#India – Mental Health Care Bill cleared by Cabinet


Music and Mental Health

The Union Cabinet  cleared the Mental Health Care Bill, 2013 that makes access to mental health care a right of all persons

Submitted on Fri, 06/14/2013 – 16:55

The Union Cabinet on Thursday cleared the Mental Health Care Bill, 2013 that makes access to mental health care a right of all persons. Such services should be affordable, of good quality and available without discrimination, it said. The proposed law decriminalises suicide.

The Bill, in consonance with international laws, has the provision of Advance Directives — described as a progressive and far-sighted step. No person who has recorded an Advance Directive to State that he or she should not be admitted to a facility without consent can be so admitted.

A rights-based Bill also has a provision wherein a person with mental illness can appoint a nominated representative to take decisions for him or her. Under the provisions of the Bill, government has an obligation to provide half way homes, community caring centres and other shelters for mentally ill people. This has been planned under the District Mental Health Programme in the 12th Plan.

In 2005, the National Commission on Macroeconomics and Health reported that 10-12 million or one to two per cent of the population suffered from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million or five per cent from common mental disorders such as depression and anxiety, yielding an overall estimate of 6.5 per cent of the population. The prevalence of mental disorders was higher among women, those who were homeless, poor and living in urban areas, Union Health and Family Welfare Minister Ghulam Nabi Azad told The Hindu.

The new Bill, once approved by Parliament, will repeal the Mental Health Act, 1987, which had vested extraordinary power in the hands of the treating psychiatrists. There was enough evidence of misuse and unscrupulous families collaborating with psychiatrists in addition to badly functional or non-functional Central and Mental Health Authorities primarily because of lack of funds.

Under the proposed new law, there is provision for voluntary admission with supported admission limited to specific circumstances; appeals can be made to the Mental Health Review Commission, which will also review all admission beyond 30 days and free care for all homeless, destitute and poor people suffering from mental disorder. The Bill provides right to confidentiality and protection from cruel, inhuman and degrading treatment, in addition to right to live in a community and legal aid. It bans the electric-convulsive therapy without anesthesia and restricts psychosurgery, Mr. Azad said.

He said the Bill tries to address the needs of the families and caregivers, and the needs of the homeless mentally ill. It provides for setting up Central and State Mental Health Authorities, which would act as administrative bodies, while the Mental Health Review Commission would be a quasi-judicial body to oversee the functioning of mental health facilities and protect the rights of persons with mental illness in mental health facilities.

Credit and Source: The Hindu

 

#Chattisgarh – Maoists do not “obstruct” government health programmes- Jairam Ramesh


Health services in Maoist areas a challenge and an opportunity: Ramesh

SUVOJIT BAGCHI, The Hindu

His letter to Azad acknowledges Maoists do not “obstruct” government health programmes

Union Rural Development Minister Jairam Ramesh, in a letter to Health Minister Ghulam Nabi Azad, has acknowledged that Maoists do not “obstruct” government health programmes.

Mr. Ramesh has defined delivery of health services to Maoist-controlled areas as an “opportunity” to reach millions of tribal people in the remotest areas of the country. However, government health workers and administrators cite Maoist intervention as a reason for non-delivery of health services.

In underdeveloped areas of Chhattisgarh, especially in Maoist-controlled districts, government healthcare is virtually non-existent. In most cases, primary health centres (PHC) are miles away from villages and people could hardly make it to the PHCs due to non-availability of transport, hostile terrain and extreme climatic conditions.

In addition, health workers rarely visit the PHCs due to what is perceived as “Maoist threat.” Even in a place like Chintagufa in Sukma district, next to a Central Reserve Police Force camp on the main arterial road, the health centre is only occasionally visited by health workers, the villagers toldThe Hindu .

Moreover, according to data released by the Chhattisgarh Health Department, a huge percentage of health workers’ posts are vacant across the State. For example, in Dantewada, 60 per cent posts are vacant. The situation is more or less the same in all tribal districts.

Interestingly, the National Rural Health Mission (NRHM) has also failed to fill the vacant positions announced by them. The demand-supply gap of health workers has been met by quacks and barefoot Maoist doctors, who provide basic health care to villagers.

Mr. Ramesh has said in his letter, a copy of which is with The Hindu , delivery of health services in Maoist areas is “both a challenge and an opportunity.” “It is an opportunity since the health programmes are not obstructed by the Maoists, and if delivered effectively, [it] has the potential to soften the local tribals’ attitude towards the government,” wrote Mr. Ramesh.

Mr. Ramesh has suggested to Mr. Azad to introduce some “flexibility” in the NRHM to deal with “health challenges” in Maoist areas. He has strongly recommended government support for four non-profit health organisations, which have done substantial work in central India. These are Ramakrishna Mission (RKM) in Narayanpur and Jan Swasthya Sahyog (JSS) in Bilaspur district of Chhattisgarh and the organisations led by Dr. Abhay Bang and Dr. Prakash Amte in southern Maharashtra.

He feels the NRHM should not only be used “to support existing institutions,” but also to create “new [health] networks,” and, therefore, “such organisations” should be supported under the NRHM.

 


  • In underdeveloped areas of Chhattisgarh, government healthcare is non-existent
  • Health workers rarely visit PHCs in remote areas due to perceived ‘Maoist threat’

 

#India- Clinical Trials offer no security to clinical trial participants


 


Trial and error

Author(s):
Kundan Pandey
Issue Date:
2013-4-15

Recent notifications offer no security to clinical trial participants

Trial and errorVICTORIn the past eight years, 2,868 deaths have occurred during clinical drug trials across India. But only 89 have been attributed to such trials and compensation has been paid in 45 cases, said the Union health minister on March 5 in Parliament. Considering the Supreme Court’s recent observation that uncontrolled clinical trials “are causing havoc to human life”, Ghulam Nabi Azad’s speech only highlights the poor state of regulations for clinical drug trials.

