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Acid Test For Excellence in Crisis Leadership

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On April 12, 2020 – in the morning of the day 19 of the national lockdown, India’s total number of Coronavirus positive cases reached 8,504 with 289 deaths. The country’s trajectory is reportedly  steeper than most Asian peers, such as Singapore, Japan, and Indonesia. Incidences of new infections and deaths are also rising faster. The report also highlighted a possible link between number of tests conducted and the number of confirmed cases across the States. The aggregated impact of Covid19 outbreak has created an unprecedented health, social and economic calamity, changing everybody’s life – now and beyond.

However, going by Prime Minister Modi’s announcement on March 24, 2020, the national lockdown to contain the pandemic should continue till April 14, 2020. But, the above scenario is creating a huge dilemma within almost all Coronavirus crisis management leadership in the States, with the final decision resting upon the Prime Minister of India. Meanwhile, on April 09, 2020, Odisha government decided to extend the lockdown until April 30, followed by Punjab, Maharashtra, Karnataka and Telengana on April 11, 2020. However, all will get to know India’s decision in this regard for the rest of India, as you read this piece today.

The top leaders of Asia, Europe and American continents are handling the grave situation differently, with a varying degree of success, so far. Everybody is watching different world leaders in action – each trying hard to gain control over the unprecedented crisis, making it an acid test for excellence in Crisis Leadership.

Three different types of needs for the country:

As I see, three specific types of needs of three specific classes of people in the social milieu, are emerging in India:

  • Only need is to save life from the disease, with not much problem in procuring other essential requirements – having enough wherewithal to pull through the critical period, better than most others.
  • Strong need exists to save life, but facing tough challenges in arranging for essential needs for daily living.
  • Need to save life, but feel desperate for the means of livelihood – to protect family and defendants from hunger, in a seemingly uncertain future.

In the current situation, while trying to contain the spread of pandemic effectively, the sufferings of especially, the second and third group, as stated above, also need to be addressed, ‘and this is much aided by a participatory democracy.’

An acid test for crisis leadership at the top:

The situation isn’t just a war against Covid19, but much beyond that. The Nobel Laureate Professor Amartya Sen at Harvard University  explained the situation so well in an article, published on April 08, 2020. He lucidly illustrated, that the needs of people in a natural calamity, such as Coronavirus caused a pandemic, are different from a conventional war – against an enemy country. Desirable leadership qualities are also significantly different.

As Professor Sen wrote, while managing a crisis situation during a conventional war, ‘a leader can use top-down power to order everyone to do what the leader wants – with no need for consultation.’ But, managing a crisis during a natural calamity, a leader should demonstrate skills for a ‘participatory governance and alert public discussion.’ Listening to public discussion makes the top leadership understand what needs to be done by the policy makers.

Another paper, titled “Steering Through the Storm,” published in the ‘People + Strategy’, also reiterated the same with different words. It emphasized, “during a crisis, like natural calamity, leaders should engage actively with their constituents whenever possible, distinguishing critical issues from less pressing needs, communicating risks, and maintaining readiness. Throughout the crisis, leaders should remain accessible and open to new sources of information, and take care of their own needs when necessary and appropriate.”

How different countries are demonstrating crisis leadership:

Like other countries, crisis leadership is now clearly visible even in India – right from 1 day ‘people’s curfew’, to the announcement of 21-day national lockdown for Covid19 outbreak. An interesting article, published in Forbes on March 10, 2020, deliberated on what China, Italy and the United States teach us about crisis leadership. These examples give a sense of how different countries, facing similar but country-specific problems with Covid19, reacted with remarkable ‘different approaches and results.’ I am paraphrasing below some recent illustrations on crisis leadership, as captured in the above paper:

China: China was the first country to face this calamity beginning in Wuhan of the Hubei province. With command and control leadership and decisive action China was able to immediately to garner and consolidate all its resources for an aggressive response. The World Health Organization called it as, “perhaps the most ambitious, agile and aggressive disease containment effort in history.” This includes closing down manufacturing sectors, sharing information widely, executing mass testing and quarantining millions of people. The Chinese government made the decision to absorb a significant economic cost to contain COVID-19 rather than potentially lose control and the result was effective - the number of new cases has steadily decreased in weeks’ time.

However, the downside of this type of leadership is the possible erosion of trust in the system. As the Atlantic documented, local Chinese officials reported the Covid19 outbreak to the federal government weeks after it began. They also understated the extent of the disease spread, until whistle-blowers stepped forward – and were subsequently punished. This delay probably cost China valuable time in containing the initial outbreak.

This demonstrates, under a command and control ‘crisis leadership’, when people are afraid to tell the truth and discouraged from speaking up, critical information may not reach leadership, until the problem intensifies, the paper added. That said, whether the COVID19 outbreak may have been contained earlier under different leadership conditions, cannot be concluded for sure, at least, in this case. However, official data release now shows more than doubling of new Coronavirus cases to 99 in Mainland China, on April 11, 2020. Moreover, newly reported asymptomatic Coronavirus cases also nearly doubled to 63 on the same day. Hence, the fire has still not been doused. The crisis lingers.

Italy: The catastrophic impact of Covid19 in Italy, helps identify some avoidable areas in ‘crisis leadership’. With rapidly changing and inconsistent messaging, the leaders possibly created panic and distrust among people of all kinds. The top leadership seems to have underestimated the potential spread of the virus, and was not acting in coordination with various groups and stakeholders to contain it, initially.

It happened, despite Italy is a democratic country, unlike China. But, the country, apparently, did not comply with the robust and critical ‘crisis leadership’ norm of fact-based ‘participatory governance and alert public discussion’, as discussed above. This reconfirms that ‘crisis leadership’ must be very careful in saying something they will end up contradicting later, while handling, especially a social calamity, like Covid19 outbreak.

The United States: With the fire of Covid19 outbreak spreading fast in the United States, one finds again, some basics of crisis management norms were missing in the top leadership of the oldest and a robust democracy of the world. Instead, President Trump demonstrated ‘a tendency to rely heavily on his inner circle rather than subject matter experts and to state opinions as facts.’ The President also contradicted experts on his own task force attempting to educate the public, most notably by consistently overstating the scientifically acknowledged timeline to create a vaccine and the preventive medicine combo. He also questioned the reported fatality rate of the virus.

This type of ‘crisis leadership’ is likely to fail in inspiring trust and confidence with the masses, the article concluded. This is evidenced by the current status of the country. The lethal firepower of Covid19 is still hitting the United States very hard, against all its might to fight the invisible enemy garnering all its resources and possibly taking more lives than what it lost, as on date, while fighting all its wars. As on April 11, 2020, the death toll from Coronavirus in the United States eclipsed Italy’s for the highest in the world, surpassing 20,000 marks.

Now let me focus on India, with my own assessment about the ‘crisis leadership’ while responding to this crisis, of course, initially.

