 to welcome you all to another exciting episode of USP COVID Connect. Through this series, we speak to various leaders of pharmaceutical and healthcare sector to get fresh insights on the impact of COVID-19. The series really just helps us share with the global audience the challenges and the best practices to overcome the barriers due to the pandemic. Today on our episode, we are honored to have Dr. Rathnadevi. She's the CEO and co-founder of Takshama Health and Education, an organization that is dedicated to working for access to health, patient education and advocacy. Dr. Rathnadevi leads a cross disease patient alliance in India. It's called the Indian Alliance of Patient Groups and she works towards policy change, human resource, capacity building and systems strengthening. Dr. Rathnadevi has over 30 years of experience as a medical doctor, as a public health and management professional, working to improve health outcomes in India. Thank you, Dr. Rathnadevi, for being a part of our COVID Connect series. It is a very warm welcome to you. Thank you, Suresh. So we'll start our conversation today talking about quality of the medical products that we use and the substandard products that affect all of us. So we've seen throughout this pandemic, healthcare workers have treated patients by working day and night to fight this virus. However, healthcare professionals themselves in the hundreds have died from infection themselves and even when they have seemed to follow some safety protocols. So it is thought that substandard PPE or lack of PPE kits are a significant reason behind such infections. We all know it's natural that there's an increased demand for healthcare services during a pandemic, whether it is for hospital visits or treatment or medicines or personal protective equipment. Now this increased demand seems to allow substandard products to get into the system easily. So Dr. Rathnadevi, how do you think we can ensure the safety of patients or even healthcare workers from substandard products while managing a crisis like COVID-19 pandemic? Thank you, Suresh. That's a very, very relevant question. It is rather unfortunate that in spite of facing earlier healthcare crises like say the HIV pandemic and the Ebola scare and other viruses and infections that spread really fast where personal protective equipment played a very strong and significant role for healthcare workers in particular, those lessons really did not translate into best practices in many countries. And therefore when COVID-19 struck, many of the countries were caught unawares and did not have the wherewithal to manage the needs that the healthcare workers needed. The pandemic was such that there was no opportunity for healthcare workers to make a decision between whether or not to treat a patient irrespective of whether the personal protective equipment is present or not. And this actually provided an opportunity for many manufacturers to sort of throw all quality protocols to the wind and just jump in for the profit making. And because the pandemic's magnitude was so vast, even if you have a very strong regulatory mechanism in a country, it is almost impossible to supervise and monitor the kind of manufacturing that took place, especially in the context of a country like say India where every single industry sort of jumped into the bandwagon because they saw a business opportunity there. So in short, I would just like to say that personal protective equipment is not something that's required just now, it will always be required. And having it from the lessons and the mistakes that we have committed, there should be very strong written guidelines on what quality parameters PPE kits should measure up to. And there should be some kind of a demarcation or a mark that sets aside the quality so that you're not buying things off the street. Right now, a layman does not understand the difference between personal protective equipment that passes a certain quality standard and something that has been manufactured in a backdoor garage for example and sold to a private nursing home. So how do you create that awareness that personal protective equipment is not just about a suit covering you, but it has certain medical quality standards that it needs to pass for it to be really safe, both for healthcare workers as well as for other workers. I mean, even the sanitization workers and others also need those PPEs in these kind of pandemics. So A, we need very strong written protocols and B, we need a really strong mechanism to regulate the manufacturing so that not everybody can jump into the van wagon and manufacture it and sell it into the market. So some kind of quality measurement before you actually approve sales of such products. And then lastly, a huge awareness amongst people so that innocent people don't die by buying substandard protective equipment. So do any of these exist? Dr. Ratna, what you've talked about the written protocols. Is it an implementation issue, regulatory enforcement issue or are you saying that we do not have such written guidelines on PPE and quality of PPE and that needs to actually happen? So we do have some guidelines for PPEs but most often they are not followed. And therefore, and even the ones that we have need some kind of review. So for very stringent to quality that is used in say surgical procedures and there has much suits and all that stuff you do have some written protocols and they are followed. And the procurement processes for that is very stringent. But otherwise for a routine say what duty or for other OPD services, there is no written protocol. And I think we need to have something that guides the manufacturers and that manufacturers who actually get into this business have to follow certain standards before they are allowed to manufacture. Otherwise we have seen linen manufacturing units, small terrain shops, every single one jumping into the bandwagon to produce these you know, things like raincoats have passed off as PPE kits. So, you