To tighten guidelines for conducting these trials, the health minstry had amended the Drugs and Cosmetics Rules by passing three not ifications between January and Febr uary. The notifications specify procedures for compensation and functioning of the ethics committee, which is constituted by an institution conducting the trial.

Health activists say the notifications are rife with loopholes. The first one deals with compensation in case of injury or death during clinical trial but the onus of deciding the injury continues to be with those carrying out the trial. S Srinivasan of All India Drug Action Network says, “The notification does not define injury. How does one  prove that an injury is related to the trial? Who is the appellate body in case the compensation is not satisfactory?” Amar Jesani, editor of Indian Journal of Medical Ethics, says it is important that arbitration boards are created at local and regional levels to arbitrate on the quantum of compensation a provision that was present in the draft but is missing in the notification.

Claiming compensation continues to be difficult. As per the first notification, the Drugs Controller Gen eral of India (DCGI) will be the final authority to determine cause of injury and compensation amo unt. There is a provision that the victim, if not satisfied with the compensation decision, can approach the Centre. How ever, it is not clear which Central body should be approached. In the abs ence of an appellate body, the final auth ority should have been a neutral body, say activists.

The first notification ensures that compensation is received within six months. But what if the pharma company does not agree with DCGI’s decision? If it approaches a lower court, the decision could get prolonged indefinitely.

sordid<br />
tale” src=”<a href=http://www.downtoearth.org.in/dte/userfiles/images/20130415_21-table.jpg&#8221; width=”237″ height=”257″ align=”left” border=”1″ hspace=”5″ vspace=”5″ />Activists say since the majority of the participants in clinical trials are poor, there should be provision that the aggrieved party can promptly approach the resp ective high court. This will fast track the case.

In view of the complications in obtaining compensation, activists have long been demanding that in case a participant starts showing signs of an adverse effect he or she be immediately paid half of the compensation. Although the draft had met this demand, the final version makes no such mention. Srinivasan says the compensation model needs clarity (see http://www.downtoearth.org.in/content/clinical-trialsillogical-compensat… [1]).

Another sphere where government efforts have fallen short is in defining the role of ethics and expert committees in the third notification. Jesani, who has participated in many ethics committees, informs, “The notification on ethics committees is in response to the criticism that they are not registered with public authorities and there is no supervision over them.” The notification, however, does not satisfy on two counts. First, there is no information on how the Central Drugs Standard Control Organisation, which oversees pharma companies and clinical trials, will manage since it is short of staff and low on funds, says Jesani. Secondly, he says, unless all ethics committees adopt a uniform procedure for monitoring trials, their decisions would become arbitrary. “They also need to be independent of their institution’s interests.” Similarly, the third notification does not define the constitution of the expert committee, which is tasked to recommend quantum of compensation to DCGI in case of death. “On what basis will the expert committee recommend has also not been defined,” says Jesani.

 


 

#India 436 deaths recorded during clinical trials last year


 

New Delhi |  March 12, 2013 5:06:02 PM IST

 

A total of 436 deaths were recorded during clinical trials in India in 2012, parliament was told Tuesday.

While 438 deaths took place during clinical trials in 2011, 668 people died during 2010, Health Minister Ghulam Nabi Azad said told the Rajya Sabha in reply to a question.

Out of the 436 deaths in 2012, 16 were caused due to the clinical trials, he said. Rest of the deaths might have been disease-related in the cases of terminally ill patients suffering from cancer, cardio-vascular diseases and AIDS or due to side effects of drugs administered during the trial.

Azad said compensation is paid in cases of deaths and injury which are attributable to clinical trials.

The Drugs and Cosmetics Rules, 1945 have been amended specifying the procedures to analyse the reports of serious adverse events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines, he added.

Indo-Asian News Service spc/vd/dg

 

 

 

#India- The Doctor Only Knows Economics #Sundayreading


Lucknow In a daze, a poor couple bring their sick child to a government hospital, holding up a drip bottle. For many like them, private hospitals are out of reach. Care at government hospitals is poor.
HEALTH: SICK & SOLDOUT
This could be the UPA’s worst cut to its beloved aam admi. Healthcare has virtually been handed over to privateers.

Not For Those Who Need It Most
Govt seems to have abandoned healthcare to the private sector

Diagnosing An Ailing Republic

  • 70 per cent of India still lives in the villages, where only two per cent of qualified allopathic doctors are available
  • Due to lack of access to medical care, rural India relies on homoeopathy, Ayurveda, nature cure, and village doctors
  • While the world trend is to move towards public health systems, India is moving in the opposite direction: 80 per cent of healthcare is now in private sector
  • India faces a shortage of 65 lakh allied health workers. This is apart from the nurse-doctor shortage.
  • According to World Health Statistics,  2011, the density of doctors in India is 6 for a population of 10,000, while that of nurses and midwives is 13 per 10,000
  • India has a doctor: population ratio of 0.5: 1000 in comparison to 0.3 in Thailand, 0.4 in Sri Lanka, 1.6 in China, 5.4 in the UK, and 5.5 in the United States of America
  • Fifty-six per cent of all newborn deaths occur in five states: UP, Rajasthan, Orissa, MP and Andhra Pradesh
  • Forty-nine per cent of pregnant women still do not have three ante-natal visits to a doctor during pregnancy
  • An estimated 60,000 to 100,000 child deaths occur annually due to measles, a treatable disease
  • Uttar Pradesh, the most populated state in the country, does not have a single speciality hospital for cancer
  • The top three causes of death in India are malaria, tuberculosis and diarrhea, all treatable
  • The WHO ranked India’s public healthcare system 112th on a roster of 190 countries
  • Post-independence India’s most noteworthy achievement in the public health arena has been the eradication of polio and smallpox