India:

To get a perspective of Covid19 spread in South Asia on a relative yardstick, let’s look at the following Government released figures, as quoted in the Reuters report on April 08, 2020:

Country Ind Pak Afghan Sri Lanka Bangladesh Maldives Nepal Bhutan
Cases 5274 4072 444 189 218 19 9 5
Death 149 58 14 7 20 0 0 0

On April 11, 2020, the World Bank estimated, the ‘worst economic slump in South Asia in 40 years.’ Further, India, Bangladesh, Pakistan, Afghanistan, Sri Lanka and other three smaller nations, with 1.8 billion people and thickly populated cities, although have so far reported relatively few Coronavirus cases, could be the next hotspots for Covid19.

With this, let us look at the Covid19 narrative being unfolded in India, so far. In a lighter vein, following the interesting events with ‘sound’ and ‘light’, the ‘camera’ of time has indeed captured a commendable display of high quality ‘crisis leadership’ in India. Especially, under the given circumstances prevailing at that juncture. The leadership approach fits so well into one of the most critical requirements of crisis management – ‘participatory governance and alert public discussion.’

Even, some seemingly pointless events for some, at the end of the day, did raise morale of many in the fight against Covid19 outbreak, besides their level of participation and involvement in this crisis. Whether or not it is purely due to the personal charisma of the Prime Minister and his huge followings, also doesn’t matter much, as the point is, what really happened, instead of why it happened.

Besides, right from the declaration of ‘Peoples Curfew’ of March 22, 2020 to 21-day national lockdown, the Prime Minister has involved the State Chief Ministers, but also the leaders of opposition parties. Indian Council of Medical Research (ICMR) is also visible in the forefront. The net result is the support that the Prime Minster is getting from all, despite hardship – an epitome of ‘crisis leadership,’ as on date.

Thus, the beginning has been laudable, especially when India had no option but to enforce a lockdown, in one form or the other, without having enough testing kits, Personal Protective Equipment (PPE) for healthcare manpower and required health care infrastructure for quarantine or isolation of people. Let me explain this point with a very recent example.

According to a recent report, Covid19 test guidelines presumed that most patients in India acquired the virus from their travels abroad, or from someone who travelled abroad. Accordingly, with a limited number of kits, tests were conducted to zero in on these patients, isolating and quarantining them, to curb the spread of the virus. very focused with lesser requirements of the testing kits.

However, the data compiled by ICMR from random Coronavirus tests on patients with severe respiratory diseases, indicate that 38 percent of Covid19 patients with no travel or contact history have contracted the virus. On April 10, 2020, the Government said that the testing has now been increased to 16000 from earlier 5000-6000 people per day. This raises the vital question: has Covid19 outbreak in India has progressed or progressing from stage 2 to stage 3 of the outbreak, or has the community spread of the disease begun, the last and final stage being stage 4 – the scary virtually uncontrolled Coronavirus outbreak? Alarmingly, as has been widely reported, even on April 12, 2020: ‘Coronavirus in India: Several targets missed, still no sign of rapid testing kits.’ Currently, ‘India ranks extremely low in the Coronavirus-hit countries list based on the number of tests done per million population.’

Thus, the declaration of 21-day national lockdown on March 24, 2020, at the early stage of the Coronavirus outbreak in India was an unprecedented decision. Besides, containing the rapid disease spread, it gave India a small time-space to prepare itself – with more testing kits, Personal Protective Equipment (PPE) for healthcare manpower and adequate number of high-quality – isolation, quarantine and treatment facilities, equipped the disease specific requirements, such as, ventilators.

No matter what, the decision for a 21-day nationwide complete lockdown, giving priority to life over livelihood was a tough call to take for any leader. It indeed was a part of the critical test for excellence in ‘crisis leadership,’ at that point of time.

Conclusion:

Be that as it may, as the saying goes ‘proof of the pudding is in the eating,’ the acid test for excellence in ‘crisis leadership’, obviously, will be based on the quality of outcomes and the time it will take. This will include multiple key factors, such as, the speed of health, social and economic turnaround of a country, which is sustainable. Nevertheless, the crisis is far from being over – anywhere in the world, just yet, and the jury is still out.

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.

 

Are Pharma Business Ethics And Performance Interlinked?

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Way back in the 1960s, many could realize that of upcoming consumer-focused business environment will bring business practices under intense stakeholder scrutiny. This prompted both the business schools, as well as the commercial organizations to bring the concept of ‘business ethics’ under focus.

However, a boom in the ‘Business Ethics’ curriculum, virtually in every business school, globally, alongside numerous training programs, was palpable around the 90’s. This trend continues even today with as much gusto, but with increasing participation of various companies, primarily to showcase their commitment to ethical standards and values as fundamental business requirements.

Like many other industries, the same is visible in the pharma business, as well. Which is why, many pharma CEO’s, such as of Novartis, emphasized even in its 2018 CEO’s letter to the company shareholders that: ‘We have made clear to everyone at Novartis that we must never compromise our ethical standards to meet business objectives.’ The previous CEO of the same company also used similar words. Moreover, one can find a similar commitment to business ethics being displayed in the respective websites of many other drug companies.

I have discussed various different aspects on this subject since 2011. One such article is titled, ‘Business Ethics, Values and Compliance: Walking the Talk,’ published in this blog on December 26, 2011. However, in this article, after a broad outline, I shall endeavor to explore whether or not compliance with pharma business ethics is intimately related to the company’s performance, especially in the medium to longer term. While doing so, let me help recapitulate what exactly does ‘business ethics’ mean to all?

‘Business Ethics’:

As many would know, the ‘business ethics’ or ‘ethical business behavior’, is defined as ‘acting in ways consistent with what society and individuals typically think are good values. Ethical behavior tends to be good for business and involves demonstrating respect for key moral principles that include honesty, fairness, equality, dignity, diversity and individual rights.’

When this definition is applied to the pharma industry, in general, one finds, despite bringing to market top innovative drugs, a pharma player with dubious ethical behavior, may face a great risk of losing its reputation – a key element for business success, if not survival.

What is happening today in this area?

As, stated above, from various statements of pharma head honchos and also as displayed in their respective websites, it seems to be a serious area for them. Intriguingly, despite such laudable intent, the situation on the ground for many of these companies are quite different. According to reports, even in the Indian Pharma Industry, blatant disregard for maintaining basic ethical standards is, reportedly, not uncommon, either. Interestingly, no less than the Prime Minister of India is, apparently, aware of some of these issues in the pharma industry.

Ultimate ethical goals and consumer perceptions of ethical behavior:

Many research papers have been discussing this point, since long. They also flagged some critical areas, across pharma business domains, for corrective action. One such paper is titled, ‘Ethical challenges in the pharmaceutical industry,’ published in the April 2012 issue of Pharmaceuticals Policy and Law.

It clearly articulated, the ultimate ethical goal in the pharmaceutical industry is to discover and develop safe, efficacious and high-quality drugs that allow patients to live longer, healthier and more productive lives, while making a profit to reward shareholders and to invest in research for the next generation of medicines. The essence of it holds good also for generic drugs, too.

While this may be mostly happening, as the article noted, overall consumer perception of pharma business ethics is largely negative. This avoidable stakeholder perception is primarily triggered by, among others, pricing, data disclosure, clinical study design, marketing practices, cost effectiveness of treatments, and often reported ‘pharmaceutical frauds’, as quoted earlier.

