Tag Archives: Nexus

Opioid Crisis: A Looming Threat To India?

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A serious, but a typical health crisis that has shaken America, is now, apparently, in search of its prey in India – a soft target to ignite a raging fire of misuse or abuse of prescription drugs of addictive in nature. That India could probably be the next victim of this menace, is now being widely discussed and reported in the international media, though not so much in India, itself.

The January 2019 communique of the National Institute of Drug Abuse spotlights: ‘Every day more than 130 people in the United States die after overdosing on opioids.’ Whereas, in 2017, more than 47,000 Americans, among 1.7 million suffering people, died as a result of an Opioid overdose. Snowballing effect of Opioids addiction commenced over a couple of decades ago and includes – both prescription pain relievers and synthetic Opioids, such as fentanyl, among others.

The health menace of this humongous dimension is not only jeopardizing public health, but also impacting the social and economic welfare, work productivity, besides drug addiction related criminal behavior of an increasing number of addicts.

In this article, exploring the factors – that not just ignited, but fueled this fire, I shall try to explain why India could be a fertile ground for another opioid epidemic. The key intent is to thwart this menace without further delay, learning from the ‘Opioid crisis’ in the United States. Moving towards that direction, I begin with a brief description of the genesis of this crisis, primarily to ensure that all my readers are on the same page to feel the gravity of the situation.

The genesis of Opioid crisis:

The terms – ‘Opioid epidemic’ or ‘Opioid crisis’are generally referred to rapid increase in consumption of prescription and nonprescription Opioid drugs in America that began in the late 1990s. It is noteworthy, until the mid-1980s and early 1990s, physicians seldom prescribed opiates because of the fear of addicting patients. This was established in several studies, such as, the July-August 2016 Article, titled ‘Drug Company Compensated Physicians Role in Causing America’s Deadly Opioid Epidemic: When Will We Learn?’

In the ninety’s, as the above paper indicates, some “medical experts and thought leaders led by the neurologist and pain specialist Russell Portenoy, MD, proclaimed that the risks of addiction to Opioids were minimal and that not treating pain was cruel and even amounted to medical negligence.” Incidentally, Russell Portenoy was at that time known as the “King of Pain” and was the Chairman of Pain Medicine and Palliative Care at Beth Israel Hospital in New York.

The paper also articulated, “Portenoy and his acolytes wrote articles and gave lectures to physicians about the safety of narcotics. They repeatedly cited a study by Porter and Jick in ‘The New England Journal of Medicine’ that stated that only one percent of patients treated with narcotics became addicted.” It is a different matter, as the authors indicated, the above trial was ‘not a controlled study at all. It consisted of a short 101-word one paragraph letter to the editor.’

Understandably, the rapid spread of Opioid use in America commenced on the following years. As The author highlighted: “To this day in most American hospitals, nurses on their daily rounds, ask patients to rate their pain on a scale of one to ten and then may administer a narcotic accordingly.”

HHS corroborates the fact:

In line with the finding of the above paper, the U.S. Department of Health and Human Services (HHS) traces the origin of the U.S. Opioid Epidemic in the late 1990s. When, asHHS also reiterated, ‘pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers.’ Presumably, the general image of the pharma industry not being as questionable as today, ‘health care providers began to prescribe them at greater rates,’ – HHS further noted.

Thereafter, all hell broke loose, as it were.With increased prescriptions of Opioid medications, the widespread misuse of both prescription and non-prescription Opioids started taking its toll. Obviously, it happened as the prescribers were not as cautious and restrictive and concerned about prescribing Opioids because of their addictive nature, as they were before 1990s. It seems unlikely that astute medical practitioners won’t be able to fathom the devastating health impact of such highly addictive medications on the users.

America had to declare the Opioid crisis as public health emergency: 

In 2017 HHS declared Opioid crisis as a public health emergency, announcing a strategy to combat this epidemic. Separately, in October 2017, President Trump also declared the same as the ‘worst drug crisis in U.S. history’.One can sense this Presidential level urgency from the recent report of The Washington Post. It emphasized - ‘America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012, as the nation’s deadliest drug epidemic spun out of control.’