Affair of the states

***

India is taking firm steps to a certain health disaster. All of 80 per cent of healthcare is now privatised and caters to a minuscule, privileged section. The metros are better off: they have at least a few excellent public health facilities,  crowded though they might be. Tier II and III towns mostly have no public healthcare to speak of. As the government sector retreats, the private booms. In villages, if you are poor and sick, no one really cares, even if the government pretends to. You go to the untrained village “doctor”; you pray, you get better perhaps; all too often, you die of something curable. “India is the only country in the world that’s trying to have a health transition on the basis of a private healthcare that does not exist,” Amartya Sen said recently in Calcutta. “It doesn’t happen anywhere else in the world. We have an out-of-the-pocket system, occasionally supplemented by government hospitals, but the whole trend in the world is towards public health systems. Even the US has come partly under the so-called Obamacare.”

Sadly, even the few initiatives the Indian state takes are badly implemented. Hear the story of Suresh, 45, who lost his younger sister to cancer, eight months ago. He’s a guard at the guesthouse of a pharmaceutical company in Mumbai and could not afford her treatment, so he sold some ancestral farmland in Gujarat. That money covered but a few months of bills from a private hospital. He then turned to a government hospital, but it didn’t have cancer care. It didn’t help in any way for Suresh that he worked for a pharmaceutical company: his job didn’t come with medical benefits. “We brought her back home, hoping that if we saved on the hospital bills, we would be able to buy her medication. Finally, the money I had was too little to provide her basic help. Maybe if I had been able to buy her medicines, she would have been alive today.”

But the state could have ensured that Suresh’s sister lived had he been able to utilise the ambitious health insurance scheme announced in Maharashtra in 1997. The Rajiv Gandhi Jeevandayee Arogya Yojana (RGJAY) is on paper supposed to provide for 972 surgeries, therapies or procedures, along with 121 follow-up packages in 30 specialised categories. It provides each family coverage of up to Rs 1.5 lakh in hospitalisation charges at empanelled hospitals. It even allows for treatment at private hospitals. But poor implementation has ensured Suresh and hundreds of families like his do not know of such a scheme. This is true of other schemes across the country too.


Photograph by Vivek Pateria
Bhopal At the Sultaniya Hospital, as at many hospitals in the Hindi belt, there just isn’t enough space for the patients who turn up. Those who attend on patients routinely brave the open.

Meanwhile, health statistics are terrifying. More than 40,000 people die every year of mosquito-borne diseases, which are easily preventable; a maternity death takes place every 10 minutes; every year, 1.8 million children (below 5 years of age) die of preventable diseases. “We are the only country in the world with such a huge percentage of privatised healthcare. Recent estimates suggest that approximately 39 million people are being pushed into poverty because of high out-of-pocket expenses on healthcare. In 1993-94, the figure was 26 million people,” says Dr Shakhtivel Selvaraj, a health economist.

So the state’s pretence of reaching out to the poor is really quite a farce. Consider what’s been happening between the Planning Commission and health ministry. In November, the battle between then health minister Ghulam Nabi Azad and the Planning Commission came to light: Azad had pressed for increased spending on the public sector while the commission was intent on increasing private participation. This was a telling comment on the priorities of the UPA government. But with the 2014 elections in view, the government would like to present “health reforms” as a political tool. A framework for “universal health for all” is expected by April this year.

 

While talking always of the aam admi’s needs, the UPA has been handing healthcare over to the private sector.

According to the draft of the 12th Plan, the government will increase spending on health from 1.2 per cent of the GDP to 1.9 per cent, with greater emphasis on public-private partnership. While the expert group asked for scaling up public funding from the current 1.2 per cent of GDP to roughly 2.5 per cent by the 12th Plan-end (2017-18) and to roughly 3 per cent by the 13th Plan-end (2023-24), the government only relented a bit—enough to give it room to announce more populous aam admi schemes. D. Raja of the CPI believes that “through PPP (public-private-partnership), floated in the 12th Plan, the government is working as facilitator for private sector”, something that goes against the constitutional mandate of a welfare state. Former health secretary Sujata Rao says the state “cannot co-opt the private sector to provide healthcare for which government is paying money without framing stringent rules and norms.” More than 70 per cent of expenditure on health in the past five years has come from households. In its nine years in power, the UPA has overseen the shrinking of the public sector and the boom in the private. All the while, it has paid lip service to aam admi causes—even as it pushes people from the margins into the wilderness. In those five years, the well-to-do have obtained better healthcare than ever before. Both the Congress and the BJP have said in their party manifestos that they want to make India a “health tourism” destination. That has already happened. Would the UPA, champion of the aam admi’s interests, pat itself on the back for that? Meanwhile, most private facilities ignore a Supreme Court directive to reserve a certain percentage of their beds and treatment for the poor because they were given land at concessional rates. 

Barely 100 km from the national capital, the Kosi Kalan district of Uttar Pradesh, near Mathura, presents a pathetic picture of community health care. Four months ago, the primary health centre, which caters to more than 50,000 patients with two trained nurses and two doctors, was upgraded into a community health centre with a new building. However, doctors haven’t been posted at the new centre. Says Rajkumar, a doctor at the primary health centre, “We got the new building about four months ago. We are waiting for administrative sanctions”


Photograph by Tribhuvan Tiwari
Gurgaon Subedar Gupta (right) has spent about Rs 30,000 at private hospitals for his wife’s treatment in one month. He feels the hospitals have made her undergo unnecessary tests.

