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India Not To Vaccinate All For Covid Control: Upsides And Unknowns

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With 9.46 million cases and 137,621 deaths, India has currently the world’s second-highest number of coronavirus infections, behind only the United States, reported Reuters on December 01, 2020.

Fathoming seriousness of rapidly unfolding Covid induced all round disruptions across the nation, on October 17, 2020, the Indian Prime Minister issued a clarion call. He called for full preparedness of the country to ensure speedy access to Covid vaccines for every citizen.

However, the above view was subsequently changed. On December 02, 2020, quoting Union Health Ministry of India, it was reported, ‘the Government has never spoken about vaccinating the entire country.’ The Director General of the Indian Council of Medical Research (ICMR) said, “the Indian government is of the opinion that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain.’ If we’re able to vaccinate a critical mass of people and break virus transmission, then we may not have to vaccinate the entire population.”

Why the PM said ‘Covid vaccines for every citizen’ at that time?

In my view, what the PM said made perfect sense at that time. This is also vindicated by a fact-based interesting discussion in The Wire on July 16, 2020, carrying a title – ‘How Effective Does a Vaccine Need to Be to Stop the Pandemic? It quoted an in-depth study concluding, “a vaccine with an efficacy as low as 60% could still stop the pandemic and allow society to return to normal. However, most, if not all of the population would have to be vaccinated.”

This research article, titled ‘Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention,’ was published in The American Journal of Preventive Medicine (AJPM) on July 15, 2020. The study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).

The PM’s observation will make even better sense, while taking into account the draft ‘Regulatory Guidelines for Development of Vaccines with Special Consideration for Covid-19 vaccine in India. This guidance document for vaccine developers was issued by the Central Drugs Standard Control Organization (CDSCO), and was reported by the media on September 23, 2020. It also says, among other specifics, a COVID-19 vaccine candidate should show at least 50 per cent efficacy during phase III of clinical trials for it to be widely deployed.”

Why health ministry’s current plan of not vaccinating all, also makes sense:

Indian Health Ministry’s latest assessment that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain,’ also makes sense in the rapidly emerging contemporary scenario.

It makes sense, considering, even the World Health Organization (WHO) experts have, reportedlypointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity, based on scientific reasons. This raises the subsequent question of who in India will get priority for vaccination.

The priority group for Covid vaccination in India:

As reported on November 26, 2020, according to the Principal Scientific Advisor of India, about 300 million people will be part of the first ‘wave’ to receive Covid vaccines in India. This number includes, health care workers, totaling 30 million, police personnel and those above 50 and those younger with underlying illnesses that make them vulnerable. However, everything in this area doesn’t seem to be as clear or straight forward as is widely expected. India’s Covid vaccination plan still seems to be a work in progress.

India’s Covid vaccine plan is still a work in progress:

This is evident from many reports, such as one of December 01, 2020. This report says, experts still believe that the government should spell out whether the vaccination should be confined to only uninfected individuals or encompass everyone. These reports may vindicate the murmur in the corridors of power that many details of Covid vaccination in India are yet to crystallize.

Let me quote the Indian Prime Minister in this regard, as he is not only the head of the current Government, but is also the national voice on all contemporary issues in the external world.

Interestingly, on November 24, the Prime Minister himself acknowledged: ‘Will go by scientific advice on Covid vaccine, don’t have many answers yet.’ He made it clear that he did not yet have answers to:

  • Vaccine dosage
  • Pricing or sourcing

Although, his Government has been in touch with local and global vaccine developers, nations and multilateral institutions to ensure vaccine procurement, the PM added.

Curiously, unlike what the Principal Scientific Advisor of India, reportedly articulated on November 26, 2020, just a couple of days before that, on November 24, 2020, the PM has put it quite differently.He then said, priority groups for vaccine administration would be fixed based on state inputs and added that additional cold storage must be created by states. These confirm, India’s final plan on Covid vaccination is still a work in progress.

The Covid vaccination plan is still evolving in India:

Interestingly, on December 04, 2020, in an all-party meeting chaired by the Prime Minister, it was further announced - the first set to receive the Covid -19 vaccine will be about one Crore frontline health workers and the next will be two Crore armed forces, police, and municipal personnel. Besides, around 27 Crore senior citizens, too, would be receiving the vaccine. Thus, the Government’s vaccination plan seems to be still evolving. Meanwhile, something sensational happened in the global race for having a Covid vaccine for a country’s population.

Curiously, much before the commencement of Covid vaccine prioritization discussion in India, on September 14, 2020, it was reported that China is also not going for its entire population. They are prioritizing frontline workers and high-risk populations in its fight against the new Coronavirus.

The first emergency-use authorization for a Covid-19 vaccine happened:

On December 02, 2020, both the local and global media, such as The Wall Street Journal (WSJ) reported: ‘The U.K. became the first Western nation to grant emergency-use authorization for a Covid-19 vaccine, clearing a shot developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to be distributed in limited numbers within days.’

In the war against Covid pandemic, it also marks a key milestone in efforts to translate a promising new vaccine technology into a widely available shot, the report highlighted. It was developed, tested and authorized and is now poised to be distributed amid a pandemic that has sickened tens of millions of people and killed more than 1.4 million around the world, the news article added.

Interestingly, the U.K could make it happen, even before the United States, where this vaccine is now being reviewed by the USFDA, where a similar authorization could come later this month and a rollout before the end of the year. It’s noteworthy that the USFDA Commissioner has defended the pace of review of Pfizer’s COVID-19 vaccine on the grounds that a thorough assessment is needed to reassure a skeptical public.

NIAID director of the US also believes so, and has claimed, “We have the gold standard of a regulatory approach with the FDA.” This brings us to the question – will Pfizer’s Covid vaccine be available in India soon?

Will Pfizer’s Covid vaccine be available in India soon?

Just a day after U.K’s emergency approval of Pfizer’s Covid vaccine to be rolled out to the public early next week, Pfizer, reportedly, said, the Company is in discussions with many governments around the world, and “… will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval.”

However, as reported on December 06, 2020, Pfizer has now sought approval from the DCGI for emergency use authorization of its Coronavirus vaccine. In its application dated December 4, Pfizer India has sought approval to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.”

It’s worth noting, conducting Phase III clinical trials on Indian volunteers has, so far, been a pre-requisite for the DCGI to give authorization to a particular investigational Covid vaccine. For example, AstraZeneca-Oxford vaccine is, reportedly being tested in a phase-3 trial on over 1,600 subjects in India by Serum Institute. So is the Sputnik V, developed by Russia, and touted as the world’s “first registered Covid-19 vaccine” after it received Russian regulatory approval in early August 2020.

Further, the head of the Indian National Task Force on COVID-19, had also said the arrival of the Pfizer vaccine in India might take some months. This is, reportedly for two reasons. One, the vaccine has stringent temperature requirements (-75 degree Celsius), which make it unviable for the current cold-chain logistics in India. And the second, could possibly be, its Indian clinical trial requirements, as has been the practice of even Russia approved Sputnik V vaccine.

Thus, it appears, India is now looking at the vaccines being developed by Oxford-AstraZeneca or Bharat Biotech against the pandemic, as these are expected to complete clinical trials and seek a regulatory approval at an early date.

Upsides and unknowns of the current status of Covid vaccines in India:

Along the obvious upsides, such as – not all in the country needs to be vaccinated and, at least, one Covid vaccine is widely expected to come shortly that is being manufactured in India, there are several critical unknown factors, too. For example, apace with several similar articles, the research paper titled, ‘Will covid-19 vaccines save lives? Current trials aren’t designed to tell us,’ published in The BMJ on October 21, 2020, also raised this issue.

It pointed out: “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.” Yet the current phase III trials are not actually set up to prove either, it emphasized. None of the trials currently underway are designed to detect a reduction in any serious outcome, such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

Conclusion: 

As of December 06, 2020 morning, India recorded a staggering figure of 9,644,529 of new Coronavirus cases with 140,216 deaths. The threat of subsequent waves for further spread of Covid infection now looms large in many states. The Prime Minister of India is also intimately involved in search of a meaningful solution to end the pandemic.

In this scenario, that a Covid vaccine is coming so soon, is a very good news, undoubtedly. There are several obvious upsides of this development, alongside many critical unknown areas, including how long the immunity will last after administration of a Covid vaccine. Incidentally, ‘Moderna vaccine-induced antibodies last for 3 months’ says NIAID study. Even in India a ‘Minister tested positive after the first dose of vaccine.

I am sure, the right answers will surface as the research will progress. Meanwhile, there doesn’t seem to be any other alternative sans vaccines, to kick start the globalized world – for a holistic and inclusive long-term progress, economic prosperity and, if not survival with dignity, for all.

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.

Combating Covid Pandemic: When ‘Something Is Better Than Nothing’

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As the new Coronavirus overwhelms the world, since its global outbreak, up until November 29, 2020, over 1,458,305 people have died from this pandemic. Understandably, the Governments in all countries are frantically searching for some robust remedial measures to prevent these unfortunate deaths, besides protecting livelihoods of a vast majority of people.

