Tag Archives: Coronavirus

Multifaceted Coronavirus Narrative Raises Multiple Questions

Posted on by
Reply

Last night, amid the national lockdown, many people followed Prime Minister Modi’s video message, broadcasted on April 03 at 9 am for all, ‘to challenge the darkness of Coronavirus together – with a Diya, candle, torch or flashlight, at 9 pm for 9 minutes, from their respective balconies.’ That was the 12th day of 21-day lockdown, when the deadly microbe – Covid19 infected, tested and detected cases climbed to 3,577 in the country, with the death toll rising to 83. This is against 564 - the total number of confirmed cases in India when the lockdown commenced on March 24, 2020.

With all this, a mind-boggling narrative is developing at an accelerating pace. It’s not just about the rogue microbe – rampaging the world hunting for its prey. But also pans over multiple dimensions of its fallout, impacting virtually everything, for all. People of all sections of the society are participating, deliberating or debating on this issue, as the invisible camera of destiny rolls on. Unprecedented!

That’s the real world where, despite fear of an unknown future, most people prefer freedom of expression while playing a constructive role in containing the menace, collectively. We are witnessing a similar scenario – the world over. But, more in the democratic nations. Relatively enlightened citizens will always want to participate in this emerging chronicle, shaping the overall narrative and help sharpening the nations Covid19 policy further – instead of being passive onlookers.

Meanwhile, the objective of maintaining physical distancing during 21-day national lockdown period and beyond must be achieved, regardless of any public discord on its mechanics. This has to happen, primarily because of the TINA factor. Likewise, it’s also a prerequisite that the lockdown is handled efficiently, with meticulous advance planning, deft and dignified handling of any situation, by all and for all. That said, the good news is, newer scientific, evidence-based data are revealing more actionable pathways, in this multifaceted narrative.

A multifaceted narrative raises multiple questions:

As I wrote above, Covid19 narrative is multifaceted and not just one dimensional. It’s true beyond doubt: ‘If there is life, there is the world.’ But, that has to be a life with dignity, a life that help protect families and facilitates contributing to the nation, in different ways – enabling a scope of fulfillment of all.

In this article, I shall, explore some important facets of the evolving narrative on the Covid19 outbreak to drive home this point. In that process some very valid questions, as raised by many, also deserve to be addressed. Some of these include:

  • Covid19 is a war like situation where no questions are asked about the strategic details of a warfare, why the same is not being followed today? In a war some collateral damages are inevitable, why so much of noises now?
  • Why has Covid19 created a general panic with stigma attached to it?  
  • Panic is avoidable, but is the threat real. If so, why?
  • Why people violating national lockdown by migrating from the job location to respective hometowns – increasing the risk of the disease spread, must be brought to their senses mostly through the harsh measures?
  • In the absence of any vaccine or an effective curative drug, why all decisions of policymakers must be blindly accepted by all, during national lockdown and maybe beyond, as if there is ‘not to reason why, but to do or die?’

Let me now explore each of these questions.

A war like situation?

No doubt Covid19 is a war like situation, but with some striking dissimilarities between a conventional war and this war. A conventional war is fought by a well-trained and well-armed defense forces with already developed a gamut, against a known and visible enemy nation.

Whereas, the war against Covid19 is against an invisible and unknown microbe’s sudden attack, being fought in India by a limited army of health care professionals and workers. They fight this war, mostly without adequate or no battle gear, like Personal Protective Equipment (PPE), testing kits and ventilators, supported by a fragile health care infrastructure.

Moreover, in the conventional warfare, the type of advance information and intelligence that the Governments usually possess against the enemy nations, can’t be matched by any private domain experts.

Whereas, Covid 19 still being a lesser known entity to medical scientists, as on date, the remedial measures are still evolving. Only scientific-evidence-based data can create actionable pathways for combat, spearheaded by the W.H.O. Thus, most people expect the nation to comply with, at least, the current W.H.O guidelines for health-safety of the population.

Further, in the cyberspace, several latest and highly credible research data are available for all. These are being well-covered by the global media as a part of the narrative. Thus, unlike conventional warfare, external experts may know as much, if not even more than the Government on Covid19.

Some avoidable show-stoppers:

There are several such avoidable show-stoppers. For example, when one reads news like, ‘Delhi Government Hospital Shut As Doctor Tests Positive For Coronavirus,’ or something like, ‘Indian doctors fight Coronavirus with raincoats, helmets amid lack of equipment,’ alongside a jaw-dropping one, ‘India Sends COVID-19 Protective Gear To Serbia Amid Huge Shortage At Home,’ chaos in the narrative takes place.

In the tough fight against Covid19 menace, these much avoidable fallout may be construed as show-stoppers, if not counterproductive. Many may advocate to pass a gag order against revelation of such difficult to understand developments, and keep those beyond any public discussion. Instead, why not order a transparent enquiry by independent experts to find facts – holding concerned people accountable?

Why has the disease created so much of panic with stigma attached to it?

This is intriguing because, according to the W.H.O – China Joint Mission report on COVID-19, around 80 percent of the 55924 patients with laboratory-confirmed COVID-19 in China, had mild-to-moderate disease. This includes both non- pneumonia and pneumonia cases. While 13·8 percent developed severe disease, and 6·1 percent developed to a critical stage requiring intensive care.

Moreover, The Lancet paper of March 30, 2020 also highlighted, in all laboratory confirmed and clinically diagnosed cases from mainland China estimated case fatality ratio was of 3·67 percent. However, after demographic adjustment and under-ascertainment, the best estimate of the case fatality ratio in China was found to be of 1·38 percent, with substantially higher ratios in older age groups – 0·32 percent in those aged below 60 years versus 6·4 percent in those aged 60 years or more, up to 13·4 percent in those aged 80 years or older. Estimates of the case fatality ratio from international cases stratified by age were consistent with those from China, the paper underscored.

Even the Health Minister of India has emphasized, ‘around 80-85 percent of cases are likely to be mild.’ He also acknowledged: “My biggest challenge is to ensure that affected people are treated with compassion, and not stigmatized. This is also applicable for the health care workforce, which is working hard to counter this epidemic. It is through concerted, community-owned efforts, supported by the policies put in place by the government that we can contain this disease.” This subject, surely, needs to be debated by all, and effectively resolved.

Panic is avoidable, but does a real threat exist with Covid19?

As The Lancet paper of March 30, 2020 cautions by saying - although the case fatality ratio for COVID-19 is lower than some of the crude estimates made so far, with its rapid geographical spread observed to date, ‘COVID-19 represents a major global health threat in the coming weeks and months. Our estimate of the proportion of infected individuals requiring hospitalization, when combined with likely infection attack rates (around 50–80 percent), show that even the most advanced healthcare systems are likely to be overwhelmed. These estimates are therefore crucial to enable countries around the world to best prepare as the global pandemic continues to unfold.’ This facet of Covid19 also requires to be a part of the evolving narrative to mitigate the threat, collectively, with a robust and well thought out Plan A, Plan B, Plan C….

Violation of lockdown increases the risk manifold, but… 

There isn’t a shade of doubt even on this count, in any responsible citizen. Besides individual violation, recently a huge exodus of migrant laborer’s ignoring the lockdown raised the level of risk for others. This exodus should have been stopped at the very start, by better planning and with empathy and dignity by the law enforcing authorities, as many believe. Curiously, even the current Chief Justice of India (CJI) commented, on March 30, 2020: “The fear and the panic over the Coronavirus pandemic is bigger that the virus itself,” during a hearing on the exodus of migrant laborers from workplace to their respective hometowns, due to Covid19 lockdown.

To mitigate the risk, the CJI advised the Government to ensure calming down ‘the fear of migrants about their future, after being abruptly left without jobs or homes because of the 21-day lockdown to prevent the spread of Coronavirus.’ The Court felt, ‘the panic will destroy more lives than the virus.’ Thus, the Government should “ensure trained counsellors and community leaders of all faiths visit relief camps and prevent panic.”