It’s a familiar tale of rural India. But what is also significant is that in the post-liberalisation era, the government health sector has virtually vanished from Tier II and III urban centres. Subedar Gupta, 32-year-old commercial vehicle driver from Gurgaon, has discovered that the government sector is an empty shell. It’s the private sector that has fleeced him. His wife Chanda Devi has been complaining of severe bodyache, itching and weakness for the last five years and no one knows why. Gupta spent about Rs 30,000 last month at private hospitals. He is now broke. “They ask us for same tests—blood test, X-rays and ecg. She is continuously on medicines. They are sucking all the money out of us.”

 

In Tier II and Tier III towns, the public healthcare system is non-existent. Even the private hospitals here are inadequate.

Millions of Indians living in small towns go through the same agony–not knowing where to turn to in the absence of a good health system. Because of that, thousands travel to Delhi’s overburdened AIIMS and Safdarjung Hospital, which are staffed with excellent doctors. The rest just pay for a private system designed to extract the maximum from each patient. “Public health is a big question in small cities. They have government hospitals, which are not well-equipped—in terms of infrastructure or adequate numbers of doctors and other staff.  There is also a shortage of woman doctors,” says Dr Rajesh Shukla, a consultant who has evaluated icds programmes in rural areas and studied medical care in small towns. 

A large number of swanky hospitals and clinics have come up in urban India. But that does not ensure good care. There is also the issue of all this being loaded in favour of a profit-seeking system. Take the Rashtriya Swastha Bima Yojna, a government-supported health insurance scheme that rides on the private sector to provide medical care and surgical procedures at predetermined rates. Experts point to the dangers of induced demand and the prescription of unnecessary procedures to claim insurance benefits. Besides, the technology at private centres is often used to fleece patients rather than help them.

Dr Subhash Salunke, former director-general of health services, Goa, and currently director of the Public Health Federation of India, says the private sector is very scattered and unregulated, leading to lot of malpractices. This could have been checked to some extent had rules of the Clinical Establishment Act, 2010, been framed and implemented. Two years after the legislation was passed by Parliament, it hasn’t been implemented. The problem lies with the “stiff resistance from the private sector to the laying down of guidelines”.


Photograph by Sandipan Chatterjee
Calcutta Nomita Pramanik, a domestic help, has asthma. She earns Rs 2,800. A hospital visit costs Rs 250-300. She calls free treatment at government hospitals a “curse even enemies shouldn’t suffer”.

The health sector is also crippled by a shortage of doctors and nurses (see graphic). So when the government says it is serious about training more doctors and nurses, by setting up six new AIIMSes, it makes for sound planning. But politics quickly shows up: one of the AIIMSes is planned in Sonia Gandhi’s constituency, Rae Bareli. Many doctors trained in excellent government medical colleges swiftly move to the private sector; they are even reluctant to take up rural jobs or postings. “Of the 1,400 doctors appointed after a proper selection process, only 900 joined the service,” disclosed a spokesman of the Uttar Pradesh health directorate. Because of the shortage of doctors in government hospitals, the National Rural Health Mission (NRHM) had started to recruit those trained in the Ayurvedic, Unani, Siddha and homoeopathic streams, but the process was stalled by a Rs 5,000 crore scam.

So the poor continue to suffer. In a general ward of Krishnanagar Hospital in Nandia District, West Bengal, members of a patient’s family say that not a single doctor checked their ward for 24 hours after he was admitted with a cerebral condition. The doctor assigned to the hospital, who was in his chambers some 10 km away, had this to say when tracked down by Outlook, “I’m the only doctor for close to 500 patients. Is it possible for me to visit each and every patient? You have to understand my constraints. There is very little monetary incentive for doctors working in the rural areas. These are punishment postings. No one wants to come here. They want to work with rich patients and earn big money.”

As he spoke, there were close to 100 patients waiting in the visiting room to see him. They were all from the villages and small towns in Nandia district. Krishnanagar Hospital is the main district hospital and patients from all over Nadia are referred to this hospital. In Uttar Pradesh, modern private health services have yet to reach beyond a dozen key cities. The rest of the state has to depend on these 12 cities, a handful of which have facilities for tertiary care. Some facilities are available only in Lucknow, where the government has concentrated all the healthcare while the rest of the sprawling state—75 districts—goes without even secondary care. According to the NRHM’s fourth common review mission report, of the 515 community health centres in Uttar Pradesh, 308 were below norms laid down in the Indian Public Health Standards.

 

Andhra’s Rajiv Aarogyasri scheme, a brainchild of YSR, sounds perfect on paper. Only, the rich end up misusing it.

Even in states that are economically better off, such as Andhra Pradesh, it is an abject tale. Right from Seetampeta in north Srikakulam district to Utnoor in Adilabad, the public healthcare system is in a shambles. Adivasis simply have no access to potable drinking water and succumb easily to totally preventable diseases. If it’s gastroenteritis in Adilabad, it’s malaria in Paderu Agency of Visakhapatnam district. Anti-larval spraying operations are late and haphazard. Community health workers are badly trained. Human rights teams which visit these areas say the medicines provided are sometimes past the expiry date. “Deaths due to malaria are sought to be passed off as due to other diseases like cancer, heart stroke, old age or TB,” says V.S. Krishna of the Human Rights Foundation. Once touted as a model state for implementation of health insurance, Andhra Pradesh today faces a problem where the scheme is being misused by the rich. A qualified doctor himself, the late YSR, former chief minister of Andhra Pradesh, launched the Rajiv Aarogyasri Scheme in 2006, providing medical cover of up to Rs 2 lakh for bpl families. Since corporate hospitals handle a bulk of the procedures, the scheme is misused. Says a cardiac surgeon at a leading Hyderabad hospital, “The rich come and seek heart procedures under Aarogyasri, casually whipping out white cards meant for bpl families. There are no checks.” 

