Tag: affordable healthcare

The Indian Pharma Industry Can Do Better Than Conspiracy Theories and Ad Hominem Attacks

In India, systems to study and document long term effects of poor quality medicines are sparse at best. Addressing structural issues within our supply chain is important.

Katherine Eban’s recently published book Bottle of Lies exposing the state of affairs in the generic pharma industry has received much critical acclaim from most commentators and critics who track the Indian pharmaceutical industry. The Indian industry and its lobbyists, who have rarely been subject to such minute scrutiny by the press, has been predictably lashing out at the book. Too often in the process, they end up making personal attacks on the journalistic integrity of the author without making any attempt to engage with her substantive reporting. One such example is Ashok Madan’s recent post, where he accused Eban of having a “prejudiced mind.” There are others on Twitter, making even worse insinuations.

Bottle of Lies
Katherine Eban
Juggernaut

These attacks against Eban’s work is in keeping with a playbook of the Indian pharmaceutical industry to deal with its critics. This playbook includes the threat of action for defamation, actually suing critics for defamation, the ‘anti-national’ argument and lastly to claim a conspiracy theory against the Indian industry. Let me illustrate each of these tactics with an example.

It is an open secret that the regulatory framework in India encourages two different standards of quality for medicines.

In 2012, Dr Chander Gulati, the editor of Monthly Index of Medical Specialties, was sued for criminal defamation, in Bangalore, for writing about a drug called Deanxit which was being sold in India despite being prohibited in Denmark which is the country of its origin. Since then, the safety of Deanxit has been the subject of discussion in a Parliamentary report on the CDSCO; the drug has been banned twice by the health ministry. Both times, bans were quashed by the Karnataka high court, on dubious grounds. I had filed a petition last year before the Delhi high court to get the drug removed from the Indian market and hopefully the sub-committee on DTAB will make such a recommendation soon.

In 2013, when Ranbaxy’s plea to seven counts of criminal felony for supplying sub-standard drugs to the US market was publicly reported, some Indian hospitals and pharmacies wanted clarity on their drug supply and asked the then government whether to continue with the purchase of drugs that Ranbaxy sold in India. It is an open secret that the regulatory framework in India encourages two different standards of quality for medicines. One set of manufacturing facilities make “export” quality; made to comply with CGMP and another, a much lower standard under the purview of Schedule M of the D&C Act for consumption in India. When the flag bearer of the Indian pharma industry was copping with a plea against making Not of Standard Quality (NSQ) drugs for its export market (the USA), these healthcare facilities were acting in the best interest of their patients. The official stance of the Indian government and the pharma lobby groups was to float a conspiracy theory, which alleged that the Indian pharmaceutical industry was being targeted by the American government to protect the American industry from competition from the industry in India.

Also read: How India Could Fuel the Global Synthetic Drug Epidemic

One set of manufacturing facilities make “export” quality; made to comply with CGMP and another, a much lower standard under the purview of Schedule M of the D&C Act for consumption in India.

In 2014, when a group of academics in North America, including Amir Attaran at University of Ottawa, published a working paper on the issue of quality of drugs sold by the same Indian companies to different countries, the Indian government threatened to sue the academics for defaming the Indian industry. As lawyer and scholar Gautam Bhatia explained at the time, such action was legally untenable.

In 2015, when a whistleblower at GVK Bio risked his life to expose the wrongdoings at the facility, the government and industry sold the media a story of a love story that had gone wrong.

In 2016, when I approached the Supreme Court through a PIL, the drug controller general of India basically insinuated that I was an “anti-national” because I sought to question the quality of Indian medicines before an Indian court. Since the court dismissed my petition saying my arguments were academic, the government of India has made bioequivalence and stability testing compulsory – I had raised both these issues in my PIL. After a second petition of mine was admitted by the Delhi high court, two of the drugs I had targeted in the original PIL before the Supreme Court have been banned or withdrawn by the companies in question. One can judge for themselves why these manufacturers would rather withdraw profitable drugs than litigate against my petition in the court. I had the best interests of patients in India at heart in both cases.

The drug controller general of India basically insinuated that I was an “anti-national” because I sought to question the quality of Indian medicines before an Indian court. Photo: Reuters/Srdjan Zivulovic/Files

I am sure there are more instances of others who have spoken up against the industry being painted as anti-national and libellous by Indian pharma lobbyists and the government. At the end of the day, I think it is up to journalists and editors to separate sense from nonsense and ensure that crucial issues do not get drowned out by these personal attacks and threats of defamation. We have seen this playbook in action way too many times before, and all I can say is it is all too predictable.

Arguments that generic drugs make healthcare affordable, that the Indian industry played an important role in providing access to life-saving medicines during the HIV epidemic etc. are used to divert attention away from the issue at hand, quality of our drug supply.

Of late, there is one more tactic that has been added to the playbook, distraction. When unable to counter facts objectively, cheerleaders for the industry point to the good that the Indian pharma industry has done for patients worldwide. Arguments that generic drugs make healthcare affordable, that the Indian industry played an important role in providing access to life-saving medicines during the HIV epidemic etc. are used to divert attention away from the issue at hand, quality of our drug supply. Another tactic used to divert attention is to point to the wrongdoing within Big Pharma (and there is much to talk about off-label-prescription, financial fraud etc.) and somehow justify that everyone does it, therefore, it is not a big deal.

Also read: Indian Pharma Firm Complains About Documentary; Dutch Council Stands by It

None of this is relevant to the issue being debated. In fact, the book celebrates the achievements of the Indian pharma industry for precisely this; that the industry played a key role in making life-saving medicines affordable to patients globally. The thesis of the book is that when patients with meagre means are knowingly sold substandard, therapeutically ineffective medication, it does no one any favours. Especially in a country like India, where systems to study and document long term effects of poor quality medicines are sparse at best, addressing structural issues within our supply chain, like encouraging two different standards of quality when life-saving medication are concerned, fixing accountability for ensuring compliance with standards for sterility, hygiene, record-keeping etc. is an important debate to have.

When the industry performs poorly, it not only affects the interests of the shareholders who invest but also prospects of hundreds of thousands of young people who would have otherwise seen gainful employment in this area.

What the regulators, the industry lobby and its cheerleaders fail to recognise is that their tactics, which they have employed since the modus operandi of the industry became public in May 2013 have not stemmed the industry’s prospects for a precipitous decline. This industry, which was once called a sunrise industry along with Information Technology because it earned so much foreign exchange for the country, has been declining for the last five years. When the industry performs poorly, it not only affects the interests of the shareholders who invest but also prospects of hundreds of thousands of young people who would have otherwise seen gainful employment in this area. If the tactics being employed by the industry to address what it sees as a “PR Problem” have not reversed this decline in the industry’s fortunes over the last five years, how wise is it I wonder to continue to double down on the approach they have chosen to respond with?

For those who wish the Indian pharma industry to regain its lost glory of being the “pharmacy to the world,” let us debate facts, not opinions. Whataboutery plays only so well with emotions, at the end of the day, it is facts and the situation on the ground that determines whether we continue to support this fallacy that our drug supply in India is only 3% NSQ.

This article was originally published on Observer Research Foundation (ORF)

Are Mohalla Clinics Making the Aam Aadmi Healthy in Delhi?

An independent analysis of 12 Mohalla clinics in Delhi to verify the claims of the government and opposition.

Delhi’s Mohalla Clinics created quite a stir when the first one was opened in Peeragarhi in 2015. During the Aam Aadmi Party’s first year in office, the clinics were started to take diagnostics and treatment of simple ailments to people’s doorstep and reduce the footfall in tertiary care hospitals. Mohalla Clinics have been promulgated as an unprecedented step towards mitigating the stark divide in healthcare delivery across regions and class through the means of free consultation, free medicines, and free diagnostics and pathological tests.

This “Zero Cost Model” has been touted to ensure better access to primary healthcare and reduce out-of-pocket health expenditure, amongst people coming from low-income groups and underdeveloped areas within Delhi. However, at the same time opposition political parties have criticised the clinics for being marred with corruption and poor outreach.

Also Read: Congress Report Alleges Irregularities in AAP’s Mohalla Clinics Project

To assess the veracity of these claims and take stock of the situation on the ground, we undertook an independent field study of twelve Mohalla Clinics in North and North-west Delhi and interviewed 180 patients.

Who are Mohalla clinics catering to?

Mohalla clinics are making primary health care services accessible to groups with modest income; females, particularly housewives, thus helping bridge the gender gap when it comes to accessing health care facilities. About 72% of the patients in our study are females. Around 83% of the patients come from families with an annual income of less than Rs 2.5 lakh.