The CJI also directed the Government to take care of food, shelter, nourishment and medical aid of the migrants who have been stopped. This appears to be the desirable pathway of preventing the migrant exodus, causing greater risk to people, requiring better planning, deft situation management with empathy and dignity, by the law enforcing authorities. However, individual violations, if any, can be addressed by intimately involving the civil society, against any possibility of the disease spread.

Whatever decision the policy makers take, must be blindly accepted by all:

In this area, all must first follow what the Government expects us to do. Maintaining strict compliance with such requirements. But, some people do ask, is it in total conformance with the steps W.H.O recommends following? At the March 30, 2020 issue of the Financial Times reported, the W.H.O’s health emergency program has outlined four factors that might contribute to the differing mortality rates in Covid19 outbreak:

  • Who becomes infected?
  • What stage the epidemic has reached in a country?
  • How much testing a country is doing?
  • How well different health care systems are coping?

Many members of the civil society are also keen to know these facts, and may want to seek clarification, if a gap exists anywhere. After all, Covid19 outbreak has brought to the fore, an unprecedented future uncertainty of unknown duration, involving not just life, but a sustainable livelihood and a dignified living in the future, for a very large global population, including India.

Conclusion:

There seems to be a dose of chaos in an otherwise reasonably controlled scenario. One option of looking at it as a pure law and order issue, which needs to be brought to order only with a heavy hand. The second option is to accept it as a golden opportunity to take all on board, by clearly explaining what people want to know – with reasons, patience, persuasion, empathy and compassion, as is happening in many countries.  Of course, without compromising on the urgency of the situation. This is a challenging task, but a sustainable one. Overcoming it successfully, will possibly be the acid test of true leadership, at all levels. However, the slowly unfolding narrative on the ground, doesn’t appear to be quite in sync with the second option.

In the largest democracy of the world, people want to get involved in a meaningful discussion on Covid19 crisis, collectively – based on evidence-based scientific data. Then, it’s up to the policy makers to decide what is right for the country and in which way to go. In tandem, fast evolving, multifaceted Coronavirus narrative, I reckon, will keep raising multiple questions.

As the disease spreads, the pathways of combating it decisively, is being charted by different experts, led by the World Health Organization (WHO). This is being widely covered by the mainstream global media, even in the din of a cacophony. Nonetheless, it is generally believed that a true relief will come, only after a vaccine is developed and made available and accessible to all sections of the world. Till such time a ‘hide and seek’ game, as it were, is expected to continue.

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.

 

Cacophony Over Coronavirus Lockdown

Posted on by
Reply

Currently, the entire India is trying hard to comply with the 21-day lockdown of the country, as communicated by Prime Minister Narendra Modi to the nation at 8 pm on March 24, 2020. The very next day,  while addressing his parliamentary constituency of Varanasi via video, he said, “the Mahabharata war was won in 18 days but this war against Coronavirus will take 21 days.”

After this announcement most people’s life, as I myself can feel it, has changed as never before in the past. Unlike the West, in India most of us are too much dependent on domestic help, for routine chores of the family. How difficult these are, at least, I never experienced in the past. Will life, in its entirety, ever be the same gain?

In addition, shortages of most of the essential items were felt everywhere, be these vegetables, grocery items or medicines. Leave aside, the non-essential necessities. But, the bottom-line is, the lockdown has to be followed. There isn’t any other effective alternative to protect ourselves, those working for us to make our lives easier and comfortable, our respective neighborhood and thereby our country. In its midst, a cacophony over this decision is palpable, whatever may be the reason. Many are from highly credible sources.

Exploring various facets of the cacophony, this article will dwell on the question that will arise at the moment of truth – on or after April 15, 2020: What happened after 21-day lockdown of the entire nation. I shall try to focus on this question with the most relevant facts.

The Government’s rationale behind 3 weeks lockdown:

As explained by the Prime Minister and later by several Indian experts, the rationale behind the 21-day lockdown will include primarily the following:

  • The incubation period of Covid19 is around 5 to 14 days. This is also the potential transmission period of the microbe. Effective social distancing of all, may contain or even stop its spread.
  • As all viruses can sustain or exist only by replicating, they are completely dependent on a host cell for survival and can’t reproduce outside a cell. Social distancing may help in this area, as well.
  • Since, the world doesn’t have any vaccine for Covid19, as yet, prevention alternatives are limited.

Cacophony includes: Is complete national lockdown the only answer?

Several highly credible voices are asking: Is the complete lockdown of the nation the only answer? For example, Professor Vikram Patel at Harvard Medical School, wondered about the relevance of national lockdown in his article of March 26, 2020. He wrote, without any widespread community transmission of the disease, the Government might have staved off the worst without a sledge-hammer approach of national lockdown, which no country at India’s stage of the epidemic has imposed.

Elaborating the alternative approach, he suggested to intensify case finding approach through testing and contact tracing, quarantining those who are infected, physical distancing by everyone, graded travel restrictions, preparing the health system to cater to those who may need intensive care and protect health care workers. Even locking-down limited populations with community transmission will be prudent. When properly implemented these steps ‘could have stopped the epidemic in its tracks.’ Citing examples, he wrote, many of our Asian neighbors have done it successfully. Even China, the original epicenter of the epidemic, did not lock down the entire country.

According to other reports, as well, the countries, such as, Singapore, Germany, Turkey, Taiwan and China, have so far handled Covid19 much better than other countries in containing the pandemic. They all ‘refrained from imposing a complete, nationwide curfew-like lockdown.’ China did bring only the Hubei province under complete lockdown, but not the whole country. Scientists expect that Covid19 will exist despite lockdown – till an effective vaccine is developed and made available for all.

Are our doctors adequately protected against Covid19?

Today, even the doctors and other health care workers remain extremely vulnerable to the disease.  Even in AIIMS doctors, reportedly, are using masks and sanitizers made by themselves or buying them. There is already a shortage of Personal Protective Equipment (PPE), which doctors are worried about. PPE includes face masks, eye shield, shoe cover, gown and gloves. These can be used for only five or six hours before having to discard them. Even N-95 face masks cannot be used for more than a day or two. And there is an elaborate protocol in place, as well, on how to dispose them. As the report said, doctors fighting Covid19 asked: ‘Not just claps, give us personal protective gear.’

Further, the Huffpost article of March 20, 2020 had emphasized with details: “Staying home can be hard, but it’s not even an option for the health care workers and scientists on the front lines of our global effort to thwart the COVID-19 pandemic. They have to arm themselves to face potentially infected patients and deadly viruses every day.” This gets vindicated by a March 26, 2020 report. It brought to our notice that 900 people have been quarantined after a Delhi Doctor unprotected by PPE tests COVID19 positive.

Another news article reported: “A day after the entire nation flocked to their balconies to clap for the heroes in the medical field, who are working relentlessly to arrest the Coronavirus pandemic, doctors in Telangana and Andhra Pradesh were greeted with humiliation and assault.”

Cacophony expands to religious solutions and explanations:

With the panic on Coronavirus spreading, the cacophony also includes religious solutions to the disease. For example, as reported by Reuters on March 14, 2020, ‘Hindu group offers cow urine in a bid to ward off Coronavirus.’ Another YouTube video also shows: ‘Hindu activists in India drink cow urine to ‘protect’ themselves from Coronavirus.’ According to many there are many takers of such concepts, whether one likes it or not.

Intriguingly, a top film star with 40.7 million twitter followers twitted on March 22, justifying public clapping at 5 pm during ‘Janata curfew’ and attributing a bizarre reason to it: ‘clapping vibrations destroy virus potency,’ which he later deleted against strong adverse comment from the scientific community. However, a number of, apparently responsible people, a few of whom are also known to me, often comment – such things can happen and do happen in a vast country like India. It isn’t a big deal. The cacophony goes on.