know, that is a sorry state of affairs and in sheer desperation, there are many healthcare workers who actually use them because there was nothing else available. So we also need to ensure that doctors and other healthcare workers have sufficient quantity and of the right quality. So that these innocent people who actually die do not die in the future. So you've mentioned more stringent written protocols are required. We need enforcement to be better off those written protocols and that it's not that anybody can manufacture these PPEs that the manufacturers should meet a certain requirement before they are allowed to manufacture and allowed to sell. Exactly. So I will move to the next product which has also been of very high awareness and demand over the last 10 months or one year of our being in this situation which is the hand sanitizer. So the pandemic just completely reinforced the need for maintaining social distance, hygiene, day-to-day routine and we are all depending on that hand sanitizer like it will really save us no matter where we go, what we touch, right? But a few months ago, there were several cases of individuals being admitted to hospital with complaints of nausea, vomiting, headache and reports revealed that the hand sanitizers they were using contained very high levels of toxic methanol. So this simple step of trying to protect yourself if it's going to cause such consequences and harm that just shows where we are in the state of patient safety in this healthcare system. So what are the various guidelines and policies that can enable a patient, a common man or a woman to protect themselves and their families during a pandemic? Okay, in terms of policies and guidelines for hand sanitizers, we do have them but again, the implementation and the relation is a major issue. And again, because there was this deep sense of panic amongst people and most often people did not know what the contents of hand sanitizer should be. And if you see, there was so much of misinformation on the net where people were even demonstrating how to make a hand sanitizer at home. So under such circumstances, I think even though you have those regulatory mechanisms or the right information, the right kind of sensitization to the common man is extremely necessary. So they don't buy products that are harmful to them. Having said that, hand sanitizer is not a very regulator product because it does not, though it comes under the category of drugs, it is not that stringently monitored and because there was such a huge demand, a lot of products that had very basic minimal requirements were allowed to enter into the market and this led to all these contaminations, substandard, even hand sanitizers with no alcohol in it coming into the market in the guise of alcohol-based hand sanitizers. That is even more harmful because you live under the misconception that you are safe and protected whereas the sanitizer is not protecting you at all. So there were extreme ends in terms of hand sanitizers not meeting the quality standards at all in terms of what the ingredients and the content should be of alcohol-based hand sanitizer to the other end of the spectrum where you had spurious products being put into it, like the example that you mentioned which is methanol instead of ethanol, which could then lead to toxicity. But then hand sanitizers are meant to be used in very minimal quantities and if it led to toxicity then possibly those people were not using it in the proper way because alcohol will evaporate. So I'm just wondering how much they used to be used in terms of toxicity to themselves. So huge awareness is needed at the same time. I think there has to be a country readiness plan for such pandemics otherwise it is very hard to stop such manufacturers entering into the market because do what you may. The panic is so much amongst the common man that they will simply buy things off the shelf irrespective of whether those things are registered or not. And registration of course is a process that needs to be made more stringent but until we have the state and the national level working hand in hand so that some products that are registered at the state completely escape to the central level. They don't even know that such some standard products or sometimes products that would not have been approved are actually getting registered at the state level. So unless there is enough awareness amongst the regulators themselves as to what proper standard of quality should be these kinds of incidents are bound to happen and it is very, very unfortunate. And what I would like to add is this came through to the notice of people from the media but I think there should be a mechanism in which people are able to report back such incidents so that there is enough data that's being generated on such manufacturers so that even if they do manufacture and enter the market there is some action that can be taken against them. If enough people start to report such incidents I think the body of data that we can collect will be very, very rich. So you're part of patient safety, patient advocacy groups. Is there currently work going on by these groups with the government to create such awareness now that we're in month 10 or 11 in India of the situation we're in? Yes, the patient advocacy groups do a lot of awareness generation through the membership that we have but then this membership is a drop in the ocean considering the kind of populations that we have. This needs a much bigger, more concerted effort maybe from the government itself. The government has tried through some of its channels to create awareness but that was simply not enough. I think the message that went through was you have to keep yourself safe, you have to use hand sanitizer, you have to use masks but beyond that even masks, the quality has been a big concern. So what kind of masks to use and whether those masks are really good and protecting you or not. All those questions have been there in everyone's mind. So for