Shanti, 38, who works as a domestic help suffers from diabetes. She is the sole bread earner in her family of two children. Earlier, visiting a government facility for measuring her sugar level and collecting medicines used to be a harrowing experience for her. She had no one to accompany her to the doctor and getting the test done and buying medicines burned a hole in her pocket. She therefore avoided visiting the doctor until the glucose levels were too high to go unmonitored.

Now with the Mohalla clinic in her neighborhood, she gets her sugar levels measured on a regular basis. Also, with the nearness of the clinic and free medicines at her disposal, she is able to save the money that was earlier spent on commuting and buying medicines.

It is also important to take into account the kind of ailments that are being treated in these clinics. 43% of the cases observed in our field-study were seasonal and minor ailments, followed by cases of pain (26%) and chronic diseases (21%) as shown in Figure 2. These numbers make more sense when seen in conjunction with the effectiveness of the medicines. Majority of our respondents (68%) reported that the treatment they received was effective in curing their ailments. About 8% of the patients did not find the treatment effective at all. Most of these were pregnant women for whom very few provisions are available in the Mohalla clinics to cater to their needs.

Change in out-of-pocket expenditure

Mohalla clinics have played an important role in reducing the out-of-pocket expenditure of people. Around 80% of our respondents reported a decline in their medical expenses after they visited Mohalla clinics for treatment. Also, because the clinics are situated in the locality, the commuting time has reduced for almost 77 % of the patients. About 89% of the respondents came to the clinic on foot. As a result, their travel expense has also witnessed a decline. It took them, on average, 10 minutes to reach the clinic.

Also Read: Arvind Kejriwal Proposes Making Bus, Metro Travel Free for Women in Delhi

Babu Ram, 42, a migrant rickshaw puller from Bihar and resident of Vikasnagar Extension has high blood pressure and needs regular medication. He earlier visited a government dispensary, but its functioning was sporadic. He was often forced to visit government or private hospitals for checkups and medication. To do this, he had to forego that day’s earnings and spend long hours waiting for his turn as well as for purchasing the medicines from the medical stores. But now, Babu Ram says he can visit the Mohalla clinic on any day of his choice, consult the doctor and get his medicines free of cost. He does not lose that day’s work.

The way forward

Based on our assessment, Mohalla Clinics are delivering good result in terms of equality in accessibility and affordability of primary healthcare. Since these clinics are mostly located in underdeveloped areas with poor infrastructure, they are ensuring better geographical access to health services. These clinics are also reducing time and costs involved in commuting and waiting to avail the treatment. This in turn, seems to give weight to the argument that supply-side financing strategy, like the one implemented through Mohalla clinics, is more rational than the demand-side strategy of financing health insurance.

However, notwithstanding the achievements of Mohalla clinics, there are certain policy gaps that need to be addressed in the near future. First, the Delhi government has reduced the budgetary allocation for the clinics from Rs 403 crore in 2018-19 to Rs 375 crore in 2019-20. This might be translated to a reduction in the availability of essential medicines at the clinics. Currently, the Mohalla clinics have very few provisions for pregnant and lactating women who constitute a major chunk of the patients.

Finally, there are speculations that only patients with a valid residential address of Delhi, as proved through an Aadhaar card, will be treated in the clinics. This could be a huge blow to the primary idea of providing universal healthcare to the underserved population of Delhi. Migrant and seasonal laborers like Babu Ram will be the worst affected by this decision.

Acknowledgements

We would like to express our gratitude to Reetika Khera at IIT Delhi for supervising the project and providing financial support for the primary survey. Thanks are also due to Pranav Jain, associate, Delhi & NCT government, field monitors Sunil and Rishi and Angarika Rakshit, Nishant Singh, Diti Goswami, Parul Gupta and Abhigya Pandey.

Taniya Sah, Neha Bailwal, Rituparna Kaushik are research scholars at IIT Delhi. This article is the result of an independent study undertaken as a part of their coursework and does not represent affiliation to any political party.

Will Politics Ever Overcome Its Apathy Towards Operative Healthcare for All?

While there is political consensus that a robust healthcare system is needed, it is rarely at the centre of electoral politics in India.

In 2005, I joined one of Mumbai’s largest suburban Municipal hospitals as a visiting surgeon. This institution treats a large number of accident victims on a daily basis and has treated a number of those injured in the riots and bomb blasts that swept Mumbai in the past few decades.

To my disbelief, I soon realised that our department’s capacity to treat these patients was being severely compromised by the absence of a CT scan machine in the hospital. I was also shocked to observe that patients were being sent to private centres nearby for a charge or to faraway public hospitals, resulting in huge delays in treatment.

My colleagues and I soon raised this matter through multiple letters and meetings with the administration, but to no avail. We were told that a demand for a CT scanner had been pending for years. Meanwhile, patients continued to suffer and I suspect many young lives were lost due to the delay in obtaining CT scans.

Finally, with what I imagined at that time as my ‘political’ insight, I decided to use a different approach. There was a local corporator who used to meet us to inquire about patients from her constituency and seemed concerned about the hospital’s services.

Also read: What Indian Healthcare Has Looked Like Under Five Years of the Modi Govt

I suggested that she could take up the issue of the lack of a CT scan machine as a public campaign. I tried to convince her that this could help her win the elections to the Mumbai Municipal Corporation due that year. To her credit, she took up the issue, fought it out in the public health committee of the corporation and finally persuaded the authorites to procure a CT scanner.

On the day the machine was installed, she put up posters around the constituency, claiming victory in her fight for better healthcare for the citizens. We organised a small thanksgiving ceremony where I remember talking about how we could transform the hospital if healthcare becomes a local political issue.

A doctor looks at a monitor displaying a donor kidney. Credit: Reuters

The elections were soon held. She lost by a huge margin to a new candidate largely known as an organiser of the local Ganesh Festivals. When I bumped into her later, she, looking dejected, tried to explain:

People don’t necessarily vote on such issues. There are many other issues that overwhelm people when they press the button in the polling booth. I have learnt a lesson.

The dysfunctional and broken state of India’s healthcare system is there for everyone to see. All opinion, analysis and data over the years have repeated ad nauseum that across political parties, healthcare has been given low priority. As a result, India performs poorly in care delivery – our health indices are some of the worst in the word.

Healthcare as an electoral agenda

There is also consensus from the right to the left that without a well-funded and robust public health system, no country can provide decent healthcare to its citizens. The experience of some states in India and other countries is very clear on this. With so much consensus and evidence, what then is the missing link that prevents change?

We saw a substantive amount of scholarly analysis around healthcare during the build-up to this election. This was partly due to the Centre’s staging of Ayushmaan Bharat. In a piece I wrote a few months ago, I reflected on the experience of a public health insurance scheme similar to Ayushmaan Bharat as it had played out in the same public hospital.

Also read: Budget 2019: Ayushman Bharat Gets Rs 6,400 Crore, But to Benefit Private Sector

I ended the piece on a note of cautious optimism, wondering whether with Narendra Modi pushing Ayushmaan Bharat as a game changer and Rahul Gandhi responding to it with an alternative policy for universal healthcare, we were finally seeing a serious focus on health-related policy in national politics. Following that, the Congress manifesto went a step further by proposing the idea of a Right to Healthcare Act, while the BJP promised more funding for healthcare. But alas, all this was a few weeks ago.

In the meanwhile much else was blowing in the wind. Healthcare soon had to compete with Pulwama, Balakot, Chowkidari, the NRC and dynastic politics. As far as eyeballs and emotions are concerned, a powerful and unequal competition had emerged.

What the local corporator had realised after her experience, our astute political class had, perhaps, understood long ago. There are easier and quicker pathways to electoral success.

Narendra Modi and Rahul Gandhi raised the issue of healthcare, but it was soon overshadowed by other issues. Credit: Reuters

Middle class and political apathy towards healthcare

As we enter the last lap of the electoral race and await the results, I almost have a sense of déjà vu. Notwithstanding the results, what role did issues like healthcare and education finally play? And if they didn’t, will anything change at all?

Do we need to dig deeper and raise uncomfortable questions rather than just lament over the state of healthcare through op-ed pieces? Is there something more at work here? For example, is it the fact that the elite, which includes many of us, have resolved their own healthcare issues through the creation of a private sector and while we all pay lip service to it, we are no longer invested in change?

In other words, as Taleb puts it, is it that those who can change health policy no longer have “skin in the game” of public health? Shall we also question why our ordinary citizens do not force these issues to the forefront during election time and hold candidates accountable? Is there something about our cultural capacity that internalises death and disease as our fate and destiny? Are other daily challenges too overwhelming for us to notice the inequity in healthcare?