For this purpose, experts considered effective preventive measures, such as vaccines could help taming this menace, alongside existing personal prevention measures. Accordingly, scientists around the world, have are hard to accelerate development and manufacturing of safe and effective Covod-19 vaccines, within the prescribed guidelines. Equally important is the fact these vaccines must be safe with predictable effectiveness- for all age groups.

The good news is, vaccines are now a distinct possibility in the near future, with the positive interim Phase III clinical trial reports pouring in. It gets reflected in the remark of the Director General of the World Health Organization (WHO), on November 23, 2020, at the media briefing on Covid-19. He said: There is now real hope that vaccines – in combination with other tried and tested public health measures – will help to end the pandemic.

Interestingly, amid these reports, a lurking fear of many experts also surfaces – on the impact of possible side effects, that Covid vaccine may cause, besides their medium to long term efficacy in human subjects. But, with the mounting number of deaths, near collapse of the global economy, including India, there isn’t any more time to watch and wait.

Apparently, all governments now want some scientifically relevant vaccines, instead of nothing. This article will deliberate on the one hand – an unprecedented achievement, alongside some critical concerns – voiced even by the Indian Prime Minister. Let me begin with the apprehensions, as expressed by some domain experts on some rough edges, as it were, in the process of its development.

Queries on vaccine dosing, efficacy, safety and testing:

On November 23, 2020, AstraZeneca and Oxford reported interim results of their vaccine with the average efficacy of 70% prevention. This sounded good to many, as it falls within the expectations of above a 50% standard that the FDA had set for Covid vaccines. However, the puzzling part in this result was – bigger (standard) doses of the vaccines were less efficacious. The vaccine was only 62% effective in a group that got two full doses spaced about a month apart. But among about 2,700 people who got a half-dose followed by a full, the number rose to 90%, the report highlighted. This incident prompted several questions about the most effective dose of AstraZeneca and Oxford vaccine, including its safety record and the approach to testing. Consequently, apprehensions surfaced whether the Drug regulators will clear it, based on the currently available data.

It now appears, AstraZeneca ‘s Covid-19 vaccine is ‘headed for an additional global trial as the drug maker tries to clear up the uncertainty and confusion surrounding favorable results in its current study.’ Incidentally, in India - AstraZeneca and Oxford vaccine will be manufactured by Pune-based Serum Institute of India (SII) under a collaborative arrangement. Let me now dwell on a broader as aspect in this space.

Could current Covid vaccines become useless in the future?

There isn’t an iota of doubt that developing Covid vaccine in ten months, which otherwise takes around ten years – is an unprecedented achievement. However, there are several other important areas in this space, where pundits have expressed uneasiness through various articles.

One such paper is titled, ‘Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees,’ published in the Nature on March 16, 2020. According to the author, a critical point in this regard is to consider ‘the potential for emerging and re-emerging Coronaviruses to cause future outbreaks.’

This is because, ‘the virus behind COVID-19 might mutate in ways that would make previously effective vaccines and antivirals useless.’ Testing vaccines and medicines without taking the time to fully understand safety risks, could bring unwarranted setbacks during the current pandemic, and into the future. ‘Despite the genuine need for urgency, the old saying holds – ‘measure twice, cut once’, the author commented.

The article concluded by suggesting, ‘any regulatory agency considering ways to accelerate treatments into testing should also weigh up how likely these drugs are to work beyond this particular Coronavirus.’ Moreover, according to the WHO, it’s too early to know if COVID-19 vaccines will provide long-term protection.

Possible side-effects of COVID-19 vaccines:

As people’s hopes swell, expecting Covid vaccines to ultimately end the deadly global pandemic, experts caution about their reported – annoying and unpleasant side effects. The November 12, 2020 paper – ‘Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes,’ published by the Kaiser Health News (KHN), also articulated similar apprehension.

It said, most Covid vaccines, including much publicized ones from Pfizer and Moderna, will require two doses to work, injections that must be given weeks apart, as company protocols show. Scientists anticipate the shots will cause enervating flu-like side effects — including sore arms, muscle aches and fever — that could last days and temporarily sideline some people from work or school.

Even with the Pfizer vaccine, which is touted to be over 90% effective, 1 in 10 recipients would still be vulnerable. There could also be a possibility that a vaccine may not suit everyone due to side-effects, especially the most vulnerable elderly population. That means, at least in the short term, as population-level immunity grows, people can’t stop social distancing and throw away their masks, the report emphasized. Even Prime Minister Modi has informed the nation about possible side effects of Covid vaccines.

PM Modi also warns of possible vaccine side-effects:

Being adequately briefed on the above perspectives related to Covid vaccines, the PM has also warned the nation about the possible side-effects. This is probably to ensure that the unpleasant experience of side-effects, after being administered the first dose, do not catch the population off-guard. Mostly because, no one should miss the second dose of vaccine for the same.

He said, during a recent video conference with the state chief ministers, ‘like many other popular medicines, any COVID-19 vaccine could lead to side-effects in some people.’ Emphasizing that both speed and safety are equally important in launching a vaccine, he assured that ‘the government would only go by science in finalizing a vaccine for the country.’

Is something better than nothing?

In the current situation, it appears so, as there is no other alternatives, except maintenance of social distancing, frequent hand sanitizing and wearing masks while outdoors. The Prime Minister also articulated sans any ambiguity: ‘Whatever vaccine makes it through the world’s certified processes, we will have to accept them and move ahead.’

In the meantime, he urged the states to keep distribution infrastructure, such as cold storages ready, the report said. Interestingly, according to Serum Institute CEO Adar Poonawalla, India could approve the emergency use of the Oxford-AstraZeneca COVID-19 vaccine by December 2020.

That said, for mass vaccination of the population across India, another factor that is extremely important to decide which vaccine to go for – is the required storage temperature of various Covid Vaccines under development.

Required cold chain storage temperature of various Covid vaccines:

Required cold chain storage temperatures of various Covid vaccines are as follows:

Company

Type

Doses

Effectiveness*

Storage
Oxford-AstraZeneca Viral Vector (genetically modified virus) Two 62-90%** Regular fridge temp.
Moderna RNA (part of virus genetic code) Two 95% -20C up to six months
Pfizer-BioNTech RNA Two 95% -70C
Gamaleya (Sputnik V) Viral Vector Two 92% Regular fridge temp.

Source: Respective Companies, WHO – BBC News. *Preliminary Phase III results. **Two full doses: 62%, A half dose followed by a full dose: 90%, Average: 70%

From the above table, it appears, from the perspective of continuous cold chain storage facility of vaccines – till these are administered to each person, Oxford-AstraZeneca and Russian Sputnik vaccines will be more practical, despite issues with them. Viewing from this perspective, as well, it appears ‘something is better than nothing’ term can be applied in this area, as well.

Conclusion:

The Covid pandemic continues to worry India, immensely. As on November 29, 2020 morning, India recorded a staggering figure of 9,393,039 of Coronavirus cases with 136,733 deaths. The threat of subsequent waves for further spread of Covid infection now looms large in many states.

Unprecedented speed in developing vaccines to effectively combat Covid Pandemic has created some initial issues. Some of these Covid vaccine challenges include, vaccine side effects, its future usefulness, or challenges towards maintaining required stringent cold chain storage requirements, especially in a country like India. Powder version of Covid vaccines, in the future, would possibly resolve this issue for all countries, across the world.

Currently, in tandem with keeping the cold-chain distribution infrastructure ready, at least, for vaccines that require regular fridge temperature, there is a need to make people aware of Covid vaccine side-effects. Otherwise, after getting first shot of a Coronavirus vaccine, many people may get so scared of its side effects that they may not come back for the second dose. If this happens, the very purpose of mass vaccination will get defeated.

However, from the Indian perspective, Covid vaccines that the country, hopefully, will shortly get, may not be the best, out of the available ones, in terms of safety and efficacy. But, for combating Covid Pandemic across India at this juncture, I reckon, the good old dictum still holds good – ‘something is better than nothing.’

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.

 

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

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In the ‘perfect world’ one takes ‘perfect decisions’, while in the ‘real world’ one takes a ‘real decision’ – as the saying goes. In tandem, a raging debate continues on what is ‘perfect’ and what is ‘real’, in the world we live in today. This may cause a dilemma to many, which seems to be all pervasive today. Understandably, many critical industry practices and processes are also a part of this quagmire. The pharma industry, the world over, including India, is no exception, where such dilemma and debates span across virtually all the business domains of the industry.

However, in this article, I shall focus only on one specific issue – alleged pharma marketing malpractices that continue unabated, regardless of severe punitive measures in many cases, from several parts of the world. Has it then become a universal ‘culture’ in this area? For greater clarity, let me start the ball rolling by trying to understand the line that differentiates ‘the perfect world’ norms from ‘the real world’ ones.