things like masks and hand sanitizers, personal protective equipment, et cetera there has to be a mass awareness campaign and a very strong drag by the government to curb the people who are flouting the laws so that and then made an example so that these people were punished or some action was taken against them so that the general people or the general masses become aware and then are more alert and start asking the right questions. Right now you go to any shop you can find a hand sanitizer, it need not be a medical shop. You can buy a hand sanitizer everywhere and that should not be allowed if it is actually categorized as a drug. So there are lots of things to do but I believe we are all learning lessons from this pandemic. So I'll switch gears to talking about another hot topic that maybe for six or eight months we've been discussing on clinical trials. For vaccines to be available which we are all eagerly waiting for we need healthy volunteers for trials but there's a fear of enrollment of these healthy volunteers to participate in clinical trials maybe because of possible adverse events maybe a fear of potentially being a guinea pig. So a serious adverse event is when a participant requires hospitalization after complaining of any issue and believed to be caused by that particular medicine or vaccine under the trial. Now since human participation is such an important crucial phase of any clinical trial when there are adverse events which happen it can lower the trust that the people have in trials in general. So, and this happens in many countries not just in India. So what in your view Dr. Ratnaket companies and governments do to protect patients to ensure their safety during a trial and instant confidence in public about these trials by ensuring safety so that we actually see healthy volunteers participate. What could governments and companies do for this? Okay, so companies who are the manufacturers can actually be very transparent in putting out the information about the trial itself in terms of who can participate and what can be the expected side effects what can be some of the fatal events if at all there has been any documentation about it and also show some kind of commitment to the volunteers at least giving them the confidence that should they need a hospitalization or any further investigation because of any side effect and the company stands by and does not leave the patient on the way side. You know, it should not be that there is a side event and the person is now unable to continue with the trial and therefore is rejected and then nobody asked the person what happened to him or her. It should not be like that. There has to be some trust-building that the company will stand by this person through the trial and beyond should there be something that is required beyond the clinical trial. As far as the governments are concerned I think there has to be far more transparency in terms of who's getting enrolled and how they are getting enrolled. What is the purpose? I mean, it has to be made very clear that it is altruistic that there are no compensations nothing else that is involved in this trial it is purely for the purpose of a trial to prove the efficacy of the vaccine or any other product for that matter. And then they have to establish mechanisms that should there be an adverse event or a serious adverse event then that is documented really well and there is a process followed to investigate why that serious adverse event happened so that other participants into the trial do not have the same issue and this is made public so that it doesn't deter future participants from enrolling into the trial and then possibly if there is a serious adverse event then the trial may need to be stopped for a while while the investigation is going on. This the company should not interpret as a blot on them or as something that is going against the trial but part of a scientific process where a proper investigation is conducted to see what really created that adverse event it could be something that has got nothing to do with the vaccine but something inherent to the participant which could then become an exclusion criteria in the future but to be able to arrive at those conclusions a proper investigation with clinical people who are qualified and trained in that has to be done and it could be a combination of government clinical scientists and researchers as well as the company scientists and researchers and they jointly arrive at some kind of a report that then is made public to the extent possible so that there is trust gained by the common man in those trials and future registrants are not fearful of not being given the right kind of audience should there be an adverse event or a serious adverse event and I don't know how in our country hospitalization costs etc. are managed but I think it should be either a responsibility of the government in terms of a pandemic or the company that is doing the trial to be able to manage those hospitalization costs and the well-being of the participant. So transparency seems like the absolute need before the trial, during the trial especially if there is an adverse event we expect that the company should make it public and that ongoing information should be made public by the company and then I think if we expand that to role of the government as well so I think there's a lot of questions on safety of vaccines and people wonder whether they should take one or not also because they're not it's not very clear how the emergency authorizations are being made it's not what is the criteria for approval of a drug a treatment drug or even a vaccine and this seems to be different across countries so what in your view is being made available in India and what would instill more confidence in the public on COVID vaccines and treatment? I think there's a whole bouquet of vaccines that's being made available in India and I think states have been left to make a choice as to which one they would like to offer to