Regardless of drug industry claim, consumers generally perceive new drug discovery as a fundamental business necessity for the industry. Whereas, they are more interested in access and affordability to these drugs, besides other related business practices. This brings us to the question – Are alleged breach of ‘business ethics’ systemic in nature for pharma?

Are ‘business ethics’ related issues, systemic in nature?

While many pharma CEOs keep highlighting, how ethical their operating standards and corporate values are, reports keep coming that these issues are not superficial but systemic in nature. One such report was published in Fierce Pharma on October 14, 2019 carrying a headline – “Novartis appears to have a systemic ethics problem. What can it do make amends?” Justifying this caption, the news article elaborated:

‘When a company is repeatedly embroiled in scandals or compliance breaches—from on-the-ground sales activities to decisions made at the very top—an isolated infection isn’t to blame. It’s a systemic illness. And judging by the long list of allegations and infractions at Novartis, that’s what the Swiss drug maker is facing. But is there a cure? Some soul-searching and a closer look at the company’s culture could help.’

Quoting a corporate ethics and compliance expert Hui Chen, the article underscored, for such malpractices ‘don’t just blame everything on a few rogue employees.’ Pharma leadership may wish to accept this reality and make amends wherever necessary, soon. With the above perspective, it will also be worth looking at, how is this toxin invading a corporate system, jeopardizing its business performance, and why?

Even patients expect pharma to demonstrate ethical business practices:

Generating new and more prescriptions for patients’ treatment being the lifeblood of any pharma business, the core strategic focus of the business should naturally be on patients, and the society they belong to. This is a fundamental requirement, not just for making profit in business, but for its survival, too. It is now clear that even patients are becoming increasingly aware of this fact.

Consequently, they expect the pharma players to demonstrate ethical behavior and follow ethical business practices, instead of being on a self-serving mode. Scores of instances, across the globe, suggest that many pharma players are failing again, again and again in this critical area of business. One may say that commercial interests overshadowing consumers’ interests, is not uncommon in business. But wait a minute, we are talking here about an industry that patients look up to, while fighting dreaded diseases to save lives. Thus, the question that follows – why is this virus of non-compliance to business ethics invading a corporate system?

How is this virus invading a corporate system?

Search for an answer to this question isn’t new. It was discussed in the Harvard Business Review - more than 25 years ago, in its May-June 1993 article – ‘What’s the Matter with Business Ethics?’ Even at that time, the author noted: The more entrenched the discipline of business ethics becomes in business schools, the more bewildering it appears to managers. This discussion brought to the fore many interesting points. One such was, the field of business ethics is largely irrelevant for most managers. It’s not because that they are hostile to the idea of business ethics, but ‘real-world competitive and institutional pressures lead even well-intentioned managers astray.’

Presumably, because of this reason, as the Author acknowledged, all managers face “hard issues whose solutions are not obvious,” where the “reconciliation of profit motives and ethical imperatives is an uncertain and highly tricky matter.”

Thus, I reckon, many organizations find achieving organizational expectations, especially for demanding short-term financial goals, while maintaining business ethics, is becoming a real challenge. Similar sense would obviously influence many practicing managers, too. Now, the question that comes is, what happens to the organization, if its managers keep doing so to achieve the set financial objectives of the company?

When achieving end-goals by following business ethics is considered impractical:

If the business strategy is increasing brand prescription generation by any possible manner to outperform competition, the means adopted to meet the goals may find easy acceptance by many in the company. In the pharma industry, such situation may arise while chasing annual and monthly targets or at times closing the month-end sales deficits, too. Such acts may help achieve short-term goals with flying colors, regardless of blatant violation of business ethics or breaking legal norms, such as, bribing prescribers for writing prescriptions.

When remains undetected, such practices continue. But, when repeated compromises on the ethical practices of a company at the cost of patients’ interest, surface and reported by the media, one precious asset of the organization gets seriously damaged – its reputation. Again, one may ask, will it have any impact on the company’s medium to long term financial performance?

How are ethical ‘business practices’ and the company’s performance interlinked?

The fine thread that links these two, is the corporate reputation – an invaluable asset of the organization, having a strong connect with stakeholders, including patients – for a sustainable business growth. The broader aspects of its consumer-connection have been discussed by both academia and individual experts. One such illustration may be drawn from the Charter College of the United States.

It underscores: ‘Not only does it feel good to be part of a company with a great reputation, but it’s great for business. When you have a reputation for consistently being ethical in how you source and build products, and treat employees, customers and the community, more people will want to do business with you. This means you’ll appeal to a variety of people and organizations that will be great for boosting your business…’

This means, compromising with ethical business practices to achieve short-term goals comes at a great risk of jeopardizing the medium and long-term success and sustainability of the organization. This is not a mere theoretical possibility. Research studies also vindicate that ‘reputation is an economic multiplier.’

Reputation is an economic multiplier:

Some may conclude, ethical business practices may help enhance company’s reputation, but don’t create any significant impact on business performance. This point has been well deliberated by the Reputation Institute (RI) in its analysis, titled - ‘The Business Case for Reputation.’

The analysis established ‘a strong reputation yields 2.5 times better stock performance when compared to the overall market.’ This vindicates the point that reputation indeed enhances corporate performance for its stakeholders and is an economic multiplier. Understandably, the paper reiterated: ‘This is not a bold claim — it’s a fact.’

Conclusion:

The drug industry, in general, and research-based pharma players in particular, seem to feel that propagating its focus and efforts on bringing innovative drugs to the market, would help build a good reputation. But it doesn’t really happen that way. Instead, public perception that helps create corporate reputation, is often driven mainly by issues such as drug pricing – access and affordability, besides various widely reported alleged unethical business practices of drug companies.

Many such purported breaches in ethical behavior of a company are recurrent, such as one that was reported on October 22, 2019. It said, Novartis’ Zolgensma launch has been anything but boring: First a record-setting price tag, then a data-manipulation scandal and now the company is facing “manufacturing questions” that will delay Zolgensma’s approval in the EU and Japan.

The impact of these alleged unethical business practices of drug companies also got reflected in the 2018 2018 Gallup Poll where the pharma industry came out as the most poorly regarded industry, ranking last on a list of 25 industries that Gallup tests annually. Interestingly, the Reputation Institute (RI) also reported a 3.7 percent decline in pharma reputation between 2017 and 2018.

Thus, the core point that stands out is, ethical business practices and company performance are interlinked. Ethical business behavior plays a key role to enhance a company’s reputation, which in turn add value to the long-term financial performance of the company and vice-versa.

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.

 

Blockchain: A Game Changer For Safe Medicines

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‘Your medicine box may have fake drugs’ was the March 18, 2018 headline of a popular pan Indian news daily. Just the year before, the 2017 report of the World Health Organization (WHO), also flagged that around 10.5 percent of all medicines in low-and middle-income countries, including India are substandard or fake. Even prior to this, another news headline of February 15, 2016 highlighted: ‘1 In 7 Indian Drugs Revealed As Substandard.’ These reports paint a scary situation for consumers of medicine in India, especially when the same incidence is just around one percent in the high-income countries of the world. Nevertheless, getting into a protracted discussion to prove the veracity of this issue, may not yield much, either. Some may even term these as efforts to ‘sensationalizing’ the situation.