The above information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States – from manufacturers and distributors to pharmacies in every town and city. The data would provide an unprecedented look at the surge of legal pain pills that fueled the Opioid epidemic, resulting in nearly 100,000 deaths from 2006 through 2012, as the article highlighted.

In view of this, and also looking at the chronology of the genesis of this crisis, it is worth exploring the role of pharma companies in triggering this health hazard in America.

The role of pharma companies in the crisis: 

That there is, apparently, a role of some big pharma players in the Opioid crisis was widely reported by the international media. One such article titled, ‘Big Pharma Is Starting to Pay for the Opioid Crisis. Make Those Payments Count,’ was publishesby The New York Times, on August 28, 2019.

It said: ‘As innumerable court documents and investigations have shown, Opioid makers, including Purdue and Johnson & Johnson, routinely and knowingly misled the public about their products. They played down the risks of addiction, insisting that their drugs were safe and, if anything, underutilized. And they combated growing concerns with aggressive lobbying and public relations campaigns.’

The September 01, 2019 article titled – ‘America’s Opioid catastrophe has lessons for us all, about greed and racial division’, published in The Guardian went a step forward. Explaining the reason for the situation to attain a ‘crisis’ stage, it said, ‘big pharma saw huge profits in medicalizing the social stress of the white working class.’ Thus, the question that comes up, is there any strong and credible evidence to associate Opioid crisis with pharma marketing?

Association of Opioid crisis with pharma marketing:

Several reports point towards a possible pharma-doctor nexus for the Opioid crisis. One such evidence is provided by the same  July-August 2016 Article, as quoted above. The paper said:‘Recently and belatedly, Portenoy has backtracked and admitted he was wrong about the addictive properties of Opioids.’ He was quoted in the article saying: “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”

Another original investigation report in this regard, titled ‘‘Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses’, was published in JAMAon January 18, 2019. The paper concluded:‘In this study, across US counties, marketing of Opioid products to physicians was associated with increased Opioid prescribing and, subsequently, with elevated mortality from overdoses. Amid a national Opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.’

The article also indicated: ‘Recent data suggest that when physicians receive Opioid marketing, they subsequently prescribe more Opioids.’ The researchers pointed out:‘Amid a worsening Opioid crisis, our results suggest that industry marketing to physicians may run counter to current efforts to curb excessive Opioid prescribing.’

Again, the same September 01, 2019 article, published in The Guardian, also stresses– ‘The relationship between big pharma and US doctors can only be described as corrupt.’ Quoting the official figures, it highlighted: ‘The total paid to doctors and hospitals by drug companies was more than $9bn. Unsurprisingly, the greater the payments, the more willing doctors were to prescribe Opioids.’

The India’s tryst with Opioid drugs:

As many would know, India has remained for a long time one of the largest Opioid medicine producers in the world. However, most of the country’s population had a restricted access to Opioid pain relief drugs.

This was because, the International Narcotics Control Board, established in 1968, and the Narcotic Drugs and Psychotropic Substances Act of 1985 ‘codified the bureaucratic thicket for any doctor who wanted to prescribe opioid painkillers. Physicians feared fines, jail sentences and losing their medical license if they skirted regulations.’

The amendment came in 2014:

According to reports, the need for pain relief being “an important obligation of the government,” the Narcotic Drugs and Psychotropic Substances Act, was amended in 2014, creating a class of medicines called the “essential narcotic drugs.” The list of which includes, morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone. Alongside, the conditions for bail in drug offenses will be relaxed and the mandatory death penalty for those previously convicted of certain offenses will be revoked.This is expected to create a better balance between narcotic drug control and the availability of Opioid drugs, for beneficial use of patients.

The flip side – a looming threat?