The ailments of the poor often have nothing to do with the agendas of rich and powerful pharma companies. Are there lessons India can learn from the world? Experts say that the US has one of the worst public healthcare systems in the developed world. But in most countries, in Latin America or Europe, universal healthcare been achieved through governments. In Asia, Sri Lanka and Thailand can teach India some lessons on the health front. So India may be a powerful nation simply by dint of its size and market. But it is also a ‘sick’ nation, where there’s no help for the poor when they fall sick. It’s a country where a poor man can die on the pavement outside a gleaming state-of-the-art hospital with the best medical technology in the world.


By Amba Batra Bakshi & Lola Nayar with Sharat Pradhan, Madhavi Tata, Dola Mitra, Panini Anand, Chandrani Banerjee, Prarthna Gahilote and Prachi Pinglay-Plumber

 

India -Supreme Court warns it can ban clinical trials


Published: Tuesday, Oct 9, 2012, 8:24 IST
By Rakesh Bhatnagar | Place: New Delhi | Agency: DNA

 

Distressed at the rampant misuse of the practice of clinical trials by negligent doctors and drug companies that have killed 1,954 patients since 2009 in the country, the Supreme Court has asked the Centre and various states governments to reveal the truth behind such gruesome tragedies.

Expressing anguish at the sordid affairs in the private and government hospitals including mental hospitals, a bench of justice RM Lodha and justice AR Dave on Monday also asked Union government to inform about the side effects of these trials and whether the close relatives of victims had been adequately compensated.

During the inconclusive hearing in a PIL filed by an NGO Swasthya Adhikar Manch alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs, the court said “we are very serious about this matter’’.

“We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith. It must suffice, we are very serious about it,” judges told additional solicitor general Siddharth Luthra.

Responding to an earlier direction, the Madhya Pradesh government sought to put the record straight and said charge sheets have been filed against several private and government doctors who had been performing these tests illegally.

It has admitted that both private clinics and government hospitals had been indulging in the tests illegally.

However, it also drew the court’s attention towards Union health minister Ghulam Nabi Azad’s statement in parliament confirming deaths of 1,954 persons from 2009 till June 2012 due to “serious adverse events of death” in clinical trials. Azad also told the House that these deaths could be attributed to various reasons and the side effects of the drugs not ruled out.
Seeking blanket ban on clinical trials that were engineered by various pharmaceutical firms from India and abroad, petitioner’s counsel Sanjay Parikh contended that permission for trials were granted by the Central government without consulting the states.
However, MP’s lawyer Dushyant Dave said the states cannot be faulted for the tests.

But the judges pointed out that the clinical trials were conducted in state governments hospitals whose employees and doctors are under the control of the respective state governments.

Judges said there are reports about deaths due to clinical trials saying “one person is dying every day. Human beings are treated as guinea pigs. We do not know personally but we believe a responsible statement is made before the court’’.

In the public interest litigation, Parikh had said over 3,300 patients were used for the tests in Madhya Pradesh.

 

India- Govt to bring essential medicines under price control #goodnews


 

, TNN | Sep 28, 2012, 12.54AM IST

Govt to bring essential medicines under price control
Once these essential medicines are brought under Drug Price Control Order (DPCO), it cannot be sold at a price higher than that fixed by the government.
NEW DELHI: India will, for the first time, put a cap on the maximum price at which essential drugs, like some commonly used anti-AIDS and anti-cancer drugs, besides a horde of painkillers, anti-TB drugs, sedatives, lipid lowering agents and steroids, can be sold in the country.

In a landmark decision, a group of ministers (GoM) headed by agriculture minister Sharad Pawar on Thursday cleared the proposal to bring all 348 drugs on the National List of Essential Medicines (NLEM) under price control. These drugs, with annual sales of around Rs 29,000 crore, account for about 60% of the domestic market.

Once these essential medicines are brought under Drug Price Control Order (DPCO), it cannot be sold at a price higher than that fixed by the government.

The GoM, which included health minister Ghulam Nabi Azad, decided on a “weighted average price formula”. This means the average price of all the brands sold in individual segments with a minimum market share of 1% will be the maximum retail price now.

The GoM will send its recommendations to the Cabinet within a week for approval. “The proposal will now go to the Cabinet which will take the final view,” Pawar said.

Prices rose 40% in 10 years

At present, the government, through the National Pharmaceutical Pricing Authority (NPPA), controls prices of 74 bulk drugs and their formulations. Drug prices have shot up phenomenally in India over the past decade and a half. There was a nearly 40% rise in all drug prices between 1996 and 2006. However, during the same period, the price of controlled drugs rose by 0.02%, while those in the Essential Drug List (EDL) increased by 15%. The price of drugs that were neither under price control nor under the EDL grew by 137%.

Interestingly, experts say there could a small downside to the proposal. “Price of costly drugs will definitely come down. But because the formula will put a cap on the MRP, the price of drugs for the same ailment, which are presently sold at a lower price, will go up,” experts said.

Minister of state for chemicals and fertilizers Srikant Jena said, “The GoM arrived at a consensus on the option which entails the use of weighted average prices for all the drugs which have a market-share of more than 1%.”

The concept of essential medicines, first introduced by the World Health Organization in 1977, has been adopted by many countries including India.

The list includes the most cost-effective medicines for a particular indication. Essential medicines are those that satisfy the priority healthcare needs of the majority of the population. The list is specific to India and addresses the disease burden of the nation besides being the commonly used medicines at primary, secondary and tertiary healthcare levels.

The latest NLEM 2011 has 348 medicines which cover 489 formulations, including 16 fixed dose combinations. These drugs are considered to be adequate to meet the common contemporary health needs of the general population of the country.

