Chandrachur Datta - Hello and welcome to the Counterpoint Podcast by Vector Consulting Group. I am Chandrachur Duta, Partner in Vector Consulting Group. I am filling in for Shubham for this episode. We at Vector have been working with multiple clients from the pharmaceutical industry to improve their quality operations. Today I'll be exploring the nuances and challenges of the world of pharma quality.

I have with me Dr Rajiv Desai, Senior Technical Advisor, Quality and Regulatory with Indian Pharmaceutical Alliance or IPA.

So, to quickly introduce Dr Desai - he was the Executive Vice President, Global Corporate Quality at Lupin. He was responsible for quality management of API, different kind of formulations like aseptic, OSD injectable and biotech, even biotech manufacturing facilities and development quality assurance at R&D centre.

He has over 38 years of experience, that's rich sir, for in India as well as abroad. His other assignments earlier were as Head of Corporate Quality Management in multiple firms like Dr. Reddy’s, Mylan and Alembic.

So, welcome Dr Desai to Vector Consulting Group’s Counterpoint Podcast.

Dr. Rajiv Desai - Thank you!

Chandrachur Datta - So, for our audience it would be good if we introduce them a little to the pharma QC environment. So I'd like you to talk about why is pharma quality such an important topic for the Indian pharma industry.

Dr. Rajiv Desai - Thank you so much for this question. Basically, what happens is when you talk about pharma, pharmaceuticals, medicines, it's about patients.

Chandrachur Datta - Yes sir.

Dr. Rajiv Desai - If you talk about the patients they have to get the medicines of the right quality and consistent, because they are taking medicines for their ailments. And India as you know is into generic business. We are making products formulations and APIs which are used by several countries as an alternative to the innovators also after the patents have expired. So, it's important that the individual regulatory agencies which are looking at the quality standards of the medicines have to be of high quality, and consistency is very important in this case.

Chandrachur Datta - Thank you for explaining it so easily for our audience. Yes, all the medicines are impacting someone's life that's what we are talking about here. So, what are the quality related issues that are coming in the Indian companies typically, what they're facing, especially when they're exporting it to let's say US or EU what is your experience?

Dr. Rajiv Desai - The most common thing is when you have inspections done by the regularity agencies inspectors over here and obviously they have a very large responsibility to ensure that the manufacturers are making the products of right quality. So, when they come here they find that whatever has been written, whatever has been mentioned in the documents may not be the same and this is something that is quite an embarrassment also, on one hand you have the products in the market but the way the manufacturing is done, the way the testing is done sometimes there are areas which need to be really looked at. And, most important is, when there is a failure, when there is an investigation to be done these things are not given the scientific rigour which is required for these kind of issues.

Chandrachur Datta - Okay. So, if I understand it correctly - basically you are saying when there is a problem that is there in the lab operations there is supposed to be a proper investigation of that problem so that whenever there is an audit by the regulatory agencies they find out what the problem was, how was the problem investigated and what were the actions that were taken to completely eradicate this kind of problem from happening again, correct.

Dr. Rajiv Desai - The expectation is that it should be first time right.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - There should not be any failures.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - But any activity that you do, any manufacturing, there's always going to be some issues, somewhere, and that is not something that nobody denies it. So when you have any failure, the first thing is to identify why it failed? Why there was an issue? Why there was an aberration in your manufacturing process or the quality standards. Now the idea is not to just please the agency or please the regulatory agencies, for that matter, but to make sure that this issue or the failure does not repeat again that's very important and when you do a proper investigation of why it failed you're bound to get the proper reason for it.

Chandrachur Datta - Correct.

Dr. Rajiv Desai - And that reason will help you to make sure that the failures do not repeat again in our case what happens is invariably you know the inspections are the focus point. The companies tend to say that okay I'm trying to create documents which will you know be helpful for me to sail through the inspections. But most important is look at the patients, make sure that the patient gets the right quality medicines. And it's not only pleasing the inspections but making sure that you get it right the first time and if your scientific rigour is maintained, a proper investigation is done for the failures you're bound to get the product of good quality.

Chandrachur Datta - So, first time right is possible, that's what you are saying.

Dr. Rajiv Desai - It is possible it is possible it is possible

Chandrachur Datta - So, can you share some examples of these kinds of incidents when companies faced you know significant consequences due to, you know lapses in their quality processes, any examples without probably naming anybody, of course.