So far so good. Nevertheless, another article – ‘How big pharma is targeting India’s booming Opioid market,’ appeared in The Guardian on August 27, 2019, shows the flip side of this development. It says, as India loosens its stringent narcotics laws, ‘American pharmaceutical companies – architects of the Opioid crisis in the United States and avid hunters of new markets – stand at the ready to fuel that demand.’

Many are truly concerned about it, especially in a country like India, where any medicine can be procured over the counter, hoodwinking robust drug laws. Thus, as the above article adds, ‘a looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at local chemist shops.’

Providers of pain management are increasing, so also self-medication:

Today, ‘pain management’ as a specialty treatment, can be seen in many hospitals of the country. In tandem – apparently, ‘at the insistence of the professional societies that accredit hospitals in India, nurses and doctors are now encouraged to assess pain as a “fifth vital sign“, along with pulse, temperature, breathing and blood pressure.’ Besides, as The Guardian article of August 27, 2019 also noted, ‘General practitioners have started prescribing these drugs.’

Yet another important point to note, according to studies, one of the most common reasons for self-medication is for pain – 18.34 percent, where self-medication is done with nonsteroidal anti-inflammatory drugs in 49.4 percent of cases. Keeping pace with this trend, most generic pharma companies are having pain management product in their brand portfolio, unlike a couple of decades ago.

Early signs of drug companies’ special marketing activities:

There are many examples. But I shall quote The Guardian article again to drive home this point. The paper talks about hints of ‘American pharma’s fingerprints’ in a glass cabinet in the waiting room of a famous clinic in Delhi. Some of these include ‘awards from Johnson & Johnson honoring the doctor for symposia on pain management; a plaque for “his valuable contribution as a speaker” about tapentadol, an Opioid marketed by Johnson & Johnson in 2009. The dispensing counter does a brisk business in Ultracet, branded tramadol tablets made by a Johnson & Johnson subsidiary.’

Alongside, another interesting point is peeps in – the drugs, which are now commonly prescribed for chronic pain were first approved for use by cancer patients. ‘One of the first formulations of fentanyl, for example, was a lollipop because chemotherapy left cancer patients too nauseated to eat. In India, pain physicians now prescribe fentanyl patches to patients with chronic muscular pain.’

Every year, more of such drugs are coming to market. Many chemists, hospitals and medical shops are also acquiring requisite licenses for keeping these drugs. Curiously, Opioids are available in not just oral, but injectable, patches and syrups – the article noted.

Conclusion:

There are many striking similarities between the developments that preceded the American Opioid crisis and the emerging scenario of the same in India. One such is, its onset in America was in the late 1990s, with the regulatory relaxation in introducing Opioid drugs. However, the first announcement of the full-blown crisis on the same, took a couple of decades to come.

In India, the regulatory relaxation for some Opioid drugs came in 2014, and now its 2019. Thus, it’s possibly too early to even track, in which direction it is moving. However, given the prevailing overall healthcare scenario in India, the concern remains palpable. The decision makers, hopefully, would consider putting in place effective checks and balances, taking a leaf from the American Opioid epidemic. The measures should include, among others, effective implementation of legal and regulatory provisions; making health care delivery systems robust and transparent; protecting vulnerable patients from rampant and irresponsible self-medication, besides promptly addressing general concerns with pharma marketing practices.

The whole process should be aimed at benefitting the deserving patients, suffering from excruciating pain, while minimizing Opioid drug misuse or abuse. There should not be any repetition of human sufferings on this score, like what people are now witnessing in America. Effective action from all concerned – right from now, will decide whether or not Opioid crisis is a looming threat that India can successfully neutralize.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Is The Department of Pharmaceuticals On The Same Page As The Prime Minister?

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“The open secret is that pharmaceutical companies throw all manners of inducements on doctors to prescribe their medicines. The victim of their misdemeanors is the unsuspecting patient. Mr. Modi clearly wants to break this self-serving chain” – highlighted a media report on April 20, 2017.

“Prime Minister Modi wants to end the unholy doctor-drug industry nexus” – echoed another media headline on the same day.

