Dolo650 became a household medicine during the pandemic. … but the latest controversy of freebies being given to promote it has yet again brought the spotlight on the questionable marketing practices of pharma companies. Host Kiran Somvanshi probed the issue with stakeholders - Dr. Viranchi Shah, National President, Indian Drug Manufacturers Association (IDMA), Malini Aisola, National Co-convenor of All India Drug Action Network (AIDAN), Santanu Chatterjee, General Secretary of Federation of Medical and Sales Representatives’ Association of India (FMRAI) and Vikas Dandekar, Editor - Pharma & Healthcare at ET Prime. Credits: CNBC TV18, WION and Medical Dialogues Youtube Channel

This is an audio transcript of The Morning Brief podcast episode: The Dolo Debate - Is Pharma Paying for Prescriptions?

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This is the morning brief from the economic times

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the makers of dolo have been accused of bribing doctors that's what India;s tax authority says

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not possible dolo 650 maker microlab denies all allegations of rupees 1000 crore worth freebies to doctors.

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You can't call it freebies which brand remind us.

Kiran Somwanshi 0:30  

The allegation and then the explanation, but the dolo drama is far from being done and dusted. Do dolo 650 became a household medicine during the COVID pandemic. On getting vaccinated, most of us were prescribed the paracetamol tablet. But now we all are questioning how these drugs are marketed before they make it to the prescriptions we pay for it deep dived into this issue. Starting with the blunt truth from an industry observer.

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Corruption does exist it cannot be denied.

Kiran Somwanshi 1:05  

Medical reps give us the revenue realities.

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Quick earning money is the order of the day. Everybody wants to earn big.

Kiran Somwanshi 1:13  

the defense from the drug manufacturers.

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It is important that it constructive engagement continues between the pharmaceutical companies and the various healthcare providers and elements of the healthcare system.

Kiran Somwanshi 1:28  

And the important argument that something has got to change and quick

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voluntary marketing ethical marketing code and that provides a very convenient and widely exploited loophole for corrupt and unethical practices.

Kiran Somwanshi 1:43  

It's Thursday 25th of August. I'm Kiran Somwanshi, your host from the economic times. And today on the morning brief. You are listening to the Dolo debate is pharma paying for prescriptions. Before delving into the widely known but questionable marketing practices of the pharma companies, it is critical to start with the facts. So I sat down with my colleague Vikas Dandekar who is editor pharma and healthcare at ET prime and our in house pharma guru, about the whole dolo episode, the whole controversy about freebies being offered to the doctors. And now the statement from micro labs. What exactly is the crux of the matter?

Vikas Dandekar 2:33  

So basically, in July, the Income Tax department did some searches on micro Labs, which is the maker of dolo 650. And they found some incriminating evidence where they mentioned that in the name of sales and promotion, the company has offered freebies to the tune of 1000 crore rupees. So, that's the statement that created this entire new buzz about how pharmaceutical brands are promoted. Important to note here is that when the mentioned rupees 1000 crore in that statement, of freebies that were detected, there isn't any mention of the period of order time duration, in which this 1000 Crore has been accounted. Nonetheless, the very mention of freebies and gifts do mean that things have not been going all according to the ethical guidelines, which actually got aggravated. Now, when the Supreme Court was hearing a public interest litigation filed by medical representatives Association body where the PIL mentioned that 1000 Crore freebies were given by this company and the judge hearing the case mentioned that this is a very serious issue that triggered a new wave of concern of briberies and the entire Nexus that we see between the industry, pharmaceutical industry and the healthcare professionals.

Kiran Somwanshi 4:12  

There is a very thin line of demarcation between what is ethical and what is unethical. Some things are natural to be in the process of a pharma company pitching its products and some things are probably beyond beyond ethics. So how do you differentiate between the two?

Vikas Dandekar 4:28  

Yes, so first of all, this pharmaceutical industry does get this bad reputation pretty frequently across the world. So there have been fines that have been imposed on the biggest of the names from Pfizer to GSK to J&J for unethical marketing, even in the US in China a couple of years ago, GSK was fined. Some were around $500 million. So it's it's it's not Just about India, across the world, this happens in India, it happens more because of this entire breathless race for copies. And the only way you can do is probably to influence the doctors and how do you influence the doctors, it starts with a very small point, like giving gifts like pens, and something that you can keep on the table and the doctor can remember, like small notepads. But then this has kept on growing and it's grown so big that it became a bad habit, both for the industry and for the doctor. So the start of 2015, the government actually said that, okay, let's do a voluntary code of conduct the Universe uniform code of pharmaceutical marketing practices UCP MP, and that will be reviewed every six months. Now, as we all know, voluntary is something that is determined within the company and it depends on how well do the medical reps or the industry, the companies adhere to that and it didn't really work. And so again, there is a pressure now that we should make it a statutory requirement. So the UCP MP makes it very, very clear that no gifts, no inducements no travel should be given to the healthcare professionals. I've seen air tickets, where pharmaceutical companies do give these freebies even with the family some of the conferences that I have attended abroad, I have seen doctors with their families, even in conferences, some of the top doctors do take these things and it has definitely come down now. But corruption does exist it cannot be denied.