their own citizens because I did see a message coming from the government of Haryana the state where I stay to enroll myself for a particular vaccine so this is helping a state subject especially for high-risk groups and the healthcare workers who will be given the first priority there is the state is making a choice as to which company or manufacturer they would like to buy the vaccine from in terms of guidelines on which vaccines to buy and which one to distribute in the country apart from of course the actual outcomes and the processes that the vaccines has gone through I think the logistics and the storage and the transport and all that also play a very large role in a country like ours with very high temperatures where some vaccines would need very stringent logistic measures to be able to actually be taken to far off places in the country and stored in a viable way I think all these things will play a very big role in the decision making of the government however you know much of these vaccines once they start rolling out will actually be the test of how successful they are in terms of reaching the populations that they are supposed to reach in terms of you know the efficacy again it's not the vaccine that actually saves the person but the vaccination that saves the person so the vaccine may be of the highest quality but if you do not store it properly you do not administer it properly it's not going to be effective so there's a huge training issue involved here there's a huge human resource capacity issue involved here and of course the transport and the logistics part of is also there I don't know if I've answered your question but yeah one additional aspect this definitely throws a light one additional aspect I was asking about is the transparency around approvals and what can the government do what is it doing currently and what can we do to ensure a patient safety but also confidence so the government has certain guidelines that I mean very limited information that is available on the approval process and if a patient body were to ask for more information I'm not sure whether that would be made public so one of the concrete steps that can be done is to have government portals you know listing out all the vaccines that have been approved by the drug controller and the criteria for which those approvals have been given and you know what were the steps taken to ensure safety of the population and you know how would they ensure that should something happen to the patient then the patient is taken care of right now there is nothing mentioned you know if there is an adverse event after the vaccine what happens I think it's left to the state to manage that but the states also have no guidelines as such as to how to manage it so it might be useful if there is public information that is available on who can take the vaccine what are the vaccines available what kind of approval mechanisms have been put into place to be able to bring those vaccines into the government formulary or approval process and whether there are any risks involved in any of those and should there be an adverse event or some untoward event where should the patient go to and report because it is possible that you might after a point of time you might be able to take the vaccine through the private channel as well because not all populations will be covered by the government so once it comes into the open market who then becomes responsible and where should the patient report if there is an adverse event I think all these things need to be made more transparent and much more information needs to be provided So given that we are not exactly hearing a lot and a lot has not been made available it definitely influences the trust that patients have and it probably influences the behavior which is whether or not people will feel comfortable getting vaccinated Is there specific patient groups that are working with the government to ask for this, to demand for this? How can we as patients and groups really demand to have this that has such a huge influence on the outcomes or whether or not people will get vaccinated? Given that what we've established is there's not that much information that's coming from the government So my question is how can patient groups influence that? How can we as patients influence that? The best way to ask questions but then even if you ask questions not many are answered at least not immediately Also, there is this huge stress or anxiety among in people's mind and so the stress is equally divided between what if I don't take the vaccine and I'm infected to what if I take the vaccine and have a side event, an adverse event and really there is no good answer with the patient because the patient doesn't know either side of the story and a lot of people are actually asking these questions and a lot of people are asking them openly on public forums, writing to various professional bodies but I think even at the top level there aren't any clear answers right now and therefore until the, shall I say an action plan or something like that is put into place which has some clear steps that will take move forward in terms of how the vaccine will be delivered who will receive it and what other steps and measures to its being made available in various states I think we will have to just wait and watch because we did ask a few questions but we haven't yet received any answers So I'll change the topic towards the quality of medicines something that USP, we work day in and day out on quality of medicine related challenges Recently in India, we saw just this year in 2020 11 children had died and several others fell ill after consuming a cough syrup for the common cold Now these children suffered major organ damage before they died and the grieving parents got to know that the cough syrup that the children consumed was of compromised quality and it resulted in their death Now that is the parents worst nightmare right you just have a child with a cold and you're giving