Understanding the ‘line’ between the ‘Perfect World’ and the ‘Real World’:

I reckon, in ‘the perfect world’ people develop ideal values, ethical standards and practices. The social, business and economic environments also encourage and promote an uncompromising value system that culminates into perfect and desirable behavioral traits for all. Consequently, there are no grey areas in the ethics and value judgement, especially regarding what is ‘right’ and what is ‘wrong’.

Whereas, in ‘real world’, the surrounding social, business and economic environment usually encourages and promotes self-serving interests, mostly from the shelter of ‘perfect world,’ as we shall see later. There also appears to be a flexibility in the overall value system – drawn around different guidelines, for preferred behavior and practices in most spheres of life. Consequently, one can spot many grey areas in that space, which are subject to different interpretation by different people. ‘Exceptions’ to the preferred behavior are also many.

As construed by many, one contemporary and broad example could perhaps be, the ethics, values and governance – enshrined in the Indian Constitution, arguably belong to the ‘perfect world.’ The same for ‘the real world’ is, what the majority of the population, including those who are governing the country demonstrate through words, deeds and action on the ground.

Living in ‘the real world’ – most expect others to practice ‘the perfect world’ norms:

Although, most people, including several different entities, actually prefer to live in ‘the real world,’ following commensurate practices and exceptions – generally expect others to practice ‘the perfect world’ norms – following commensurate ethics and values. Governments usually, try to exhibit that they want all citizens to be in ‘the perfect world’. However, under pressure of different nature, their policy enforcement arms keep maintain the status-quo of ‘the real world.’

Let me illustrate this point from the Indian perspective, with some recent examples related to the prevailing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the country. Here itself, we shall find, even the Government machinery vacillating between the both worlds.

Government vacillating between ‘both worlds’:

A recent media report related to the ongoing allegation on pharma marketing malpractices in India raised a controversy. It reported, on January 13, 2020 – ‘PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets,’ during his meeting with the senior officials from top drug-makers. This move was, reportedly, triggered by the report of “Support for Advocacy and Training to Health (SATHI)” – an NGO.

Prior to this, on May 03, 2018, it was also widely reported, “Prime Minister Narendra Modi recently opened a Pandora’s box by condemning the allopathic doctors of the country during an interaction called ‘Bharat ki Baat, Sab ke Saath’ with the diaspora in London. The PM condemned the Indian doctors on charges of corruption and malpractice. He emphasized on the doctor-industry nexus and shared concerns on the fallout of such a relationship.”

The above statements, as reported, reflect deep anguish of the Prime Minister for violation of ethics and values in pharma marketing practices – as expected in the ‘Perfect World.’ Following this outburst at the top echelon of the country’s governance hierarchy, the logical general expectation is, commensurate action by the Department of Pharmaceuticals (DoP), at least, to contain those contentious practices.

But, the Government seems to be vacillating: 

Instead, just after a few weeks from what was quoted in the above January 2020 report – on February 09, 2020 another media report highlighted something that confirms vacillation of the Indian Government from ‘the perfect world’ to ‘the real world’, albeit too frequently, on this issue.

Despite UCPMP being in force for all drug companies to abide by, voluntarily, since January 2015, the situation in this area hasn’t improved a bit, which the DoP also seems to be well aware of. The obvious question, therefore, that follows: Is the DoP on the same page as PM Modi?

Interestingly, despite the PM’s assertion in this regard, the DoP Secretary, reportedly, kept playing the same old tune even after 5 years of the UCPMP’s unsuccessful implementation. He again repeated: “We have strictly instructed all the stakeholders to follow the code voluntarily. If not complied seriously, the department will bring in stricter regulations at the time to come and also think about making it mandatory for effective compliance.” This threat, from the ‘perfect world’ perspective, continues with the ‘real world’ understanding for action.

The possible reason for the above vacillation:

Many consider, intense lobbying by the pharma associations as the possible reason for vacillation of the Government. This is vindicated by another report of January 17, 2020 that claimed, a powerful Indian industry association has sought multiple tweaks in the current UCPMP – meant for voluntary implementation by the drug industry in India. Two of these, among several others, were reported as follows:

  • Relaxed rules for the distribution of free samples.
  • Permission for doctors to work at pharmaceutical companies.

As reported, this proposal of the industry has been floated among pharmaceutical companies, for comments. ‘Once approved by all member companies, it will be sent to Department of Pharmaceuticals secretary P.D. Vaghela.’ However, it appears, there doesn’t seem to be anything new in it, as news archives reveal, similar proposals were submitted by the Indian drug industry associations, in the past, as well.

At this stage, let me hasten to add that the above January 2020 report, quoting the Indian PM’s anguish, was denied by a domestic industry association by a statement.

The first report was denied – albeit vaguely – by an industry association:

Curiously, the January 2020 report was denied by the domestic Industry Association - Indian Pharmaceutical Alliance (IPA) by releasing a statement. It said, the meeting convened by the Prime Minister Narendra Modi with the healthcare industry on January 01, 2020 was to discuss future road map for growth of the industry.

It further emphasized, the focus of the discussion was to promote research and development, build an innovation ecosystem, improve access to high-quality medicine and strengthen global competitiveness of the industry. The purpose was to take the industry to the next level and leverage opportunities going forward in the pharmaceutical sector. “There was no discussion on uniform code of pharmaceutical marketing practice in the meeting,” the statement added.

However, this statement appears rather vague to many, as it doesn’t emphatically deny that the PM did not say or mean those words, regardless of the context. Neither, the PMO, reportedly, has done so, as yet.

Probably because of this reason, another news article reported on January 15, 2020 that the Indian Medical Association, the country’s largest body of doctors, urged Prime Minister Narendra Modi to “prove, deny, or apologize (for)” the purported statement attributed to him asking pharmaceutical companies ‘not to bribe doctors with foreign trips, gadgets and women.’ I am still not aware of any response from the PMO on the same. Hence, some people find the industry association’s statement, especially considering the core issue under discussion today, albeit vague.

Some key findings on UCPMP:

Be that as it may, as I indicated in one of my previous articles in this blog, a survey report by Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, was released in September 2011 on the UCMP and MCI guidelines. It highlighted some of the following points:

  • More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
  • Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
  • 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal control system to ensure compliance with the UCPMP.
  • 72 percent of the respondents felt that the MCI did not stringently enforce its medical ethics guidelines.
  • Just 36 percent of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies.

Although, this report may be a bit dated, its key findings don’t seem to have changed much as on date. It is also worth noting that there are umpteen examples of similar malpractices in the pharma industry, globally.

Conclusion:

“Compared to a strictly controlled manufacturing environment, the marketing environment for the pharmaceutical industry in India is less regulated, but will move towards greater regulation in times to come”, predicted ‘The Global Guide to Pharma Marketing Codes,’ a few years ago. The situation remains unchanged.

Alongside controversy over pharma firms allegedly ‘bribing’ medical professionals, the Alliance of Doctors for Ethical Healthcare (ADEH), a network of doctors from across the country has demanded that the UCPMP framed five years ago be made mandatory, as another media report highlighted on January 21, 2020.

But the reality is, the Government wants the drug industry to follow ‘the perfect world’ ethics and values in marketing practices to safeguard patients all round interest. Whereas, the drug industry wants the policy makers to appreciate the business compulsions of ‘the real world’ and introduce exceptions to the rules.

Both the stances are unlikely to meet a common ground, because general population expects the Government to adhere to ethics and values of ‘the perfect world’, in health care. Whereas, in public, pharma industry leaders often take vows of practicing so, but seem to act differently in ‘the real world’ situation, expanding the credibility gap.

In the perceivable future, it appears unlikely that the Government’s ‘perfect world’ expectations, and the ‘real world’ actions of most pharma players will be in sync with each other. Unless, of course, either the Government moves away from ‘the real world’ marketing ethics and values – safeguarding patient interest, to meet ‘real world’ expectations of the industry, or make pharma players to fall in line with ‘the perfect world’ expectance, by making the UCPMP mandatory.

Is the question, therefore, how to take a ‘perfect world’ decision for the people’s health interest, in the ‘real world’ of the pharma industry? Till this issue is resolved, UCPMP will continue to exist, but no more than a ‘toothless tiger’, as it were.

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.

 

 

Deadly Climate Change Impact On Human Health: How Prepared Is India?

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It’s not uncommon to find many people, including heads of countries, expressing their serious apprehensions in public, about the scary impact of climate change. Just the last year, on November 26, 2018, BBC News captured one of such incidences with the astonishing headline: “Trump on climate change report: I don’t believe it.” The findings of this report have underscored, ‘unchecked global warming would wreak havoc on the US economy.’

Similarly, a few years ago, on September 05, 2014,CNN News 18 quoted Prime Minister Narendra Modi as saying: “Climate has not changed. We have changed. Our habits have changed,’ while answering to a question on climate change. Regardless of the outcome of any split-hair analysis of the rationale behind such statements from the world leaders, such public discourse could trivialize the possible catastrophic impact of climate change on the planet earth.