Kiran Somwanshi 6:49  

But as Dolo outstripped Crocin to become the number one paracetamol brand in monthly sales, one wonders, was there a plan to push the product by doling out freebies to the doctors.

Vikas Dandekar 7:01  

So what happens is that there is a fever foundation that micro Labs had created to explore. This is much before even the pandemic started to explore how Dolo can be actually made more focused. And some more studies can be handled on the types of fever Fever can be from chikungunya, it could be from COVID, it could be from anything. So the company does say that there is a need to make doctors aware of how this drug can be used better. So from a very clear, ethical standpoint, this is how they have been positioning the whole episode now, facts will reveal exactly where this money was spent. It mentions that freebies that included travel expenses, perquisites and gifts to doctors and medical professionals for promoting the group's products under the head motion and propaganda. So we don't know the full facts that will come out probably in the next few weeks.

Kiran Somwanshi 8:03  

And it is these very facts that Vikas talks about that form the basis of the PIL filed in the Supreme Court by the Federation of medical and sales representatives Association of India. The dolo controversy originated from this very PIL I spoke to Shantanu Chatterjee, the General Secretary of FMRAI, to understand what pushed the medical reps trade union to take this action and why now,

Shantanu Chatterjee 8:29  

we had raised a PIL in the Supreme Court in March 2021. Regarding the unethical practices that are taking place in the industry, pharmaceutical industry as a whole, and this we raised because we have been raising it to the government for quite some time. The government has also been responding to us, but they have never acted on it. And in this context that the case was registered in 2021. And it came up in hearing in the 2022. Beginning and on that day, the lawyer from representing our organization just submitted a document which is published in the media regarding the rate on a company by CTBT. And the implications that they have drawn it was a media report, which is submitted incidentally that company is also the makers of a popular brand which was used during the COVID. So this is how the controversy started with the brand names our intention in the industry is simple that this rampant practices malpractices in the industry should be stopped. And the reason that we have gone to the court is that this is adding up to the drug prices and the people of the country can have medicines such a much lesser cost. That is why we went to the Supreme Court because the government was not hearing us the industry associations were unable to regulate the UCMP when it was violated.

Kiran Somwanshi 9:58  

The scanning and scrutiny is just about starting medical reps are afraid to come ahead and make big accusations against those who pay their salaries on the promise of anonymity we tried to understand what is really the trade practice in this paid prescription debate from medical reps including marketing heads. While most were reluctant to speak, here are a few voices

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I would not say that doctors generally ask for things at least in superspeciality and speciality that does not happen. Yes, there is a difference or other variability in the things that might be asked first of all the asking depends on the doctor and the company or medical reps relationship or rapo between each other, if a rapo is created there or something the doctor does ask now, the askings might be of a different kind ask is might be for possible sponsorship of travel or stay in a specific conference, that is academic gratification for the doctor

BG 11:00  

actually doctors they will not ask particular kinds of things to the medical reps. So, any pharmaceutical company, they want to create the brand for themselves. So, they will what they will do they will offer some fridge or any AC cooler any AC kind of thing and they will put the brand name in there. So that the doctor will remind okay whenever he is going to the clinic and in front of him the product brand name is there. So, definitely he will prescribe in that way. So, most of the times it will be with the Indian companies maybe they will be offering some sponsor to the some us kind of things you play doctor is going somewhere else they will be sponsoring these kind of things maybe. So, most of the doctors they will be having their own medical stores. The doctors will not talk to us directly but they will hit us okay if your brand is to be like that, then you have to provide these to the chemists or they will directly into the chemist and the chemist will take whatever the things okay. You had suggested this thing. Our doctor suggested the thing can you provide this on?

Kiran Somwanshi 12:01  

The picture gets smokier. Malini Aisola, a public health activist and national co convener of the NGO all India drug Action Network reveals the loopholes and the leverage that the pharma industry is rampantly enjoining. 