them a cough syrup and you wouldn't expect such a significant harm So quality medicine does one of the major challenges that the world faces and what is the direct and indirect effect on patient safety? What are your views on this, on medicine quality? There are so many such incidents if we start listing them, we can write a compendium I mean the Madhya Pradesh case where substandard antibiotics were given to women after family planning operation resulting in sepsis or even the recent Andhra Pradesh case and the cough syrup one then there are so many such cases where over and over again we cry ourselves hoarsing that these drugs are not of the quality that they are meant to be and they should not be in the market at all they should not be getting any approvals they should not be allowed to manufacture I mean the approval will come after the manufacture how are they even manufacturing it? Who's giving them the licensing to manufacture? These are questions that have been asked over and over and over again but in a country like ours we are a very, very complex country and there are so many layers that people of these companies who want to make quick profits find the loopholes and the gaps in these layers and use them, those loops and gaps loopholes and gaps to their advantage Again, we also have a very big problem of a huge quantity of medicine being OTC over the counter and therefore many, many patients actually are given stuff that they might not have been prescribed at all and therefore again a gap in implementation and regulation and these kind of medicines, as I said there is no words to describe the apathy that is there when such people give medicines to newborn children or young children or pregnant women there's absolutely no ethics there However, as I said before much of this can be easily stopped if there was a very robust reporting mechanism for every single adverse event or even failure of care or failure of cure if somebody is giving a antibiotic for seven days and the person is not responding and if there is a proper mechanism to find out why that antibiotic is not working and you report then you actually find out whether that antibiotic was meeting all the quality standards or not However, we have so many manufacturers especially in the generic medicine category that it is almost impossible to regulate every single one I think we need a much more robust mechanism where who gets to manufacture drugs and what kind of quality processes they follow needs to be made extremely stringent and some very strong punitive measures need to be put into place for people who default or who are caught with these kind of spurious medicines Again, as I said, there's a lot of patient awareness that needs to be done that you cannot buy medicines without a prescription and then of course this even if there is a prescription then this whole quality issue of whether the person who is prescribing is a qualified medical practitioner or not So how do we increase awareness amongst patients that you should go to a qualified medical practitioner you should get a medicine on a prescription and then you should go to a registered pharmacy to buy that medicine and when you buy the medicine, see the labeling so you know that whether it is genuine or not most often the labels will give it away if it is not a proper medicine So just check the labels to see whether the medicine is of at least trust worthy quality and source or not These are some of the things and then from the government side of course you need far more surprise checking and factory checking and all those other procedures that need to be done to catch these kind of people and then have some kind of punitive mechanism so that they don't come back into the market again Most often our country is so corrupt that they get away and they come back under a new company name and they start manufacturing all over again This is a sad part of the story So regulatory enforcement is really a key here and even when we have guidelines in some cases we may not have but wherever we have guidelines it seems the enforcement is where we fall short over and over again that causes a lot of these painful tragedies to happen and I think on a similar note even pregnant women when they depend on the institutional delivery there are so many cases of mothers dying during childbirth due to excessive bleeding and sometimes the issue was of oxytocin and similarly where you have said in terms of the quality of the medicine and enforcement So is there patient safety factors that need to be highlighted to stop such incidences and save the lives of patients? So we do have a rational patient safety framework which has some guidelines for state at the national level on what to do and how to move forward and set up a technical committee at the state level that regularly monitors the activities at the state level and then this gets consolidated at the national level to be able to come up with some kind of data that will help you understand which states are defaulting the most and where are the most incidents happening how are these incidents being managed in terms of regulatory checks and cancellation of licenses or fines and other things but though this policy came in 2018 except for a couple of meetings nothing much has moved forward and it is very, very disappointing that when we talk at the national level we understand that there isn't enough fund allocated for this unit to move forward So I think it needs a lot more commitment from our policy makers if patient safety is not just a policy document but actually getting translated into action then it not only needs commitment in terms of finances so that they have the relevant expertise to be able to take the whole patient safety framework agenda forward but also be able to translate that into action at the state level and the district level So because there is not much activity happening except for those guidelines which anyway are just guidelines and the states are free to adopt them