Be that as it may, regardless of enthusiastic public clapping and availability of cow-urine based solutions – fighting deadly Covid19 of potentially infected patients – without PPE, I reckon, is quite akin to asking a professional army to fight a tough battle without having adequate battle-gear.

Level of India’s preparedness just before national lockdown:

To ascertain this, leaving aside other critical areas, such as, quarantine and isolation facilities, let me cite a few examples related to PPE and testing kits. A news that came just a day before the national lockdown, reported a Government official commenting on a textile material used for masks and other PPEs: “Currently, demand is for 8 lakh bodysuits and N95 masks of the material. Orders for these have been placed.”

However, the Directorate General of Foreign Trade (DGFT), reportedly, banned the export of textile material for masks and coveralls, under the Foreign Trade (Development) and Regulation Act, just recently. Interestingly, as Reuters reported on March 28, 2020, ‘India needs at least 38 million masks and 6.2 million pieces of personal protective equipment as it confronts the spread of Coronavirus.”

Further, when testing is the only acid test to diagnose Covide19 infection – as on March 19, 2020, India, reportedly, had tested 14,175 people in 72 state-run labs, which is regarded as one of the lowest testing rates in the world. This is because: India has limited testing facilities. Thus, only those people who have been in touch with an infected person or those who have travelled to high-risk countries, or health workers managing patients with severe respiratory disease and developing Covid-19 symptoms are eligible for testing. Whereas, according to W.H.O, “All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded”.

However, after declaration of the national lockdown, the Indian Council of Medical Research (ICMR) on March 25, 2020, reportedly, invited quotations from manufacturers for supply of 1 million kits to test patients suspected of suffering from COVID-19. After getting a glimpse of the cacophony over the national lockdown for Coronavirus supported by a few examples, let us see what steps the W.H.O advises for all countries to follow in this pandemic. 

The steps W.H.O recommends following:

On March 16, 2020, the Director General (DG) of the World Health Organization (W.H.O) said: “We have a simple message to all countries – test, test, test.” On that day, observing that more cases and deaths have been reported in the rest of the world than in China, as compared to the past week, the DG elaborated the following:

  • Although, there has been a rapid escalation in social distancing measures, like closing schools and cancelling sporting events and other gatherings, but, not an urgent enough escalation in testing, isolation and contact tracing – which is the backbone of the response.
  • Social distancing measures can help reduce transmission and enable health systems to cope with. Handwashing and coughing into your elbow can also reduce the risk for yourself and others. But on their own, they are not enough to extinguish this pandemic. It’s the combination that makes the difference. Thus, all countries must take a comprehensive approach.
  • The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected. We have a simple message for all countries: test, test, test. Test every suspected case.
  • If they test positive, isolate them and find out who they have been in close contact with up to 2 days before they developed symptoms, and test those people too. Every day, more tests are being produced to meet the global demand.

Curiously, even three months after the massive outbreak of the Coronavirus epidemic in China, India doesn’t seem to have procured enough PPEs for the doctors and testing kits to diagnose the disease. Besides, lack of advance preparation to create adequate quarantine and isolation facilities in the country make the situation even more complex to effectively deal with.

Other challenges and frugal options:

With eight doctors per 10,000 people in India, compared to 41 in Italy and 71 in Korea and one state-run hospital for more than 55,000 people, the general population has developed a much avoidable habit, over a period of time. It is quite likely, even in the event of getting flu-like symptoms, the majority may not go to doctors. Instead, may try home remedies or go to a retail chemist for drugs. Some may even resort to self-medication, until a full-blown disease surfaces, complicating the situation further.

Hence, only two options are left. One – for each individual to take care of personal hygiene and physical distancing, and second – for the Government to announce a national lockdown, through its second sudden and late evening order, effective midnight of the same day. This took almost everybody by surprise and possibly creating a widespread panic – not so much about the disease – at least initially, but more for regular availability of essential daily necessities – food and for many people – medicines, besides means for daily living of scores of families. This was further fueled by the gross lack of empathy by the law enforcers.

Conclusion:

As reported, if Covid19 continues to spread at its current pace, India could face between around 100,000 and 1.3 million confirmed cases of the disease caused by the new Coronavirus by mid-May, according to a team of scientists based mainly in the United States. It’s important to note that with just 6.8 tests per million, one of the lowest rates in the world, India has been criticized for not testing enough.

Moreover, besides panic and economic fallout of the disease, the long-term impact that Covid19 may have on the mental health of different people, for various reasons, will also need to be ascertained. As Professor Vikram Patel of Harvard Medical School said in his above article, ‘the deliverable is not how many people clanged pots and pans’ or how many obediently followed the Prime Minister’s advice of staying indoors. “The deliverable is how many people got tested, how many doctors have protective gear, how many ventilators the government managed to manufacture or buy overnight.” Another deliverable is isolation centers, temporary hospitals in indoor stadia and quarantine facilities that are fit for human beings, he added.

On November 24, 2020 – when 21-day national lockdown commenced, the total number of confirmed cases in the country were reported as 564. Just at the beginning of the 5th day of the lockdown on March 29, 2020, as I write this piece, as many as 1032 people have been tested positive for Covid19 with 28 deaths. Against the above backdrop, some critical points that surfaced while exploring the cacophony over the national lockdown, can possibly be wished away only at one’s own peril.

Nevertheless, under the prevailing circumstances, there was no other alternative for the Government, but to announce immediate national lockdown, which all should abide by, religiously. However, whether Coronavirus will be won in India with 21-day of national lockdown – just three days more of what the Mahabharata war took, as the Prime Minister expects, will start revealing from April 15, 20120 – as the moment of truth arrives.

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.

 

What A New Microbe Can Man Can’t?

Posted on by
Reply

Our world is indeed so fascinating, where mankind is in possession of a predictable lethal power to annihilate fellow citizens of any country or countries – just in minutes or hours or days, as it would decide. Whereas, any sudden attack of an unpredictable crippling power of unknown microbes, can make the same mankind feel helpless – grappling to save lives of the citizens – along with its socioeconomic fabric.

Because of the sudden nature of such crippling attacks, mankind is put to fight against time to build a new arsenal of medicines and vaccines – while defending itself under an umbrella of preventive measures. It’s not that such a situation was never envisaged. On the contrary, as we shall see below, the warning from the same came from several credible sources. Even Bill Gates during a TED Talk five years ago had warned: “If anything kills over 10 million people in the next few decades, it’s most likely to be a highly infectious virus rather than a war – not missiles, but microbes.”

A few years later, the 2018 publication of the World Health Organization (WHO) – ‘Managing epidemics,’ articulated a similar cautionary note, which I am quoting in verbatim: “We are continuously learning about the unpredictable powers of nature. This is nowhere more true than in the continuous evolution of new infectious threats to human health that emerge – often without warning – from the natural environment.” Elaborating the point, it further cautioned: “Given the effects of globalization, the intense mobility of human populations, and the relentless urbanization, it is likely that the next emerging virus will also spread fast and far. It is impossible to predict the nature of this virus or its source, or where it will start spreading.”

Ironically, in about a year’s time, by end 2019, a new Coronavirus broke out in Wuhan of China. From January to March 22, 2020, 13,569 people, reportedly, died globally due to Coronavirus (Covid 19) infection. In India, as I write as I write during 14 hours long public curfew, 341 confirmed cases and 6 deaths have been reported. This outbreak has now shaken, almost the entire world – more than even before. The reverberation of the life-shattering impact of the disease, is now being felt and heard across all the facets of human life, including social, economic and political. Thus, the broad point to ponder in this article: Why the mankind can’t do what a new microbe can?