In a step towards this direction for the benefits of patients, the PM hinted at making prescriptions in generic names of drugs mandatory through a legal framework. There could be many challenges ahead to achieve this objective, but the fact remains just the same. A study published in a well-acclaimed medical journal, even after the PM’s much talked about pledge, re-establishes the adverse impact of this alleged nexus through a bioequivalarge research study.

In this article, I shall not go into the details of what the PM had said in this regard and the impact of the same on patients, pharma companies, different types of service providers to the branded-generic business, and the Indian Pharma Market (IPM), as I have already done that. Neither shall I focus here on the action expected from the Union Ministry of Health, as they have, at least, amended the statute making the bioequivalence studies mandatory, though several other action steps need to follow. Today, I shall deliberate only on one question: Is the department of pharma on the same page with the PM on effectively addressing the alleged ‘doctor-drug industry nexus’?

A recent study:

The following very recent study elegantly highlighted the criticality of snapping this unholy link, as many believe, for the patients’ sake.

The May 2, 2017 JAMA editorial titled, “Reconsidering Physician – Pharmaceutical Industry Relationships” articulated, physicians need to balance the risk and benefits of treatments, especially when inputs come from companies whose interests may conflict directly with those of patients. Drug costs, though revenue to their respective manufacturers, are high out of pocket expenditure to patients, many of whom seriously struggle to afford their medical treatment.

The above editorial comment was based on an ‘Original Investigation’ study titled, “Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing”, published on the same day in the same esteemed journal.

This large study was aimed at measuring the outcome of an effort by some Academic Medical Centers (AMCs) in the United States to regulate physicians’ conflict of interest in this area. These AMCs enacted policies restricting pharmaceutical representatives’ visits to physicians for product detailing, between 2006 and 2012. Accordingly, the paper analyzed the association between detailing policies enacted at these AMCs and the physicians’ prescribing of actively detailed and not detailed drugs. This study included 16,121, 483 prescriptions, written between January 2006 and June 2012, by 2126 attending physicians, at the 19 intervention group AMCs, and by 24, 593 matched control group physicians.

The authors concluded with a fresh reaffirmation that the implementation of policies at AMCs, which restricted product detailing by the respective company medial representatives, between 2006 and 2012, was associated with a modest but statistically significant reduction in prescribing of detailed drugs across 6 of 8 major drug classes.

Significant cost reduction, with important economic implications:

It’s worth noting, the patients did not suffer at all, in any way, with such restrictions, on the contrary were probably benefitted with this policy, though individual pharma player’s sales revenue might have been adversely impacted.

Quoting the researchers, a Public Release of May 2, 2017 titled, “Restricting sales visits from pharmaceutical reps associated with changes in physician prescribing” also reiterates: The reduction in the prescribing of detailed drugs and the increase in the prescribing of non-detailed drugs potentially represent a large reduction in costs, with important economic implications.

Why aren’t the erring players brought to justice in India?

Instances of serious marketing malpractices of several pharma companies in India are also being widely reported from time to time, both by the international and national media, including expressions of serious concern in the Parliament, and a reported Public Interest Litigation (PIL) pending in the Supreme Court.

Any instances of levying massive fines, or other punitive measures taken by any competent Indian authority for such delinquency by many pharma companies operating in the country, have not been reported, just yet, in my view. This is because, India doesn’t have in place any specific regulatory mechanism with built-in legal teeth that would deter, detect, investigate and take exemplary punitive actions against the erring players, wherever justifiable.

Is the department of pharma on the same page as the PM?

Much before this recent development, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report, placed before the Parliament on May 08, 2012, strongly indicted the Department of Pharmaceuticals (DoP) for not taking any tangible action in this regard. The committee observed that the DoP should take immediate action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.

It has just been reported, soon after the Prime Minister’s hint for a legal framework mandating doctors to prescribe in generic names, 73 percent doctors surveyed across the country opposed the PM’s initiative, raising concerns about the quality of all non-branded generic drugs. The report further stokes the apprehension of a concerted effort by this alleged nexus to further strengthen the make-believe perception, sans requisite credible favorable evidence, that branded-generics as a category is superior in quality to non-branded generics, which is not the fact.