Malini Aisola 12:19  

So I would say the example of micro Labs is just a case of one company being exposed for what is completely a rampant and open secrets of how the industry operates. The industry, business and sales strategy at the moment is based on unethical promotion. And everyone is aware, of course of the huge number of pharma companies in India of all sizes, which are all jostling for a piece of the market, and companies may stop at nothing to get ahead. In order for the companies to be successful. One has to win over the medical fraternity because the doctors are the ones that will be prescribing and helping to push up the consumption. And that is where really the unethical marketing and promotion plays a major role. But the truth is that the majority of the healthcare providers in the country are very willing partners. And that is what is really sustaining this ecosystem of corruption, you know, the huge sales forces that are retained by these companies in the form of medical representatives on their roles. So no one is really so naive to believe that the MRs are actually providing educational information to doctors, which was what was supposed to be the original role. But now it is basically just to serve as medical professionals provide inducements and then actively generate the business

Kiran Somwanshi 13:37  

right on the ground. What is it that you know, most of the listeners wouldn't know or cannot imagine that okay, these are the kinds of practices that companies are doing,

Malini Aisola 13:46  

what we have noticed in the last few years as the industry has actually evolved from those basic strategies to more sophisticated and innovative ways to offer the inducements and also to conceal them in a way so as to give the appearance of them being legitimate activities. And I will give you a lot of examples. There is also you know, customized attention being given by the companies to different tiers of doctors. So, for certain key opinion leaders in the field, they would be actively sought out by the company and to and literally quoted because you would want them on your side and you know to be viewing and using your products favorably and giving positive recommendations for the entire medical fraternity. Then, of course, you have engagement through funding of research studies or clinical trials, providing fellowships and training grants, and of course, the details of the expenditure on grants or funds for medical research. remuneration to principal investigators and clinical trials or to institutions for sponsoring a clinical trial are all opaque. You will also see in the annual reports of many pharma companies with a few exceptions, huge expenditures under the category of professional fees or some similar heading. And yet no details are available about what these expenses until or what services are being rendered by the doctors in such engagements. Yet, you know, there's been a complete lack of enforcement or scrutiny by the government in terms of trying to understand what these professional engagements entailed with the medical practitioners and also with health care institutions and hospitals in order to identify any form of corruption or violation of ethical standards, there is also no oversight or enforcement mechanisms with regarding wrongful promotional activities involving actors in the supply chain of pharmaceuticals. And interestingly, you know, the doctors associations and medical associations remain completely outside the purview of the MCI ethics regulations, and also the voluntary UCPMP, which is the voluntary marketing ethical marketing code. And that provides a very convenient and widely exploited loophole for corrupt and unethical practices. 

Kiran Somwanshi 16:10  

So Malini, this is interesting, I'm just wondering that tomorrow, if you know, this code really becomes a law. And it's regulated, how well that regulation will be like, there are enough ways of, you know, watering it down. So how do you see that panning out?

Malini Aisola 16:27  

If the Supreme Court does direct, for example, the government to to put in place some sort of a regulation that would be interesting to see, at the moment, the government has made it stand very clear, including extremely recently, a few days back, there was also an answer provided in Parliament, that they have actually no intention of bringing about a legal instrument. And there is a bit of a history to this whole issue there. You know, obviously, there is a lack of will. But there are also some very specific reasons one of them being the specific role of the Department of pharmaceuticals, which is under the Ministry of chemicals and fertilizers, the Department of pharmaceuticals has actually been complicit with the industry in blocking any regulation and in trying to, you know, in attempting to replace the UCPMP with a legal instrument. And this is a very long saga that goes back for more than a decade. And, you know, one suggestion that has been made throughout is that perhaps the ministry to be handling this issue, and the subject matter is the Ministry of Health rather than the ministry of chemicals and fertilizers, because the DOP is really charged with promotion of the industry and not really regulating it, the DOP has actually actively, you know, worked alongside the industry to protect it and never acted on any information or any complaints that have been provided by any civil society or patient groups, and ensured that there would not be any regulation in this, it has actually allowed the industry to continue with non compliance. So there have been, you know, time and again, in over the last few years, a one sided meetings being held between the DOP and industry associations, pulling them up and sort of asking them where they stand in terms of compliance. And it is a very sorry, state of affairs, because we know that when we know that most of these associations have not even complied with the most basic requirements under the code, which you know, would be putting it up on the website or providing procedure for complaints, how you can complain and reporting on the status of the complaints and what action has been taken basic things that are required. And so so the problem is also that the UCPMP, as we know, self regulation just doesn't work. And I think there is very clear evidence of how the industry is taking it very lightly, because they know that they have the protective cover of the Department of pharmaceuticals that will never take any action. The problem is also that the owners cannot be on the public and on patient groups to muster that evidence, which is incredibly hard to get one and we know that this is rampant, and then you have a completely unbelievable story, which is the account of the association's that actually there is not a single complaint there is nothing happening in the field that points to any sort of illegitimate activities. So you know, they have nothing to report and nothing to take action on.

Kiran Somwanshi 19:26  

But till now, I have really only got one side of the story. The central character in this debate is the pharma industry. Dr. Viranchi Shah, National President of Indian drug Manufacturers Association, gives us the filmmakers perspective. Why is the industry having an important marketing code like UCP MP are being followed on a voluntary basis by its members.