Various elements to it:

There are various elements of the above broad issue. A comprehensive response to which would involve, at least, two critical sub-questions:

  • Was it avoidable? If so, to what extent?
  • Or, at least, could its overall impact have been blunted?

Moving in that direction, let me try to explore some important facts that may help taking an unknown microbe bull by the horn, if such calamity strikes again – unannounced, in future.

None of these facts were unknown:

As we have seen above, the possibility of emergence and a sudden crippling strike of a new microbe was not unknown, including the warning of a global crisis from the W.H.O.  Besides, ‘nearly 50,000 men, women and children are dying every day from infectious diseases; many of these diseases could be prevented or cured for as little as a single dollar per head.’

Another interesting report: ‘Global rise in human infectious disease outbreaks,’ published in the Journal of the Royal Society interface on December 06, 2014, presents more facts. It says: Since 1980, over the last 30 years till 2014, outbreaks of infectious disease mostly caused by bacteria and viruses are steadily increasing with different health impact in different countries.

Several reasons for the high death rate related to infectious disease:

Several reasons could be attributed to high death rates for infectious disease, despite the availability of a large number of powerful antibiotics in the world, which include the following:

  • Developing nations with lesser access to drugs.
  • Fast development of Antimicrobial Resistance (AMR) owing to misuse and abuse of antibiotics.
  • Emergence of new bacteria and viruses, such as, Covid19 catching the population off-guard, as is being warned by top experts, from time to time.

Several times in the past, I wrote on the subjects of access to medicine, Antimicrobial Resistance (AMR), as well as the recent Coronavirus outbreak. Nevertheless, for this specific discussion, I shall focus only on the second and the third points, in the reverse order, with a different perspective.

Fresh threats of new infections are ongoing:

As the 2018 paper of ‘Managing epidemics’, published by the World Health Organization (WHO) had articulated – besides new microbial pandemics, the history of previous viral outbreaks can also possibly repeat themselves. That means: ‘A new HIV, a new Ebola, a new plague, a new influenza pandemic are not mere probabilities. Whether transmitted by mosquitoes, other insects, contact with animals or person-to-person, the only major uncertainty is when they, or something equally lethal, will arrive.’

As these being ‘newer’ types – just as Covid19 is so different from commonly occurring Flu - in all probability would be unique viruses with unique characteristics. For example, as the W.H.O describes, while Seasonal Flu cannot be stopped, countries still have the chance to limit cases of Covid19, through stringent implementation of scientific protocols. More, importantly, Covid-19 seems to lead to much more severe disease than Seasonal Flu strains.

Effective solution of both – the new and the new forms of known viruses, would require successfully navigating through tough challenges, involving multiple areas, such as, medical, technological, social, economic and political. No doubt, the world has progressed a lot in this area. But, effective ‘capacity building’ to combat the sudden onslaught of any deadly microbial pandemic, still remains an unfinished agenda.

The world has moved a lot, but still needs to accelerate capacity building:

Just in 2018, the world remembered the devastating Great Flu pandemic of 1918 on its 100th anniversary. Although, it lasted only a few months, claimed 50 million to 100 million lives worldwide. The book - ‘Influenza: The Hundred Year Hunt to Cure the Deadliest Disease in History,’ provided a glimpse of that scenario. Interestingly, Flu still kills about 1 percent of those infected by this virus. Whereas, about 3.4 percent of Covid-19 cases have been fatal, as on date, according to the W.H.O.

A comparison of these two pandemics will include both the similarities and the differences. The most striking similarity being – in both the global pandemics, most people are just not afraid, but are also getting panicked.

Whereas, the key differences between the two episodes are – the quality health care infrastructure in today’s globalized world, speed of diagnosis and the versatility of available drugs – even for ‘repurposing’, as being done in the present situation. Now, many people understand the need of putting the exposed persons in isolation – or under quarantine, besides co-operating with various infection control measures, as prescribed by the health authorities. In the midst of this crisis, an ongoing and very related critical issue remains virtually ignored - fast developing AMR, as I mentioned above.

Fast developing AMR continues taking many lives:

In this article, instead of dwelling on the cause of AMR and how to address it, I would rather focus on the current threats that AMR poses and will pose in the future, if not addressed on a war footing, collectively.

The latest details in this area are available from the paper – ‘The Antimicrobial Resistance Benchmark 2020’, published by the Access to Medicine Foundation. It emphasized that infectious diseases are still the cause of “more than 500,000 deaths each year, including more than 200,000 infant deaths. In India, for example, resistance exceeds 70 percent for many widespread bacteria.” As I mentioned in one of my previous articles that the 2017 Review Article, titled ‘Antimicrobial resistance: the next BIG pandemic,’ has termed India as ‘the AMR capital of the world.’ Even a 2020 news report says: Two million deaths are projected to occur in India due to AMR by the year 2050.

The current status:

The following two reports of WHO, published in January 2020, unfolded some interesting facts:

The analysis demonstrated, although, many drug companies are making enough investments to discover and develop innovative medicines, anti-infective therapy area does not feature there for most companies. As the reports unraveled:

  • Not just a declining trend of investment, even the current clinical pipeline remains insufficient to tackle the challenge of AMR.
  • With large drug companies continuing to exit the field, primarily due to commercial considerations, small and medium-sized enterprises (SMEs) are entering this space, but not with as much resources and other wherewithal.
  • All the eight new antibacterial agents, approved since July 01, 2017, offer limited clinical benefits.
  • One new anti-TB agent, pretomanid, developed by a not-for-profit organization, has been approved for use within a set drug-combination treatment for MDR TB.
  • The current clinical pipeline contains 50 antibiotics and combinations and 10 biologicals. Six of these agents fulfil at least one of the innovation criteria; only two of these are active against the critical MDR Gram-negative bacteria, with a major gap in activity against metallo-β- lactamase (MBL) producers.

As the AMR situation is getting worse, globally, unlike any possible repetition of a new microbial attack in the future, AMR isn’t a future problem. It needs to be addressed here and now. Fixing the problem does not require a scientific miracle. It demands a very human solution, spearheaded by the R&D based drug companies, the academia and the Governments, collectively. The reasons of why it is not happening - is known to many, but how to chart an effective pathway for its meaningful resolution – possibly isn’t. The signal today is loud and clear that infectious diseases are reemerging and threatening human lives – be it due to AMR or a sudden attack by a new microbe such as Covid19.

Conclusion:

It is loud and clear that infectious diseases will continue to reemerge in various shapes, forms and virulence – having the incredible power of shaking the world, including the most powerful and developed nations, as we all are experiencing today. As and when Covid19 pandemic gets over, and it will, learning from the past situation and picking up the global best practices to combat and decisively win over any such future crisis, will be critical. But, this is easier said than done – going by the past.

All concerned can feel it today, without any shade of doubt. There is no room for complacency in this regard, for anyone, regardless of having the best of health care infrastructure, diagnosing facilities, state of the art treatments of all types, including vaccines, for a wide range of number of life-threatening conditions.

As the W.H.O said, ‘The microbes didn’t go away. They just went out of sight. Instead, the focus turned to chronic, noncommunicable diseases, which came to receive much more attention. But nature was by no means in retreat. In fact, it seemed to return and took many health institutions and decision makers by surprise.’

It’s, therefore, high time for all to read the writing on the wall. A time to accept and realize that, when it comes to an unpredictable, crippling power of bringing the entire world to virtually a grinding halt – making even the most powerful nations feel helpless and highly vulnerable – what a new lethal microbe can do in one go, even the most developed and the powerful nation can’t. An all-time preparedness against biological threats, therefore, has emerged as a new normal.

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.

Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review

Posted on by
Reply

The Coronavirus outbreak has reached a “decisive point” and has “pandemic potential”, said the Director General of the World Health Organization (W.H.O), reportedly, on February 27, 2020, urging governments to act swiftly and aggressively to contain the virus. He further added, “We are actually in a very delicate situation in which the outbreak can go in any direction based on how we handle it.” Alerting all, he appealed, “this is not a time for fear. This is a time for taking action to prevent infection and save lives now.”