That said, the good news is, the Government Think Tank Niti Aayog and also the Drug Technical Advisory Board (DTAB) of India,are reportedly contemplating to combat this menace with cutting-edge technology. In this article, I shall dwell on this threat, starting with its profound impact, not just on human health, but also on the economic and the socioeconomic space of India.

Why is it so important?

The most obvious fallout of this hazard is of course borne by the consuming patient.  The other two critical impact areas has also been well captured by the World Health Organization (WHO) in its 2017 study, titled ‘A study on the public health and socioeconomic impact of substandard and falsified medical products’. I am summarizing those 3 key impact areas hereunder:

A. Health impact: 

  • Adverse effects (for example, toxicity or lack of efficacy) from incorrect active ingredients
  • Failure to cure or prevent future disease, increasing mortality, morbidity and the prevalence of disease
  • Progression of antimicrobial resistance and drug-resistant infections, loss of confidence in health care professionals, health programs and health systems

B. Economic impact:

  • Increased out-of-pocket and health system spending on health care
  • Economic loss for patients, their families, health systems and manufacturers (and other actors in the supply chain) of quality medical products
  • Waste of human effort and financial outlay across the health system, further straining resources, staff and infrastructure
  • Increased burden for health care professionals, national medicine regulatory authorities, law enforcement and criminal justice systems.

C. Socioeconomic impact:

  • Lost income due to prolonged illness or death
  • Lost productivity costs to patients and households when seeking additional medical care, the effects of which are felt by businesses and the wider economy
  • Lack of social mobility and increased poverty

What the Government contemplates in India? 

According to the April 09, 2018 news report, “Indian policy think tank Niti Aayog is working to put the entire inventory of drugs made and consumed in the country on blockchain with an intent to crack down on counterfeit and spurious drugs, according to two government sources. The government wants to complete a proof of concept (PoC) solution by the year-end and begin implementation in 2019.”

On May 16, 2018, DTAB reportedly deliberated and approved a Track and Trace mechanism to address this issue. The proposal is a stand-alone measure to combat fake or counterfeit drugs covering 300 pharma products. However, it does not intend to cover the entire drug supply chain integrity with Blockchain technology, in a comprehensive manner.

According to the above report, this particular approach involves asking the pharma manufacturers to print a unique 14-digit alphanumeric code on the package of the drug. While buying any medicine, the individual can inquire via a text message, whether the drug bearing that code is genuine or not.

I wrote an article in this Blog on the use Blockchain by pharma players, on January 22, 2018. You may wish to refer that to know more about it in context of the pharma industry.

Recent Blockchain initiatives by global pharma majors:

Some global pharma layers have already covered some ground with Blockchain, especially in this area.On September 21, 2017, an article titled ‘Big Pharma Turns to Blockchain to Track Meds’, published in Fortune, presented some interesting facts. It indicated: to stop a flow of fake, spurious or counterfeit medicines entering the supply chain and reaching patientshow the pharma industry appears to be on the verge of resolving this long-time problem with the intervention of one of the most modern technology – Blockchain.

A group of companies, including Genentech and Pfizer has announced the MediLedger Project for creating blockchain tools to manage pharmaceutical supply chains. The group, has completed a successful pilot program to track medicines, where all concerned – from drug manufacturers to wholesalers to hospitals and retailers will be recording drug deliveries on a blockchain. This would ensure that, at each step of the distribution process, a network of computers will vouch for the ‘provenance and authenticity’ of a drug shipment—making it virtually impossible for counterfeiters to introduce fake drugs – the article highlighted.

Quoting domain experts, the authors underscored the key difference between current practices in this area and managing supply chain through Blockchain technology. At present, most companies use various software to manage the supply chain. However, these usually consist of a mishmash of different databases. ‘The introduction of a Blockchain system, in which each participant controls a node on the network, and transactions require a consensus, is thus a significant leap forward’ – the experts noted.

On scaling up, if this project achieves the intended goals, it would possibly be a game changer for the pharma companies in addressing the counterfeit or fake drug menace, effectively.

How will Blockchain combat fake or counterfeit drugs?

In India, there are basically four constituents in the pharma supply chain: source of procurement of various ingredients – manufacturers – C&F Agents – wholesalers – retailers, besides hospitals and dispensaries. To avoid counterfeit or fake/spurious drugs in a comprehensive way, it is critical for these constituents to see and share relevant data based on a modern and tamper-proof technology platform. Unfortunately, the current practices mostly fail to address this serious threat in a holistic way.

Experts envisage Blockchain delivering a superior value in this area, as it has the potential to cover end-to-end supply chain network of a pharma business. A November 14, 2017 article appeared in a Harvard Business School publication of Technology and Operations Management (TOM) explains its rationale very well. The paper is titled “Can blockchain help solve the problem of counterfeit drugs?”

In the context of a supply chain it says, blockchain can be used to track the flow of goods and services between businesses and even across borders. At each step of the distribution process, a network of computers can unmistakably indicate the provenance and authenticity of a shipment, making it harder or counterfeiters to introduce fake drugs. The key advantage of this technological process is that

it is virtually impossible for malicious actors to alter the event logs. Another advantage is speed: should a shipment be disrupted or go missing, the data stored on the common ledger would provide a rapid way for all parties trace it, and determine who handled the shipment last, the author elaborates.

Common anti-counterfeit-measures:

In many countries, including India, drug regulators are focusing on putting in place various anti-counterfeit measures, such as, ‘track and trace’ and ‘mass serialization.’ In some nations these mandatory in nature. At present, the most common process, globally, is to have machine-readable codes carrying a serial number featuring on each and every pack of medicines. Many anti-counterfeit solution providers call these in various different names, to position themselves on a marketing high ground. Other such measures include, forensic markers, cloud-based supply chain data repositories are also being talked about.

So far so good, but the current reality continues to remain scary for patients, probably more in India. Each year ‘tens of thousands dying from $30 billion fake drug trade,’ – reported Reuters just recently – on November 28, 2017. As reported by IntelligentHQ on November 3, 2016, ‘studies have shown that the pharmaceutical industry still struggles on two main counts: interoperability between all the participants, from the manufacturer to the dispenser and data management, to better integrate the serialization systems. Being able to avoid drug counterfeiting is just one of the reasons for which it is so critical to successfully track products down the supply chain.’

Conclusion:

Ensuring safety and security of the pharma supply chain – from sourcing to manufacturing to logistics to retail chemist and ultimately to the final consumer, is now possible with the application of Blockchain. In fact, this process has already been developed, and tried in many continents of the world, including Africa (video).

Thus, in my view, for an effective anti-counterfeiting system to work or even a substandard drug ingredient going into any original final product that ultimately will be consumed by patients, the most important requirement is to ensureend-to-end supply chain visibility and integrity.Any stand-alone anti-counterfeit measure can’t possibly provide such holistic solution.