Be that as it may, that climate change is taking place, carrying all its ill-effects, is real now, without any ambiguity. There is also widespread consensus among the members of the United Nations that ‘the Earth is warming at a rate unprecedented during post hunter-gatherer human existence.’

It is worth noting that way back in 2001, the ‘Third Assessment Report of the Intergovernmental Panel on Climate Change’, further recorded: “There is new and stronger evidence that most of the warming observed over the last 50 years is likely to be attributable to human activities”, most importantly the release of greenhouse gases from fossil fuels.

Several ‘International Agreements’, including the Paris Agreement on Climate Change - all supported by hard scientific data, have called for immediate, quantifiable measures in each country to address the ‘wide-ranging environmental threats, such as ozone depletion and long-range transboundary air pollution.’ Against this backdrop, in this article, I shall focus on the dreadful effect of climate change in the proliferation of a wide-variety of ailments, especially infectious diseases, within a few decades. While doing so, let me first have a quick recap on what is ‘Climate Change’, in a simple language.

Climate Change – a quick recap:

According to the United Nations, ‘Climate Change is the defining issue of our time and we are at a defining moment. From shifting weather patterns that threaten food production, to rising sea levels that increase the risk of catastrophic flooding, the impacts of climate change are global in scope and unprecedented in scale. Without drastic action today, adapting to these impacts in the future will be more difficult and costly.’

It’s important to note, although, the planet Earth’s climate is constantly changing over geological time, the current period of warming is occurring more rapidly than many past events. Scientists are concerned that the natural fluctuation or variance, is being overtaken by a rapid human-induced warming, as they emit more greenhouse gases. As these gases get trapped in the atmosphere, more heat is retained that has serious implications for the stability of the planet’s climate, even impacting human health with grave consequences. The World Health Organization (W.H.O) has also warned that the health of millions could be threatened by increases in malaria, waterborne disease and malnutrition.

Its impact human health:

The direct and indirect impact of climate change on human health is profound. Before I go into the specifics, let me indicate some of the direct ones, as captured by the Center for Health and the Global Environment (CHanGE), University of Washington. This is sans any charts and maps, unlike the usual practice:

  • Increasing temperatures are causing poor air quality that can affect the heart and worsen cardiovascular disease.
  • Increasing exposure to pollen, molds, and air pollution, all of which can worsen allergies and other lung diseases, such as asthma.
  • Changes in the geographic range of disease-carrying insects, such as mosquitoes, ticks, fleas and other similar ones, which can fast spread many tropical ailments, such as dengue fever and malaria to humans.
  • Increasing frequency and severity of extreme weather and climate events can cause, besides many physical illnesses, several kinds of mental illnesses – increasing both morbidity and mortality.
  • Frequent flooding events and sea level rise can contaminate water with harmful pathogens and chemicals, potentially causing food-borne and waterborne illnesses.
  • Changing weather patterns affect the quality and quantity of nutritious foods with increasing incidence of under-nutrition and micronutrient deficiencies.
  • Additional stress placed on hospital and public health systems, could limit people’s ability to obtain adequate health care during extreme weather events and disease outbreaks.

Most specific and the deadly one:

The World Health Organization (W.H.O) publication - ‘Climate change and human health – Risks and Responses,’ clearly flagged that ‘Changes in infectious disease transmission patterns are a likely major consequence of climate change.’

Citing a pertinent analogy to explain the reason, it said: “Humans have known that climatic conditions affect epidemic diseases from long before the role of infectious agents was discovered, late in the nineteenth century. Roman aristocrats retreated to hill resorts each summer to avoid malaria. South Asians learnt early that, in high summer, strongly curried foods were less likely to cause diarrhea.”

Would pharma players convert these problems into opportunities?

Curiously, some pharmaceutical investors are researching to fathom potential business opportunities lying underneath the above problem, especially for vaccines and newer antimicrobials. It’s probably a blessing in disguise not just for the drug companies, but also for the general public, considering the following two issues, prevailing in the current scenario:

  • According to W.H.O, Antimicrobial Resistance (AMR) is an increasingly serious threat to global public health. It threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi, causing the success of even major surgery and cancer chemotherapy seriously compromised.
  • ‘Pharmaceutical companies are backing away from a growing threat that could kill 10 million people a year by 2050’, reported a July 19, 2018 article. This is because, ‘Antibiotics Aren’t Profitable Enough for Big Pharma to Make More,’ wrote another article, published in Bloomberg Businessweek, on May 3, 2019.

Interestingly, a recent report analyzed and evaluated how this can be done, and which companies will be benefitted most in that process. 

“Climate change to fetch a big business opportunity for pharma”:

As reported on July 25, 2019, Morgan Stanley told investors that climate change will cause an increased prevalence and rapid spread of infectious diseases that may be a boon for some drug companies with big vaccine portfolios. It also highlighted, between 383 million and 725 million more people may be exposed to Zika, dengue and other diseases by 2050, depending on the pace and severity of global warming.

The analysts estimated, especially 7 pharma companies will be critical to fighting infectious diseases brought on by climate change. According to the research note of thebank, ‘the USD 500 billion infectious disease market could see demand for an added USD 125 billion in new vaccines, or as much as USD 200 billion assuming premium pricing for more complex new treatments.’

The top possible gainers:

Identifying the top possible gainers, Morgan Stanley apprised, vaccine development being more difficult and expensive, companies that are already in that business will have an upper hand.

Hence, Sanofi and GlaxoSmithKline are expected at the top, given their existing pipelines and manufacturing capacity. Takeda and Merck both have vaccines in the works for dengue fever, one of the diseases that climate change is likely to exacerbate. Janssen and Pfizer are both active in the vaccines market, but would need to establish new research programs to take on tropical diseases. ‘Moderna’ is also in a good position because it has demonstrated a potential pipeline for drugs combating the Zika virus., as Morgan Stanley further elaborated.

Nevertheless, Morgan Stanley isn’t the only bank looking at investment opportunities from climate change, on July 24, 2019, Goldman Sachs also, reportedly, said it was hiring a sustainable-finance group that is looking into issues related to sustainability. Thus, on the positive side, climate change could fetch a big business opportunity for many pharma players, across the world.

600 million people at risk for climate change in India:

On June 24, 2019, a reputed national business news daily of India reported, “600 million people at risk: Climate change may soon turn critical in India.” Against this threat, the current public health care infrastructure in the country, continues to remain fragile, as stated in India’s National Health Profile, 13th Issue.

It also states, the cost of treatment has been on the rise in India and it has led to inequity in access to health care services. Intriguingly, the country spends around 1.02 percent of its GDP towards public health, which has remained static to declining over a long period of time. Although, health insurance is a growing segment, it hasn’t taken off fully. Several measures are needed to improve and expand insurance coverage.

Further, according to the report by the Center for Disease Dynamics, Economics & Policy (CDDEP) in the US, India is facing shortage of 600,000 doctors and 2 million nurses. This report was widely quoted by the Indian media, on April 14, 2019.

These facts give a perspective on what is India’s level of preparedness to address the critical health issues related to climate change, especially the havoc that the dreaded infectious diseases can cause to so many.

Conclusion:

Astute health policy makers, including a large section of the top political echelon of the country are, apparently, aware of various ill effects of climate change. They also seem to be cognizant that these are likely to accelerate the worsening health problems of the population, including infectious diseases, asthma and other respiratory diseases.

Assuming, new and modern drugs will keep coming to help treat these ailments, do we have a functioning and efficient public health infrastructure to grapple with such issues. What about high out of pocket expenditure towards healthcare for a large section of the population, regardless of Ayushman Bharat?

As the (W.H.O) publication - ‘Climate change and human health – Risks and Responses’ recommended, ‘early planning for health is essential to reduce, hopefully avoid, near future and long-term health impacts of global climate change. The optimal solution, however, is in the hands of governments, society and every individual—a commitment to a change in values, to enable a full transition to sustainable development.’

That said, as India is also a signatory to the latest Paris Agreement on Climate Change, can we assume, India will walk the talk to significantly contain its deadly impact on human health? How is India preparing itself to meet this great challenge of Probably it is anybody’s guess, at least, as on date?

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.

Why D&I Is A Powerful Growth Driver For Pharma Industry

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‘Diverse India’ now needs an ‘inclusive society’, vowed the Prime Minister of India, after his massive electoral win on May 23, 2019. Many may consider a part of it as rhetoric, notwithstanding, as and when the government policy of Diversity and Inclusion (D&I) gathers wind on its sail, the realization of its importance would reverberate – even in the corporate world, including the pharma industry, especially in India.

I discussed this subject in my article of June 25, 2018 ,in the context of transforminga pharma company to a customer-oriented, profit-making organization, with implementation D&I within the organization. However, in this article, I shall deliberate, over and above, the current status of D&I in the pharma industry, why most drug companies are still not leveraging it as one of the powerful business growth drivers. While opening this discussion, let me recapitulate what these two words mean to us, and their importance in the drug industry.