As on March 08, 2020 – 106,211 coronavirus cases (view by country) were reported globally, with 3,600 deaths and 60,197 patients recovered. Thus, the most relevant question now is the level of preparedness of each country, to prevent a possible epidemic, which may even strike at a humongous scale. This will be relevant for both, the countries already infected with a coronavirus – in a varying degree, as well as, those who are still out of it.

From the drug industry perspective, equally pertinent will be to assess on an ongoing basis its impact on the medical product supply-chain and further intensifying ongoing efforts to find the ‘magic bullet’ – an effective remedy, partly addressing the unease of all, on this score. In this article, I shall try to ferret out the current status on these points, based on available and contemporary data.

The impact assessment has commenced:

While on the current impact assessment, I shall restrict my discussion on the largest pharma and biological market of the world – the United States (US) and of course, our own – India, starting with the former. On February 14, 2020, the US released a statement of the Commissioner of Food and Drugs Administration titled, ‘FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad.’ Highlighting the proactive actions of the regulatory agency, the statement recorded:

“We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Adding further, he revealed that the US-FDA is in touch with regulators globally and has added resources to quickly spot “potential disruptions or shortages.”

Whereas in India, the Chemicals and Fertilizers Ministry has also announced: “The Government of India is closely monitoring the supply of APIs/intermediates/Key starting materials (KSMs) which are imported from China and the effect of the outbreak of a novel coronavirus in China on their supply.”

The current status:

As this is an ongoing emergency exercise, on February 27, 2020, by another statement, the US-FDA reported the first shortage of a drug, without naming it, due to the COVID-19 outbreak. It identified about 20 other Active Pharmaceutical Ingredients (APIs) or finished drug formulations, which they source only from China. Since January 24, the US-FDA has, reportedly, been in touch with more than 180 manufacturers of human drugs to monitor the situation and take appropriate measures wherever necessary. However, the prices of some key ingredients have already started increasing.

Back home, on March 03, 2020, Reuters reported, the Indian Government has asked the Directorate General of Foreign Trade (DGFT) to restrict export of 26 APIs and other formulations, including Paracetamol, amid the recent coronavirus outbreak. Interestingly, these 26 active pharmaceutical ingredients (APIs) and medicines account for 10 percent of all Indian pharmaceutical exports and includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12, among others, as the report indicated.

It is unclear, though, how this restriction would impact the availability of these medicines in the countries that import from India, especially formulations, and also China. For example, in the United States, Indian imports, reportedly accounted for 24 percent of medicines and 31 percent of medicinal ingredients in 2018, according to the U.S. Food and Drug Administration. Be that as it may, it still remains a reality that China accounted for 67.56 per cent of India’s total imports of bulk drugs and drug intermediates at USD 2,405.42 million in 2018-19.

Prior to this import ban, a report of February 17, 2020 had flagged that paracetamol prices have shot up by 40 percent in the country, while the cost of azithromycin, an antibiotic used for treating a variety of bacterial infections, has risen by 70 percent. The Chairman of Zydus Cadila also expects: “The pharma industry could face shortages in finished drug formulations starting April if supplies aren’t restored by the first week of the next month,” as the news item highlighted.

No significant drug shortages reported, just yet:

From the above details, it appears, no significant drug shortages have been reported due to Coronavirus epidemics in China – not just yet. Moreover, the Minister of Chemicals and Fertilizers has also assured: ‘No shortage of drug ingredients for next 3 months.’ He further added: ‘All initiatives are being taken to ensure there is no impact of the disease in India.’

However, on March 03, 2020, W.H.O, reportedly has warned of a global shortage and price gouging for protective equipment to fight the fast-spreading coronavirus and asked companies and governments to increase production by 40 percent as the death toll from the respiratory illness mounted. Moody’s Investors Service also predicted, coronavirus outbreak may increase demand, but poses a risk of supply chain disruptions, especially for APIs and components for medical devices sourced from China.

In view of these cautionary notes, especially the health care and regulatory authorities, should continue keeping the eye on the ball. More importantly, commensurate and prompt interventions of the Government, based on real-time drug supply-chain monitoring, along with the trend of the disease spread, will play a critical role to tide over this crisis.

In search of the ‘Magic Bullet’: 

Encouragingly, on February 16, 2020, the National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, for the treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province. Formerly known as Fapilavir, Favilavir was developed by Zhejiang Hisun Pharmaceutical of China. A large number of other promising R&D initiatives are being undertaken, in tandem, by brilliant scientific minds and entities to find an effective treatment for this viral disease. To give a feel of it, let me cite just a few examples, both global and local, as below.

Pfizer Inc. has announced that it has identified certain antiviral compounds, which were already in development, with potential to treat coronavirus-affected people. The company is currently engaged in screening the compounds. It is planning to initiate clinical studies on these compounds by year-end, following any positive results expected by this month end.

Several large and small pharma/biotech are now engaged in developing a vaccine or a treatment. Gilead has, reportedly, initiated two phase III studies in February 2020, to evaluate its antiviral candidate – remdesivir, as a treatment for Covid -19. Takeda is also exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19, besides developing a plasma-derived therapy for the same. Pipeline candidates of other companies are in earlier stages of development, as reported.

Whereas in India, Serum Institute of India (SIL) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Zydus Cadila, as well, has launched a fast-tracked program to develop a vaccine for the novel coronavirus, adopting a two-pronged approach, a DNA based vaccine and a live attenuated recombinant measles virus vectored vaccine to combat the virus. These initiatives seem to be a medium to long-term shots – laudable, nonetheless. 

Current off-label drug treatment for coronavirus:

Some of the drugs, reportedly, being used in China to treat coronavirus include, AbbVie’s HIV drug, Kaletra and Roche’s arthritis drug – Tocilizumab (Actemra). However, none of these drug treatments have been authorized yet by drug regulators, to treat patients with coronavirus infection.

According to the Reuters report of March 04, 2020, China’s the National Health Commission, in its latest version of online treatment guidelines, has indicated Roche’s Tocilizumab for coronavirus patients who show serious lung damage and elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases.

However, there is no clinical trial evidence just yet that the drug will be effective on coronavirus patients and it has also not received approval from China’s National Medical Product Administration for use in coronavirus infections. Nonetheless, Chinese researchers recently registered a 3-month clinical trial for Actemra on 188 coronavirus patients. According to China’s clinical trials registration database, the period of trial is shown from February 10 to May 10. 

Is coronavirus becoming a community transmitted infection?

Even while grappling with an increasing number of COVID-19 positive patients, the Indian Government is showing a brave front, as it should. However, it has also confirmed “some cases of community transmission.” This unwelcome trend makes India the part of a small group of countries, including China, Japan, Italy and South Korea, where community transmission of the virus has taken place. This is a cause of an additional concern.

Although, there has been no significant drug shortages reported yet, shortages of  hand sanitizers,recommended for frequent use by the W.H.O and other competent bodies, as they can, reportedly kill Covid-19. Similarly, N95 masks useful to prevent the spread of the disease, have also disappeared, adding more fuel to fire, if not creating a panic-like situation, for many.

Conclusion:

Most global drug players with a business focus on branded – patented drugs, are not expected to fight with the supply disruptions. As reported, ‘Several top drugmakers – including Pfizer, Johnson & Johnson, Bayer, Merck KGaA and Roche—recently confirmed to FiercePharma that they have stock policies in place to minimize the impact.”