Unfortunately, nothing substantive has yet happened on the ground regarding this issue, except the announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP on various pretexts, such as continuing discussion with the pharma trade associations and other stakeholders or to give legal teeth into it with penal provisions.

This situation prompts an important question: Is the DoP on the same page with the PM to contain, if not eliminate, the alleged unholy doctor-drug industry nexus?

Scope of mandatory UCPMP goes beyond prescriptions with generic names:

The scope of several intricate types of marketing malpractices, goes well-beyond influencing prescriptions for brand name drugs, due to various reasons. Hence, what Prime Minister Modi recently hinted at is not an alternative or a replacement for UCPMP, which will fall within a legal framework and be applicable to all the concerned players. Although, there could possibly be some degree of overlap with the prescriptions in generic names, mainly from the perspective of protecting patients’ health interest, the scope of both these initiatives is mutually exclusive, in many respects.

This would also encourage, especially the millennial generation, for innovative strategic thinking to work out cutting edge pharma marketing game plans with active patient engagement, while charting the uncharted frontiers, despite prescriptions in generic names, as and when it comes, if at all. As a result, new warhorses with proven cerebral power and agility would get newer opportunities to hold the leash and occupy the center stage in the pharma marketing warfare.

But…the indefinite wait continues:

Although the DoP apparently maintains a radio-silence on this important issue, a media report of February 26, 2017 indicates that the department will ‘soon’ issue an order making UCPMP mandatory for the drug manufacturing industry, bringing all doctors, chemists, hospitals and states in its ambit, and a blanket ban on expensive freebies such as cruise or vacation tickets. Intriguingly, no one seems to know how ‘soon’ would this ‘soon’ be – hence, the agony of an indefinite wait for justice continues.

Conclusion:

For the last three and a half decades, ‘Code of Pharmaceutical Marketing Practices’, prepared by various global pharma trade associations and many large global pharma companies individually, has come into existence for ‘strictest’ voluntary adherence. These are being relentlessly propagated by them as a panacea for all marketing malpractices in the drug industry.

Squeaky clean ‘pharma marketing codes for voluntary practices’ can be seen well placed in the websites of almost all large global pharma players and their trade associations. Although, its concept and intent are both commendable, a regular flow of media reports on such malpractices raises a relevant question: Do the votaries, sponsors and creators of these codes “walk the talk”?

If yes, why then mind boggling sums in billions of dollars are being paid as settlement fees by a large number of global pharma companies for alleged colossal marketing malpractices in different countries of the world.

This scenario prompts many stakeholders believe, though over-hyped by the global pharma industry, ‘Voluntary Practices’ alone of Pharma Marketing Code’, has never worked anywhere in the world. Thus, India needs a legally binding UCPMP for all concerned.

Prime Minister Modi has hinted at an effective pathway to mitigate this malevolent nexus for the benefit of patients. Understandably, that way can’t be construed as an exhaustive one, nor a cure-all. A slew of other effective steps should follow from different Government authorities, in tandem. The Union Ministry of Health has, at least, taken a related measure falling in their space. Nevertheless, an intriguing apathy of the DoP, as it were, in this area would encourage many to ponder: Is this important Government department on the same page as the PM in containing the alleged ‘doctor – pharma industry nexus?’

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Slugfest in Pharma Land: Isn’t ‘The Pot Calling the Kettle Black?’

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Close on the heels of detention of a British Citizen, an American citizen too has  been reportedly detained, for the first time, by the Chinese Government in connection with unfolding mega corruption scandal in the country’s pharma industry involving even ‘third party’.

A slugfest over this corruption scandal too has already begun. Media reports highlight, vested interests, as usual, retaliate by saying that China’s attention to the alleged corruption by MNCs is to benefit the local Chinese companies.

As per reports, big global pharma innovator companies like, GlaxoSmithKline, AstraZeneca and UCB are currently being questioned by the Chinese authorities related to this scam.