Just to emphasize on this point – what happens, if anything goes wrong during sourcing of ingredients, or during the manufacturing of the original drug? The drug in question, although could be substandard, can’t be termed counterfeit. Hence, any standalone anti-counterfeit mechanism will obviously indicate ‘all is well’ for the patients to consume this original medicine – before the product is ultimately recalled, if and when the defect is detected by other means.

From this perspective, the application of Blockchain technology covering end-to-end supply chain network has the wherewithal of being a game changer – offering safe medicines to patients.

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.

Does Healthcare Feature In Raisina Hill’s To-Do List?

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At the Capitol Hill, while addressing the joint session of the United States Congress, on June 08, 2016, our Prime Minister Mr. Narendra Modi well articulated the following, in his inimitable style:

“My to-do list is long and ambitious. It includes a vibrant rural economy with robust farm sector; a roof over each head and electricity to all households; to skill millions of our youth; build 100 smart cities; have a broadband for a billion, and connect our villages to the digital world; and create a 21st century rail, road and port infrastructure.”

This ambitious list is indeed praiseworthy. However, as the Prime Minister did not mention anything about health care infrastructure, while referring to rapid infrastructure development in India, it is not abundantly clear, just yet, whether this critical area finds a place in his ‘to-do’ list, as well, for ‘We The People of India’.

This apprehension is primarily because, no large scale, visible and concrete reform measures are taking place in this area, even during the last two years. It of course includes, any significant escalation in the public expenditure for health.

Ongoing economic cost of significant loss in productive years:

“The disease burden of non-communicable diseases has increased to 60 per cent. India is estimated to lose US$ 4.8 Trillion between 2012 and 2030 due to non-communicable disorders. It is therefore critical for India to transform its healthcare sector,” – says a 2015 KPMG report titled, ‘Healthcare: The neglected GDP driver.’ 

This significant and ongoing loss in productive years continues even today in India, handicapped by suboptimal health care infrastructure, and its delivery mechanisms. Such a situation can’t possibly be taken for granted for too long. Today’s aspiring general public wants the new political leadership at the helm of affairs in the country to address it, sooner. A larger dosage of hope, and assurances may not cut much ice, any longer.

Transparent, comprehensive, and game changing health reforms, supported by the requisite financial and other resources, should now be translated into reality. A sharp increase in public investments, in the budgetary provision, for healthy lives of a vast majority of Indian population, would send an appropriate signal to all.

As the above KPMG report also suggests: “It is high time that we realize the significance of healthcare as an economic development opportunity for national as well as state level.”

Pump-priming public health investments:

With a meager public expenditure of just around 1.2 percent of the GDP on health even during the last two years, instead of rubbing shoulders with the global big brothers in the health care area too, India would continue to rank at the very bottom.

Consequently, the gaping hole within the healthcare space of the country would stand out, even more visibly, as a sore thumb, escaping the notice, and the agony of possibly none.

With around 68 percent of the country’s population living in the rural areas, having frugal or even no immediate emergency healthcare facilities, India seems to be heading towards a major socioeconomic imbalance, with its possible consequences, despite the country’s natural demographic dividend.

According to published reports, there is still a shortage of 32 and 23 percent of the Community Health Centers (CHC) and the Primary Health Centers (PHC), respectively, in India. To meet the standard of the World Health Organization (WHO), India would need minimum another 500,000 hospital beds, requiring an investment of US$ 50 Billion.

Moreover, to date, mostly the private healthcare institutions, and medical professionals are engaged in the delivery of the secondary and tertiary care, concentrated mostly in metro cities and larger towns. This makes rural healthcare further challenging. Pump-priming public investments, together with transparent incentive provisions for both global and local healthcare investors, would help augmenting the process.

Help propel GDP growth:

As the above KPMG report says, the healthcare sector has the ability to propel GDP growth via multiple spokes, directly and indirectly. It offers a chance to create millions of job opportunities that can not only support the Indian GDP growth, but also support other sectors of the economy by improving both demand and supply of a productive healthy workforce.

Three key areas of healthcare:

Healthcare, irrespective of whether it is primary, secondary or tertiary, has three major components, as follows: 

  • Prevention
  • Diagnosis
  • Treatment 

Leveraging digital technology:

As it appears, leveraging digital technology effectively, would help to bridge the health care gap and inequality considerably, especially in the first two of the above three areas.

A June 06, 2016 paper titled, ‘Promoting Rural Health Care: Role of telemedicine,’ published by the multi-industry trade organization -The Associated Chambers of Commerce and Industry of India (ASSOCHAM) said: “With limited resources and a large rural population telemedicine has the potential to revolutionize the delivery of healthcare in India.”

As the report highlighted, it would help faster diagnosis of ailments, partly address the issues of inadequacy of health care providers in rural areas, and also the huge amount of time that is now being spent in physically reaching the urban health facilities. Maintenance of the status quo, would continue making the rural populace more vulnerable in the health care space, than their urban counterparts.

The study forecasted that India’s telemedicine market, which has been growing at a compounded annual growth rate (CAGR) of over 20 per cent, holds the potential to cross US$32 million mark in turnover by 2020, from the current level of over US$15 million.

According to another report, currently, with around 70 percent overall use of smartphones, it is quite possible to give a major technology enabled thrust for disease prevention, together with emergency care, to a large section of the society.  

However, to demonstrate the real technology leveraged progress in this area, the Government would require to actively help fixing the requisite hardware, software, bandwidth and connectivity related critical issues, effectively. These will also facilitate keeping mobile, and other electronic health records.

Disease treatment with medicines:

To make quality drugs available at affordable prices, the Indian Government announced a new scheme (Yojana) named as ‘Pradhan Mantri Jan Aushadhi Yojana’, effective July 2015, with private participation. This is a renamed scheme of the earlier version, which was launched in 2008. Under the new ‘Pradhan Mantri Jan Aushadhi Yojana’, about 500 generic medicines will be made available at affordable prices. For that purpose, the government is expected to open 3000 ‘Jan Aushadhi’ stores across the country in the next one year i.e. 2016-17.

The question now is what purpose would this much hyped scheme serve?

What purpose would ‘Pradhan Mantri Jan Aushadhi Yojana’ serve?

Since the generic drugs available from ‘Jan Aushadhi’ retail outlets are predominantly prescription medicines, patients would necessarily require a doctor’s physical prescription to buy those products.

In India, as the doctors prescribe mostly branded generics, including those from a large number of the Government hospitals, the only way to make ‘Jan Aushadhi’ drugs available to patients, is to legally allow the retailers substituting the higher priced branded generic molecules with their lower priced equivalents, sans any brand name.

Moving towards this direction, the Ministry of Health had reportedly submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration. Wherein, the Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

For this reason, the ‘Pradhan Mantri Jan Aushadhi Yojana’, appears to be not so well thought out, and a one-off ‘making feel good’ type of a scheme. It is still unclear how would the needy patients derive any benefit from this announcement.

Conclusion:

On June 20, 2016, while maintaining the old policy of 100 per cent FDI in the pharmaceutical sector, Prime Minister Modi announced his Government’s decision to allow foreign investors to pick up to 74 per cent equity in domestic pharma companies through the automatic route.

