Operation cover-up

As the news of the deaths of women sterilised at a camp at Takhatpur block of Bilaspur district started to filter in on November 10, officers in Chhattisgarh’s health department pro-actively called all the 83 women present at the camp to hospitals in the district headquarters. Then, news came that women who had attended other camps too were feeling unwell. Within hours, the operation to gather all the 137 women who were sterilised in four camps-one on November 8 at Nemi Chand Jain hospital in Sikri, Takhatpur, and three on November 10 in Gaurella block-was initiated. (See `How the tragedy unfolded’).

Once the women’s health stabilised, they were sent home with a bag of goodies that included a shawl, blanket, saree, salt and a kit of toiletries for their babies. The administration began brainstorming the cause of deaths. It sought the list of medicines given to the women post-surgery in all four camps. Four drugs were common in the list-diazepam, ibuprofen, ciprofloxacin and povidine iodine. Looking at the symptoms of the affected women, they zeroed in on two drugs, namely ibuprofen and ciprofloxacin. Of these, ibuprofen tablets were manufactured in 2013 and were in circulation for some time and, therefore, considered safe.

How the tragedy unfolded   An account of what happened in Takhatpur from November 8 onwards   November 8 First camp held at Takhatpur. Eighty-three women sterilised November 10 Three camps at Gaurella, Marwahi and Pendra villages. Fifty-four women sterilised The first death occurs. Six women taken ill Compensation of Rs 2 lakh for the deceased November 11 Seven more women die R K Gupta, surgeon who operated upon women in Takhatpur, arrested by police Compensation increased to Rs 4 lakh for the deceased and Rs 50,000 for survivors November 12 Three more women die November 13 Two more die, one from Pendra town Medicines come under scanner November 14 One-member judicial commission under retired judge Anita Jha appointed November 15 Zinc phosphide found in ciprofloxacin MahawarPharma promoters arrested November 18 Private Delhi laboratory confirms presence of zinc phosphide in medicines Fixed deposit of Rs 2 lakh announced for each child of the deceased

“We found that ciprofloxacin, on the other hand, was manufactured in October 2014. This made us suspicious and we tested it,” said Ayyaj Fakirbhai Tamboli, mission director, National Rural Health Mission (NRHM), Chhattisgarh. Preliminary tests of ciprofloxacin tablets showed they were contaminated by zinc phosphide, commonly used as a rodent killer. The state government says the labs in Delhi, Nagpur and Kolkata have confirmed the presence of rat poison but it has not made the reports public. The owners of Raipur-based Mahawar Pharmaceutical Private Limited and Bilaspur-based Kavita Pharma were arrested for culpable homicide.

The culprit had been found. The poison that killed the women had been discovered. Or so it seemed.

A COVER-UP?

Dularin Patel, 27, of Lokhandi village in Takhatpur was one of the 13 women who died. “She was fine till Monday afternoon when she visited us. She had taken medicines on Saturday night and twice on Sunday,” says Gorabai, Dularin’s mother. “She started vomiting from 4 o’ clock in the evening. Then, we got a call from her in-laws, who stay 70 km away, that the mitanin (local health worker) has asked her to go to the hospital. By 3 o’clock on Tuesday morning, she was in Chhattisgarh Institute of Medical Sciences (CIMS).”

“I fed my daughter black tea and bread toast before she left home. I did not know that was going to be her last meal,” says Dularin’s mother, not being able to contain tears in her eyes. By early evening on Tuesday, Dularin was declared dead.

Preliminary results of the post-mortems of the victims have been submitted to the investigating agencies. They have not been disclosed to the public but a senior medical officer who closely monitored the post-mortems told Down To Earth (DTE) that Dularin had developed septicaemia. “She had inflammation of the peritoneum, the membrane forming the lining of the abdominal cavity. There was half-a-litre of thick yellowish fluid in her lungs and septic foci was found in all organs,” said the source, requesting not to be named. “This is a clear-cut case of postoperative infection.”

DTE has accessed seven post-mortem reports. Five of these are of women who died on November 11, one of a November 12 victim and one of November 13. All five reports from the first day showed infection of the abdomen. The report from the second day showed high infection in the body. The report from the third day showed septic shock.