Or is it that having been chronically exposed to a certain system that passes for healthcare, ordinary people cannot even fathom an alternative? How will they know that there is an alternative that currently works in many countries which guarantees immediate, decent care that is worth fighting for?

Also read: Are Political Parties Serious About Healthcare Promises?

I am aware that, in many states of India, ordinary people have indeed fought remarkable struggles for health rights. There is also a growing national movement comprising largely of the middle class against, what is nothing but, the predictable excesses of an explosion of market medicine.

Maybe these movements will converge and see through the structural discrimination within the healthcare system which has created ‘state of the art’ hospitals where one can get a CT scan within minutes at an astronomical cost while large public hospitals exist without CT scans for the grievously injured. For someone like me, who has witnessed the havoc that illnesses cause on a daily basis, I cannot but be cautiously optimistic about the future.

As for our hospital, the CT scan unit is currently facing a lack of staffing. Many patients still have to be shifted for emergency CT scans. Once again, we made an effort to highlight the issue, this time, by approaching corporators across political parties. We were largely ignored. One of them even told us curtly, “Doctor you don’t understand politics; we are in an electoral battle, this is not the best time to raise such issues.”

Sanjay Nagral is a surgeon practising in Mumbai and the publisher of the Indian Journal of Medical Ethics.

New Medical Regulation Rules in Karnataka Suggest Government Has Flip-Flopped on Private Sector

After putting out a strong draft of patient-centric amendments to regulate the private sector, Karnataka has now diluted it with new rules

After putting out a strong draft of patient-centric amendments to regulate the private sector, Karnataka has diluted it with new rules.

Credit: stevepb/pixabay

Credit: stevepb/pixabay

The government of Karnataka has flip-flopped on its healthcare responsibilities between June 2017 and February 2018.

At first, it seemed the state government wanted to end the machinations of the private health sector, thus initiating a much-lauded process in June 2017 to amend the 2007 Karnataka Private Medical Establishments (KPME) Act. The language of the government at that time was clearly about protecting patient rights and reining in a dangerously unregulated private healthcare system.

Eight months later, they pulled a U-turn.

The new draft rules for the amendments, out for public opinion, suggests two things.

First: the private hospital lobby, with its political connections, deep pockets and opposition to the Bill, has demonstrated that it will oppose regulations.

Second: the government has moved from being a regulator to a facilitator of the private sector.

With the watered down amendments issued in November 2017 and the blatantly pro-private-sector draft rules to these amendments in February 2018, the citizens of Karnataka are looking at difficult times ahead apropos their health needs.

Patient’s charter ignored

The Karnataka government had taken a progressive step by bringing in the ‘Patient’s Charter’ into the proposed amendments in 2017. It sent a strong message about the inviolable rights of the patients to be informed, and about ethical and rational healthcare.

However, the draft rules make no mention of them.

The first draft included the patient’s right to emergency treatment (without demands for prior payments), access to documents and the right to a second opinion. These have gone missing in the rules.

The amendments had also mentioned a grievance redressal forum that seems absent in the rules. Now, there is no talk about how such a forum will be instituted or what responsibilities it will have.

As a result, people are being left without adequate recourse to justice even as the government hands healthcare policymaking to the corporate sector on a platter.

Given that healthcare currently encompasses all of  medical tourism, clinical trials, health insurance, pharmaceuticals, vaccine trials and surrogacy, together with cuts and commissions, unnecessary procedures, investigations, etc., Karnataka’s care-seekers have been let down by their government.

Expert committee includes private sector players

The first draft of the amendments stated, “Every private medical establishment shall follow the rates as fixed by the government and this includes package rates for investigation, bed charges, operation theatre procedures, intensive care, ventilation, implants, consultation and any additional treatments”.

The rules discuss an expert committee comprising 11 members, six of whom  represent private sector interests.

While two members could be from secondary and tertiary private hospitals, the Suvarna Arogya Suraksha Trust (SAST), the Indian Institute of Management, Bengaluru, the Public Health Foundation of India (PHFI) and the Indian Medical Association have one representative each.

The SAST board is composed of several private players, particularly Devi Shetty, the founder of Narayana Healthcare and a vocal opponent of regulation (he once said regulating doctors would be to treat them as worse than terrorists).

The IIM Bengaluru, which has counted Mukesh Ambani, Kiran Mazumdar Shaw and Vinita Bali among its chairpersons, has shown no commitment to making healthcare accessible, affordable, ethical and regulated. Therefore, it is not a true representative of the state government.

The PHFI has been embroiled in a slew of scams and scandals, but this hasn’t stopped the erstwhile health department of Karnataka from including the besmirched body – setting a dangerous precedent.

So while the government’s original agenda had been to regulate all costs imposed by private hospitals, it now says that uniform rates will be fixed only for health insurance schemes, and by the members of the committee described above.

The rules also state that: “As far as possible, the committee shall use as reference the standard costing template formulated by the National Council constituted as under the Clinical establishment” (emphasis added).

Non-profit sector not represented

It is interesting that the state government has large excluded charitable hospitals, civil society groups and public health professionals from any of the committee.

Father Mathew Perumpil, the health secretary of the Catholic Bishops Conference of India, has said that mission hospitals have also been sidelined: “After the government sector, it was the Mission hospital network that was providing affordable care for people, especially marginalised sections of society.”

The mission hospitals do not see the KPME guidelines as a threat, although there were some concerns by doctors about severe penalties (they were later removed).

So as a first step, the Bangalore Christian Healthcare Organisations Network has decided to tabulate the costs of various procedures in each mission hospital and make it publicly available.

It is important to understand that just because a patient is able to pay does not mean that she should be charged exorbitantly. Also, higher costs do not necessarily convert to better or ethical healthcare.

All of us fall sick at different points in life, some more seriously than others. Health care has to be available to everyone as a basic right irrespective of our ability to pay or out geographic locations. It is not hard for a government to invest in the health and well being of its citizens.

Sylvia Karpagam is a public health doctor and researcher based in Karnataka.

And Now, Aadhaar Is Mandatory for TB Patients Seeking Government Cash Benefits

Until the new notification making Aadhaar compulsory under the government’s Revised National Tuberculosis Control Programme, healthcare workers say did not even know cash benefits were available.

Until the new notification making Aadhaar compulsory under the government’s Revised National Tuberculosis Control Programme, healthcare workers say did not even know cash benefits were available.

The incidence of TB in India is 217 per 1,00,000 population. Credit: PTI

The incidence of TB in India is 217 per 1,00,000 population. Credit: PTI

New Delhi: The Union health ministry has made Aadhaar a compulsory document for tuberculosis patients availing treatment under the government’s Revised National Tuberculosis Control Programme (RNTCP). According to the government notification, “An individual eligible to receive the benefit under the Scheme, is hereby, required to furnish proof of possession of Aadhaar number or undergo Aadhaar authentication.”

The notification says that the scheme offers conditional cash assistance as a benefit. The beneficiaries include TB patients, private healthcare providers and treatment supporters. The RNTCP says it aims to provide “universal access to tuberculosis care.”

India has 2.8 million cases of TB as of the data from 2015. This data was in fact revised by the WHO because India had been under-reporting TB. In 2015 alone, 6.1 million new TB cases were reported to the WHO as India had been reporting only 59% of TB cases until then.

However, several health workers say they were never informed of this cash assistance and TB patients have not been availing of it in the first place. They also see this order for mandatory Aadhaar cards as a way in which TB patients could be excluded and denied care.

“We work with many tuberculosis (TB) and HIV patients, including those who are multi-drug resistant TB patients. We heard about this cash scheme and Nikshay [an online monitoring system] for the first time today on our Whatsapp group,” says Ngangom Jina of the Delhi Network of Positive People.

“Those who we work with in Delhi are mostly migrants. We have tried to get them Aadhaar cards in the past but it has been very difficult. They don’t have Delhi residences, landlords don’t want to give them rent agreements and these are just a few things that disable them from getting Aadhaar cards,” she says.

The government’s notification says that the benefit of this scheme would only be given to beneficiaries who have an Aadhaar number. TB patients and their caregivers who want to avail of these benefits would need to enrol for an Aadhaar card by August 31, 2017. Until the Aadhaar is actually issued, beneficiaries will need an Aadhaar enrolment ID slip, a copy of the request made for Aadhaar enrolment or a range of other government-issued cards such as a voter identity card, PAN card, certificate of identity issued by a gazette officer, bank passbook, kisan photo passbook, ration card or “any other document as specified by the state government or union territory administration”.