Recapitulating D&I:

As there are several, but similar definitions of D&I, I am quoting below just one – from the Ferris State University. It goes, as follows:

  • “Diversity is the range of human differences, including but not limited to race, ethnicity, gender, gender identity, sexual orientation, age, social class, physical ability or attributes, religious or ethical value system, national origin, and political beliefs.”
  • “Inclusion is involvement and empowerment, where the inherent worth and dignity of all people are recognized.”

The relevance and importance of D&I as a corporate growth policy for the drug industry is immense. It will not just, help them recognize and create business policies, based on diversity in people – a wide range of human differences in their consumers or potential consumers. In tandem, it will also help promote, and sustain a sense of belongingness with the society and communities where it operates – their values, beliefs, expectations and desire for a healthy living.

D&I begins within the company, and for the customers:

There are clear indications that many pharma companies are slowly, but surely realizing that for a consistent and sustainable financial performance the whole approach to business needs to undergo a metamorphosis. One such area of transformation, is a sharp focus on effectively satisfying a set of well-defined expectations of both their external and internal customers.

This journey begins with the creation of a Diverse and Inclusive (D&I) workplace. Nevertheless, the key goal remains – meeting expectations of the society where the drug companies operate, including a diverse set of customers – by saving and improving their quality of life, with affordable and accessible medicines.

While talking about diversity to Business Insider on January 10, 2018, GlaxoSmithKline CEO Emma Walmsley also reiterated, for a future facing employer in an industry, D&I should be a priority corporate strategy – for aggressively modernizing the business.

D&I ‘may be most important in the health care industry’:

This has been well-articulated even in the Workforce – a multimedia publication, where it says: D&I ‘may be most important in the health care industry, where the workforce needs to be both business savvy and socially empathetic to serve their increasingly diverse communities.’

Quoting another CEO, a different article titled, ‘Diversity and inclusion in the pharma industry’, published in PMLiVE on June 27, 2018, emphasized: ‘The global Biopharma industry is one of the most powerful and important industries today, directly affecting the lives of billions of people around the world on a daily basis. In order to understand and meet the critical unmet medical needs of patients, the industry must represent the population it serves.’

D&I is a growth driver for an organization:

“Many successful companies regard D&I as a source of competitive advantage. For some, it’s a matter of social justice, corporate social responsibility, or even regulatory compliance. For others, it’s essential to their growth strategy.” This was highlighted in the January 2018 research paper of McKinsey titled, ‘Delivering through Diversity.’

The article further elaborates: ‘D&I is a powerful growth strategy for an organization because it creates ‘a diverse and inclusive employee base – with a range of approaches and perspectives – would be more competitive in a globalized economy.’

Importantly, this research established a statistically significant correlation between greater levels of diversity and inclusion in company leadership and a greater likelihood of outperforming the relevant industry peer group on a key financial performance measure – profitability.

Some drug companies are moving in this direction:

That some drug companies are gearing up to adopt this growth strategy, but still there is a lot of ground to cover in this area, gets reflected in the December 2018 ‘Diversity & Inclusion Benchmarking Survey’ of PwC. The survey included 183 corporate respondents from 5 regions and 15 countries. As many healthcare organizations have publicly declared their commitment to D&I, the study wanted to measure how they have translated strategy into execution and what impact it is leaving on the employee experience. The following are some of the key findings

  • While D&I is a stated value or priority area for 68 percent of organizations, only 51 percent of respondents disagree that diversity is a barrier to progression at their respective companies. Thus, ‘Diversity still remains a barrier to progression.’
  • Only 4 percent of healthcare organization’s D&I programs reach the highest level of maturity.
  • D&I program goals are quite varied. For about 38 percent it’s a way to attract and retain talent – 25 percent – a way to comply with legal requirements – 17 percent to achieve business results – 13 percent to enhance the external reputation and 8 percent to respond to customer expectations.
  • Interestingly, in 39 percent of cases there was no D&I program-leader in place, 32 percent cases the person reports to senior executives, 19 percent of cases the responsibility was assigned to staff with non-D&I responsibilities and only in 10 percent of cases – the leader is a peer to C-suite.
  • Only 29 percent leaders are tasked with specific D&I goals.

These may not be the points to cheer about – not yet, nonetheless, the survey findings send a clear signal about the beginning of D&I in the pharma industry.

Two facets of D&I for a pharma company:

As I said before, D&I is more important in the health care space, especially for drug companies, where the employees across the organization not just be business savvy with patient orientation, but also be inclusive and socially compassionate to benefit the diverse communities.Thus, there are two clear facets, I reckon, around which organizational D&I policies, especially for pharma players, should be formulated, as follows:

  • For employees within the organization.
  • For stakeholders outside the organization – putting patients at the core of the business strategy.

The above PwC survey is on the first one – D&I for employees within the organization. However, a holistic D&I policy requires dovetailing business savviness with a socially empathetic mindset to serve increasingly diverse communities, is even more challenging.

More challenging is dovetailing business savviness with social empathy: 

To serve increasingly diverse communities, dovetailing business savviness with socially empathetic mindset, appears to be more challenging for the pharma industry, in general. Its manifestations are varied, such as, dented image or its declining reputation – leading to trust deficit with many stakeholders, including patients. Likewise, one of primary causative factors that give rise to such manifestations is considered to be in the drug pricing area.

The current scenario in this area has been captured in a paper titled, ‘Curbing Unfair Drug Prices’, published by The Yale Global Health Justice Partnership (GHJP), Yale Law School, Yale School of Public Health, National Physicians Alliance and Universal Health Care Foundation of Connecticut. The article unambiguously states, the high cost of prescription drugs is unsustainable, wherever it is. Spending on prescription drugs is increasing, either for different payers, or directly to patients through ‘out of pocket’ expenditure – at a faster pace than any other component of health care spending. Consequently, it is forcing many patients to skip doses of critical medicines, and several others to choose between their health and necessities, like food and rent.

The paper adds: “Meanwhile, the pharmaceutical industry continues to launch new drugs at exorbitant prices, increase prices of many old drugs without justification, and reap record profits. Evidence has unequivocally shown that high drug prices are not linked to the actual costs of research, development and manufacturing. Instead, inflated drug prices are a result of drug manufacturers’ power to charge whatever price the market will bear. The need for legislative action is urgent.”

One of the most recent examples of such jaw-dropping drug price was reported by Reuters, along with many others, on May 25, 2019 as: “Swiss drug maker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants and priced the one-time treatment at a record $2.125 million.”

That said, achieving this facet of D&I, is not just desirable, but also necessary to gain a sharp and well-differentiated competitive edge in sustainable financial performance. It is noteworthy that to be successful in this area, one of the key requirements is to assign specific accountability for D&I to that individual, where the bucks stop.

Assigning specific accountability for D&I implementation:

Yet another article titled, ‘Diversity and Inclusion: A Pharma 50 Perspective’, published in PharmExec on June 23, 2016, asserted that there is little point in tackling diversity without solving for inclusion.

It underlined: ‘Whereas diversity is the hardware bringing different machines together, inclusion is the software that brings the system to life.’ The authors suggested, as many others would: ‘Hiring a chief diversity officer can help, accelerating the process at the highest levels.’

Conclusion:

The good news is, the above McKinsey research study also found: ‘Corporate leaders increasingly accept the business imperative for D&I, and most wonder how to make it work for their firms and support their growth and value creation goals.’ The article reiterated the correlation between D&I and company financial performance. Thus, to effectively leverage this factor, developing a robust corporate D&I strategy aimed at both – the employees and the society, at large, appears to be the right choice.

From this perspective, a diverse and inclusive pool of employees, with varied range of approaches and perspectives are expected to meet both business expectations and the health needs of the society with more innovative ideas. Consequently, this deserves to be an organizational growth strategy, having a sharp competitive edge. It is mainly because, the initiative will uncover newer and unconventional pathways for providing greater access to affordable medicines, to save and improve the quality of many more lives. As the process rolls-out, it will keep gathering critical momentum, with support from all around and, more importantly, the enormous goodwill that the D&I strategy will attract from public, in general.

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.

Uniting Pharma With Business Ethics: A Bridge Too Far?

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Operating ethically not only is the right thing to do but also is fundamental to success in business. Poor governance and poor ethical business practices can lead to fines, public scrutiny and distrust – overshadowing good performance, destroying reputation, and undermining the morale and engagement of employees. …We must act in ways that build and maintain the trust of patients, healthcare professionals, governments and society. This was articulated in the Novartis Corporate Responsibility Report 2017, highlighting how important it is to unite pharma operations with business ethics for each company. But is it happening in reality?

The same question haunts yet again with the announcement of a new Code of Marketing Practice by the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA),effective January 2019. The pronouncement prescribes ‘a global ban on gifts and promotional aids for prescription drugs wherever the association’s member companies operate.’