But, for the generic drug industry the disruption in the supply chain may have a snowballing effect. For example, as the March 03, 2020 edition of the New York Times (NYT) reported – supply chain disruption in sourcing some APIs from China is being felt most acutely in India, as the Government decided to stop exporting 26 drugs, most of them antibiotics, without explicit government permission. The same article also highlighted the possible multiplier effect of this development with its observation: “That’s a problem for the rest of the world, which relies on India’s drug makers for much of its supply of generic drugs. India exported about $19 billions of drugs last year and accounted for about one-fifth of the world’s exports of generics by volume”, it added.

As on date, there is no known cure for coronavirus infection. The magic-bullet has yet to be found out. However, over 80 clinical trials has, reportedly, been launched to test coronavirus treatments. This includes, repurposing older drugs, as well. Recently, only Favilavir, an anti-viral drug, has been approved for treatment for coronavirus by the National Medical Products Administration of China.

Coming back to the unease of many in India, the country’s perennial shortages of doctors, paramedical staff, hospital beds, adequate quarantine facility for a large number of patients and fragile public healthcare delivery system, still pose a humongous challenge in this crisis. More so, when just in the last week, U.S. intelligence sources, reportedly, told Reuters that ‘India’s available countermeasures and the potential for the virus to spread its dense population was a focus of serious concern.’

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.

India’s Preparedness Against Biological Threats

Posted on by
Reply

Recent Coronavirus outbreak poses a ‘very grave threat to the rest of the world’ – the head of the World Health Organization (WHO), reportedly said on February 11, 2020. Earlier, on January 28, 2020, it had changed the viruses’ risk-status from ‘moderate’ to ‘high’. As it creates a havoc in China, Coronavirus has recorded a limited spread in India, besides France, Canada, US, Japan, Thailand, Sri Lanka. This article will explore how prepared is India to tackle any similar biological threat to protect its citizens from a possible health catastrophe.

Let me begin by assessing pros and cons of the current initiatives of the Indian Government, both at the Center, as well as, in the States, in this regard.

The pros and cons:

Some of the ‘pros’, that the Ministry of Health and Family Welfare promptly initiated are as follows:

  • Updated Travel advisory for travelers visiting China. 
  • Discharge policy for suspected or confirmed novel Coronavirus (2019-nCoV) cases.
  • Guidelines on Clinical management of Severe Acute Respiratory Illness (SARI) in suspect/confirmed 2019-nCoV cases.
  • Guidance on surveillance for human infection with 2019-nCoV.
  • Guidelines for ‘Infection Prevention and Control in Healthcare Facilities’.
  • Guidance for sample collection, packaging and transportation for 2019-nCov.

The above steps are as commendable as some other prompt initiatives of the Ministry to stop Coronavirus from entering the country, such as leveraging technology for both thermal and symptomatic screening, especially at the high-risk airports.

However, according to global experts – India, along with several other countries are still ill prepared to face biological threats of a magnitude that we are now witnessing in China. On the other hand, according to February 12, 2020 publication of The World Economic Forum, there about a dozen of countries in the world who are best prepared for meeting similar health emergencies.

Similar calamity was predicted two years back by W.H.O: 

Interestingly, a similar situation was predicted by none other than Tedros Adhanom, Director General of the World Health Organization and was reported on February 15, 2018. He then said, “We have a problem. A serious one. At any moment, a life-threatening global pandemic could spring up and wipe out a significant amount of human life on this planet. The death toll would be catastrophic. One disease could see as many as 100 million dead.”

“This is not some future nightmare scenario,” he added. “This is what happened exactly 100 years ago during the Spanish flu epidemic.” Again: “A devastating epidemic could start in any country at any time and kill millions of people because we are still not prepared. The world remains vulnerable.”Explaining the reason for the same, the Director General pinpointed: “The threat of a global pandemic comes from our apathy, from our staunch refusal to act to save ourselves — a refusal that finds its heart in our indifference and our greed.”

Now, when the world is grappling with the menace of Coronavirus – may not be at the predicted global scale yet, those comments haunt us again. It flags each country’s preparedness to deal with such pandemic, as and when it strikes, unannounced.

‘Countries best prepared for health emergencies’ – and India:

The February 12, 2020 publication of The World Economic Forum, as indicated above, highlights several important realities of this subject. Let me quote below just two of these, which, I reckon, are the most profound:

  • National health security is fundamentally weak around the world, and none is fully prepared to handle such an outbreak.
  • Global biological risks are in many cases growing faster than governments and science can keep up.

Acknowledging these facts, based on the Global Health Security Index, the most prepared ones for epidemics or pandemics of all types were listed among 195 countries surveyed. Measured on a scale from 0-100, the US ranks as the “most prepared” nation (scoring 83.5). Next comes UK (77.9), the Netherlands (75.6), Australia (75.5) and Canada (75.3) featuring behind it.

Thailand and South Korea are the only countries outside of the West that rank in this category. China, the most populated country in the world – which is also at the center of the Coronavirus outbreak – is in 51st place, scoring 48.2. And, India, the second most populated country ranks 57 with a score of 46.5. The obvious question that comes up: Why India ranks so low in the Global Health Security Index, among 195 countries?

Knowing the risk – not enough, building capability is a must:

The above details will give a sense of risk exposure to pandemic or epidemic, like Coronavirus, for a country. As the experts point out, just knowing the level of risk exposures, is far from enough. Each Government has a fundamental duty to build capabilities for protecting its people from the disastrous consequences of any possible biological threat, as and when it strikes. This will call for taking quantifiable financial and other measures to fill the existing gaps in the epidemic and pandemic preparedness, as captured in many studies. 

India’s budgetary allocation for health remains frugal:

It gets reflected even in the Union Budget 2020-21for the health care sector. Although, the total allocation for the sector was about 10 percent higher from the year ago. The increase seems negligible, considering consumer price index inflation was 7.5 percent in December 2019, as analyzed by the publication Down to Earth on February 02, 2020.

The report said, over 50 percent of the increase will go into offsetting inflation and we don’t seem to be anywhere near achieving the target of allocating 2.5 percent GDP to health by 2025, as envisaged by even the current government.

More relevant to this discussion, the allocation towards schemes dealing with communicable diseases, in general, has remained unchanged, especially when ‘Indians are getting sick mostly due to infections’, according to NSSO study, as reported on November 25, 2019.

India’s ability to contain epidemic is much less than China:

In a relative yardstick, China, reportedly, has built a better health care infrastructure than India to respond to various health related needs of the country’s population, including emergency situation, such as Coronavirus. Some of the key reasons, for example, are as follows:

  • While India shows one of the lowest government-spend on public health care, as a percentage of GDP, and the lowest per capita health spend, China spends 5.6 times more. 
  • When Indians met more than 62 percent of their health expenses from their personal savings, as ‘out-of-pocket expenses’, the same is 54 per cent in China.
  • India’s ability to quarantine a large number of infected people is much limited as compared to China.
  • Health service delivery system, especially for over 70 percent of the rural population of India, lack adequate scientific and skilled manpower, alongside necessary emergency equipment to provide care to a large number of patients at the same time, if epidemics strike.
  • Around 74 percent of health care professionals happen to be concentrated in urban areas, catering to just a third of Indian population, leaving rural areas under-served, according to a KPMG report. Alongside, the country is 81 percent short of specialists at rural community health centers (CHCs).

Conclusion:

The recent Coronavirus outbreak sends a strong signal to public health authorities, across the world, about the task-cut out for them to catch the early signs of possible epidemics. Many countries, especially India, have much ground to cover to ensure the right level of preparedness in countering such unannounced biological threats.

Capacity building for prevention, early detection, taking medical countermeasures – to contain the fast spread of the deadly organisms, and effective treatment response at the earliest, is the need of the hour. India also needs to develop capabilities for rapid development of drugs and vaccines in such a situation, fighting against time. Quoting the National Institute of Virology, some recent reports indicate that India’s scientific expertise and manpower aren’t enough, just yet, to deal with similar crises.