or reject them or just ignore them I think patient safety cannot be a matter of choice it has to be made mandatory and there has to be some accountability mechanism set up in place so if there is a manufacturer who has been caught providing substandard drugs which have caused harm then whoever has provided opportunity to that manufacturer to manufacture, sell and register their drugs should also be held accountable otherwise this whole vicious cycle is never going to stop and we all know that as far as the people who are responsible for providing those licenses or for providing those approvals are concerned they are never held accountable So there has to be some kind of a public mechanism that comes into force that actually asks these questions as your example of where these children died because of adulterated cough syrup who was the person who provided the approval to market this cough syrup that person should be made public and should be made accountable unless that happens these kinds of incidences will keep repeating themselves because as I said before we are such a corrupt country that even if there is a punitive mechanism this person will probably register another company and start manufacturing another product overnight Sorry to say that but that's the truth So we do have frameworks we have a lot of the guidelines but we still see these tragedies happen we still see these incidents happen you mentioned corruption as one of the issues we also have accreditation systems as a recommendation for how we can address some of these issues we have maybe institutions that have been set up for this at the national level but why do you think they are not working? Why do you think these accreditation systems and standards that we are looking to set are not actually translating to outcomes on the field? So for anything to work there has to be either an incentivization or a disincentivization and most of our accreditation system whether it's for labs or hospitals or even for other institutions are voluntary So it's based on the institution's choice whether they wish to take it or not and there is no since in India healthcare is mostly out of pocket there is no mechanism where you can disbar an institution from practicing or managing their business just because they are not accredited we do not have those kind of mechanisms in place So if tomorrow we had a system where we said only all hospitals that are accredited can open their doors to patients then our entire public health system will go out of the scene So those kind of harsh decisions or decisions that can affect a large group of hospitals and service delivery centers are never taken because they are very unpopular and it is difficult to enforce everything in a country as big as ours So all of these are voluntary and as long as they are voluntary only people who want to use that license as a business opportunity will enroll for it The others because they can still run their system or their practice without having any accreditation they will never go for it because for them it makes no difference and because our country has got about 50% of population which is illiterate they cannot differentiate between what is accredited institution and what is not an accredited institution and that is the reason why so many of these people suffer so much but I think the future points to a scenario or an environment where such quality accreditation should become mandated instead of being voluntary or a choice All hospitals have to have some kind of accreditation system at least the basic one to for them to be able to open their doors as hospitals to the common man Great points accreditation if it is mandatory is one mechanism to really ensure safety manufacturers meeting a certain quality or standard being the only ones allowed to manufacture certain things All of these talk to standards being set and enforcement of those standards for people to begin to supply or service patients is really the way for patient safety So as we discussed very many cases in the last 30-40 minutes in all of them we have challenges and we have some areas that need to be worked on to ensure patient safety but whose responsibility is it? So whose responsibility is patient safety? Everyone's responsibility but primarily the government because healthcare is meant to be a right if I understand it correctly and therefore irrespective of whether it's a public health institute or a private health institute or a manufacturing facility or a lab I think patient safety is a responsibility of the government So either the government ensures that through its own healthcare system it is giving the highest quality and standards of quality or it makes the environment in such a way that anybody who wants to work in that environment meets a certain quality standard I think neither of that is working because we know that the quality is a big question mark in many of our public health institutions due to various factors It's lack of manpower, lack of infrastructure lack of proper training So many things and the huge of course mismatch between the available resources and the demand for healthcare services So that is a big challenge anyway but I think one of the biggest ways that the government can contribute to this is to ensure that every single healthcare institution whether it is a drug manufacturing company or a diagnostic manufacturing company or a hospital or even a training a medical college or a school or a nursing school or a pharmacy school all of these have set standards and guidelines that they are mandated to follow and where they have institutional mechanisms to check at intervals to see whether those guidelines are being followed or those standards are being followed or not and certain mechanisms put in place to either cancel the licenses or disbar them from continuing the practice if they are not meeting those standards So in all of these recommendations and work that is being done for patient safety where is really the action and