This announcement, although is intended to brighten the prospects for higher foreign portfolio and overseas company investment in the Indian drug firms, is unlikely to have any significant impact, if at all, on the prevailing abysmal health care environment of the country.

Hopefully, with the development of 100 ‘smart cities’ in India, with 24×7 broadband, Wi-Fi connectivity, telemedicine would be a reality in improving access to affordable healthcare, at least, for the population residing in and around those areas.

Still the fundamental question remains: What happens to the remaining vast majority of the rural population of India? What about their health care? Poorly thought out, and apparently superficial ‘Pradhan Mantri Jan Aushadhi Yojana’ won’t be able to help this population, either. 

With the National Health Policy 2015 draft still to see the light of the day in its final form, the path ahead for healthcare in India is still rather hazy, if not worrying. 

As stated before, in the Prime Minister’s recent speech delivered at the ‘Capitol Hill’ of the United States earlier this month, development of a robust healthcare infrastructure in the country did not find any mention in his ‘to-do’ list.

Leaving aside the ‘Capitol Hill’ for now, considering the grave impact of health care on the economic progress of India, shouldn’t the ‘Raisina Hill’ start pushing the envelope, placing it in one of the top positions of the national ‘to-do’ list, only to protect the health interest of ‘We The People of India’?

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.

Healthcare In India (2016-17): Whither Goest Thou?

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The Union Budget 2016-17 will be proposed today by the Finance Minister before the Indian Parliament. As many critical questions are currently being raised about the real health of the Indian economy, across the globe, the Union Finance Minister shoulders an onerous task to address all those apprehensions, beyond any further doubt.

Yesterday, in his monthly radio program ‘Mann Ki Baat’, Prime Minister Modi himself said, “Budget 2016 is my exam, 125 crore people will test me.” A large section of people also would probably view Union Budget 2016-17 in a similar way.

That said, we all know, that the system or the process of annual Union Budget presentation before the Parliament need not be considered as the primary platform to announce various policies of the Government to propel economic growth of the nation. Nevertheless, it certainly underscores the key focus areas, where the Government would prefer deploying country’s financial and other resources, through appropriate budgetary allocations, to effectively meet the key short and long term national goals.

Simultaneously, of course, the Finance Minister would also explain the measures that he proposes for raising the required wherewithal for the same.

The Economic Survey report 2015-16:

The Economic Survey report of the Government for 2015-16, tabled before the Parliament on February 26, 2016, reiterates a grim healthcare situation in India, for a vast majority of its citizens.

The report also underscores, that the average cost of treatment in private hospitals, excluding child birth, is currently about four times than that of public healthcare facilities. This alarming situation, fueled by the meager public health infrastructure in the country, severely limits healthcare access to many in the country. Its primary reason being, a large number of Indians are unable to incur so high out of pocket health expenditure. 

A situation like this, brings to the fore the challenges that India faces in providing affordable and accessible healthcare to all those who need it most, the Survey document commented.

Thus, with limited resources and competing demands in the health sector, it is essential for the government to prioritize its expenditure in the sector, the report recommends.

Healthcare deserves a priority focus: 

Healthcare, I believe, is one such domain that has been attracting a priority focus in all the developed and a large number of developing nations, since long. In this critical area, however, various national Governments in India have been just expressing its laudable intents, over a period of time. Unfortunately, no political dispensation, so far, has implemented anything hugely impactful to make its citizens feel a huge difference in this critical area, especially, by translating the promised intents into reality and keeping the nose to the grindstone.

Besides many other robust reasons, commercially too, the Indian healthcare industry is one of the largest growing sectors contributing around 10 percent of the GDP, employing around 4 million people. 

The D-Day:

Today is the D-Day for the Financial Year 2016-17. We shall get to know soon, in which direction would public healthcare go, as we step into another brand new financial year, and in the third Union Budget of the Government in power.

On December 7, 2015, I wrote an article in this Blog on this issue, titled, “Healthcare: My Expectations From Union Budget (2016-17)”.

My expectations on healthcare budget allocations:

In the above article, I articulated my overall expectations on the allocations for healthcare in 2016-17 Union Budget proposals, as follows:

  • Increase total public health expenditure from the current 1.2 percent to at least 2.0 percent of the GDP and then raise it 2.5 percent over a period of next three years.
  • The main source of financing for public health should remain general taxation by levying ‘Health Cess’, quite in line with with ‘Swachh Bharat Cess’ at the rate of 0.5 percent on all taxable services, besides adding a similar tax on non-essential and luxury items.
Primary focus areas:

If something similar to the above budgetary provision is made for public health in India, the details would require to be worked out, if not done already, in the following five primary focus areas, as I envisage:

A. Infrastructure and capacity building:

- Focused and well-identified investments in building high quality public health infrastructure and well-skilled human resources for rural India on priority.

- Villages, based on population, would be identified by the respective State Governments.

B. Increasing access to quality public healthcare:

- Free universal access to primary care services to start with, across the country,

- Free drugs, free diagnostics and free emergency care services in all public hospitals of the country and for all.

- Free emergency response and patient-transport systems across the country, for all. 

C. Strengthening the supply chain:

- Quality drug and diagnostics procurement system by the Central Medical Services Society (CMSS) of the Government needs to be modernized, strengthened and made more efficient with real time data, for easy availability of all required drugs and diagnostics in all public hospitals at the right time and in the right quantity.

-  Today, a large number of life saving drugs and diagnostics is highly temperature sensitive. Thus, adequate cold chain facilities are to be created right from transportation to storage in public hospitals for all such products, maintaining their required efficacy and safety standards for patients.

D. Increasing awareness for disease prevention:

- Intensive multi-pronged, multi-channel and door to door campaigns by the para-medics to increase awareness for identified disease prevention. 

E. Performance incentive: 

- To achieve the desired level of success and increase the motivation level in a sustainable way, budgetary provisions to be made for a system of well-structured individual and team performance incentive scheme, when the key implementers exceed expectations by achieving the set goals well before schedule.

- Commensurate punitive measures for failure also to be put in place, simultaneously.

I shall not broach upon the area of Research and Development (R&D) for drugs and diagnostics here, as that could probably be considered in a holistic way under overall innovation, science and technology budget allocation required for the country, as a whole.

Conclusion:

February 29, 2016 is the moment of truth, of yet another year-long expectation in the key focus areas of the Government for resource mobilization and its meaningful deployment. 

It is worth noting, however, that the much awaited “National Health Policy” has not been put in place before the Union Budget 2016-17, which could have given an indication to all, about the road map that the Government intends to follow in the healthcare domain of India.

Thus, it is possibly too late now to identify the specific health projects based on majority of citizen’s immediate health needs, from a well-articulated Health Policy for the country. Consequently, charting an action plan for joint implementation by the Central and the State Governments in unison, and making budgetary provisions accordingly for this year, to start with, may not just be feasible.

In the above situation, despite the recommendations of ‘The Economic Survey report 2015-16’, we may, at best see in today’s Union Budget, some ad hoc measures in this space. In any case discussing all these at this hour would just be a matter of speculation. Nevertheless, like many persons, I too keep my fingers crossed.

