Acid Test For Excellence in Crisis Leadership

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:

ChinaChina 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.

 

Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah

In the ongoing debate between branded-generics and generic drugs without brand names, the concern about drug quality is occupying the center stage, with the former generally being painted in white, and the later in black – with no shades of gray in-between. Interestingly, many large domestic companies manufacture and sell both these genres of generic medicines, and the marketing approval process of both is no different, in a relative yardstick. The degree of difficulty in testing their quality standards, across the country, is no different, either.

On February 25, 2017, even the USFDA, reportedly, raised concerns, for the first time, on the quality and efficacy of medicines, in general, being sold within India. The news report further highlighted: ‘Over the past two years, many domestic majors, including Sun Pharma, Dr. Reddy’s, Cipla and Zydus Cadila have faced regulatory ire over quality of medicines exported from here and sold in the US and other overseas markets’.

It is undeniable, if prescriptions in generic names are made mandatory, there could be direct job losses within the industry, just as loss of significant business clientele of many professional service providers for branded generic business, directly or indirectly. Its net impact needs to be factored-in too, while taking a final decision on this subject.

Lack of enough credible scientific data establishing superiority of branded-generics over their non-branded equivalents are also striking, so are few instances of doctors filing Pharmacovigilance reports with the DCGI on the inferior quality of non-branded generic drugs. Neither is the most competent body in this area – the Central Drugs Standard Control Organization (CDSCO), has concurred with any such claims, so far. Without these, the whole debate based on seemingly over the top claims of superiority of branded generics as a class, is based no more than a matter of conjecture.

I discussed most of these points in one of my earlier articles published in this blog on April 24, 2017. Thus, in this article, I shall focus mostly on an important generic-drug-quality related amendment, very recently made in the Drugs and Cosmetics Act of India, which hasn’t received as much attention as it deserves. This finer note in the drug regulatory playbook, in fact, got nearly masked in the high-decibel cacophony of arguments and counterarguments on Prime Minister Modi’s recent hint on making prescriptions in generic drug names mandatory.

The core issue remains the same, both for non-branded and branded generics:

In the marketing approval process of any branded generic or a non-branded generic drug, Bioequivalence (BE) studies hold immense scientific importance. It ascertains whether the generic equivalent possesses similar efficacy and safety profile as the original molecule for interchangeability. Which is why, in most countries, including Europe and the United States, BE testing is mandatory for approval of any generic drug. Even the large buyers of these drugs, such as the World Health Organization, buy only those generics with proven BE.

Nonetheless, like many other nations, in India, as well, the marketing approval standards for all generic drugs, with or without a brand name, are exactly the same. However, this approval process gets alarmingly relaxed, for both these generic types, with the passage of time, which is the core issue.

New drug definition in India:

According to section 122-E of Drugs and Cosmetics Rules, 1945 (D&C Rules) new drugs will include unapproved drugs, modified or new claims, such as, indications, dosage forms (including sustained release dosage form) and route of administration of already approved drugs and combination of two or more drugs. A new drug shall continue to be considered as new for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.

BE studies necessary only for ‘New Drugs’:

For all such new drugs and their Fixed Dose Combinations (FDC), including those which are not covered by a patent, if introduced for the first time in India, would necessarily require its applicant to submit the marketing approval documents well-supported by phase III clinical trial data, which includes BE studies against the original molecules. BE of a drug product is achieved if its extent and rate of absorption do not show statistically significant differences from those of the reference product when administered at the same molar dose.

After the 4-year period BE tests not necessary:

Interestingly, after the 4-year period, D&C rules allow subsequent manufacturers of similar drugs to generally rely on the data generated by other pharma companies to obtain marketing approvals for their drugs. In other words, after this 4-year period, manufacturers of branded or non-branded generic drugs are not required to establish comparable safety and efficacy of their formulations with the original molecule through BE and other studies. It is worth noting here, unlike India, BE tests are mandatory for approval of all generic drugs at any time, in most countries across the world.

How would a doctor select only those branded-generics with BE studies?

As there isn’t any easy way to know and identify, both by the doctors and also the patients, which branded or non-branded generics were introduced without BE studies, both these categories pose equal risks to patients – not just the cheaper generic drugs sans brand names.