“This shows the infection kept increasing among women who were sterilised on November 8. The results show definitively that the women got infection which must have come through unsterilised instruments,” says a forensic expert at Lady Hardinge Medical College in Delhi.

The administration’s beautifully crafted story of contaminated medicines collapses. The women were prescribed one tablet each of two medicines, twice a day for five days. One of the medicines was the antibiotic ciprofloxacin, which the administration claimed was contaminated with rat poison, zinc phosphide.

Zinc phosphide is linked to kidney failure. “We did not get any renal failure in our post-mortems,” informed the source. He said the infected laparoscope must have been the reason for the deaths.

As the forensic expert in Delhi explains, zinc phosphide poisoning shows up as ulceration of the gastrointestinal tract. The source confirmed that signs of this were missing in post-mortems. However, confirmation of poisoning can only be through viscera report, which is awaited.

The health department’s second assertion too falls flat. It said apart from the women who underwent sterilisation operations, 26 more people fell sick after consuming the same medicine. Six of them died.DTE accessed the post-mortem reports of three of the six. “There was no peculiar finding in their post-mortems. These can only be confirmed after the chemical analysis of viscera,” said the source.

Though the officials claim that medicines are the culprit, they refuse to provide the details, saying the matter is sub judice. The only information they are ready to part with is that two laboratories have confirmed that the medicines were contaminated with zinc phosphide. They would not say what was the concentration of the contaminant.

Experts do not believe this theory. “According to standard books, an adult female needs to consume 4.5 g of zinc phosphide to die,” says B L Chaudhary, from the Department of Forensic Medicine and Toxicology at Lady Hardinge Medical College. The Chhattisgarh administration claims that 500 mg tablets of the antibiotic were contaminated. For the sake of argument, even if one assumes that the entire 500 mg was zinc phosphide, a woman would have to consume nine tablets for the poison to prove fatal. Most women started to complain from Monday. By this time, they had taken three to five doses of the antibiotic. This casts doubt on the poisoning argument.

Citing some of these gaps, this reporter asked the officials about an alternative line of investigation. “This seems quite conclusive to us. We are not looking at any other theory. The rest, the lab reports and other tests will tell,” said Tamboli of NRHM.

The state government has set up a one-member judicial commission to investigate the deaths. It has to collect testimonies of the survivors. But the commission seems to have placed the responsibility of reporting grievances on the survivors. People wishing to give testimony will have to visit the commission’s office in Bilaspur city which remains closed most of the time. "It is impossible to understand how the poor, uneducated and sick women will travel to this place," says Sulakshana Nandi, Raipur-based member of Jan Swasthya Abhiyan, the India chapter of People's Health Movement.

The Bilaspur fiasco has also exposed irregularities in drug procurement. The much-maligned ciprofloxacin was purchased locally by Chief Medical and Health Officer (CMHO) R K Bhange. An official in the health department informed DTE that Chhattisgarh Medical Services Corporation Limited (CGMSCL) has written to at least one inquiry team, stating that the antibiotic stock was available with the authority on November 8.

“The CMHO has the discretion to buy medicines or procure from CGMSCL. Following good practice, he should have chosen the government agency, where the tenders are invited from companies that have been certified by accredited labs,” said the official.

“It was a double whammy for the women. The tragedy happened due to multiple reasons. Firstly, the operations were conducted in pathetic and absolutely unsafe conditions, leaving the women medically vulnerable. Then they were fed contaminated medicines,” says T Sundararaman, founding director, Chhattisgarh State Health Resource Centre and faculty, Jawaharlal Nehru University (JNU), Delhi. "All these factors should be investigated by an independent team. The state should be held responsible for bungling on all the fronts."

Things don't change

The manner in which the operations were conducted paints a disturbing picture. It resembles a scene straight out of the documentary on sterilisation, Something Like a War, by Bengaluru-based filmmaker DeepaDhanraj, where a gynaecologist boasts:

This year, I have done more than 2,000 operations. I could do these in school classes, college rooms and zilaparishad halls. These operations are so easy. [A woman moans in severe pain in the background.] I thought of this particular method and I took 45 minutes for the first operation... Now, I can finish this operation in 45 seconds.

