of abuse, neglect and exploitation were disturbingly common—including trials on mentally ill patientsand on Bhopal gas victims in Madhya Pradesh. After the Swasthya Adhikar Manch’s PIL was filed, the court directed that no new drug trials be allowed to begin unless they were conducted strictly under Schedule Y of the Drugs and Cosmetics Act. Further, the court noted that the only trials that could proceed were to do with unmet medical needs in the country, where risk-and-benefit analysis had been conducted, and which related to an innovation pertaining to an existing therapy.

Around the same time, the 59th Parliamentary Standing Committee report on Health and Family Welfare commented on the functioning CDSCO, claiming that there was an “apparent nexus that exists between drug manufacturers and many experts” at the organisation and that there had been many reported instances of poor and illiterate citizens of India being used as “guinea pigs” by multinational drug manufacturers.

In 2013, a committee constituted by the Ministry of Health and Family Welfare and headed by the professor Ranjit Roy Chaudhury reviewed issues pertinent to clinical trials in India, and suggested corrective measures—broadly, that clinical trials must only take place at government-accredited centres; that informed consent must be taken and that the process of obtaining it must be recorded; and there must be a provision for the care of those suffering from adverse health effects due to the trial. Schedule Y was soon amended in accordance with these. These amendments included compensation of trial injuries, limiting the number of trials an investigator can undertake, mandatory audio–video recording of the informed-consent process and reporting deadlines for serious adverse events, among others.

But after these regulations were brought in, global sponsors began pulling out and the number of new trials plummeted. The United States government halted federally funded trials in India.

Since 2015, many of these changes have been diluted or reversed. The latest rules favour the pharmaceutical companies and deliberately overlook the rights of the clinical-trial participants. For instance, a government circular issued on 2 August 2016 removed the 50-bed restriction for conducting clinical trials. The DGCI also modified the requirement regarding audio-video recordings of consent procedure, limiting it to new chemical studies or studies for anti-HIV and anti-leprosy drugs.

The CDSA’s guidelines allow the ethics committees to oversee clinical trials and decide on the level of compensation given to patients who suffer adverse events. In 2016, the government also removed the restriction on the number of trials a principal investigator can work on at any given time, which was previously set at three, stating that and this too could be decided by the ethics committee. The CDSCO also noted that the EC can approve the addition of a new site or investigator to a trial in the normal course of the trial without obtaining a No Objection Certificate from Drug Controller General of India. These new rules and circulars clearly go against the spirit of the Supreme Court orders. “Fearful of losing clinical trial business to ‘rival’ countries, the Indian government is diluting its laws related to drug trials,” Amulya Nidhi, the convenor of the Swasthya Adhikar Manch, said.

In India, the concerns regarding drug trials do not end at the procedure followed during the investigation. Several independent reports confirm that most trials in India have been conducted on the poor. While this alone is grave cause for concern, the benefits of the research that is carried out do not reach the communities that the subjects are part of—most often poor and oppressed castes—as drugs found to be effective following these trials are not affordable for these groups. Such practices are in violation of the Declaration of Helsinki, a set of ethical principles followed by the global medical community, which states that “medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.”

“The Indian example suggests that research-ethics frameworks and national policies for economic development are increasingly intertwined,” Nidhi said. “Most, if not all, clinical trials happen because of financial interests of the pharmaceutical or implant company involved in the trial. The government should ask for further transparency in such trials.”

According to Sanjay Parikh, a Supreme Court lawyer who is representing the Swasthya Adhikar Manch in their PIL, most clinical trials in India are conducted in violation of laws and human rights. “The drug companies have been exploiting the poor people, taking advantage of the fact that there is no proper implementation of laws and strict monitoring by the concerned authorities. There is still no provision for criminal liability of the pharma companies who act in gross negligence resulting in deaths and serious adverse events. If clinical trials have to be conducted in our country, there has to be strict regulation and implementation in consonance with our constitutional protections, in particular for the lives of the poor people.”

On 24 May 2018, the National Human Rights Commission issued a notice to the principal secretary in Rajasthan government’s health department and the commissioner of police in Jaipur, asking them to respond with their investigation of the Churu trials within four weeks. There has been no response till date.

For the Dalit residents of Digaria, the hopelessness that set in with the lack of jobs has only been aggravated by fear. “Till date, only the educated, the rich were migrating from the village for jobs. When the poor migrate, they turn us into guinea pigs,” said Baghu Ram. He told me that most residents have become fearful of leaving the village. The area is also rife with rumours of organ-trafficking and human trafficking. “As it is we could never finish school, we don’t have land. Now, what are they getting by incapacitating us, depriving us of the physical energy to eat two square meals?”