However, the overall scenario gets more complex to comprehend, when on January 03, 2019  Bloomberg Law reported: ‘The change is causing concern among both U.S.-based and multinational companies like Astra Zeneca, Bristol-Myers Squib, Johnson & Johnson, and Pfizer Inc. about how to balance appropriate business behavior with respect for cultural norms in other countries.’ Interestingly, the IFPMA membership virtually covers all MNC drug companies, operating across the world. Thus, any concern on its implementation, especiallyamong some of the bigger names, raises more questions than answers about its effectiveness. What exactly has been the outcome of all such actions being taken, especially by the multinational pharma industry associations, from time to time. Have the patients been benefited – at all?

Keeping this recent development as the backdrop, I shall try to gauge in this article, is the bridge still too far to mitigate the widening gap between overall pharma operations and the standard of business ethics -voluntary code of practices of pharma associations notwithstanding?

Why pharma ‘business-practices’ and ‘business-ethics’ are so important?

Before charting onto the sensitive areas of ‘business practices’ and ‘business ethics’, let me recapitulate the meaning of these two terminologies to fathom why these are so important in pharma to protect patient health interest.

  • Business practice is defined as a method, procedure, process, or rule employed or followed by a company in pursuit of achieving its objectives. Itmay also refer to these collectively.
  • Similarly, Business ethics is defined as a form of professional ethics that examines the ethical and moral principles and problems that arise in a business environment. It applies to all aspects of business conduct on behalf of both individuals and the entire company.

Thus, ethical business policies and practices for pharma industry, when worked out both by an industry association or an individual company, aims at addressing potentially controversial issues, such as corporate governance, insider trading, bribery, discrimination, corporate responsibility and fiduciary responsibilities.

Ironically, despite well-hyped announcements of voluntary codes of practices from time to time, no commensurate changes in patients’ health interest are visible in real life. Thus, the very relevance of such edicts is now being seriously questioned by many.

What do reports reflect on ongoing pharma business practices?

To get an idea in this area, let me quote below from three reports, out of which one is specifically on the Indian scenario, which has not changed much even today:

“The interaction between physicians and medical representatives (MRs) through gift offering is a common cause for conflicts of interest for physicians that negatively influence pre- scribing behaviors of physicians throughout the world.” This was articulated in an article titled, “Gift Acceptance and Its Effect on Prescribing Behavior among Iraqi Specialist Physicians”, published by Scientific Research Publishing (SCIRP) in June 2014.

A couple of years before that, on September 07, 2012, Reuters also published an article with the headline: “In India, gift-giving drives drug makers’ marketing.” Thereafter, many similar articles were published in various newspapers and magazines, possibly to trigger remedial action by the regulators in the country.

Very recently, on January 18, 2019, The New York Times (NYT) came out with a mind boggling headline – “Study Links Drug Maker Gifts for Doctors to More Overdose Deaths.” Elaborating on this JAMA study, the NYT wrote: “Counties where the doctors got more meals, trips and consulting fees from opioid makers had higher overdose deaths involving prescription opioids.”

The point I want to drive home here is that freebies in the form of gifts, travel to exotic places with free meals and stay, fees of various types clubbed under a mysterious nomenclature ‘consulting fees’, purported to influence doctor’s prescribing behavior, are now rampant. These are adversely impacting patients, as they are often compelled to buy high-priced drugs, unnecessary drugs, including antibiotics, sedatives and opioids, to name a few.

Are big pharma companies following the codes – both in letter and spirit?

The doubt that surfaces, are these changes just for displaying to the stakeholders how well and with stringent measures, drug companies are self-regulating themselves, on an ongoing basis? Before jumping to any conclusion, let us try to make out whether, at least the big pharma players are following these codes in both letter and spirit.

To establish the point, instead of providing a long list of large pharma settlements with governments for various malpractices, I shall cite just the following two relatively recent ‘novel’ examples related two top global pharma companies, for you to have your own inferences.

  • The first one is related to reports that flashed across the world in May 2018 related to Novartis. One such article described, “Congress demands info from Novartis about its USD 1.2m in outflows to Michael Cohen, just as it was negotiating payments for its cancer drug.” The report further elaborated, Novartis’ USD 1.2 million payment was made in the shell company of Michael Cohen, President Donald Trump’s personal lawyer and so-called ‘fixer’.
  • The second one is the September 13, 2018 report of The New York Times. It revealed: ‘Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.”

The report also stated: “Dr. Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech startups in prestigious medical publications like The New England Journal of Medicine and The Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.”

Indian companies aren’t trailing far behind, either:

Many Indian companies are, apparently, sailing on the same boat. Let me illustrate this point by citing an example related to India’s top ranked domestic pharma player.

What it said: Way back on November 13, 2010, Sun Pharmain a communication expressed its concern by saying: ‘Over four decades since Independence, the government nurtured a largely self-sufficient pharma industry. But the entry of MNCs is putting most drugs beyond the reach of millions.’

The communique further added: ‘Even as the domestic industry begins to feel the heat of an unprotected market, public health experts are examining why drug prices in India are higher than in Sri Lanka, which imports most of its drugs. The MNC takeover raises the specter of an MNC-dominated pharma sector selling drugs at un-affordable prices, a throw ‘back to the scenario just after Independence, which the government painstakingly changed over four decades. Are we setting the clock back on the country’s health security?’

The reality thereafter: It’s a different story that today, the same Sun Pharma, despite alleged ‘high price drugs of MNCs’, occupies the top ranking in the Indian pharmaceutical market. Be that as it may, the point to note that the same company is now facing similar charges from other countries, almost a decade after. On March 2017, a media report came with a headline: ‘Sun Pharma, Mylan face price fixing probe in US.’

Incidentally,the company is mired with allegation on governance related issues, as well. A media report dated November 20, 2018 carried a headline: ‘Governance cloud over Sun Pharma, stock at 6-month low.’ This example is quite relevant to this discussion, as well, for its link with ethical business practices, as discussed earlier.

Additionally, class-action lawsuits in the United States for alleged business malpractices, including ‘pay for delay conspiracies’, against Indian pharma companies are also on the rise – Sun Pharma and Dr. Reddy’s top the list in terms of those who face most class-action litigation, reported a leading Indian business daily on September 02, 2017.

Pharma malpractices continue, DOP is still to make UCPMP mandatory: 

In this quagmire, where self-regulation doesn’t work, the government usually steps in, as happened in the United States and Europe. Whereas, in India, no decisive government action is yet visible to curb this menace, especially for protection of patients’ health interest. Let me try to illustrate this point with the following chronology of four key events:

  • On May 08, 2012, the Parliamentary Standing in its 58th Report, strongly indicted the DoP for not taking any tangible action in this regard to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.
  • Ultimately, effective January 01, 2015, the Department of Pharmaceuticals (DOP) put in place the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for voluntary implementation, despite knowing it has not worked anywhere in that format.
  • When voluntary UCPMP did not work, on September 20, 2016, the then secretary of the DoP reportedly said, the mandatory “UCPMP is in the last leg of clearance with the government. The draft guidance has incorporated suggestions of the pharma industry and other stakeholders.”
  • After another year passed by, on April 16, 2018, a news report reconfirmed: ‘4 years on, code to punish pharma firms for bribing doctors still in works.’ Its status remains unchanged till date.

Conclusion:

Even after Prime Minister Modi’s comment on April 2018 regarding the alleged nexus between doctors and pharmaceutical firms and doctors attending conferences abroad to promote these companies, decision paralysis of DOP continues on this important issue.

Pharma companies continue practicing what they deem necessary to further their business interest, alongside, of course, announcing their new and newer voluntary codes of practices. But, patients keep suffering, apparently for the apathy of the DOP to curb such malpractices forthwith.

Coming back to where I started from, when the malice is so deeply rooted, would any global ban ‘brand-reminders’, such as gifts, even if implemented religiously, work? Thus, the doubt lingers, for uniting pharma operations with corporate business ethics is the bridge still too far?

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.

Patients’ Trust And Pharma Remain Strange Bedfellows?

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Like many other industries, pharmaceutical companies too often talk about improving focus on effective ‘stakeholder-relationship management’. The doctors obviously form an integral part of this process. There is nothing wrong with it. Nevertheless, serious concern of ‘conflict of interest’ between the two entities is being raised on the means adopted to achieve the targeted end results.

Much as the drug makers expect that these methods are easily justifiable and would not bother anyone, it usually doesn’t happen that way, especially among the informed patients. When patient-interest gets compromised in this complex transactional web, the residual impact is awfully negative. Over a period of time, such episodes lead to a patient-doctor trust-gap, having a snowballing effect on the integral constituent of this saga – the pharma industry.

In this article, I shall briefly explore the scale and depth of such trust-gap and try to fathom who can effectively address this cancerous spread. This initiative when implemented well, won’t just protect patients’ health interest, ensuring affordable health care of good quality for all. It will also help rejuvenate pharma players’ declining reputation, facilitating long-term business interest –unchained by too many stifling regulations.  