A cash benefit that TB patients have not been availing

The ‘conditional cash assistance’ comes as news to many public health professionals who work with TB patients. “We have ourselves been pooling in money for several patients over the last many years. We see people struggling without money, to travel to Delhi or Guwhati, as there are only five centres in the country providing drugs for multi-drug resistant patients. Another struggle is nutritious food. People suffer the loss of employment. And through all these years, we were never informed that the government is handing out cash assistance. Now that they are, they are asking for Aadhaar cards. How are patients without even homes supposed to have Aadhaar cards?” asks one public health professional working with TB patients.

The government’s notification says the RNTCP is being administered through a web-based application called Nikshay. The health workers spoken to have been working without it. Sunil Khaparde, deputy director general for TB in the health ministry, further explains that the money itself is transferred through something called the Public Financial Management System (PFMS). The PFMS has not been mentioned in the notification, but Nikshay has.

Although ground-level workers are surprised by this announcement of both cash transfer as well as Nikshay, the health ministry says they have been distributing cash incentives under the RNTCP mainly to care providers and not to patients. Khaparde says that this is one of the two schemes of the health ministry involving direct cash transfers. The other is the Janani Suraksha Yojana for pregnant women.

Only tribal patients are given a cash amount of Rs 1000. Apart from that, Directly Observed Treatment Short-course providers are given Rs 1000 for those in Category 1, Rs 1,500 for those in Category 2 and Rs 5,000 for those working with multi-drug resistant TB patients. Doctors who notify the government of new TB cases are given Rs 100 for the notification and Rs 400 after treatment is dispensed. This money is not given to patients, but to ASHA workers, doctors, community workers and families of TB patients. These are all one-time amounts.

“The mode of giving direct benefit transfers is in keeping with the vision of the prime minister. We are proposing to give cash to all patients, but that is still being discussed and we are not finalising it yet,” said Khaparde.

RNTCP for universalisation, but Aadhar as exclusion

“Should the TB patient be running after getting Aadhaar card or should they be just taking their treatment and therapy? If the government is giving cash, that’s a very good thing. At least they can buy nutritious food. But this is useless if people can’t get the assistance without Aadhaar. If the scheme is going to be inaccessible like this, it is as if the scheme does not even exist and is a namesake,” says Jina.

Sonamati Prajapati, who works with HIV and TB patients at Sahaara in Pune, also concurs, “We were not aware of this cash scheme here. And what is the need for Aadhaar card? If government wants to give medicine or money, patients are already recorded and are taking therapy. They have their important green ART book, which proves that they are taking therapy. What is the need for an additional proof? These patients are already marginalised, living as migrants, and this will make their life harder.”

This matter of linking Aadhaar to benefits and entitlements is also due before the Supreme Court. It has been 680 days, or nearly two years, since the Supreme Court said it would constitute a constitutional bench to look into this matter – but it remains pending.

However, Khaparde says, “Ninety percent of the country is covered by Aadhaar. So obviously there is 90% coverage within the TB community as well. Nothing specially low about Aadhaar coverage in this community.  So this notification should not be a problem. For those who don’t have Aadhaar, we are going to facilitate getting it for them.”

Importantly, Khaparde says that patients will not be denied treatment on the grounds of Aadhaar. “We are not denying treatment or diagnostics to anyone under the RNTCP. Aadhaar is not compulsory for that. It is the cash benefits to the caregivers and to tribal patients which needs to be done under a direct transfer, and hence needs Aadhaar. Previously we were giving money in cash or cheque to ASHA workers and medical officers.”

The debate on Aadhaar being an instrument of exclusion reached a high point in February this year, when the government issued orders linking Aadhaar to the mid-day meal scheme and to the Integrated Child Development Scheme. The government was widely criticised for instituting measures that would put in jeopardy the meals of 140 million children who avail of the scheme. This pushed the government to clarify that other identity documents would also be usable, but the government’s initial orders from February 2017 still stand.

The RNTCP is a centrally-sponsored scheme under the National Health Mission that seeks to promote universal access to TB care through early diagnosis and regular treatment completion. Both public and private healthcare facilities participate in the programme.

The government says it is keen to link the Aadhaar to the programme because the RNTCP involves a recurring expenditure from the consolidated fund of India. The other reason cited by the government is because the use of Aadhaar “simplifies the government delivery process, brings in transparency and efficiency and enables beneficiaries to get their entitlement directly.”

Nikshay is a platform developed by the government to have better surveillance of TB cases from the public and private sector. It also helps in the monitoring of TB patients for their adherence to their drug regimen. According to an early software manual by the WHO South East Asia office, Aadhaar was optional while filling patients details. Since 2015, the government has been asking for Aadhaar details during the notification of new cases.

According to the annual status report of RNTCP from March 2017, one of the features of Nikshay is a direct benefit transfer of cash. The government said in this report that it would do this by linking Nikshay and the PFMS to Aadhaar.

Despite the Clinical Establishments Act, Healthcare in India Has a Long Way to Go

While some states have managed to increase access to affordable healthcare, it remains below par when compared to other developing economies.

While some states have managed to increase access to affordable healthcare, it remains below par when compared to other developing economies.

Representative image. Credit: PTIRepresentative image. Credit: PTI

Representative image. Credit: PTI

This is the second article in a two-part series analysing the asymmetric status of healthcare delivery across Indian states. Read the first part here.

Aiming to ensure the delivery of a minimum standard of services by clinical establishments across India, the central government enacted the Clinical Establishments (Registration and Regulation) Act in 2010. All types of clinical establishments, except those run by the armed forces, fall within the ambit of this Act. The need for such a legislative act was sparked off by wide variation in healthcare delivery across providers, resulting not only in compromised patient safety but also concerns about transparency and accountability in healthcare costs.

The Clinical Establishments Act seeks to ensure that the operative functioning of healthcare delivery systems in states is in compliance with prescribed, transparent guidelines and keep any form of regulatory malpractices in check (related to drug pricing, licensing provisions or procurement, for instance). This Act has been in effect in Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all union territories except the National Capital Region of Delhi since March 1, 2012.

A closer look at the data on the number and type of clinical establishments across some of the above states clearly indicates a skewed distribution of healthcare providers.

Compared to the other states, Delhi has registered the maximum number of clinical establishments.

In the figure below, looking at the structural composition of the healthcare establishments in Delhi, there is a need for the state to expand government-funded diagnostic centres and nursing homes in proportion to the clinical centres available.

In terms of the total number of government clinical establishments like primary healthcare centres, sub-centres and district hospitals, states like Himachal Pradesh and a few northeastern states have done well in improving access to public healthcare facilities, particularly since the introduction of National Health Mission and National Rural Health Mission as centrally-funded schemes. Still, the delivery of standardised basic medical care services across states remain below par when compared with other developing economies like Thailand, China or Brazil.

Beyond the states listed that have introduced the Act, West Bengal introduced and passed its own legislation called the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017. This aims to streamline the procedures of registration of clinical establishments, medical licensing systems and accounting for criminal offences related to medical practice under a prescribed adjudicating, regulatory body called the West Bengal Clinical Establishment Regulatory Commission. One of the critical points raised by this Act relates to identifying criminal punishment for all doctors charged with medical negligence.

According to the newly enacted Bill, doctors or healthcare facilities may face criminal proceedings under Indian Penal Code, including a cancellation of their medical license, if found guilty of medical negligence. The Indian Medical Association (IMA) has raised strong objections to this clause. The IMA wants a single-window accountability for doctors to reduce the scope of harassment and no differentiation in treatment between the private sector and government-appointed doctors.

The implementation of the Act and its outcomes may qualify as a subject of greater scrutiny in the coming months. However, on a more systemic level, the very nature of regulating healthcare service raises two key issues, currently marring the healthcare delivery system in India (previously highlighted in this article). This pertains to the mandate and legality of government agencies – their capabilities and the feasibility of carrying out identified outlays or health goals.

As a case in point, the 2017 National Health Policy proposes the need for strengthening existing medical colleges and converting “district hospitals to new medical colleges to increase number of doctors and specialists, in States with large human resource deficits”. But there is no clarity on the financial feasibility of such a proposal. It is not sufficient to regulate the private sector; the public healthcare system needs to be revamped to serve as a substitute. Setting price ceilings and imposing punitive measures may serve as a disincentive to providers, thereby hampering delivery. This will only make matters worse, whereby neither is the public sector living up to the standard, nor is the private sector incentivised to deliver what it is capable of delivering.