Critical role of ‘Third Party’ in pharma bribery and corruption: 

Although in the above Chinese scam, a third party, in form of a travel agency, has been accused to have played a critical role in the GSK case, it will be hard to believe that this is a solitary example.

Internal ‘Compliance Systems’ of global pharma companies, in most cases, are believed to be robust enough and will generally be found squeaky clean by any audit. Unfortunately, as it appears from various international reports, corruption still enters through cracks between seemingly robust ‘compliance firewalls’ for business gain.

Invariably in response, expensive and high decibel Public Relations (PR) machineries are put to overdrive. These extremely capable PR agents, with their  all guns blazing, keep trying to establish that such incidents, though quite frequent and are taking place across the world unabatedly, are nothing but  ‘small aberrations’ in pursuit of pharma ‘innovation’ for newer drugs just to benefit the patients.

As one understands from the GSK case, the ‘third party’ travel agent reportedly attempted to keep all transactions at arm’s length to avoid detection of any unholy nexus by the Chinese regulators. 

However, in the real world, it could possibly be any crafty and well-identified ‘third party’, intimately associated with the pharmaceutical business process. These ‘third parties’ are crafty enough to exploit the loopholes in the seemingly robust compliance systems of the concerned companies to help facilitating their financial performance. 

An interesting commonality in all such often repeated scams is the lack of top management accountability of the companies involved. This would probably surprise even the recent public sector scam tainted concerned ministers and top bureaucrats of India.

Much to everybody’s dismay, such incidents reportedly continue to take place in various parts of the world and in all probability in India too.

Other countries initiated probes:

Unlike the high-octane development in China, in many developed countries probes against such corruption have already been initiated at a different scale and level. For example, in Canada a conservative MP reportedly testified on October 17, 2012 to the ‘Standing Senate Committee on Social Affairs, Science and Technology’ as an expert witness regarding post-approval drug monitoring and the corrupt practices of pharmaceutical companies.

Global Corruption Barometer 2013:

When a person talks about corruption, it usually gets restricted to corrupt practices in the Public Sector. Any such issue involving Business, Healthcare, Education and even Judiciary, Media and NGOs are considered at best as misdemeanor, if not minor aberrations.

In this context it is worth mentioning that ‘Transparency International’ has released Global Corruption Barometer 2013 recently.  This ‘2013 Barometer’ is the world’s largest public opinion survey on corruption. It surveyed 114,000 people in 107 countries.

The reported global findings of this survey, which indicate a general lack of confidence in the institutions tasked to fight corruption, is as follows:

  • More than one in two people thinks corruption in their country has worsened in the last two years.
  • 54 per cent of people surveyed believe their governments’ efforts to fight corruption are ineffective.
  • 27 percent of respondents have paid a bribe when accessing public services and institutions in the last 12 months, revealing no improvement from previous surveys.
  • In 51 countries around the world, political parties are seen as the most corrupt institutions.
  • In 36 countries, people view the police most corrupt, in 20 countries they view the judiciary as most corrupt.
  • 54 percent of respondents think that the government in their country is run by special interests.

Situation alarming in India:

However, in India, the situation is much worse. Besides political parties, police and legislature, institutions like, Health Systems, Business, Judiciary, NGOs and even Media smack of high level of corruption, as follows:

No: Institutions Bribe Quotient %
1. Political Parties 86
2. Police 75
3. Legislature 65
4. Education 61
5. Health Systems 56
6. Business 50
7. Judiciary 45
8. Religious Bodies 44
9. Media 41
10. NGO 30
11. Military 20

Moreover, as per the report, approximately one out of four people paid a bribe globally in 2012, while in India, the bribe-paying rate was twice, with a little over one out of two people paying a bribe. Based on this indicator alone India occupies 94th rank out of 107 countries.