In any case, we all shall get to know today, the Finance Minister’s comprehensive budgetary proposals for this year, including healthcare. Till then, at least for 2016-17, the same question will keep haunting: Healthcare In India: Whither Goest Thou?

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.

“Make in India…Sell Anywhere in The World”: An Indian Pharma Perspective

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In his Independent Day speech from the ramparts of the Red Fort on August 15, 2014, Indian Prime Minister Modi gave a clarion call to all investors of the world, “Come, make in India”, “Come, manufacture in India”, “Sell in any country of the world, but manufacture here”.

The Prime Minister did not stop there. In his inimitable style, following it through on September 25, 2014 he gave an official status to ‘Make in India’ slogan and launched a global campaign.

“My definition of FDI for the people of India is First Develop India. This is also a responsibility for the people of India,” he further clarified.

An Indian perspective:

If I juxtapose this vision of the Prime Minister in the Indian pharmaceutical industry perspective, one finds that many small, medium and large size local domestic manufacturers are currently manufacturing drugs not just for the domestic market, but are also exporting in large quantities to various countries of the world, including, North America, South America and Europe.

The United States (US) is one of the most critical markets for majority of the Indian drug exporters. This transaction was taking place without any major regulatory hitches since quite some time. Unfortunately, over the last few years, mostly the Federal Drug Administration of the US (USFDA) and the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) have started raising serious doubts on the quality of medicines manufactured in India, making a significant impact on the drug exports of the country.

Most of these quality issues are related to ‘Data Integrity’ in the dug manufacturing and its documentation processes.

The impact:

According to industry data, in 2013-14, Indian drug exports registered the slowest growth in nearly the last 15 years. In this fiscal year, pharma exports of the country with a turnover of US$ 14.84 billion grew at a meager 1.2 percent. Pharmexcil attributed its reason to USFDA related regulatory issues and increasing global competition.

US accounts for about 25 percent of India’s pharma exports and its Federal Drug Administration (USFDA) has been expressing, since quite a while, serious concerns on ‘Data Integrity’ at the agency’s  previously approved production facilities of a large number of Indian pharma players.

The issue is causing not just a serious concern to USFDA and some other overseas drug regulatory agencies, but also posing a huge threat to future growth potential of Indian drug exports.

It is worth noting that Indian government had set an objective, in its strategy document, to register a turnover of US$ 25 billion for pharma exports in 2014-15. In all probability, it would fall far short of this target at the end of this fiscal, predominantly for related reasons.

Why is so much of ‘fuss’ on ‘Data Integrity’?

Broadly speaking, ‘Data Integrity’ in pharmaceutical manufacturing ensures that finished products meet pre-established specifications, such as, for purity, potency, stability and sterility. If data integrity is breached in any manner or in absence of credible data, the product becomes of dubious quality in the eyes of drug regulators.

Manufacturing related ‘Data Integrity’ is usually breached, when data from a database is deliberately or otherwise modified or destroyed or even cooked.

Over the last several years, ‘Data Integrity’ related issues in India are attracting enormous attention of both the USFDA and the MHRA, UK. As a result, concerned pharma manufacturing facilities are receiving Import Alerts/Warning Letters from the respective overseas drug regulators, refusing entry of those medicines mostly in the United States and some in the UK.

Recent warning letters:

Just over a year – from May 2013 to July 2014, around a dozen ‘Warning Letters’ have been sent to the Indian drug manufacturers by the USFDA on ‘Data Integrity’ related issue, as follows:

Recent ‘Warning Letter’ issued to: Date of issue
1. Marck Biosciences Ltd. 08. 07. 2014
2. Apotex Pharmachem India Pvt Ltd. 17. 06. 2014
3. Sun Pharmaceutical Industries 07. 05. 2014
4. Canton Laboratories Private Limited 27. 02. 2014
5. USV Limited 06. 02. 2014
6. Wockhardt Limited 25. 11. 2013
7. Agila Specialties Private Limited 09. 09. 2013
8. Posh Chemicals Private Limited 02. 08. 2013
9. Aarti Drugs Limited 30. 07. 2013
10. Wockhardt Limited 18. 07. 2013
11. Fresenius Kabi Oncology Ltd 01. 07. 2013
12. RPG Life Sciences Limited 28. 05. 2013

(Source: RAPS, 19 August 2014)

Another report states that USFDA has, so far, banned at least 36 manufacturing plants in India from selling products in the US.

Importance of US for Indian generic players:

Generic drugs currently contribute over 80 percent of prescriptions written in the US. Around 40 percent of prescriptions and Over The Counter (OTC) drugs that are sold there, come from India. Almost all of these are cheaper generic versions of patent expired drugs. Hence, India’s commercial stake in this area is indeed mind-boggling.

The ‘Data Integrity’ issue is not restricted to just US or UK:

A report quoting researchers led by Roger Bate, an American Enterprise Institute scholar and funded by the The Legatum Institute and the Humanities Research Council of Canada, concluded that many Indian pharma companies follow double manufacturing standards, as they are sending poor quality drugs to Africa compared to the same pills sold in other countries. This study was based on tests of 1,470 samples produced by 17 Indian drug manufacturers.

Besides India, the researchers took drug samples from pharmacies in Africa and middle-income countries, including China, Russia and Brazil.

According to this paper, the researchers found that 17.5 percent of samples of the tuberculosis therapy rifampicin sold in Africa tested substandard, which means the drug has less than 80 percent of the active ingredient than what it should otherwise. Against this number, in India, 7.8 percent of the medicine sampled was found substandard.

Moreover, Almost 9 percent of samples of the widely used antibiotic ciprofloxacin sold in Africa tested substandard, as compared to 3.3 percent in India.

Thorny issues around golden opportunities:

Much reported breach in manufacturing ‘Data Integrity’ detected at the manufacturing sites in India, are throwing fresh doubts on the efficacy and safety profile of generic/branded generic medicines, in general, produced in the country and more importantly, whether they are putting the patients’ health at risk.

A new analysis by the U.S. National Bureau of Economic Research pointed out some thorny issues related to ‘Data Integrity’ of drugs produced by the Indian pharmaceutical companies, which supply around 40 percent of the generic drugs sold in the United States, as stated above.

The researchers examined nearly 1,500 India-made drug samples, collected from 22 cities and found that “up to 10 percent of some medications contained insufficient levels of the key active ingredients or concentrations so low, in fact, that they would not be effective against the diseases they’re designed to treat.”

The report also highlighted that international regulators detected more than 1,600 errors in 15 drug applications submitted by Ranbaxy. The Bureau Officials commented that these pills were “potentially unsafe and illegal to sell.”

Frequent drug recalls by Indian pharma majors:

The above findings came in tandem with a series of drug recalls made recently by the Indian pharma companies in the US.