Planning Commission panel had suggested that all drugs on the NLEM should be brought under price control since the cost of medicines constitutes over 60% of the total cost of healthcare of Indians. The commission’s report had said, “Taking advantage of lax regulations on drug pricing, the pharmaceutical industry has been able to reap high margins through complex price setting activities.”

It added, “It has been observed that the price of a therapeutically similar drug could vary around 1,000% between the most expensive and the cheapest brands. The variation between the market and procurement price of similar drugs could range anywhere between 100% and 5,000%. The panel recommends price control on all formulations in the EDL.”

The report said direct price control should be applied to formulations rather than on basic drugs.

A note prepared by the drug controller general of India and available with TOI says, “A total of 348 medicines excluding repetitions are present in NLEM 2011. In NLEM 2011, 181 medicines fall under the category of primary, secondary and tertiary use, 106 medicines fall under category of secondary and tertiary use while 61 medicines are categorized as tertiary use only. In comparison to NLEM 2003, number of medicines deleted is 47 and 43 medicines have been added.”

It added, “Out of the 348 medicines, 37 medicines are currently under prices control by National Pharmaceutical Pricing Authority.”

 

India- Free medicine scheme gets Rs 1,300 crore boost #rightohealth


Kounteya SinhaKounteya Sinha, TNN | Sep 20, 2012, 02.12AM IST

Union health minister Ghulam Nabi Azad has cleared Rs 1,300 crore under the National Rural Health Mission (NRHM) for states to support their purchase of medicines.
NEW DELHI: India has made its first major move towards providing free medicines for all.

Union health minister Ghulam Nabi Azad has cleared Rs 1,300 crore under the National Rural Health Mission (NRHM) for states to support their purchase of medicines. The largesse will not only help buy general drugs for government-run hospitals but also those needed under the Janani-Shishu Suraksha Karyakram (JSSK).

Under the JSSK, all pregnant women delivering in public health institutions are entitled to free and cashless delivery, free C-section, exemption from user charges, free medicines, blood, consumables and diagnostics and free diet for three days in case of normal delivery and seven days in case of C-section.

The minister has also asked the states to prepare a policy articulation document, an essential drugs list and standard treatment protocols and introduce a procurement system and supply chain management.

“States already have a budget to purchase drugs but it isn’t enough. The latest allocation is to support the state budget for 2012-13,” said a ministry official.

Officials said that states will have to procure drugs through an open tender. Companies applying for the tenders will have to have good manufacturing practices compliance certificate, a no-conviction certificate and should have a specified annual turnover. The drugs will also have to carry a not-for-sale label printed on the packaging.

The ministry says upto 75% of private out-of-pocket (OOP) health expenditure is on purchasing drugs of which 76% is spent on purchasing OPD drugs.

The free medicines for all the programmes are estimated to cost Rs 28,560 crore during the 12th five year plan.

At present, the public sector provides healthcare to 22% of the country’s population and it is likely to swell to 52% by 2017 once medicines are provided for free from 1.6 lakh sub-centres, 23,000 primary health centres, 5,000 community health centres and 640 district hospitals.

Planning Commission says 39 million Indians are pushed to poverty because of ill health every year.

Around 30% in rural India didn’t go for any treatment for financial constraints in 2004. In urban areas, 20% of ailments were untreated for financial problems the same year. About 47% and 31% of hospital admissions in rural and urban India, respectively, were financed by loans and sale of assets.

A ministry official said it is being made mandatory for all doctors in the public sector to prescribe generic drugs and salt names and not brands.

The Cabinet has approved the setting up of a Central Procurement Agency (CPA) for bulk procurement of drugs.

“Only a handful states will be able to roll out free medicines by this year end,” a ministry official said.

Strongly backed by Prime Minister Dr Manmohan Singh himself, the free-medicines-for-all scheme has been referred to as the “real game-changer”.

The ministry has sent the National List of Essential Medicines, 2011, (348 drugs which includes anti-AIDS, analgesics, anti-ulcers, anti psychotic, sedatives, anesthetic agents, lipid lowering agents, steroids and anti platelet drugs) to all the states to use it as reference to prepare their EDL.

Tamil Nadu has been providing free medicines in its public health centres for the past 15 years, while Rajasthan introduced it last October. Both these states have a corporation that runs the show with complete functional autonomy.

A Planning Commission panel had said drug prices have shot up by 40% between 1996 and 2006. It said that during the same period the price of controlled drugs rose by 0.02%, while those in EDL increased by 15%. The price of drugs that were neither under price control, nor under EDL grew by 137%.

States have cut down on spending to purchase drugs, adding to aam aadmi’s woes.

A study by the Public Health Foundation of India recently found that while India’s per capita OOP expenditure for healthcare costs has gone up from Rs 41.83 in 2005 to Rs 68.63 in 2010, the per capita spending on drugs increased from 29.77% to 46.86% during the same period, while hospitalization cost went up from 11.20% to 22.47%.

Outpatient expenditure also increased from 30.63% to 46.16%.

Catastrophic spending, or percentage of households spending more than 10% of their overall income on healthcare, is nearly 15% in states that have insurance in place as against 11% in those that don’t have such policies.

Times View

Indians spend heavily out of their own pockets to purchase out-patient drugs, so providing free essential medicines is a welcome move from the government. However, it will remain a meaningless gesture unless good-quality drugs are provided, doctors are monitored to ensure that they prescribe generic drugs rather than branded ones and states put in place a transparent procurement system and supply chain management.