momentum globally and where is India in relation to all of that momentum of doing the right things and putting the right things in place for patient safety? We are very, very far behind very, very far behind Frankly for us, patient safety is not on the top of our priority list because A, there are so many conflicting priorities that safety doesn't really matter it's more about how you reach the masses at the minimum cost and when access and affordability Yes, so it is the speed at which you reach the masses along with the cost at which you reach them So when you want a high speed low cost delivery mechanism with not many checks and balances in place because that would reduce the speed then you will be compromising on quality unless of course you have an extremely well-oiled machinery working right from the beginning and because that is a priority that it is like if I'm saving 100 lives at the cost of losing two then it's like a balance that I have saved 98 and I lost just two so it's okay but every life is as precious as every other life and I think we should not take that approach for us if we should while ensuring the last mile delivery at the highest speed possible also ensure that the highest quality is also given to every person because that is their right they deserve the highest quality every citizen deserves the highest quality it is not the question of where they live or how much they can afford I think that's a non-negotiable So in terms of global best practices I think we still are way behind we need a lot of catching up to do So patient safety is non-negotiable I like that I'm just looking at the time and I'm going to ask the participants in case they have any questions and I'll continue to ask as I see any questions from them One of the questions I see right now is what is the current storage condition for COVID vaccines and plans for it? Yeah, I might not be the best person to answer this because I'm not a cold storage specialist but I do know that we are gearing up our storage capacity and I think the choice will be between very high sort of labor intensive or resource intensive vaccines to something that can be stored maybe at a near room temperature not very high temperatures but near room temperature and can be transported easily because we should not forget that India is a very, very big country and has a very large population So as I said before even though we might spruce up our storage capacity for they say the minus 70 degrees or whatever it is at some select centers just to be able to have that vaccine also available with us if somebody should need it the choice will be what can we store at a room temperature or a near room temperature and transport easily so that you do not need specialized vehicles that have to run on the road to transport these vaccines I mean you should be able to transport this in any normal vehicle if not two stringent storage mechanisms are required so that will be the choice and while other questions come up I'm going to go back to the last question you were answering on the global efforts for patient safety and that India is lagging behind especially because we are concerned about access and affordability and in the process of facilitating access and affordability we may be compromising on safety and quality what are some of the examples from the global efforts and the global action on patient safety that India could potentially adopt as low-hanging fruit there may be many things we need to do and some may be easier to implement than others can you think of one or two examples you can share with our audience on what could India do on patient safety that others have already implemented and we can catch up there are several and one could talk from individual to institutional so because there is a mechanism of storing patient data in central databases and retrieving that data for the purpose of predictions or pandemics or any epidemiological use any patient reported adverse event also gets stored and can be retrieved quickly to be able to analyze and use this for national use we do not have such a national database of patient data ours is a very, very desegregated sometimes not even key or data because much of it is not recorded electronically and is a paper-based data and therefore sometimes it's difficult to capture so I think moving forward considering that we are declaring ourselves a digital nation we should have some mechanism of capturing patient data into an electronic form where adverse events are also captured into the patient history both self-reported as well as physician-reported and manufacturer-reported this could be one very easy low-hanging clue because anyway every single physician writes a prescription all you need to do is convert it into digital then the second one is certain never events or events that should not happen or are considered a blot in terms of quality for example, sepsis so sepsis is not meant to happen especially if you have had a successful surgery so any sepsis event or anything that bars an outcome a successful outcome of a surgery is recorded meticulously in many countries and there's a whole investigation into why that sepsis happened or which antibiotic did not work or what precipitated what was the source of infection and we all know that most sepsis occurs because of hospital-acquired infections so there is a complete audit that is conducted so to identify where the source of infection could be and those findings of those audits are strictly adhered to and deliberated upon and actions taken so if there is any infecting source coming from some person or some instrument or some lab then those are isolated and stringent measures are taken we do not have those systems we do not have a hospital audit or a death audit or a sepsis audit I think those kind of things are very easy to do it's just a question of institutionalizing those mechanisms in place and making it a culture of reporting without any blame if that happens then you get start to get more and more