For being in the paradise of health care…

‘Trust’ is the bedrock of any meaningful relationship and is usually built based on one’s experience, perception and feelings, besides a few other factors. It falls apart in the presence of deception or lies, even if these are well camouflaged. Similarly, clandestine acts when unearthed could also lead to the same outcome. The charted pathways for development or collapse of patients’ trust regarding doctors, or government policy makers trust towards pharma players are fundamentally no different.

In a scenario where patients can trust doctors for suggesting the best affordable treatment of good quality, including safe and effective drugs; hospitals and caregivers are just and conscientious; insurance companies are caring and fair in their dealings; drug prices are rational; published clinical trial reports on drug efficacy and safety are unbiased, the communication from pharma companies are trustworthy without any hidden agenda – we are living in the paradise of health care.

Nonetheless, the same paradise built on patients’ valuable trust would get shattered, as the drug regulators and the media get to know and unearth lies and clandestine dealings between doctors and pharma companies. Patients soon realize, though the hard way that they are being short-changed. A trust-gap is created, giving rise to an avoidable vicious cycle in the healthcare space. It is difficult to break, as one witness today, but not impossible, either.

The trust-gap is all pervasive:

Although, we are discussing here the trust-gap between doctors and drug companies on the one hand, and patients, drug policy makers and the regulators on the other – the trust-gap is all pervasive. This is vindicated by a startling headline of the January 16, 2018 edition of a leading Indian business daily. It says: “Over 92% people don’t trust the health care system in India: Study”.

It quotes the GOQii India Fit 2018 report saying a large part of which includes doctors, hospitals, pharma, insurance companies and diagnostic labs. The following table shows the ranking of some these constituents in terms of trust gap of Indians.

Rank Healthcare system People don’t trust (%)
1. Hospitals 74
2. Pharma companies 62.8
3. Insurance companies 62.8
4. Medical clinics 52.6
5. Doctors 50.6
6. Diagnostic Labs 46.1

The survey emphasizes that a series of failure, particularly the negligence of hospitals in the recent past has made it hard to trust in the system. The lack of transparency was the other reason that stands out.

Not a recent phenomenon, but increasing:

A trust-deficit in the healthcare system isn’t a recent phenomenon. This was corroborated in the article, titled ‘Doctors, patients, and the drug industry: Partners, friends, or foes?’ It was published almost a decade ago – in the February 07, 2009 edition (Volume 338) of the British Medical Journal (BMJ). The authors quoted a contemporary report issued by the ‘Royal College of Physicians’, which captured an all-time low relationship between the drug industry, academia, healthcare professionals, and patients, even at that time. The paper suggested that it is in the interests of all parties to bridge the trust-gap, without further delay.

As mentioned before, this particular discussion will focus on just two areas – pharma companies and the doctors – not all constituents of the health care system. This is primarily to have a congruity with my previous discussion on the importance of ‘perception’ in pharma. From that perspective, it is evident from the BMJ paper that a trust-gap exists not just in the doctor-patient relationship, but also between the drug policy makers and the pharma industry. I shall try to drive home this point with the following two examples.

 A. The trust-gap in doctor-patient relationships for ‘Conflict of Interests’:

The article titled, “Conflict of Interest in Medicine” featuring in the JAMA Network on May 02, 2017 described ‘Conflict of Interest’ as ‘a situation in which a person is or appears to be at risk of acting in a biased way because of personal interests.’

The article further elaborated thatdoctors’ relationships with drug companies (including any payments or gifts received from the companies) might affect how they report the results of research studies, what they teach medical students about particular drugs, or what treatments they recommend for patients. Moreover, doctors may preferentially refer patients to those diagnostic facilities for tests that may financially benefit them for doing so.

B. The trust gap between the government policy makers and the pharma industry:

That such trust-deficit is all pervasive, gets reverberated even through the speeches of no less than the Prime Minister of India.

On April 18, 2018, during an interactive session of theBharat Ki Baat, Sabka Saath‘ diaspora event at the Central Hall in Westminster, UK, Prime Minister Modi,reportedly said that doctors visit Singapore and Dubai to attend conferences, and not because someone is sick. “The pharma companies invite them for that. To finally break the resultant sale of expensive medicines, the government has launched generic stores where medicines of similar quality are sold at cheaper prices” – the PM further added during his interaction with the audience present in this function at London.

As expected, the medical community in India expressed displeasure over the remark of the PM on doctors and pharma companies on a foreign soil, the same media report highlighted.

Interestingly, just a year ago, on April 17, 2017, while inaugurating a hospital in Surat, a home to several top Indian generic drug makers Prime Minister Modi had said: “We are going to make legal arrangements to ensure that when doctors write prescriptions they write that generic medicines are sufficient and that there is no need for any other medicine.”

Some ineffective interventions:

As I said before, this downward spiral with a widening trust-gap in the healthcare space of the country needs to be arrested soon, with effective steps. The best remedial measure in such cases will obviously be self-regulation by all concerned, keeping patients’ interest at the center.

As an antidote to this problem, in the previous Government regime, ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ was put in place, but only for voluntary implementation by the drug companies.

Enough time has elapsed in experimenting with this process, since then. Regrettably, like many other countries, self-regulation in this area to address the malady of trust deficit hasn’t worked in India too. Both the ‘Professional Conduct and Ethics’ of Medical Council of India (MCI) for doctors, and the UCPMP of the Department of Pharmaceuticals (DoP) for drug companies intended to address the so-called doctor-pharma industry unholy nexus, have not yielded expected results. The saga continues, unabated.

Conclusion:

From the patient-interest perspective, what is happening today in the global healthcare space is indeed baffling. Improving access to good quality, affordable drugs for all, has become a challenge in many countries, just as in India. Consequently, alleged unholy doctor-industry nexus that contributes a significant part to this problem, is attracting greater public attention today. The issue is being often raised even at the highest echelon of the incumbent government. But, more puzzling is, even after the PM’s public anguish, the DoP doesn’t seem to have walked the talk. Much hyped – the proposed mandatory UCPMP has not yet seen the light of the day, despite a clear indication of the same.

The question then arises, what happens if it does not happen due to political or any other compulsions? In that case, I reckon, the primary initiative to bridge the existing trust-gap, should rest on pharma companies. They may not always agree with all public allegations leveled against them, as the creator of this ungodly collaboration, and rightly so. Nonetheless, remaining in a perpetual denial mode in this regard, won’t help the pharma industry, anymore. More so, when the number of net-savvy, reasonably well-informed and globally connected patient groups, are fast increasing. Besides being fair in all business transactions, drug players need to sincerely engage with patients, not in usual condescending ways, but with due respect, for mutual benefits.

Otherwise, despite pharma industry and patients being interdependent in so many ways, sans a strict regulatory framework with legal teeth, ‘patients’ trust’ and ‘pharma’ will continue to remain uneasy, if not strange bedfellows.

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.

Draft Pharma Policy 2017 And Branded Generics

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In its first reading, the 18-page draft Pharma Policy, 2017 gives me a sense that the Government has followed the much-desired principle of ‘walk the talk’, especially in some key areas. One such space is what Prime Minister Modi distinctly hinted on April 17, 2017, during the inauguration function of a charitable hospital in Surat. He clearly signaled that prescriptions in generic names be made a must in India, and reiterated without any ambiguity whatsoever that, to facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines.

Immediately following its wide coverage by both the national and international media, many eyebrows were raised regarding the feasibility of the intent of the Indian Prime Minister, especially by the pharma industry and its business associates, for the reasons known to many. A somewhat muted echo of the same could be sensed from some business dailies too, a few expressed through editorials, and the rest quoting the views on the likely ‘health disaster’ that may follow, if ‘branded generics’ are not prescribed by the medical profession. Obviously, the main apprehension was centered around the ‘shoddy quality parameters’ of unbranded generic drugs in India. It’s a different matter though, that none can possibly either confirm or pooh-pooh it, backed by irrefutable data with statistical significance.

Be that as it may, making high quality generic drugs accessible to most patients at affordable prices, avoiding any possible nexus between the doctors and pharma companies, which could jeopardize the patients’ economic interest, deserves general appreciation, shrill voices of some vested interests notwithstanding.  Nonetheless, if the related proposals in the new pharma policy come to fruition as such, it would be a watershed decision of the government, leaving a long-lasting impact both on the patients, as well as the industry, though in different ways, altogether.

I raised this issue in my article titled, “Is Department of Pharmaceuticals On The same Page As The Prime Minister?”, published in this blog on May 15, 2017. However, in today’s discussion, I shall focus only on how has the draft pharma policy 2017 proposed to address this issue, taking well into consideration the quality concerns expressed on unbranded generics, deftly.

Before I do that, let me give a brief perspective on ‘brand name drugs’, ‘generic drugs’, ‘branded generics’ and ‘unbranded generic drugs’. This would basically serve as a preamble to arrive at the relevance of ‘branded generic’ prescriptions, along with the genesis of safety concern about the use of un-branded generic drugs.