India’s public healthcare system and its delivery mechanism are still not robust enough either to keep in quarantine or in providing effective treatment and care for a large number of patients during any epidemic situation.

Against this perspective, I reckon, India is still grossly underprepared to face any biological threat, if it strikes with all its might. In that sense, the scary Coronavirus episode may be construed as yet another wake-up call to break the perceived slumber of the Government, if not apathy, as it were.

Thus, the question that surfaces: Shouldn’t the country, at least now, deploy enough resources to protect its citizens from any possible biological threats and aggression, just as it does, to provide safety, security and well-being of the population against any other external or internal threats?

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.

Criticality of Drug Quality In The Moment Of Truth

Posted on by
Reply

When global health emergencies strike unannounced – in the scale and magnitude of new coronavirus, it shakes the health care system of all countries, in varying degree though, irrespective of the robustness of the economy. In such situation, the robustness of health care infrastructure, stringent manufacturing quality standards, operational flexibility for seamless sourcing of all drug ingredients in the required quantities, besides speed and agility of the delivery system – are put to the acid test.

Anytime readiness to effectively neutralize this crisis is of utmost importance. Accordingly, the key national goal should be to create a robust ‘whole’ that is much more than the sum total of each of each of the above factors – a sturdy ‘drug security system’ for the country. The most populous country of the world – China may have succeeded in building a 1,600-bed hospital coronavirus hospital in just 10 days, completing on February 05, 20120. But it is still looking for necessary drugs from other countries, such as the United States.

Curiously, China hasn’t yet disclosed its reason. More so, when the country is the top global supplier of Active Pharmaceutical Ingredients (API), including antiretroviral (ARV) drugs, along with India, according to the World Health Organization (W.H.O). This draws many to look at the general apprehension on the questionable quality of drugs that China, allegedly, produces. But, could this be the reason?

Nevertheless, regardless of inquisitiveness to know the reason, the question mark on its drug quality remains. And this is also not the risk-taking time for any nation, as it could possibly endanger lives of scores of the impacted population. The criticality of drug quality in ‘The Moment of Truth,’ such as, the new coronavirus emergency, can only be wished away at one’s own peril.

On the other hand, the confidence expressed in India, as we shall see below, in ‘drug security’, just based on adequate ARV drug availability appears to be coming from a different plane, although the drug quality issue is exactly the same in India, if not more concerning. From the above perspective, my today’s article will focus on this subject, purely based on available data, starting with the request of the Chinese authorities for ARV drugs from the United States.

Chinese request for ARV drugs:

‘U.S. Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus – AbbVie, Gilead, others respond to Chinese authorities’ requests for antiviral drugs to test effectiveness against deadly respiratory illness.’ This was reported by The Wall Street Journal (WSJ) on January 27, 2020. It goes without saying that these antiviral drugs also include Anti-Retrovirals (ARVs).

AbbVie Inc. and Johnson & Johnson  are among the drug makers that have begun shipping drugs approved to treat HIV, while Gilead Sciences Inc. is exploring whether it should send an antiviral therapy it is developing.

It isn’t known whether the drugs would be able to help contain the explosion of respiratory virus infections sweeping the country or provide relief to infected patients. Chinese authorities have requested the shipments to test the drugs’ effectiveness in containing the new coronavirus, the report added.

An intriguing difference between India and China:

Interestingly, China is looking for sourcing some of these ARV drugs from the United States and not from India, either – one of the top producers of these drugs, as W.H.O reported.

In contrast, according to an Indian report of February 04, 2020: ‘Leading domestic drug companies have said they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus (2019-nCoV).’

As I said earlier, although, China hasn’t yet specified the reasons behind their decision on ARV drug import from the United States, but could it have any link on the internal general apprehension of these drugs quality, safety and effectiveness?

Acknowledging for a moment that this is global allegation on Chinese drugs, in general. So is regarding India, as we shall see below. Then where does India stand on this score, especially in view of the confidence with ARV drugs, as exhibited in the above media report from India? That said, the logical question that surfaces now – why is the request for ARV drugs?

Why ARV drugs?

Although W.H.O said that there is ‘No known effective treatments’ for new coronavirus, as yet, various reports do indicate the use of ARV drugs in the treatment of 2019-nCoV:

  • A combination of flu and HIV medications are helping treat severe cases of the new coronavirus in Thailand.
  • Chinese health officials are already administering the HIV and flu drugs to fight the coronavirus, but the combination of the three together in a cocktail seemed to improve the treatment.

The Scientist, on February 02, 2020 reported that large doses of the flu drug oseltamivir combined with HIV drugs lopinavir and ritonavir, reportedly, improved the conditions of several patients in Bangkok, Thailand.

Global dependence on Chinese and Indian generic drugs:

About 80 percent of the Active Pharmaceutical Ingredients (APIs), including many ARVs, which are used for manufacturing of drug formulations in the United States are said to come from China and other countries like India. This appeared in the article titled, ‘U.S. Dependence on Pharmaceutical Products From China,’ published by the Council on Foreign Relations (CFR) on August 14, 2019.

India’s dependence on Chinese APIs:

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament show that in 2017-18, Indian imports of APIs and drug intermediates from China increased to 68.36 per cent. The same at 67.56 per cent in 2018-19, still remained the largest share in total Indian imports, with the overall India’s dependence on imports going up by 23 per cent from 2016-17 to 2018-19.

As reported in the media on November 22, 2019, India’s national strategies, such as, “2015 – Year of Active Pharmaceutical Ingredients” or ‘Make in India’ campaign, to promote indigenous means of production continue to be relegated on paper. Even, the current National Security Advisor had warned that Chinese dependence on API can be a national security threat.

According to the Department of Pharmaceuticals (DoP), Chinese API imports are due to economic considerations, which are essentially cheaper and more cost-effective for the Indian drug manufacturers, the above report highlighted.

Against this backdrop, the above local media report indicating, leading domestic drug companies are ready to supply anti-retrovirals (ARVs), may invite more questions than answers. Added to this come the critical quality issues with drugs manufactured in China and India.

Quality issues with Chinese drugs:

Credible documents highlight, as China’s pharmaceutical industry is not effectively regulated by the Chinese government, its regulatory apparatus is inadequately resourced to oversee thousands of Chinese drug manufacturers. Even if Beijing made such oversight a greater priority. This has resulted in significant drug safety scandals.

Although, the drug quality related concerns seem to be even more related to India, the drug industry of the country, reportedly, remains in a denial over most of such charges involving drug-quality.

India tops with the most quality related FDA warning letters in 2019:

The author of the above article reiterates, ‘Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.’

To avoid ‘your-opinion-versus-my-opinion’ type of a debate with this article, let us look at some hard facts. These are from the ‘warning letters’ on drug quality, issued to various pharma companies, across the world, by the USFDA’s Center for Drug Evaluation and Research (CDER). The details were well captured in an article, titled ‘The country with the most FDA warning letters in 2019,’ published by Pharma Manufacturing on January 20, 2020.

Some key CDER findings:

As I consider, the top three CDER findings may be summarized as follows:

  • In 2019, CDER issued dozens warning letters for manufacturing issues to pharma companies outside the U.S. One country in particular – India – received the highest number of letters.
  • CDER’s office of Manufacturing Quality Letters issued 43 letters to companies outside of the U.S. Of those letters:

-   20 were aimed at facilities in India.

-   With 11, China received the second most manufacturing quality warning letters.

-   The rest of the letters were distributed among plants in Europe, Costa Rica, Singapore, Turkey and others.

  • The data from CDER shows that India has the poorest rate of FDA inspections with acceptable outcomes (83 percent) — much lower than China (90 percent) and the U.S. (93 percent).