This was 1991. Cut to 2014. Like the gynaecologist in the film, R K Gupta, operating surgeon at Takhatpur, performed surgeries like an assembly line (see ‘Evil of efficiency’). He was awarded by the state government on January 26, 2014, for a record 50,000 surgeries in his career.

Accounts of healthcare providers at the Takhatpur camp show gross violation of the 2006 guidelines, Standards for Female and Male Sterilisation (see `Flouting of norms on November 8’). Even basic medical ethics went for a toss. According to the accounts, women started coming to the camp from 10.30 am. Their blood and urine tests were conducted by junior doctors. It was only at around 3.15 pm that R K Gupta came and he was gone by 5.00 pm after operating 83 women, giving less than one-and-a-half minutes to each woman. The same syringe and suture needle were used for all the women. The staff did not even change their gloves. The hospital floor was just mopped, on which the operated women lay down in the absence of beds. “This is a sure-shot recipe for fatal infection. The women could have acquired infection at any stage,” says Subha Sri, member, Common Health, a non-profit working on maternal and neonatal health.

Flouting of norms on November 8   What happened at the camps and what should have happened   Event at the camps 83 women sterilised One doctor sterilised them all Each woman sterilised in one to one-and-a-half minutes One laparoscope used No woman knew of the side effects Nemi Chand Jain hospital was shut since April No woman knew of other methods of avoiding pregnancy Operation theatre was cleaned with a mop Guidelines of 2006 Only 30 persons to be sterlised in one camp One doctor cansterlise only 10 in a day Prescribed standards would take an average of 5-6 minutes per case Three laparoscopes to be used for a maximum of 30 patients Women should be counselled about side effects Camp should be conducted in a working hospital Women have to be counselled about contraceptives and IUDs The operation theatre should be fumigated thoroughly by burning formaldehyde tablets and liquid ammonia 48 hours before the surgery

India has always leaned heavily on sterilisation, neglecting other methods of birth control

On being asked if she knows about spacing methods like intra uterine device (IUD) or contraceptive pills, Takhatpur survivor Rina Patel answered in the negative. She also said that no one counselled her at the camp about side effects and post-operation precautions after sterilisation. (See ‘Sterilisation overdrive’.)

Overemphasis on sterilisation has its roots in the policy followed by India since 1952 when it became the first nation to adopt an official family planning programme. A United Nations Advisory Mission visited India in 1965 and persuaded the government to fix targets for widespread use of IUDs. The next year, the government set up a department of family planning within the health ministry. While IUDs did not become popular, India embarked on a target-driven, camp-based approach. Incentives in the form of money and goods like transistors were offered to sterilisation candidates.

The first camp was organised in 1970 in Ernakulam, Kerala, for vasectomies. Other parts of the country followed and in 1970-71, nearly 1.3 million vasectomies took place in India. During Emergency, scores of men were coerced into vasectomy. Addressing the joint conference of the Association of Physicians in India in January 1976, then prime minister Indira Gandhi said, “We must now act decisively and bring down the birth rate...Some personal rights have to be held in abeyance for the human rights of the nation.” Nearly 6.5 million men were sterilised by the end of 1977.

Gandhi had to pay a price after 1,774 sterilisation-related deaths and her party lost the elections after the Emergency. “The lesson learnt was: don’t touch the men. And then, the focus shifted to women,” says Mohan Rao, professor of public health at Jawaharlal Nehru University in Delhi.

The department of family planning was also renamed department of family welfare to make it sound more agreeable. Following a spurt in female sterilisations and irregularities in operations, the ministry issued guidelines for sterilisation. By the late 1990s the expenditure on family planning overtook the health budget (see ‘Skewed Investment’). "It is a lopsided priority," says Rao. "Better health will help control birth rates, too. Healthier people, especially children, will mean low infant mortality rate, encouraging people to reproduce less."

The National Population Policy of 2000 discouraged targets. But in reality it is targets that hold sway. The target for Takhatpur block, which has 39 sub-centres, for 2014-15 was 2,121 sterilisations, including 1,800 women, explains Poonam Muttreja, executive director of the national non-profit, Population Foundation of India, that recently released a fact-finding report on the Bilaspur deaths. It was further divided among local health workers, so the average target for female sterilisation per worker was 46.