Based on the available data, there remains a strong need by more states to recognise the Clinical Establishments Act with support of the Union government and put in additional financial resources in facilitating more nursing homes and diagnostic centres (in proportion to clinical centres); ensure monitoring of prescribed agency considerations for public health departments; and ensuring affordable healthcare in a transparent way.

It is vital for the Indian state to not only consider increasing clinical establishments in semi-urban and rural areas (where access is sparse), but also to ensure compliance of basic minimum standards of medical treatment by doctors in existing clinical establishments, which is essential for delivering quality medical care services to everyone. From a policy perspective, ensuring affordable healthcare access for mother-child care, reduction in out-of-pocket expenditure due to asymmetric distribution of healthcare services (via public and private healthcare centres), standardised medical training and monitoring of doctors (across states) and healthcare insurance (linked through an Aadhaar-registered scheme) require greater deliberation and focus by the Union government.

Ayona Bhattacharjee is assistant professor of economics at Jindal Global Business School, O.P. Global Jindal University and Deepanshu Mohan is assistant professor of economics at Jindal School of International Affairs, O.P. Global Jindal University.

India’s Healthcare System Is Becoming More and More Unequal

Despite the high out-of-pocket costs, a large number of patients across rural and urban India are choosing private healthcare options.

Despite the high out-of-pocket costs, a large number of patients across rural and urban India are choosing private healthcare options.

Patients and their attendants are seen inside Apollo hospital in New Delhi, India, September 8, 2015. Credit: Reuters/Adnan Abidi/Files

Patients and their attendants are seen inside Apollo hospital in New Delhi, India, September 8, 2015. Credit: Reuters/Adnan Abidi/Files

This is the first article in a two-part series analysing the asymmetric status of healthcare delivery across states in India.

Kenneth Arrow, in a seminal paper titled ‘Uncertainty and the Welfare Economics of Medical Care‘, emphasised that medical care deserves a special mention in any welfare-driven economic analysis. According to him, the privatisation or marketisation of medical care cannot deal with some of its systemic uncertainties characterised by moral, ethical and psycho-social issues, usually non-existent in other services. As Arrow notes, “The failure of the market to ensure against uncertainties has created many social institutions in which the usual assumptions of the market are to some extent contradicted…the medical profession is only one example.”

Any developing state’s role in optimally allocating financial resources and identifying appropriate roles for its public agencies in order to improve healthcare delivery systems should qualify as a subject of intense policy deliberation and debate, regardless of the status of an economy’s growth. The Indian state, however, has had an indifferent, limited approach to using the existing regulatory framework on healthcare.

Asymmetries in the healthcare system

The healthcare sector in India remains one of the largest sectors in terms of both employment and revenue generation. This sector has grown at a compounded annual growth rate of 16.5% and is likely to be worth $280 billion by 2020. This significant growth within the healthcare industry has been facilitated by a rapid privatisation of healthcare (particularly in secondary and tertiary healthcare services). Multiple household surveys conducted across India show a significant prevalence of, and also preference for, private healthcare delivery both in rural and urban areas.

The 71st National Sample Survey (NSS) conducted during January-June 2014 found that out of the total hospitalisation cases in rural areas, 42% were in public hospitals and 58% in private. The corresponding shares in urban areas were 32% in public and 68% in private. Looking at NSS findings over the last two decades clearly depicts a decline in the share of public hospitals in treating patients. This has created an asymmetric healthcare distributive network across states in India that is disproportionately scattered between the public and private healthcare sector.

The information asymmetry between public and private healthcare providers and patients gives monopolistic power to few conglomerated private providers, which if left unregulated or poorly monitored can result in distorted prices in medical treatment and diagnostics. High healthcare costs combined with low insurance penetration have often resulted in greater out-of-pocket expenditure (for diagnostics, medical counsel and treatment) for people across the country.

In spite of concerns regarding high medical costs in the private sector, it is surprising that a growing number of individuals are still resorting to private healthcare provisioning. The reason for this seems to do with the pitiable quality and accessibility of public healthcare systems across rural and urban areas – which remain dismally funded, poorly monitored and inadequately standardised.

The figure below shows reasons why households prefer private healthcare sources, as reported by the 60th NSS round. First, it clearly stands out that most households prefer the latter as they are not satisfied with government doctors and second, public healthcare systems are seen as relatively inaccessible.

While this may be considered good news from the perspective of seeing a potential rise of the private sector in healthcare services, leading to higher competition and probably a lower burden on public healthcare, it is a major cause of concern to those residing in semi-urban and rural areas, where access to basic primary healthcare services remains deplorable.

Additionally, as highlighted in an article earlier, our understanding of patient behaviour and the quality of healthcare providers suffers from a ‘good doctor/naive patient’ model. Recent studies highlight how in most of rural India (particularly in northern and central parts of the country), medical doctors are untrained, with healthcare providers prescribing high rates of antibiotics warranting a need for independent quality control checks on medical licenses and treatment practices.

When it comes to assessing the need for adequate government intervention in ensuring basic medical care for all, it is a resolved matter that a laissez-faire solution alone to medical care (via greater privatisation) is insufficient. Public intervention in healthcare delivery is necessary and can take various forms. Some of the following steps warrant the state’s more immediate attention:

  • Collecting data on prices of similar treatments in public and private facilities to identify and address the exact reasons for the price divergence between public and private healthcare delivery systems,
  • Safeguarding periodic monitoring of quality healthcare services within both public and private systems while linking suitable insurance facilities for patients (including those who are terminally ill) to minimise healthcare risk,
  • Ensuring cheaper, effective diagnostic facilities at affordable cost for people in accessible distance from clinics/hospitals,
  • Complimenting development of healthcare systems with better provision of ancillary municipal services like good pest control, sewage systems, water purification systems and treatment of waste, and
  • Giving equal investment weightage to education (primary and secondary) incorporating elements of healthcare awareness to inculcate habits of proper hygiene, basic nutritional requirements, mental well being and physical exercise amongst the young to prevent the incidence of chronic ailments.

We are at a critical juncture, where the debates regarding universal health coverage have reinvigorated interests in healthcare financing and provisioning. Whether the appropriate solution lies in a complete marketisation of healthcare service delivery or in enhancing the role of government through intervention to avoid equity concerns, a balanced approach to safeguard a robust, basic primary healthcare network remains vital for transforming the socio-economic trajectory of India.

The second article in this series will focus on the Clinical Establishments Act.

Ayona Bhattacharjee is assistant professor of economics at Jindal Global Business School, O.P. Global Jindal University and Deepanshu Mohan is assistant professor of economics at Jindal School of International Affairs, O.P. Global Jindal University.

For Medical Tourists in India, Scams Worsen an Already Traumatic Experience

Most medical tourists need translators, who are hired by hospitals and charge high commissions. Patients are also often forced to do expensive tests, even if they may not understand what’s going on.

Most medical tourists need translators, who are hired by hospitals and charge high commissions. Patients are also often forced to do expensive tests, even if they may not understand what’s going on.

Zubaida. Credit: Ishtiaq Wani

Zubaida. Credit: Ishtiaq Wani

New Delhi: “I had got only $2,000 from Afghanistan,” she says, sitting on a bed with her leg plastered and small bandage on her left hand. Her forehead is covered with sweat as the fan wobbles in the humid room. Medical prescriptions and tests are spread over the two beds, with blankets neatly kept aside.

Zubaida suffers from severe back pain. Along with her son, she came to India for medical treatment thinking it would be affordable. She had never thought she would be duped by her compatriot, who had called her “sister”. Her translator, an Afghani, took Rs 50,000 more than the hospital charged her and fled to Afghanistan when confronted.

Medical tourists coming to India are frequently duped into paying extra by hospital middlemen and touts. Most often, self-appointed translators – who are the first contact of these tourists in India – take them to the hospitals and trick them into paying extra.

According to the Ministry of Home Affairs, in the first six months of 2016, 96,586 medical tourists had come to India. Due to the comparatively lower prices of the procedures and treatment, India attracts people from all over the world. In 2012, 41% of the medical tourists came from Middle East and North African countries, and 48% from Asia Pacific region.

Zubaida and her son rented a place in Lajpat Nagar in South Delhi thinking that since other Afghans live there too, it would be easier for them to spend their time and get the information they need. Neither of them speak Hindi.

“Translators charge 30-40% commission. An operation costing Rs 1 lakh would then cost Rs 1.5 lakh,” says Dev Singh Bisht, a pharmacist in Bhogal, who has been working with patients from different countries for over seven years. He learnt Pashto from his Afghan customers and often listens to the problems they face. He has seen laboratories extracting extra money from the customers and translators taking them to the hospitals that pay them the highest commission.