Coming back to healthcare in India, manifestations of high level corruptions in this critical area taken together with the same, as reported for its close connects like, as follows, are indeed alarming:

  • Business houses (include pharma companies)
  • Education (produces doctors, nurses etc.) 
  • Judiciary (also resolves various pharma disputes) 
  • Media (help creating unbiased public opinion) 
  • NGOs (takes care of Patients’ interest) 

The prevailing situation is highly disturbing, as any meaningful reform measures in the healthcare space of India could be effectively blunted, if not negated, by influencing related corrupt institutions.

It is important to note that bribery in the Indian healthcare sector was as rampant as Education and Judiciary in 2012, as follows:

No. Sector Bribe Paid in 2012 %
1. Police 62
2. Registry & Permits 61
3. Land 50
4. Utilities 48
5. Education 48
6. Tax Revenue 41
7. Judiciary 36
8. Health 34

Source: Global Corruption Barometer 2013

Where there’s smoke, there’s fire:

All these numbers vindicate the well-known dictum ‘where there’s smoke, there’s fire’ for the healthcare sector, in general, and the pharmaceutical sector, in particular, of India.

Bribery and corruption appear to have emerged as the key compliance related issues in the pharma sector. A report indicates that this is mainly due to manipulable environment in the pharma industry, just like in many other sectors as mentioned above.

Such manipulations could range from influencing drug procurement prices in return for kickbacks, giving expensive freebies to the medical practitioners in return of specific drug prescriptions, and even making regional regulatory bodies to provide favorable reports overlooking blatant malpractices.

High level of tolerance:

KPMG Fraud Survey Report 2012 also highlights, though bribery and corruption continues to be an issue, pharma industry shows reluctance to discuss it openly. Moreover, close to 70 per cent of respondents surveyed said, they faced no significant threats from such issues.

The report also indicated, around 72 per cent of respondents expressed that their respective companies have in place a robust mechanism to address bribery and corruption. However, only few respondents expressed inclination to explain such in-house mechanisms. This vindicates the point of high levels of institutional tolerance to bribery and corruption in the pharmaceutical sector of India, just like in many other countries.

“Collusive nexus”:

Even a Parliamentary Standing Committee in its findings reportedly indicted India’s top drug regulatory agency for violating laws and collusion with pharmaceutical companies to approve medicines without clinical trials with the following remark:

“There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.”

A Research Scientist fumes:

Following is a reported comment of a research scientist on corruption and bribery in the pharmaceutical industry of India:

“It would not make me happy, to put it mildly, to think of a drug that I’d had a part in discovered being flogged via sleazy vacation offers and sets of cookware dumped on a doctor’s office floor.”

Where pharma and political slugfests unite:

This short video clip captures one of too many pharma slugfests given a very high level and fiery political dimension in the global pharma land.

Conclusion:

As we have seen in the ‘Global Corruption Barometer 2013’, the respondents regarded almost all key institutions and industrial sectors in India as being corrupt or extremely corrupt.

As per the above report, corruption seems to have engulfed the private sector too, and alarmingly has not spared even the ‘healthcare system’ at large , as it quite prominently shows up in the ‘Corruption Barometer 2013’. 

As deliberated above, some ‘third parties’ of any type, working within the pharmaceutical value chain, could well be the fountain heads of many types of corruptions, as reported in China. They should be put under careful vigil of the regulators, placed under magnifying glasses of scrutiny and the rogues must quickly be brought to justice wherever and whenever there are violations. A report stating, Chinese administration has decided to punish 39 hospital employees for taking illegal kickbacks from pharmaceutical companies as a part of country’s widening investigation against pharma corruption, would justify this point.

That said, the task in hand is much tougher. On the one hand an Indian Parliamentary Panel observes that both regulators and the pharma companies are hand in glove to fuel corruption, instead of dousing the fire.

On the other hand, the global pharma industry has been accusing the Indian government of ‘protectionism’, ‘lack of transparency/predictability in its policy measures’ and ‘draconian IP laws’.

In the midst of all these cacophony, haven’t the stakeholders and the public at large, with exposure to contextual information, started pondering:

Gosh! in the slugfest on the pharma land, isn’t ‘The Pot Calling the Kettle Black?’

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.