No definition in Indian drug laws:

Although, Drugs and Cosmetics Act of India 1940 defines a drug under section 3 (b), it does not provide any legal definition of ‘brand name drugs’, ‘generic drugs’, ‘branded generic drugs’ or ‘un-branded generics’.  Hence, a quick landscaping of the same, as follows, I reckon, will be important to understand the pertinence of the ongoing debate on ‘branded generic’ prescriptions in India, from the patients’ health and safety perspectives:

‘Brand name’ drugs:

Globally, ‘brand name drugs’ are known as those, which are covered by a product patent, and are usually innovative New Chemical Entity (NCE) or a New Molecular Entity (NME). Respective innovator pharma companies hold exclusive legal rights to manufacture and market the ‘brand name drugs’, without any competition till the patents expire.

Generic drugs:

Post patent expiry of, any pharma player, located anywhere in the world, is legally permitted, as defined in the Intellectual Property Rights (IPR) regulations, to manufacture, market and sell the generic equivalents of ‘brand name drugs’. However, it’s a global norm that the concerned generic manufacturer will require proving to the competent drug regulatory authorities where these will be marketed, that the generic versions are stable in all parameters, and bioequivalent to the respective original molecules. According to US-FDA, a ‘generic drug’ will require to be the same as the original ‘brand-name drug’ in dosage, safety, strength, quality, purity, the way it works, the way it is taken and the way it should be used.

‘Branded generic’ drugs:

Branded generics are generic molecules marketed and prescribed by their respective brand names. Around 90 percent of generic formulations are branded generics in India, involving heavy sales and marketing expenditure in various forms, which has become a contentious issue today in India. The reason being, although branded generics cost significantly more than unbranded generics, the former variety of generic drugs are most preferred by the medical profession, as a group, in India. Interestingly, there is no difference whatsoever in the marketing approval process between the ‘branded generics’ and other generic varieties without any brand names.

Unbranded generic drugs:

Unbranded generic drugs are those, which are sold only in the generic names, sans any brand name. I reiterate, once again, that there is no difference in the marketing approval process between the ‘branded generics’ and ‘unbranded generic medicines’.

The core issue:

The whole debate or concern related to both efficacy and safety on the use of unbranded generic drugs in India stems from a single regulatory issue, which is widely construed as scientifically improper, and totally avoidable. If this subject is addressed in a holistic way and implemented satisfactorily in the country, by and large, there should not be any worthwhile concern in prescribing or consuming single ingredient unbranded generic drugs in India, which generally cost much less than their branded generic equivalents.

This core issue is primarily related to establishing bioequivalence (BE) with the original molecules for all generic formulations, regardless of whether these are branded or unbranded generic drugs. Thus, positive results in bioequivalence studies, should be a fundamental requirement for the grant of marketing approval of any generics in India, as is required by the regulators of most countries, across the world.

This has been lucidly articulated also in the publication of the National Institute of Health (NIH), USA, underscoring the critical importance of generic drugs in healthcare is unquestionable. The article says: “it is imperative that the pharmaceutical quality and ‘in vivo’ performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. Assessment of ‘interchangeability’ between the generic and the innovator product is carried out by a study of ‘in vivo’ equivalence or ‘bioequivalence’ (BE).”

The paper further highlights, “the concept of BE has, therefore, been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe.”

Why is BE not mandatory for marketing approval of all generic drugs in India?

It is intriguing, why is this basic scientific and medical requirement of proving BE is not mandatory for granting marketing approval of all generic drugs at all time, without any exception – covering both branded generics and their unbranded equivalents, in India.

As I have already deliberated on this subject in my article titled “Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah ”, published in this blog on May 08, 2017, I shall now proceed further to relate this critical issue with the Draft Pharma Policy 2017.

Brand, branding and branded generics:

Nevertheless, before I focus on the draft pharma policy 2017, let me skim through the definitions of a ‘brand’ and the ‘branding process’, in general, for better understanding of the subject.

American Marketing Association defines a brand as: ‘A name, term, design, symbol, or any other feature that identifies one seller’s goods or services as distinct from other sellers.’ Whereas, ‘The Branding Journal’ articulates: ‘A brand provides consumers with a decision-making-shortcut when feeling indecisive about the same product from different companies.’

Business Dictionary describes the ‘branding process’ as: ‘Creating a unique name and image for a product in the consumers’ mind, mainly through advertising campaigns with a consistent theme. Branding aims to establish a significant and differentiated presence in the market that attracts and retains loyal customers.’

How does it benefit the branded generic consumers?

One thing that comes out clearly from the above definitions that brands, and for that matter the branding process is directed to the consumers. Applying the branding process for generic drugs, the moot question that surfaces is, how does it benefit the pharma consumers, significantly?

Besides, the branding process being so very expensive, adds significant cost to a generic drug, making its price exorbitant to most patients, quite disproportionate to incremental value, if any, that a branded generic offers over its unbranded equivalents. Thus, the relevance of the branding process for a generic drug, continues to remain a contentious issue for many, especially where the out of pocket expenditure for medicines is so high, as in India.

Marketing experts’ view on the branding process for drugs:

An interesting article titled ‘From Managing Pills to Managing Brands’, authored by the Unilever Chaired Professor of Marketing and a research fellow at INSEAD, published in the Harvard Business Review made the following observations on brands and the branding process for drugs:

“…It takes a huge investment to build a successful brand, consumer goods manufacturers try to make their brands last as long as possible. Some consumer products—notably, Coca-Cola, Nescafé, and Persil (a European laundry detergent) -  have stayed at the top for decades. That’s not to say the products don’t evolve, but the changes are presented as improvements and refinements rather than as breakthroughs.”

“In the pharmaceutical business, by contrast, a new product is always given a new name. Drug companies believe that only by introducing a new name can you signal to the market that the product itself is new. Unfortunately, this approach throws out the company’s previous marketing investment entirely; it has to build a new brand with each new product. That may not have mattered when pharmaceutical companies could rely on a large, high-margin market for each drug they wheeled out. But in a crowded market with tightening margins, the new-product, new-brand strategy is becoming less and less feasible.”

The above observations when applied to expensive ‘branded generics’, which are nothing but exact ‘me too’ varieties among tens other similar formulations of the same generic molecule, do not add any additional value to the patients, in a well-functioning drug regulatory environment.

Hence, to reduce the out of pocket drug cost significantly, Prime Minister Modi hinted at bringing an appropriate legal framework to address this critical issue, which gets well-reflected in the draft pharma policy 2017, as I read it.

Six key features of the draft pharma policy related to ‘branded generics’:

Following are the six key features enshrined in the draft pharma policy 2017 to translate into reality what the Prime Minister spoke about on this subject in Surat on April 17, 2017.

1. Bio-availability and Bio-equivalence tests mandatory for all drug manufacturing permissions:

For quality control of generic drugs, Bio-availability and Bio-equivalence tests (BA/BE Tests) will be made mandatory for all drug manufacturing permissions accorded by the State Drug Regulator or by the Central Drug Regulator. This will be made compulsory even for the future renewals of manufacturing licenses for all.

2. WHO GMP/GLP mandatory for all drug units:

The government shall ensure to get the World Health Organization’s Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) adopted by all manufacturing units.

3. No branded generics for single ingredient off-patent molecules:

The government will pursue the policy of sale of single ingredient drugs by their pharmacopeial name/salt name. To keep the identity of the manufacturer, the manufacturer would be allowed to stamp its name on the drug package. For patented drugs and Fixed Dose Combination (FDCs) drugs the brand names may be used.

4. ‘One company – one drug – one brand name – one price’:

The principle of ‘one company – one drug – one brand name – one price’ would be implemented for all drugs.

5. Aid and assistance to prescribe in generic names:

To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerized and the medicine name will be picked up from a drop-down menu of salt names.

6. UCPMP to be made mandatory:

The marketing practices of several pharmaceutical companies create an unfair advantage. To provide a level playing field, the regulation for marketing practices which is at present voluntary will be made mandatory. Penalty will be levied for violations and an agency for implementation would also be assigned.

Conclusion:

I have focused in this article only on those specific intents of the government, as captured in the draft pharma policy 2017, to reduce the out of pocket expenses on drugs for the Indian patients, which is currently one of the highest in the world. This area assumes greater importance to many, keeping in mind what Prime Minister Modi hinted at in this regard on April 17, 2017. If implemented exactly as detailed in the policy draft, this specific area would have a watershed impact both on the patients, as well as, the pharma companies, including their related business associates, lasting over a long period time.

Far reaching consequential fall outs are expected to loom large on the way pharma players’ strategic business processes generally revolve round ‘branded generics’ in India. I hope, the Plan B of many predominantly branded generic players is also receiving final touches on the drawing board by now, as this aspect of the draft policy proposal can in no way be construed as a bolt from the blue, catching the industry totally off-guard. That said, would the same changes as proposed in the draft pharma policy 2017, if and when implemented, be a ‘wow’ moment for patients?

By: Tapan J. Ray 

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