Oma Ram said that his wife Mamta left 20 days after his return from Jaipur. “She said I was a coward who was making excuses not to work,” he said, before adding, “At least she will get two square meals at her parents’ house.”

Churu Drug Trials: Four months on, Dalit victims report severe damage to health and caste-based harassment

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‘Digital India’ De-facto ‘Deleted India’ #Poem

 

By- Rohit Prajapati

Slum Dwellers will be ‘Deleted’ in ‘Digital India’.

Street Vendors will be ‘Deleted’ in ‘Digital India’.

Small Shops will be ‘Deleted’ in ‘Digital India’.

Ordinary People will be ‘Deleted’ in ‘Digital India’.

Public Transport System will be ‘Deleted’ in ‘Digital India’.

Not Poverty, but Poor will be ‘Deleted’ in ‘Digital India’.

Natural Resources will be ‘Deleted’ in ‘Digital India’.

Ponds and Lakes will be ‘Deleted’ in ‘Digital India’.

Rivers and Ravines will be ‘Deleted’ in ‘Digital India’.

Employment will be ‘Deleted’ in ‘Digital India’.

Equality will be ‘Deleted’ in ‘Digital India’.

Environment will be ‘Deleted’ in ‘Digital India’.

Nature will be ‘Deleted’ in ‘Digital India’.

Love and compassion will be ‘Deleted’ in ‘Digital India’.

Gender Justice will be ‘Deleted’ in ‘Digital India’.

Communal Harmony will be ‘Deleted’ in ‘Digital India’.

Public Health Facilities will be ‘Deleted’ in ‘Digital India’.

Public Education Schools will be ‘Deleted’ in ‘Digital India’.

Right to Protest will be ‘Deleted’ in ‘Digital India’.

Voice of Dissent will be ‘Deleted’ in ‘Digital India’.

Freedom of Expression will be ‘Deleted’ in ‘Digital India’.

Rule of Law will be ‘Deleted’ in ‘Digital India’.

Democracy will be ‘Deleted’ in ‘Digital India’.

Real Life will be ‘Deleted’ in ‘Digital India’.

Dignified Life will be ‘Deleted’ in ‘Digital India’.

Peace & Justice will be ‘Deleted’ in ‘Digital India’.

That is why I want to ‘Delete’  ‘Digital India’.

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Ex-MCI boss – Dr Ketan Desai escapes prosecution again as Gujarat bails him out #WTFnews

Rema Nagarajan| TNN | 

Eight years after the Medical Council of India (MCI) headed by him was dissolved by the government for corruption charges, corruption cases against Dr Ketan Desaicontinue to be dropped because sanction for his prosecution has been refused. The latest such instance was in the Patiala House court last month. While the CBI had filed a chargesheet in the case, it informed the court that the State of Gujarat, the competent authority in this case, had declined sanction to prosecute.
Under the law, public servants above a certain level can be prosecuted under Section 197 CrPC or Section 19 of the Prevention of Corruption Act only after obtaining sanction from the “competent authority”.

On August 17, the CBI counsel showed the Patiala House court the Gujarat government’s order declining sanction. Earlier, on May 29, the court had been told that the Delhi High Court had directed that proceedings against Dr Desai should be dropped till sanction to prosecute was received from the competent authority.

On August 18, the court ruled that while proceedings against Desai would have to be dropped in the absence of the sanction, the four others who are co-accused in the case will be prosecuted. Thus, despite having filed a detailed 143-page chargesheet against the five accused on September 6, 2011, the CBI had to drop all proceedings against accused no.1, Dr Desai.

In the Delhi High Court, Desai’s lawyers had cited a 2015 order of the Special CBI Judge, Lucknow which had dropped proceedings against him till CBI received sanction from the competent authority to prosecute him. They had argued that the same principle should apply to the case being heard in the Delhi courts.

The CBI sought disposal of the petition by the Delhi high court “with the liberty to the respondent CBI to obtain the sanction”. On February 12, 2018, the HC ruled, like the Lucknow court, that proceedings against Dr Desai were dropped till sanction was received but the trial would re-commence once sanction was received. The CBI did not respond to TOI’s queries about the competent authority and the grounds on which sanction was declined.

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