“I saw an Arab patient with a translator in a medical store, the patient was trying to ask the chemist when he has to take his medicines and how. The translator said to the pharmacist in Hindi, ‘Gadha hai (He’s an idiot)’,” says Rezwan. He is in Delhi with his sister Zarmati, whose ailment doctors could not detect in Afghanistan. A journalist by profession, this is his second visit to India. He too thought treatment would be affordable here, but had the opposite experience.

On Rezwan and Zarmati’s second day in India, they went to meet a doctor in a South Delhi hospital. Right away, the doctor recommended tests costing Rs 11,500 and charged Rs 7,500 for the examination. This was a much higher amount than he had expected.

On the day the results of the tests came, they visited the hospital again. The doctor was not available. They waited for a long time, even went back again in the evening, but he didn’t show up. They called the hospital the next day, the doctor was still not back. Zarmati was in a lot of pain.

They visited another doctor with her medical reports, but the doctor rejected the results of the tests the first doctor had asked for. This doctor asked for all new tests, saying that her joints were constricted and that’s why she was in pain.

After spending Rs 85,000 on tests, the doctor suggested an operation that would cost them Rs 5 lakh, plus his fees.

“But how could her joints move, if she had constricted joints?” wondered Rezwan. On asking the doctor, he retorted, “You are not the doctor, I am a doctor.”

Rezwan was faced with a dilemma – either he had to go ahead with the operation or find a different doctor. He was confused, and the behaviour of the doctors he had met so far was only making things worse. He decided to search for another doctor. This was their fourth day.

On the fifth day, they visited another doctor, with the hope that he might be able to help. The new doctor asked for more tests that cost Rs 18,000 and prescribed injections that would ease her pain.

“Her muscles have elongated,” the doctor said. Her pain was gone. They didn’t bother to ask what the disease was called. They are home now.

According to a Grant Thorton and CII report, the medical tourism industry in India is expected to grow to $8 billion by 2020. It is estimated that the current 9% of medical tourists coming from European countries will increase to 16% by 2018, with an additional 45% coming from the MENA region.

Maryam Ahmad Abdullah, 65, a Yemeni, is being treated for cancer at AIIMS, where she is accompanied by her 27-year-old son Abdul Jabbar Makrash.

She was diagnosed with rectal and lung cancer a year ago in Yemen, just a few weeks after her son got engaged. Planning for the wedding ceremony was on, but the news of her illness damped their happy spirits.

Immediately, Makrash applied for two visas to India. “We had to travel to submit the doctor’s prescription at Djibouti and then apply for a medical visa there,” he says. The application procedure included strings of processes; application for visa, approval letters from hospitals, arrangements for lodging, booking interpreters – the list is endless. From getting approval letters and signing piles of permission papers to making a sea journey to Djibouti in East Africa, it took a month’s struggle to complete the travel formalities.

Medical tourists from Arab countries usually find rentals around Malviya Nagar, Lajpat Nagar, Bhogal, Okhla, Tughlakabad and Gurgaon, because these areas are close to private hospitals.

Maryam Ahmad Abdullah and Abdul Jabbar Makrash. Credit: Ishtiaq Wani

Maryam Ahmad Abdullah and Abdul Jabbar Makrash. Credit: Ishtiaq Wani

According to a study by Medical Tourism hub, a not-for-profit organisation based in the US, “Direct air connectivity, proximity, and cultural connectivity have helped people from Gulf to feel comfortable during their medical tour in India.”

Within three days of arriving in India, Makrash and Abdullah visited a private hospital in South Delhi. The first test cost them Rs 40,000 and the medical report stated – unlike the previous diagnosis in Yemen – that Abdullah was only suffering from rectal cancer. The report emphasised that she needed urgent laser therapy and chemotherapy, costing a total of Rs 3 lakh. That was in August 2016.

Makrash hadn’t brought a lot of money, but he could not think of going back home unsuccessful. “I want to see my mother healthy, this is the most important thing to me,” he says, placing a kiss on his mother’s forehead.

Within a span of three months, they spent Rs 6 lakh. His pockets were close to empty and he was slowly running out of hope.

Their expenses – rent, food, conveyance and treatment-related charges like blood tests, x-rays, scans and medicines – kept increasing.

Makrash’s family land in Yemen had been sold off by now to pay the hospital bills. The mother and son duo soldiered on, listening to doctors and paying them in cash for each successive test.

During the last months of 2016, Makrash could no longer afford the medical charges.

“I sold our property, gold and our ancestral weapons, one by one,” he says.

After the chemotherapy was completed, doctors suggested another surgery in a private hospital – but Makrash couldn’t afford it. At the end of December, a few of his friends in the embassy and elsewhere advised him to try his luck at AIIMS. Abdullah was admitted to AIIMS on humanitarian grounds. A few months into the procedures, she felt better.

However, by now, all their savings were over. Makrash’s Arab friends studying in the city started collecting funds for further procedures. With that, they managed to cover the expenses at AIIMS.

Zalmi*, who was admitted to a Gurugram hospital, was not as lucky. He had to return to Iraq without completing the treatment. Before coming to India, he had been to Lebanon, Jordan and Egypt, but his condition had not improved there.

“In India, it is good but expensive,” says his father, who accompanied him. They knew no one here and had to rely solely on translators.

“Anyone can be a translator, contact marketing people in the hospital and you become one. Without being certified and without regulations, they do their work,” says Zayeen*, an Arabic translator working in a Gurugram private hospital.

Zubaida’s son, meanwhile, tried to get his money back from the hospital she was treated at. They refused, saying that they were dealing only with the translator. They tried to lodge an FIR, but police refused to file it. Contacting the Afghanistan embassy didn’t help. Calls to the translator would either be cut or he would answer and threaten them.

“He returned Rs 25,000 and warned us not to approach police. He said this is happening everywhere,” says her son, speaking in Pashto.

*Name changed.

If Modi Really Wants Affordable Medicines, Why is His Niti Aayog Pushing in the Opposite Direction?

The government’s premier policy-formulating agency recently recommended measures to deregulate the pharmaceutical sector and make essential medicines more expensive.

The government’s premier policy-formulating agency recently recommended measures to deregulate the pharmaceutical sector and make essential medicines more expensive.

People walk past a chemist shop at a market in Mumbai, India, June 25, 2015. Credit: Reuters/Shailesh Andrade

People walk past a chemist shop at a market in Mumbai, India, June 25, 2015. Credit: Reuters/Shailesh Andrade

New Delhi: Even as the prime minister repeatedly expresses his commitment to providing affordable medicines in the country, it appears that the NITI Aayog and the Department of Pharmaceuticals (DoP) may be working in an opposing direction. Documents between October 2016 and April 2017 show the intention of various government arms to push for drug pricing to be deregulated in line with the demands of the pharmaceutical industry, making the prime minister’s recent statements seem like an aberration.

On May 1, Swadeshi Jagaran Manch – a ‘nationalist’ lobbying group backed by the Rashtriya Swayasevak Sangh – wrote a strongly-worded letter to the prime minister and called out various sections of the government for just this. The organisation named the NITI Aayog, which is the government’s premier policy-formulating institution, the Ministry of Health and Family Welfare, the DoP in the Ministry of Chemicals and Fertilisers and the Department of Industrial Policy and Promotion (DIPP) in the Ministry of Commerce and Industry, and said that these bodies were working to prevent medicines from being more affordable in the country.

“So powerful has the hold of the pharmaceutical companies been that the secretaries and joint secretaries of [these] three ministries … are now holding meetings along with the NITI Aayog to completely dismantle the system of price control. Of course, some kind of pretence, under the guise of pro-poor policies, will be made that they are going to introduce a better system,” their letter said.

Letter from Swadeshi Jagaran Manch to the prime minister, alleging that government bodies are trying to make drugs unaffordable.

The letter made the allegations without offering proof for them, but what the SJM is pointing too is a certain mood that has been observed by close watchers of the pharmaceutical sector as evidenced by communications within and between these government bodies over the past few months. The Wire reached out to three relevant officials at the NITI Ayog but they did not reply to calls, SMSs or emails. The relevant bureaucrat at the DoP said he is “not competent” to speak on the matter, although his office has been coordinating meetings on drug pricing recently.

Modi pushes for affordable medicines

On April 16, Prime Minister Narendra Modi told a gathering in Surat that his government planned to bring a law making it compulsory for doctors to prescribe generic medicines. He also tweeted that his office has pushed for price control, “even if that meant pharma companies are unhappy with us,” and all of this because, “The poor must have access to quality and affordable healthcare.”