Conclusion:

Today, a host of effective drugs and vaccines are available to treat a number of both non-infectious and infectious ailments, including many life-threatening viral diseases. However, the effectiveness of these medicines in treating such diseases, as well as many other illnesses, gets significantly compromised by questionable quality and distribution of these medicinal products. Even way back, a similar concern was deliberated in an article captioned, ‘Substandard drugs: a potential crisis for public health’, published in the British Journal of Clinical Pharmacology (BJCP), on November 29, 2013..

It may ordinarily remain undetected, sans stringent and wide-scale regulatory scrutiny. Additionally, a number of involved countries still remain in a denial mode. It’s also a fact, several governments may not have wherewithal for the same, particularly when the manufacturing units are too many, such as in China and India.

However, when a critical national health emergency strikes, unannounced, like the new coronavirus, the moment of truth dawns. Obviously, the national governments would want to be risk averse and prefer sourcing the best of drugs, to rapidly contain the spread of the disease, saving more lives. It’s not difficult to fathom, either, any country is unlikely to admit this reality, in public, even while taking measures for the same.

China’s sourcing of ARV and other drugs from the United States may or may not be due to the drug quality reasons. Nonetheless, I reckon, the criticality of drug quality issues can possibly be best realized, mostly when the ‘Moment of Truth’ arrives. Unannounced! Just like a bolt from the blue!

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.

China Coronavirus And API Sourcing – A Threat… Or An Opportunity For India?

Posted on by
Reply

‘2015 – Year of Active Pharmaceutical Ingredients’ (API), announced the Government of India by a Press Release on February 25, 2015. This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’.

Two years down the line, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ It reiterated, India has proven capabilities in the generic drug formulations, but over dependence on China for sourcing – 70-75 per cent of APIs does not augur well for the Indian pharmaceutical sector. Because, as any interruption in supply from China can badly impact the sector, jeopardizing the health of millions of people, not just in India, but across the world, as well.

The reason for Indian drug formulation makers depending on China-supplied APIs, is mainly for its low cost, and not for any technological other reason, the article said. Regardless of the India’s announcement – ‘2015 as the year of API’, the API industry continued to struggle without much tangible support. Despite a lot of decisions still being in the pipeline, let me hasten to add, some inconclusive signs of early recovery have been captured in this space by some recent studies.

With the outbreak of the recent ‘coronavirus’ menace, the moment of truth has arrived in the country. On the one hand, it is posing a threat to the country’s API sourcing, on the other it could throw open a door of opportunity for Indian API manufacturers, as the Chinese API prices would start climbing up. But the question is, in which way it would evolve? In this article, I shall focus on this aspect of the new coronavirus menace, starting with a brief description of the background.

China coronavirus – when the alarm bell rang: 

According to the World Health Organization (WHO), on December 31, 2019, it was alerted to several cases of pneumonia in Wuhan City, Hubei Province of China. The virus did not match any other known virus, raising a great concern. No one knows how it affects people who are sick with it – how they can be treated, and what the countries can do to respond. One week later, on 7 January, Chinese authorities confirmed that they had identified a new virus.

What it does?

This new virus is a coronavirus, which is a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, such as Severe Acute Respiratory Syndrome, such as SARS and MERS.

Since the virus, reportedly was first detected in Wuhan in people who had visited a local seafood and animal market, it is likely to have transmitted from an animal to humans. Nevertheless, several known coronaviruses are known to be circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV) and is the seventh coronavirus known to affect humans.

W.H.O has been working with Chinese authorities and global experts to learn more about it. However, because this is a coronavirus, which usually causes respiratory illness, the world body has circulated advice to people on how to protect themselves and those around them from getting the disease.

The damage, thus far:

Bloomberg on February 02, 2020 reported the death toll from the coronavirus outbreak has risen to 305, with 14,555 confirmed cases worldwide.  The first death outside of China took place in the Philippines on February 01. Alarmingly, 2019-nCoV infections have also spread to at least 15 other countries. These numbers keep increasing.

Nearer home, India, on January 30, 2020, also announced its first case. “One positive case of Novel Coronavirus – a student studying in Wuhan University — has been reported from Kerala,” said a statement released by the Health Ministry. On February 02, 2020, Reuters reported the second case of coronavirus in Kerala.

This scenario prompted the World Health Organization (WHO) to meet again on the last Thursday and declare the new coronavirus an international public health emergency.

The impact on the pharma industry:

Responding to the criticality of this situation, health authorities across the world are trying to put in place effective ways to overcome this crisis. In the healthcare space, medical scientists are ‘racing to develop a vaccine to protect people from the virus.’ One lab in California, reportedly. has plans for a potential vaccine to enter human trials by June or July this year.

Alongside, many are wondering about the looming threat that it poses on the API sourcing from China by the global pharmaceutical industry, including India. However, as I said earlier, some Indian experts, are also sensing an opportunity for country’s API manufacturers to fill the possible void, as it gets created.

API sourcing concern:

An exclusive survey conducted by Kemiex, titled ‘Coronavirus impact analysis for APIs, feed and food additives,’ among 97 life sciences professionals, published by them on January 20, 2020, reports some interesting findings. Some of the key ones are, as follows:

  • 85 percent experts foresee API and other ingredient supply disruptions, with 35 percent expecting a high and 50 percent envisaging a low impact.
  • Orders planned for the 1st quarter with delivery in 2nd quarter are expected to be mostly affected, while disruptions might continue a quarter. Only a minority believes the disruptions will last until year end or beyond 2020.
  • The biggest impact is expected from extended Chinese New Year holidays and delayed production start.
  • A first impact analysis based on preliminary information shows that only selected products such as amino acids (taurine…), certain vitamins and other APIs and additives could be affected.
  • European and other suppliers report readiness and stocks to secure delivery to end users during interruptions in China, or some of its districts. respectively.

However, other reports also underscore, with the proliferation of the new coronavirus the incidences of confirmed infection with clear symptoms and deaths are also expected to increase. This may lead the Chinese government to extend lock down several commercially important parts of the country. Which, in turn, could impact, among others, manufacturing and shipments of API and pharma ingredients for several months.

Some green shoots are now visible in India?

Quoting a JM Financial analysis, some media reports predicted, a worsening coronavirus crisis may benefit Indian API manufacturers, as it observed some green shoots in the Indian API manufacturing space. Analyzing the stocks of six local API manufacturers – Galaxy Surfactants Ltd., Fine Organic Industries Ltd., Navin Fluorine International Ltd., SRF Ltd., PI Industries Ltd. and UPL Ltd., it found that the stocks of these companies have beaten the market trend in recent years. They observed, the robust growth of these companies was fueled by end-user industries, and exports to China – which has closed many chemical facilities on environmental concerns.

Moreover, the increase in overall API demand – caused by shortages triggered by a serious disruption of API production in China’s Hubei province, and restriction of movement within China, is likely to drive the prices up with the spread of the epidemic. The cumulative impact of all this, would possibly help the Indian bulk drug manufacturers, significantly, helping India to tide over the API sourcing crisis.

Conclusion:

‘Scientists are racing to develop a coronavirus vaccine, but it could take years to reach the market,’ as media reports highlight. Meanwhile, researchers are, reportedly, also looking at ways of quickly repurposing existing antiviral drugs to see whether any might work against the new coronavirus.

The serious health menace caused by the new coronavirus that prompted the W.H.O to signal it as a global emergency, has also raised a serious concern on API sourcing. This is because, around 80 percent of the API used by drug formulation manufacturers is sourced from China.

Looking only at this aspect of the issue, and also from the Indian perspective, the point to ponder – is it all threat? Or a veiled opportunity worth cashing-on to neutralize, at least, a part of the API sourcing threat?

Against the backdrop of the Indian Government’s announcements, such as, ‘2015 – Year of Active Pharmaceutical Ingredients’ (API), alongside the well-publicized ‘Make in India’ campaign, and some recently reported green shoots in this area – the expectation of an ‘opportunity in waiting’, could well be a reality. Who knows? But, a lurking apprehension still lingers!

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.