By the time each state's budget is decided under National Rural Health Mission (NRHM) and the money reaches the block, half the year is lost. As a result, most of the camps are crammed into a narrow period of October to February. The camp approach is being questioned after the Bilaspur tragedy in the new guidelines on sterilisations to be released in 2015.

Incentives continue to be the norm. A letter by NRHM issued in October says that family planning is crucial to meet Millennium Development Goals. Citing the Family Planning 2020 document, it explains that the recently computed global goals also underline the importance of sterilisation in family planning. It, thus, revised compensation for sterilisation—from Rs 600 to Rs 1,400 for each sterilisation candidate, and from Rs 75 to Rs 150 for the surgeon. The budget for each sterilisation was doubled from Rs 1,000 to Rs 2,000. The revision made tubectomy a lucrative option for surgeons, luring them into the number game.

The role of foreign agencies

International agencies too have played a role in shaping India’s policy. In 1952, international agency Ford Foundation gave $9 million to India for family planning. When Indira Gandhi spoke of national rights over personal rights, she was under instructions from the World Bank to bring down India’s population growth if the country wanted food for its hungry.

From 2007-2012, India’s family planning was primarily funded by USAID, World Bank and Department for International Development of the UK government. They contributed $1 billion. The funding came under attack in 2012, after sterilised women of a camp in Bihar’s Araria district complained to the police of irregularities. At present, family planning is funded only by the Indian Government.

But international agencies continue to influence policies of the developing world. In November this year, pharma major Pfizer and non-profits Bill & Melinda Gates Foundation (BMGF) and Children’s Investment Fund Foundation announced expansion plans for injectable contraceptive, Sayana Press. This is part of BMGF’s $1 billion project on population control. Sayana Press is made of the same chemical as Depo Provera, medroxyprogesterone acetate. Depo Provera has been criticised for adverse health impacts. “Side-effects of Depo Provera include heavy bleeding, amenorrhoea, depression, weight gain, breast tenderness, bone thinning, liver damage and cancers,” says Subha Sri of Common Health.

BMGF is sponsoring trials in Africa to see if it is practical for women to inject themselves. “This makes it scarier. If self-administered, the hazards include increased chances of HIV transmission,” says Sri. Though India has not yet been mentioned by Sayana Press’s promoters, it is a matter of time before the discussions begin, experts think.

Analysts believe the reasons for international agencies’ interest in developing countries’ populations are much deeper. “Population policies shift the blame for poverty, climate change and food crises on to the poor and suggest that existing development models which benefit corporate capital and which are intensifying poverty and inequality don’t need to be changed,” says Kalpana Wilson, who teaches at the Gender Institute, London School of Economics.

The Bilaspur tragedy calls for an overhaul of policy on reproductive health

Since the the tragedy in Chhattisgarh, doctors, policy-makers and public health experts have been trying to find ways to avoid a repeat. A team of doctors from AIIMS in Delhi went to Bilaspur to help the doctors there provide the best treatment to the ailing women. Teams of non-governmental organisations too went on fact-finding missions. The state government has set-up a judicial inquiry, as well as a health department probe while police investigates the case. While the probe reports are yet to be released, public health experts and other concerned people have suggested some short-term and long-term solutions.

Asking for the operations to be shifted from camps to proper health facilities, Brinda Karat, former member of Parliament and a prominent voice on women's issues, said, “The choice of whether to reproduce, method of birth-control and time should rest with the individual. Sterilisation as an individual’s choice has to be provided in a proper health facility through the year.”

Consensus among the experts is that in the long-term India needs a thorough review and overhauling of its family planning programme. An overwhelming demand is to stop using monetary incentives to attract people to unsafe family planning practices. Target-based sterilisation must end. Instead of camps, family planning programmes should be available as part of regular healthcare services. It has to be ensured that women alone are not targeted for sterlisation and a basket of contraceptive methods is made available to families. They demand that the women in Bilaspur be provided justice and their healthcare needs be met. They also suggest that government doctors be trained to carry out such surgeries safely. In the light of the alleged role of contaminated medicine, experts suggest that drug procurement policies should also be reviewed.