Viranchi Shah 19:49  

So mdam I think we should have a re look on how we call it a voluntary guideline because in our section the UCPMP is not voluntary as we only know there are stentuets and guidelines, then support ethical marketing practices in India. UC PMP is just one of the wings of the entire it, I would say end of things that we have therefore, I would not call it simply as a voluntary mechanism. It's not for a company to say that, okay, I want to indulge myself in unethical practices. So there is no control over me. It's just a voluntary thing that if I think it is good to do ethethical I would do it's not like that. If a company indulgences or do activities, which are not in line with the law and the guidelines, there are both legal and otherwise there are mechanisms to review to bring things to law. And in their context, I think that it would not be prudent for us to call it totally voluntary,

Kiran Somwanshi 20:49  

right. But are there any past instances where Association has taken any actions on the violating members? Like could you mention any of those,

Viranchi Shah 21:01  

so it would not be good for me to name give names, specific instances. But yes, there have been instances where certain complaints were made. And we had done a review of those in complaints, we have submitted our reports to the Department of pharma and to the government. Taking this forward, we had a similar we had a meeting very recently, about a few months back with our committee, we are also in the process of framing our own SOPs of how to deal with them in a more structured way. And going forward, we will continue our efforts to make sure that the UCP MP is adhered to by our members. And if there are any exclusions, if there are any deviations, the same could be reviewed, 

Kiran Somwanshi 21:47  

right Has the association been able to kind of reach out to the Medical Council of India to also look at regulating doctors and the way they kind of interact with companies,

Viranchi Shah 21:59  

there has to be a ethical, justifiable interaction, or constructive engagement between the pharmaceutical companies marketers, the healthcare providers, that could be the doctors, it could be the hospitals, the paramedics, even the researchers, the intent behind this constructive engagement is these are medicines where these stakeholders are in direct contact with the patients. So, for example, there is a pandemic or there is a viral infection that is there in the society. I'm just giving you an example, interacting with the doctors help the pharmaceutical companies to understand as per their experiences, particular experiences of the available drugs, which are the drugs of choice, what have they experienced? And these kind of information help us to one review our supply chain to to understand what are the forthcoming trends and how do we come with medicines that are more useful to the prescribers and to the patients so that we make a better society. So it is important that it constructive engagement continues between the pharmaceutical companies and the various healthcare providers and elements of the healthcare system.

Kiran Somwanshi 23:15  

Right Of course, but you know, there is a thin line of demarcation about how much to engage and in what way to engage. So, where does like you know, the association or the members draw the line.

Viranchi Shah 23:25  

So, there are very clear guidelines that have been demarcated of what you can do and what you can not do. For example, what kind of priors reminders you could do, or what kind of samples that could be held out. If there is a in terms of medical education, what can be done, what cannot be done. So there are very clear laid down guidelines there. And these guidelines are followed by our members. There could be you know, small instances here and there were probably they have not been adhered either because of lack of awareness or maybe because somebody doesn't simply want to do in that case, the mechanisms are available both with the associations like IDMA and the MCI with the Department of pharma and these can be addressed.

Kiran Somwanshi 24:13  

The pharma industry body as expected, remains pretty defensive on this issue. As patients, we have kind of learnt to turn a blind eye towards the malpractices related to the drugs we consume. The government seems to have failed to uphold the interest of the patients. It is now up to the highest court of the country to ensure that the basic tenet of health care of keeping the patients first is followed. To begin with making the marketing code mandatory for the industry will be a welcome move. Hopefully doctors do are brought under its ambit and are restricted from accepting any quid pro quo arrangements. As they say dher aye durust aye but such a law will not be panacia in stopping corruption. There are enough instances of Big Pharma paying billions in fines for indulging in unfair practices. The penalties have hardly served to be a strong deterrent. But not having a law at all is not a solution. A legal framework will provide a grievance mechanism to the patient's empower them and maybe make Indian pharma firms pause and then ponder before pushing the prescriptions. 

You have been listening to the dolo debate with me Kiran Somwanshi only on the morning brief. Thank you to our guests Vikas Mr. Chatterjee, Dr. Shah and Malini for the perspectives. The episode was produced by Sumit Pandey from the economic times and Soundarya Jayachandran from Aawaz. Sound Editors Ragas Naik from the economic times and Swati Joshi from Aawaz executive producers Anupriya Bahadur and Arijit Barman. We hope you liked this episode. Do share it on your social media networks. The morning brief drops every Tuesday, Thursday and Friday. Do tune into et play our latest platform for all audio content, including the morning brief. Have a great week ahead. All clips used in this episode. belong to the respective owners credits mentioned in the description.

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