In February, the National Pharmaceutical Pricing Authority (NPPA) brought life-saving cardiac stents under price control, slashing their prices by nearly 85%. The prices of bare metal stents were capped at Rs 7,260 and drug eluting stents at Rs 29,600. Modi praised the BJP for this move at rallies in Uttar Pradesh and in Himachal Pradesh, though it came after a Delhi high court ultimatum that left the government no alternative.

NITI Aayog pushes for drug price deregulation

The prime minister’s intentions notwithstanding, on April 23, NITI Aayog released its draft ‘Three Year Action Agenda’ (2017-2020). Health is in the second but last chapter, and in a small section titled ‘Access to Medicines’, the government’s think-tank writes briefly:

 “A balanced approach towards regulation is needed for achieving the twin objectives of access to effective medicines and a strong pharmaceutical industry. There is a trade-off between lower prices on the one hand and quality medicine and discovery of breakthrough drugs on the other. It is therefore recommended that the Drug Price Control Order may be delinked from the National List of Essential Medicines.”

For Swadeshi Jagaran Manch, their fears have been evidenced in this last line, which calls for delinking. In fact, they say the NITI Aayog is creating fear by taking the prime minister’s idea for more generic and affordable medicine in the country, and then insinuating in their draft report that affordable medicines will be of low quality.

In their letter to the prime minister, they say that these recommendations by the NITI Aayog are in continuation of their “attempt to deregulate the pharmaceutical market.” They “protest the ill-intentioned recommendations which will increase the prices of essential medicines to further unaffordable levels and is revealing of the NITI Aayog’s apathy towards the welfare of the poor people of the country.”

Implications of delinking NLEM and DPCO

Although it is a brief section, what the NITI Aayog’s draft agenda does is draw a connection between medicines that are affordable with medicines that are substandard or spurious. Their logic is that just because the medicines are cheap, they will automatically be dangerous. These insinuations aside, what will perhaps be most impactful is NITI Aayog’s last and technically-worded sentence: the government think-tank recommends the delinking of the National List of Essential Medicines (NLEM) from the Drug Price Control Order (DPCO).

The NLEM is currently a list of 376 drugs, listed in Schedule 1 of the DPCO. The DPCO is an order that draws its powers from the Essential Commodities Act, 1955. As far back as 2003, the Supreme Court had directed the Government to consider and formulate appropriate criteria “for ensuring essential and lifesaving drugs not to fall out price control.” Despite the noise made by the pharmaceutical industry about how price-control is repressive, it is in fact only as recently as 2013, when drugs listed in the NLEM began the slow process of having their prices fixed. It took ten years for the Government to bring the Court’s order to this limited state of fruition. 

The underlying philosophy for this is larger than just drugs. The Essential Commodities Act allows the government to also keep tabs on prices of several items considered important for life and livelihood, such as cattle fodder, cotton, edible oil seeds, sugar cane, coal and so on. It allows central and state governments to control the production, supply and distribution of these commodities and protect them from price fluctuations.

The NLEM makes medicines affordable to those who need it the most. The list is significant because it comes under the DPCO which allows for drug prices to be regulated. Without this linking of the two, the NLEM is just an inventory. Thus if they are delinked as the NITI Aayog recommends, there will be no incumbency on the centre or state to ensure that those listed drugs are made accessible, available or affordable. These listed medicines could then be priced at the fancy of the market. This would be a reversal to the pre-2013 time of exorbitant pricing for essential medicines.

Government tells different stories in the Supreme Court and parliament

It seems the NITI Aayog is also at odds with what the government told the Supreme Court in an affidavit this year. In January 2017, the government told the court that it was not planning to dismantle the NPPA or change the mode of price control in the country. It made this filing in an ongoing public interest litigation, ‘All India Drug Action Network and Others versus Union of India.’ The petitioners had asked the court for a rational drug-pricing policy devised on a cost based formula. The case began in 2003 and is now in its final arguments.

The main petitioners last year informed the court that they “fail to understand how the government can even think of dismantling DPCO 2013 when the matter is sub judice.” To this, the government replied in its affidavit, in clear terms: “regarding dismantling of the DPCO 2013, which at present is just an apprehension of the petitioner, as no such decision to dismantle DPCO 2013 has been taken by the Government.” The government also said that all news stories reporting it were “misconceived and misleading and they cannot be relied upon.”

Excerpt from the government’s affidavit in the Supreme Court in January 2017

Excerpt from the government’s affidavit in the Supreme Court in January 2017

Then there’s the matter of what the government has been saying in parliament. Hints on the NITI Aayog’s efforts had reached MPs as well and a few questions asked in parliament recently pertain to this. On December 9, 2016, Mansukh L. Mandaviya, minister of state in the Ministry Chemicals and Fertilisers, was asked in the Rajya Sabha whether the NITI Aayog has recommended that NLEM be delinked from DPCO and if the ministry is considering this proposal. Mandaviya denied this and also said that there wasn’t any proposal to bring a new DPCO soon.

Replies given by MoS Mansukh L. Mandaviya on price deregulation

Replies given by MoS Mansukh L. Mandaviya on price deregulation

Ongoing talks about pharmaceutical pricing in the PMO

On October 19, 2016, a meeting was chaired by the principal secretary in the prime minister’s office (PMO) to discuss issues relating to the pharmaceutical sector. Present in the meeting were the CEO of NITI Aayog and the secretaries of the health ministry, DoP and DIPP. According to the minutes of this meeting, the bureaucrats decided that the “Drug Price Control order may be delinked from the National List of Essential Medicines and, the National Pharmaceutical Pricing Authority, in its present form and current function may be wound up and deployed in the D/o Pharmaceuticals with a new mandate.” They also said that the secretary of the health ministry should consult with the CEO of NITI Aayog and the secretary of the DOP and the Department of Economic Affairs (DEA) before she takes any decision on which essential medicines can be listed in Schedule 1 of the DPCO.

The implication of this is that the access to essential drugs will be decided by government bodies who have an interest in promoting corporate interests, such as the DIPP and DEA. The health ministry will not be able to take decisions on its own, but will need to take guidance from the NITI Aayog and the DoP as well.

On March 28, 2017, another meeting was held in the PMO to discuss the concerns of the pharmaceutical industry. Orders seen by The Wire say that following this meeting, again chaired by the principal secretary, the members decided that files containing documents pertaining to the agreements and contracts between drug manufacturers and marketers would no longer go to the NPPA for analysis before price fixing. This was because “the Industry has represented that it compromises commercial information not directly relevant to decision on price fixation of a new drug.” Another decision taken in this meeting was also directed at the NPPA – the price regulator was told it cannot revise the price of a drug for five years (except for revisions based on a court order or the wholesale price index).
Minutes of the meeting in the PMO on October 19, 2016, regarding drug pricing and other issues

Minutes of the meeting in the PMO on October 19, 2016, regarding drug pricing and other issues

The DoP is also conducting its own meetings on drug pricing. On March 31, the DoP issued a notice setting up a ‘committee for ensuring enhanced accessibility of drugs to the poor’. It is expected to suggest in six weeks, the “measures to be taken for making pricing policy more in favour of poor patients affordable medicare and health security.” They have held two meetings so far. The most recent meeting, on April 21, was designed to be a stakeholder meeting. Twenty-four industry and trade bodies were invited as well as 12 civil society organisations, besides bureaucrats.

“Why should bureaucrats be pleading for the industry’s interests? They should be pleading for the people,” says Ashwani Mahajan, the co-convenor of the Swadeshi Jagaran Manch. In their letter to the prime minister, the organisation said that the real purpose of this committee chaired by the joint secretary of policy in the DOP “is to pander to the pharmaceutical companies and undermine the good work done by the NPPA, and ultimately to abort any attempt to do effective price control and make medicines affordable in India.”

What this means is that in three months, the government has either reversed its position from what it told the Supreme Court in January or that the NITI Aayog disregards that affidavit all together. For the NITI Aayog, nothing much has changed in it approach. From their meeting in the PMO in October last year through to April of this year, its stance has been consistent. The body is still recommending the deregulation of drug pricing and the dilution of the NLEM. The lines are surprisingly drawn, given that all of this happens even as the prime minister calls for affordable medicines and a case in the Supreme Court on drug pricing is going through final arguments.

(This story will be updated if and when the government bodies concerned get back with a response.)

Niti Aayog, Other Government Departments Meddling in Drug Pricing, Alleges RSS-Linked Outfit

Swadeshi Jagran Manch has accused several government arms of lobbying for pharmaceutical companies and negating the NPPA’s attempts to make medicines affordable.