Some of the reported recent drug recalls in America, arising out of manufacturing related issues at the facilities of two well-known Indian pharma majors, which are going to merge soon, are as follows:

  • Sun Pharmaceuticals recalled nearly 400,000 bottles of the decongestant cetirizine (Zyrtec) and 251,882 of the antidepressant venlafaxine (Effexor) this May, because the pills failed to dissolve properly. The drugs were distributed by the drug maker’s US subsidiary Caraco Pharmaceutical Laboratories, but were manufactured in India.
  • In the same month – May, Ranbaxy recalled 30,000 packs of the allergy drugs loratadine and pseudo-ephedrine sulphate extended release tablets because of manufacturing defects in packaging.
  • In March, Sun Pharma recalled a batch of a generic diabetes drug bound for the US after an epilepsy drug was found in it. A patient discovered the error after noticing the wrong medication in the drug bottle.
  • Again in March, Ranbaxy recalled nearly 65,000 bottles of the statin drug atorvastatin calcium (Lipitor) after 20-milligram tablets were found in sealed bottles marked 10-milligrams. A pharmacist in the U.S. discovered the mix up.

Indian media reinforces the point:

Indian media (TNN) also reported that there is no quality control even for life-saving generic drugs and the government is apathetic on ensuring that the quality protocol of these drugs is properly observed.

This happens, as the report states, despite government’s efforts to push generic drugs, as they are more affordable. The report gave an example of a life-saving drug, Liposomal Amphotericin B, which is used to treat fungal infections in critically ill patients.

Are all these drugs safe enough for Indian Patients?

Though sounds awkward, it is a fact that India is a country where ‘export quality’ attracts a premium. Unintentionally though, with this attitude, we indirectly accept that Indian product quality for domestic consumption is not as good.

Unfortunately, in the recent years, increasing number of even ‘export quality’ drug manufacturing units in India are being seriously questioned, warned and banned by the overseas drug regulators, such as USFDA and MHRA, UK, just to ensure dug safety for the patients in their respective countries.

Taking all these into consideration, and noting increasing instances of blatant violations of cGMP standards and ‘Data Integrity’ requirements for ‘export quality’ drugs, one perhaps would shudder to think, what could possibly be the level of conformance to cGMP for the drugs manufactured solely for the consumption of local patients in India.

A cause of concern, as generic drugs are more cost effective to patients:

It has been widely recognized globally that the use of generic drugs significantly reduces out-of-pocket expenditure of the patients and also payers’ spending.

The findings of a study conducted by the Researchers from Brigham and Women’s Hospital (BWH), Harvard Medical School and CVS Health has just been published in the Annals of Internal Medicine on September 15, 2014. In this study the researchers investigated whether the use of generic versus brand name statins can play a role in medication adherence and whether or not this leads to improved health outcomes. The study concluded that patients taking generic statins were more likely to adhere to their medication and also had a significantly lower rate of cardiovascular events and death.

In this study, the mean co-payment for the generic statin was US$10, as against US$48 for brand-name statins. It is generally expected that the generic drugs would be of high quality, besides being affordable.

I deliberated on a related subject in one of my earlier blog posts of November 11, 2013 titled, “USFDA” Import Bans’: The Malady Calls For Strong Bitter Pills”.

Conclusion:

According to USFDA data, from 2013 onwards, about 20 drug manufacturing facilities across India attracted ‘Import Alerts’ as against seven from China, two each from Australian, Canadian and Japanese units and one each from South African and German facilities.

Unfortunately, despite intense local and global furore on this subject, Indian drug regulators at the Central Drugs Standard Control Organization (CDSCO), very strangely, do not seem to be much concerned on the ‘Data Integrity’ issue, at least, not just yet.

In my view, ‘Data Integrity’ issues are mostly not related to any technical or other knowledge deficiency. From the “Warning Letters” of the USFDA to respective Indian companies, it appears that these breaches are predominantly caused by falsification or doctoring of critical data. Thus, it basically boils down to a mindset issue, which possibly pans across the Indian pharma industry, irrespective of size of operations of a company.

Indian Prime Minister’s passionate appeal aimed at all investors, including from India, to “Make in India” and “Sell Anywhere in The World”, extends to pharma industry too, both local and global. The drug makers also seem to be aware of it, but the ghost keeps haunting unabated, signaling that the core mindset has remained unchanged despite periodic lip service and public utterances for corrective measures by a number of head honchos.

Any attempt to trivialize this situation, I reckon, could meet with grave consequences, jeopardizing the thriving pharma exports business of India, and in that process would betray the Prime Ministers grand vision for the country that he epitomized with, “Make in India” and “Sell Anywhere in The World”.

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.

Healthcare reform process and policy measures to reduce socio-economic inequalities should be implemented in tandem for optimal economic progress of a nation.

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Important research studies indicate that health of an individual is as much an integral function of the related socio-economic factors as it is influenced by the person’s life style and genomic configurations.It has now been well established that socio-economic disparities including the educational status lead to huge disparity in the space of healthcare.Healthcare preventive measures with focus just on disease related factors like, hygiene, sanitation, alcohol abuse, un-protected sex, smoking will not be able to achieve the desired outcome, unless the underlying socio-economic issues like, poverty, hunger, education, justice, values, parental care are not properly addressed.

It has been observed that reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, the minority population with adequate access to knowledge, social and monetary power will always have necessary resources available to address their concern towards healthcare, appropriately.

Regular flow of newer and path breaking medicines to cure and effectively treat many diseases, have not been able to eliminate either trivial or dreaded diseases, alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhoea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, polio, hepatitis and measles, our children still suffer from such diseases. All these continue to happen mainly because of socio-economic considerations.

Following are some research studies, which I am using just as examples to vindicate the point:

• HIV/AIDs initially struck people across the socio-economic divide. However, people from higher socio-economic strata responded more positively to the disease awareness campaign and at the same time more effective and expensive drugs started becoming available to treat the disease, which everybody suffering from the ailment cannot afford. As a result, HIV/AIDS are now more prevalent within the lower socio-economic strata of the society.

• Not so long ago, people across the socio-economic status used to consume tobacco in many form. However, when tobacco smoking and chewing were medically established as causative factors for lung and oral cancers, those coming predominantly from higher/middle echelon of the society started giving up smoking and chewing of tobacco, as they accepted the medical rationale with their power of knowledge. Unfortunately the same has not happened with the people of relatively lower socio-economic status. As a consequence of which, ‘Bidi’ smoking, ‘Gutka’/tobacco chewing have not come down significantly within people belonging to such class, leading to more number of them falling victim of lung and oral cancer.

Thus, in future, to meet the unmet needs when more and more sophisticated and high cost disease treatment options will be available, it will be those people with higher socio-economic background who will be benefitted more with their education, knowledge, social and monetary power. This widening socio-economic inequality will consequently increase the disparity in the healthcare scenario of the country.

Phelan and Link in their research study on this issue has, therefore, remarked:

“Breakthroughs in medical science can do a lot to improve public health, but history has shown that, more often than not, information about and access to important new interventions are enjoyed primarily by people at the upper end of the socioeconomic ladder. As a result, the wealthy and powerful get healthier, and the gap widens between them and people who are poor and less powerful.”

Conclusion:

Though healthcare reform measures are essential for the progress of any nation, without time bound simultaneous efforts to reduce the socio-economic inequalities, it will not be easy for any nation to achieve the desirable outcome.

By Tapan 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.