Changes recommended:

This laxity in the regulatory framework in India did create a lot of uneasiness about the quality of branded and non-branded generic medicines approved by the drug regulators and sold in the country. Responding to this issue, Professor Ranjit Roy Chowdhury Committee Report recommended in July 2013 to make BE and bio­availability studies mandatory for all types of generic drugs, even after the 4-year period.

Cacophony masks an important note:

The good news is, on April 3, 2017, by a Gazette Notification, Indian Government enacted amendments to the Drug and Cosmetics Act (1940) requiring mandatory BE studies for marketing approval of all generic drugs even beyond the 4-year period of the ‘new drug’ definition. It says, “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for the grant of a license of the oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”

Biopharmaceutics Classification System:

The Biopharmaceutics Classification System (BCS) is a scientific framework to differentiate the drug formulations based on their aqueous solubility and intestinal permeability, and mainly depends on two factors:

  • How well the drug dissolves in the stomach and intestinal fluids (drug solubility)
  • How readily the drug passes through the intestinal wall into the blood flow (drug permeability)

The BCS was introduced by Gordon L. Amidon in 1995 to classify drugs into the four categories based on these parameters, as follows:

  • Class I: High Solubility – High Permeability
  • Class II: Low Solubility – High Permeability
  • Class III: High Solubility – Low Permeability
  • Class IV: Low Solubility – Low Permeability

CDSCO still needs to find the right answer to a key question:

Interestingly, this so important note in the regulatory playbook of India got masked in the high-voltage cacophony on branded and non-branded-generics. However, CDSCO would still require finding out the right answer to a key question: how would a doctor or a patient possibly know on which branded and non-branded generic drugs BE tests were not carried out, before the above amendment came into force.

Reported data on substandard drugs in India:

Quoting CDSCO data, the September-October 2015 issue of the ‘Indian Journal of Endocrinology and Metabolism’ summarized that ‘during the years 2011-2014, the regional laboratories tested samples at 91 percent of the installed capacity, but their overall detection rate of sub-standard drugs were only 3.6 percent’. Many have expressed doubts about these numbers though, nevertheless, these are Government data, and don’t fall in the realm of any conjecture.

In any case, the Union Ministry of Health doesn’t seem to concur that the issue of substandard drugs in India, that includes both the branded and non-branded generics, has assumed a public health menace in India or even alarming.

No qualms on value added branding of generic drugs, but fix the loophole for all:

It is understandable, when generic drugs are branded for tangible value-added product differentiation even within the identical or the same drug molecules. There are no qualms on such branding per se, though it comes at a high cost.

Marketing approval requirements being the same for all branded and non-branded generic drugs with the same pitfalls of no mandatory BE-testing requirement after the 4-year period, branding should add commensurate tangible value. Otherwise, why should most patients pay a significantly extra amount for heavily promoted branded-generics? Is it to help the pharma companies fighting with each other to increase their respective pies of revenue and profit on an essential commodity? Instead, stakeholders should now focus on easy detection of all those branded and non-branded generic drug formulations that avoided mandatory BE studies, prior to April 3, 2017.

In conclusion:

Despite CDSCO’s statistical data on substandard drugs, the general concern regarding the efficacy and safety of medicines manufactured in India is often raised both inside the country, as well as by some well-respected overseas drug regulators. Curiously, when raising the same concern CDSCO banned hundreds of branded FDCs, as these drugs came to the market without carrying out required scientific tests due to some major lacunae in the regulatory system, there was a huge protest in the country raised by almost the same people, as business interests prevailed over patients’ health interest.

Interestingly, displaying a sharp contradiction in today’s cacophony, patients’ health interest has been put in the forefront to protect business interests, especially when the CDSCO has raised no such concern, whatsoever.

The reverberating claims on superior drug quality for branded-generics as a class, over their cheaper non-branded equivalents, with the former generally being painted in white, and the later in black – with no shades of gray in-between, as I said before, is based mostly on conjecture rather than enough hard facts. Thus, the question comes up, who is responsible for ensuring drug efficacy and safety for the patients in India – CDSCO or non-fact based claims being raised mostly by those who have a direct or indirect financial interest in branded-generic business?

Keeping this in perspective, it is indeed intriguing, why such an important regulatory step of April 3, 2017 requiring mandatory BE studies for marketing approval of all generic drugs, even after the 4-year period, is getting masked in the cacophony, mostly favoring the branded-generics as a category. However, it’s no-brainer to understand that this din would continue, projecting all generic drugs sans brand names – a pariah!

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.