Swadeshi Jagran Manch has accused several government arms of lobbying for pharmaceutical companies and negating the NPPA’s attempts to make medicines affordable.

The RSS outfit has appealed to PM to intervene. Credit: Reuters

In a strongly-worded letter to Prime Minister Narendra Modi, the economic wing of the Sangh parivar, the Swadeshi Jagaran Manch, has accused several government departments of interfering in drug pricing. This follows the prime minister’s recent statements where he said the government plans on introducing a law so that doctors prescribe generic drugs, thus making healthcare more affordable.

In the letter dated May 1 to which The Wire has access, the organisation has claimed that pharmaceutical companies that are marketing the most essential medicines are “making profits in the range of 500%-4,000%” because the existing formula for ceiling prices is “market-based” and “against the interests of the people”.

Swadeshi Jagaran Manch has further alleged that government arms – the health ministry, department of pharmaceuticals (DoP), department of industrial policy and promotion, and the Niti Aayog – are attempting to “completely dismantle the system of price control.”

“So powerful has the hold of the pharmaceutical companies been that the secretaries and joint secretaries of three ministries, namely health and family welfare, commerce and industry through DIPP [Department of Industrial Policy and Promotion] and chemicals and fertilisers through DoP, are now holding meetings along with the NITI Aayog to completely dismantle the system of price control. Of course, some kind of presence, under the guise of pro-poor policies, will be made that they are going to introduce a better system,” says the letter.

The organisation appreciated the work of the National Pharmaceutical Pricing Authority (NPPA) for capping the prices of cardiac stents in 2016 and capping the prices of diabetes and cardiovascular drugs in 2014. Their letter says that government ministries, particularly the DoP, did not favour the attempts of the regulatory agency to “counter prevalent uncompetitive market conditions,” and that “plans are afoot to sabotage the NPPA.”

The Swadeshi Jagaran Manch further alleged that the actual purpose behind the formation of the ‘Committee for Ensuring Enhanced Accessibility of Drugs to the Poor’ was to “pander to pharmaceutical companies” and negate NPPA’s attempts to do make medicines affordable. The letter says:

“It is now known that ironically a ‘Committee for Ensuring Enhanced Accessibility of Drugs to the Poor’ has been formed on March 31, 2017 and chaired by the Joint Secretary (Pharma Policy), DoP. Its real purpose is to pander to the pharmaceutical companies and undermine the good work done by the NPPA, and ultimately to abort any attempt to do effective price control and make medicines affordable in India

It has also come to our notice that NITI Aayog has contacted representatives of various ministries with the intention of framing a new drug police and revamping the DPCO [Drug Price Control Order] 2013. It is our understanding that this issue is sub-judice before the Supreme Court (W.P. (Civil) 423 of 2003) wherein the final hearing is underway. While the Supreme Court is already seized of the matter and the price fixation methodology, it is not appropriate for the government to make further modifications in the drug policy and DPCO 2013 to suit the ends of the pharmaceutical industry.”

Commenting on Niti Aayog’s “ill-intentioned” recommendation in its ‘Three Year Action Agenda’ that the Drug Price Control Orders 2013 be delinked from the National List of Essential Medicines, the organisation stated that doing so would increase the price of essential medicines, saying that the act is “revealing of the Niti Aayog’s apathy towards the welfare of the poor people of the county.”

Labelling the actions of the government arms as being “against national interests and fundamentally anti-poor,” Swadeshi Jagaran Manch has appealed to Modi to intervene to ensure affordable access to medicines.

Read the letter in full below:

Shri. Narendra Modi
Hon’ble Prime Minister of India
South Block, Raisina Hill
New Delhi – 110011

29 April 2017

Dear Modi ji,

Subject: Essential medicines selling at exorbitant profits

Dept. of Pharmaceuticals colluding with pharma companies

Niti Ayog preparing to sabotage the drug price control regime

It was heart warming to hear statements made by you to the effect that it is your desire that the poor of India get essential medicines at reasonabe and affordable prices. Unfortunately, your departments are acting against what you have promised the people of India.

We are deeply concerned that prices of most essential medicines are too high for the majority of the people and contribute towards the impoverishment of millions each year. The pharmaceutical companies marketing these medicines are making profits in the range of 500% – 4000% and that too after imposing price controls. This is because the current formula for arriving at a ceiling price is an irrational market-based formula that legitimises profiteering and which is against the interests of the people.

Until very recently, i.e., till May 2013, when the Drug Prices Control Order (DPCO) of 1995 was in force, the drug price regulation ceiling prices were calculated as the cost of production, then doubled for certain marketing expenses and profit. This was a rational formula which gave the pharmaceutical companies a reasonable profit.

Unfortunately the pharmaceutical companies could influence the Department of Pharmaceuticals (DOP), which changed the ceiling price formula as a result of which the pharmaceutical companies were able to make super profits. So powerful has the hold of the pharmaceutical companies been that the Secretaries and Joint Secretaries of three ministries namely Health & Family Welfare, Commerce & Industry through DIPP, and Chemicals and Fertilisers through DOP, are now holding meetings along with the NITI Aayog to completely dismantle the system of price control. Of course, some kind of pretence, under the guise of pro-poor policies, will be made that they are going to introduce a better system.

The National Pharmaceutical Pricing Authority (NPPA) which was authorised by the Central Government to pass orders under the Essential Commodities Act read with the DPCO 2013, to control the retail prices of essential medicines, has been doing a rather remarkable job. The NPPA has recently done a commendable job through your support of bringing coronary stents under price control and capping huge trade margins to bring much needed relief to cardiac patients.

Previously in 2014, the NPPA, in another commendable initiative, had capped the prices of several medicines for cardiovascular disease and diabetes, using special powers vested with the Government to act in the public interest under the DPCO 2013, and thereby acting to counter prevalent uncompetitive market conditions and benefit the public. These activities have not been liked by the above mentioned ministries and secretaries, particularly the DOP, and plans are afoot to sabotage the NPPA, possibly by dismantling it altogether.

It is now known that, ironically, a “Committee for Ensuring Enhanced Accessibility of Drugs to the Poor” has been formed on 31 March 2017 and chaired by the Joint Secretary (Pharma Policy), DOP. Its real purpose is to pander to the pharmaceutical companies, undermine the good work done by the NPPA and ultimately to abort any attempt to do effective price control and make medicines affordable in India.

It has also come to our notice that the NITI Aayog has contacted representatives of various ministries with the intention of framing a new drug policy and revamping the DPCO 2013. It is our understanding that this issue is sub-judice before the Supreme Court (W.P. (Civil) 423 of 2003) whereinthe final hearing is underway. While the Supreme Court is already seized of the matter and the price fixation methodology, it is not appropriate for the Government to make further modifications in the drug policy and DPCO 2013 to suit the ends of the pharmaceutical industry. It is to our utter shock that such hurried attempts are being made to ease out the price control, which is only to the tune of 11-12% of the market, in the interest of the pharmaceutical industry, and to the detriment of the poor of this country.

We note that the NITI Aayog has a history of aligning with the vested interests in the relevant ministries to dismantle the regime of price control and wind up the NPPA. In continuation of the NITI Aayog’s attempts to deregulate the pharmaceutical market, it has made the following recommendation in the Three Year Action Agenda, 2017-18/2019-20, 23 April 2017:

“21.27 A balanced approach towards regulation is needed for achievning the twin objectives of access to effective medicines and a strong pharmaceutical industry. There is a trade-off between lower prices on the one hand and quality medicine and discovery of breakthrough drugs on the other. It is therefore recommended that the Drug Price Control Order may be delinked from the National List of Essential Medicines.” (pg. 144)

We strongly protest this ill-intentioned recommendation which will increase the prices of essential medicines to further unaffordable levels and is revealing of the NITI Aaayog’s apathy towards the welfare of the poor people of the country. We are also appalled at the misleading statements that make a false link between price regulation and poor quality of medicines, lesser innovation and deteriotion of the industry.

All these actions are against the national interests and are fundamentally anti-poor. It is shocking to see senior officials of these three ministries and the NITI Aayog acting in such a concerted fashion to lobby for the crass commercial interests of the pharmaceutical sector.

We request you to kindly intervene to thwart the moves afoot to undermine the declared intentions of the Government to ensure affordable access to medicines for all in India. We also suggest that the NPPA be strengthened and made an autonomous body rather than left as a subordinate agency of the DOP.

Sincerely,

Dr. Ashwani Mahajan

Swadeshi Jagaran Manch

Copy to:

ShriNripendraMisra, Principal Secretary
ShriPradeep Kumar Sinha, Cabinet Secretary