information on such never events or events that should not happen and then you can put in those quality mechanism in place and this is the institutional and the public part of it but more importantly what the government should do is if they are getting a cluster of events reported from a particular state or a site then they should investigate deeply to find out what the source of such information is sorry and take the necessary action so that such events are never repeated again also I think transparency is a big, big, big, you know big issue that we need to address we try to hide everything under the carpet the more transparent we are the more openly we discuss the more the confidence of the public will be there and reporting such things and there has to be some mechanism where citizens are able to report directly to the government in an anonymous way so that you get more information right now the kind of information that government receives is so small that it hardly generates any evidence so instead of say 100,000 or 200,000 events that get reported annually if you had 2 million events getting reported that's so much information and that actually empowers the government to take much more stringent action so the lowest hanging fruit on patient safety that can have a very big impact is data is putting systems in place IT institutionalizing mechanisms for reporting within the hospitals and also allowing reporting mechanisms by an average citizen in an anonymous way so all of this goes back to data collection so that we have information to work off of and given India's strength in IT and software and the kind of technology that we can have and the talent we have I think this is something that you're right about it being a low hanging fruit can go a very long way it brings me to this other question on patient safety research the framework also mentions patient safety research as one of the things that should be done what is the status of patient safety research in India and what's the scope that this research could undertake so patient safety research could mean many many things and one of the most important thing that India is currently focusing on is antimicrobial resistance and we all know that OTC prescription of antibiotics is actually leaving and if you see the global data then 25% of antimicrobial resistance globally is generated, being generated from Southeast Asian countries with a huge focus in India, Bangladesh and these countries so I think there's a lot of data and research that's being collected and being done by the government of India under the age of ICMR to see what prescription practices are there what kind of antimicrobial stewardship program should move forward and how can we have safe prescription practices as far as antibiotics are concerned so while the research is growing and they're trying to isolate the strains that are becoming resistant so that there are certain government guidelines to restrict use of those lifesaving antibiotics as I said, you know even the non-qualified medical practitioners can prescribe antibiotics and it can be made available from a pharmacist without a proper prescription so there has to be some mechanism to stop that there is also some research that is happening on safe surgery, blood safety all these things, there is a lot of research happening but it's a slow process so much of these results are not really available to the common man or in the public domain to be able to see where the research has gone or what kind of progress is happening but we do get some information through meeting minutes et cetera to understand that these kind of research is happening but as I said before the kind of investment that is there in patient safety is too low and I think there needs to be a dedicated fund for patient safety for this to gather in Peters and move forward and I think this is the right time because WHO has just declared the decade of patient safety the 2020-30 plan and since we are a signatory to that and we have accepted that it's the right time that the country sits down to focus and put some money into where the plans are so that at least there are some human resources that can drive it forward. Thank you. There's a question from a participant the Oxford Serum Institute vaccine has a success rate of 60 to 70% from a patient safety perspective is it wise to proceed with that percentage to treat the patients? I think they're referring to the efficacy percentage and whether it is safe to proceed with that to treat patients. Personally, if you ask me, no. But WHO pre-qualification says 50% and above is approved. So because of the magnitude of the calamity that the pandemic has created I think the standards have been lowered a little bit. It will also depend on which countries can afford what kind of vaccines and what kind of efficacy they are looking for and what populations are there. So if there is a small country which has almost reached herd immunity and there are just a few people who need to be vaccinated who are maybe high risk then probably this vaccine will work. But if there is a native population that is not exposed ever and needs immunity so that they do not acquire or get infected by the virus then I would say no. As a human being, as a personal opinion I would say no, nothing less than 90%. And is that usually vaccines take 10 years or so to develop and actually become part of inoculation programs? Is that usually the efficacy percentage that those vaccines aim at 90 plus percent? Yes, of course. Yes. I think we are at time. So I wanted to thank you, Dr. Ratna for taking the time to talk to us today. We had a few participants today but we host these talks on USP website and we share that widely with our global stakeholders. They watch it in their own time zones. So this has been super informative. We really appreciate your time and your views and look forward to working together on quality, medicine quality and other medical quality issues for patient safety. Thank you so much.