It is being pointed out that the rate of population growth in India has now decreased and the anxiety for speedy population control must stop. According to census of India, the decadal population growth from 2001-11 came down to 17.6 per cent. It remained above 21 per cent for the preceeding five decades.

“There is a concept called population momentum. It means that population is growing because of a large number of people in the reproductive age group. So, even if they have two to three children only, population growth will be high. We can’t do anything about it," Rao says. Around 60 per cent of the population growth today is due to population momentum, 20 per cent due to unmet demand of family planning services and 20 per cent is due to unwanted reproduction, according to a Planning Commission report. Still, India continues to spend a large part of its population control budget on sterilisation (see ‘India’s lopsided approach’).

This iterates the need to give up the camp approach to family planning. “The goalpost of the family planning debate has shifted. Now women themselves seek family planning services. They do not want more than two-three children. We have to see to it that their demand is met,” says T Sundararaman, founding director, Chhattisgarh State Health Research Centre. Integrating family planning with the rest of the public system would remove the need for incentives to meet targets. “We do not need separate camps. The government can fix one day a week when a laparoscopic surgeon would be present for sterilisation,” he says.

The main challenge is shortage of trained surgeons. “Bilaspur has two surgeons in the district hospital who are trained in laparoscopy. These surgeons perform other surgeries too. How can we start a weekly service?” asks S K Nanda, superintendent, Bilaspur District Hospital. To this, Sundararaman suggests training more doctors.

Alok Banerjee, member of technical committee on family planning of Government of India, says that minilaptubectomy should be encouraged. "It is a simple and inexpensive procedure. While laparoscopy requires high competency, this can be learnt faster. Also, equipments for minilaptubectomy cost a few thousand rupees, while one laparascope costs Rs 10 lakh. Its success rate is also higher. It is not promoted because even a trained surgeon would take 10-15 minutes to perform one surgery. But it is time we cared for meeting demands and providing safe operations than rushing to sterilise more people," he says.

Jashodhara Dasgupta, convenor of National Alliance for Maternal Health and Human Rights, says it is disappointing that India has not been able to provide basic human rights to women. A pledge to ensure this was taken 20 years ago. In 1994, at the UN conference on population and development held in Cairo, a 20-year action plan was adopted. This action plan asked countries to consider women’s needs instead of blindly following demographic demands when planning population control strategies.

Basket of different options for sterilisation also includes male sterilisation which does not receive any focus. Apart from the fact that women are seen as easy target for motivation to sterilise, awareness is also an issue. "Vasectomy is surrounded by many myths like impotency. Government should create awareness and motivate more men to opt for it," says Sri.

A report by a fact-finding mission says that the tragedy in Chhattisgarh was waiting to happen. In 1974, Karan Singh, the then health minister had declared: “development is the best contraceptive”. This was ignored at that time. The time has now come to understand this basic concept.

`Phase out the camps'   Alok Banerjee,a member of the technical committee that is redrafting the 2006 guidelines on family planning, spoke to Down To Earth about the impact of the deaths. Excerpts   What challenges does India face in family planning? There is non-adherence to national standards and guidelines. The camp sites are not cleaned properly, patients are not screened by surgeons and many other violations are rampant. Quality of drugs, their procurement, storage and supply are also compromised. Would the Bilaspur deaths impact the new family planning guidelines? Indeed. Earlier, the new revised guidelines were to be released on November 18-19. Now, they would be released in 2015. According to the proposed guidelines, doctors are to be trained for sterilisation at MBBS level. More emphasis is to be put on spacing methods. Having a counsellor at district hospitals and community health centres would be made mandatory. Did your Bilaspur visit force a rethink on any suggestions you were planning to recommend in the committee? I will see to it that strong emphasis is placed on phasing out the camps. Also, I will ensure more focus on minilaptubectomy. What is the way forward? If we can successfully implement the position of counsellor in public health facilities and ensure proper follow-up care, then long acting hormonal methods like injectables, implants and vaginal rings can be introduced. In any case, spacing methods have to be widely promoted.