Plan panel wants govt to retreat from healthcare #Goodnews


 

Nitin Sethi & Kounteya Sinha, TNN | Aug 8, 2012, 02.17AM IST

NEW DELHI: In a move that has angered the health ministry, the Planning Commission has asked for reversal of the long-standing public health policy from the 12th plan onwards ending governments’ dominant role in providing health services and transiting to greater privatization of the health sector, something along the lines of the ‘managed care’ system which is followed in the USand Mexico.The health ministry has taken a tough stance against what is referred to as “corporatization of health care” and will send a strong reply on Wednesday to plan panel deputy chairman Montek Singh Ahluwalia arguing that “the first priority should be to strengthen the public health system and involve the private sector only for critical gap filling”.

The letter from health minister Ghulam Nabi Azad says that “the private sector should not substitute but actually supplement the public sector”.

TOI accessed a draft, finalized at the end of July, of the 12th five year plan‘s health chapter which sketches the dramatic policy reversal that would bring in universal health insurance coverage by allowing a selected ‘network’ of private and other operators to sell their services on competitive basis to the government for which they would be paid on what the health industry calls ‘capitation’ basis or simply on fixed rates for different treatments for every person handled.

The plan panel’s prescription visualizes government’s role in delivering primary healthcare as restricted to mere essentials like antenatal care, leaving more lucrative medical treatment to the ‘managed-care’ system where private players will compete with cash-strapped government-run hospitals to run the ‘networks’.

The commission’s proposal runs contrary to what even its High Level Expert Group (HLEG) on health reforms had said as recently as November 2011.

The HLEG, headed by Dr K Srinath Reddy, had recommended, “Purchases of all healthcare services under the universal healthcare system should be undertaken either directly by the central and state governments through their departments of health or by quasi-governmental autonomous agencies established for the purpose.”

In other words, the HLEG recommended that health delivery services should be run by the government and where a need arises, the government can hire private hospitals for which they would be paid on fixed basis. Under this system, the private players would not be competing but filling the gap.

The HLEG went against the ‘managed care’ system that the Planning Commission has now recommended.

“It becomes necessary, therefore, to either explore a completely different approach towards the use of insurance companies and independent agents – more in the ‘managed care’ framework, where they take on explicit population level health outcome responsibilities or invest further in the capacity of the ministries and departments of health to directly provide and purchase services from contracted-in private providers wherever necessary. We favour the latter option,” the expert group had held.

HLEG will meet on Thursday to discuss the commission’s latest proposal.

Dr Reddy told TOI, “We have clearly voted for strengthening of the public sector. We will meet on Thursday to discuss where there is a mismatch between our recommendations and the commission’s proposal.”

He added, “We have clearly said that the public sector needs to be strengthened and should be the main provider of services under the UHC. Where needed, the private healthcare provider could be contracted to supplement these services through a well designed system. Both public and private providers should be monitored by an independent regulator for quality of care so that the entitlement under the UHC is properly delivered through technically competent and ethically correct health care.”

The health ministry, however, is livid. An official told TOI, “We should not forget the exploitation of patients that goes on in the private sector every day through over prescription and over diagnosis. The health challenges in India‘s urban and rural areas are completely different. The private hospital chains have no presence in such backward areas facing the worst health indicators. How will they perform there?”

The ministry is also worried that such a move by the Planning Commission will take away “the few doctors that are still practicing in public hospitals”.

“The National Rural Health Mission needs to be continued. We have invested huge amount of money and planning over the last seven years over it and are finally seeing results. A National Urban Health Mission needs to be floated for the urban poor,” the ministry said.

Sources said at stake in this controversial move is the health sector pie which is set to rise substantially as the government ups its investment in the 12th five year plan to Rs 10,85,369 crore.

At present, almost all health funds provided to states are part of the flexible arrangement to help states set public health priorities.

The Planning Commission has recommended that this be kept to a minimum of 10% of the total funds and the rest be part of an ‘incentive fund’ which will be linked to the state governments undertaking such ‘reforms’ and other targets. This would also effectively reduce the funds that the health ministry controls substantially.

Oddly, the Planning Commission’s report even misinterprets what the HLEG recommended and claims, “The expert group has recommended that we should move towards a system of a network of health service providers at the primary, secondary and tertiary level which is funded on the basis of per capita payment to the network. The system managed as a network of service providers and individuals is registered on payment of a charge per person covered. Once enrolled, the individual’s health problems are handled by the network as a whole, with proper regard to the need for preventive care and a sequence of care from primary to the higher level as needed.”

Times View

India’s healthcare system is already among the most privatised in the world and the last thing we need is a further retreat of the state in this sector.Far from reducing its role, the government should be focussing on increasing it.

Not only does it need to spend much more on building infrastructure like hospitals and primary health centres, it must ensure that these are adequately staffed and equipped.Of course, ensuring that the money spent is well-utilised is important, which also means constant monitoring of whether doctors and paramedical staff are actually present where they are supposed to be.

The immunisation programme too needs to boosted and urgently. These are not options but necessary steps because, like education, healthcare too must be seen as something all citizens are entitled to.

 

Letter to Dr. Manmohan Singh on Universal Access to Health Care


Contact address:
Flat no-1 B, Orient Manor

15, High Street, Cooke Town,

Frazer Town Post

Bangalore-560 005

Telefax-91-080-25461920, 25471680

 

To,

The Honourable Prime Minister,

Government of India

 

Copy to-

Mr. Ghulam Nabi Azad, Minister of Health and Family Welfare, GoI

Mr. Montek Singh Ahluwalia, Deputy Chairman- Planning Commission, GoI

Dr. Syeda Hameed, Member- Planning Commission, GoI

Mr. P.K. Pradhan, Union Health Secretary, GoI

 

Subject: Regarding Universal Access to Health Care.

 

Dear Dr. Manmohan Singh,

 

Janaarogya Andolana Karnataka (JAAK) is the Karnataka state unit of the global People’s Health Movement (PHM) and the national level Jan Swasthya Abhiyaan (JSA) and comprised of public health professionals, activists, progressive people’s movements and representatives of community-based organizations.

 

JAAK had a one day state level convention on 30.05.2012 in Bangalore to debate and discuss the various processes underway to roll out Universal Access to Health Care (UAHC) in the country.

 

While we appreciate your efforts to place health as an important agenda on the 12th five year plan, we would also like to express certain apprehensions following the publication of the PC-SCH report which we feel is not in the right spirit of a truly Universal Health care system.

 

We support the recommendations of the High Level Expert group with regard to strengthening the public health; primary funding through tax-based funding, abolition of user fees of all forms for accessing health care facilities and provision of free essential medicines for all. One more specific recommendation which we support is the advice against any forms of commercial insurance for organizing the healthcare in this country.

 

The subsequent PC-SCH report of February 2012 shows significant deviation from the vision of Universal Access to Health Care. Some of our concerns are as follows:

 

Essential Health Package (EHP) – The PC-SCH restricts the EHP to only Reproductive Child Health and the vertical programs. This would lead to exclusion of several medical conditions which contribute to significant mortality and morbidity in the country. Since one of the principles of UAHC is that healthcare services are arranged according to the needs of the community, curtailing these needs would defeat the spirit of universality. In addition to this, the PC-SCH proposes that the services additional to EHP should be purchased by the families from open market with “top-ups”. This is tantamount to encouraging user fees and we strongly denounce such a move to introduce user fees through other means. Given that one of the objectives of Universal access to Health Care is to reduce out of pocket expenditure (OOPE), ‘top-ups’ as proposed by PC-SCH will only aggravate OOPE leading to further impoverishment of vulnerable families. The UAHC model should involve comprehensive primary, secondary and tertiary care with the government as the provider of choice.

 

Financing of UAHC – The HLEG, while giving prominence to the public health systems

strengthening, had suggested that the public expenditure should be increased from the

present 1.2% of GDP to 2.5% of GDP by the end of 12th plan and to 3% of GDP by 2022 for the UHC system. We are now given to understand, even though not explicitly mentioned in the PC-SCH report, that there is a move to reduce this to 2.1% by the end of the plan and the Union contributing only 30% and the rest 70% expected from the states. Going by the financial situation that the states are in and also due to the fact that some of the revenue generating avenues for the states have got transferred to the Union, it would be unreasonable to expect the states to contribute to the UAHC system. This would also run counter to your own Independence Day 2011 pronouncement that funds would not be a constraint to the important areas of health and education.

 

Health insurance – We also strongly condemn the present Rashtriya Swasthya Bima Yojana (RSBY) model of financing the private and public providers on a fee-for-service basis. This would result in not only huge cost spiral and waste of precious public resources but only focus on some tertiary care further consolidating the dominance of private providers and weakening of the public provision. JAAK believes that private providers should never substitute public provision of health care services.

 

Additional Central Assistance (ACA) – We have noted with apprehension the proposed model by the Planning Commission to provide ACA directly to the District societies which has the potential of bypassing the Ministries of health and family welfare at both the union and the state levels (p24). We strongly oppose any such move as we strongly feel the leadership for UHC should come from the respective Health ministries.

 

Contracting in private services – The PC-SCH report points to making public health facilities compete with private providers while allowing for financial and operational autonomy. JAAK opposes the corporatization and privatization in health and other social services, whether at the planning, policy making, financing and provisioning of health care services and in all its forms including user fees, contracting-in, and public private partnerships.

 

Autonomy of district units – JAAK is deeply concerned with the drive towards making primary, secondary and tertiary health units autonomous and functioning as Societies. While operational autonomy (planning and day to day functioning) is desirable, these hospitals/ health centers should not have to raise their own funds or provided only conditional performance-based grants. Further, they should be accountable to district or local health authorities.

 

Regulation of the private sector – The PC-SCH report repeatedly mentions regulating the health sector including the private sector. We welcome this, but the report lacks the details for bringing about concrete and effective regulatory mechanisms. If this important piece of reform is left vague without giving sufficient attention and detail, we feel that it would be subjected to regulatory capture by vested interests. A strong regulatory structure must be set up for the private sector. This would cover hospitals, medical colleges, private practitioners, diagnostics labs and all other health providers. The private sector must be made more transparent and accountable.

 

Piloting in a single district – The PC-SCH proposes that to be eligible for the ACA, the states have to prepare a UHC plan along with a District Health plan; Frame standard treatment guidelines and to ensure its compliance; strengthen the program units both at the state and district levels; empanelment of private providers by means of a transparent selection system put in place; enhancement of community involvement in planning and management and development of a strong monitoring and evaluation mechanism. While these are all laudable objectives, it must be noted that most of these processes that have to happen at the state level at both systemic and legal levels. The states would have very little incentive to bring in all these reforms just for piloting in a single district. In the absence of these state level enabling reforms just piloting at the district level is bound to fail. Hence we urge that the piloting of these reforms must happen at the state level rather than a piecemeal approach of doing it at district level.

 

We also note with some concern that the states, which are largely responsible for healthcare services, are kept largely out of discussion. JAAK advocates for a central role for the government in stewardship, governance, financing, regulating and provisioning of health care services, with community participation in planning, implementing and monitoring of health care at all levels.

 

Keeping the above concerns in mind, we urge you to use your high offices to organize further consultations with all the stakeholders giving the Union Ministry of Health and Family Welfare the lead role in the larger interest of the health of the people of this country and to make your Independence Day pronouncement reach its logical conclusion.

In solidarity,
K B Obalesha, State convenor, JAAK, 9742586468, thamate2005@yahoo.co.in

Dr Gopal Dabade, MBBS, DLO, Chairperson JAAK 9448862270, drdabade@gmail.com