Dr. Rajiv Desai - The most common thing is when they come down for the inspections to our facilities - the way our people interact, the way people demonstrate the work that has been done and this is something that is quite a common practice that they're not able to talk properly, one is fear, because every inspection is always a hyped up process and that creates a kind of a nervousness amongst the people working in the plants, and if they're not able to explain the inspectors do not have that kind of confidence whether they have done it correctly.

Chandrachur Datta - Correct

Dr. Rajiv Desai - Secondly in most of the recent times the inspectors have a process actually watch the activities.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - And watch not for a few minutes, but for almost half an hour 45 minutes 1 hour also.

Chandrachur Datta - Okay

Dr. Rajiv Desai - And to see if the activity has been done correctly, especially in the injectable facilities where the movement of the people is so very important, the interventions that they do, if there is some kind of issue, how do they handle it.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - The movement is very essential to make sure that the contaminations are under control. And if they are not done properly obviously they will cite observations.

Chandrachur Datta - Understood. So, are you saying, you told me something like that, everybody is trying to prepare for sailing through the audits, this kind of practice, do you think it is sustainable, do you think it is helping or do you think this needs to change now.

Dr. Rajiv Desai - Definitely it needs to change. I mean gone are the days that people and the companies prepare for the inspections. They should be ready any time and I can tell you that many companies now have realised that being ready every day ‘all time readiness’ as they call it, is something that they are really practicing.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - So, I remember recently one of the senior person from FDA had come here and they were asking some of the company representative when do you think is the right time to tell you about our inspection dates, he said don't tell us you can come anytime, so that kind of confidence gives a you know strong evidence about the way the processes are done so you don't have to prepare for inspection you make sure that the process is done right so absolutely correctly.

Chandrachur Datta - And the processes are so strong that the inspection is just another event. We are following the quality processes on a day-to-day basis.

Dr. Rajiv Desai - So, inspection should not be considered as a top priority, it should be a way of life, it should be part of the process.

Chandrachur Datta - So, let's call this ‘Perpetual Quality Readiness’ – this to be state that we all want to be, so. what all do you think we must cover toto achieve this ‘Perpetual Quality Readiness’?

Dr. Rajiv Desai - One is make sure that the people who work in any area should be properly trained, correct training should be done for creating records. And this is something that has happened in the recent times that they feel that if you create records that will please the inspectors don't create records, train the people to make sure that they are fit for the purpose for the activities that they're doing. When they're confident they'll be able to demonstrate, they'll be able to talk to the inspectors and that confidence is very important.

Chandrachur Datta - So, like you said, if they have been observed for 45 minutes or they are being interviewed closely by an auditor, it will be much better if they are trained for this, in the sense that they're practising it on a daily basis they don't have to be you know remembering this stuff what to answer to their question.

Dr. Rajiv Desai - You're right, first of all, don't put that pressure of inspection, There are companies who still talk about inspection as the only priority.

Chandrachur Datta - It's like that the event for which you are preparing for.

Dr. Rajiv Desai - The event. That should not be done. I mean nobody says that you should have every equipment brand new, you can still use older equipment but the way you operate the way you keep it, the maintenance of the equipment is very important. And this is something that people fear that ‘oh if the machine is old we'll not be able to demonstrate and show that it still works’. It will still work, but make sure that you have a proper maintenance, you have proper preventive, you know activity done on it, the calibrations are done correctly,

Chandrachur Datta - Correct

Dr. Rajiv Desai - People are aware of what's going wrong or right in that, so that they are in complete control of the processes.

Chandrachur Datta - So, just to add here what I find funny is people put a lot of importance on you know external - how to put it, a glaze of things, they put, like you saying, they put a lot of importance on new machines anywhere, someone new takes charge the first things that he finds fault in is - that there should be new machines here the lab should be painted and need a much bigger area. So, you are saying instead of that it's not like it's not required but first importance should be on the processes like you said the calibration of the machine maintenance all that if it is in place then these are secondary I must do that also but if these are in place then I will be sailing through the inspection anyways and my people will be much better responding to a quality question, am I understanding it correctly?

Dr. Rajiv Desai - See, if the equipment and the people you know are being used in the right manner obviously the surrounding areas and the first impression about the facility, they will always have that in mind and that will be done, just don't make sure that you know like a fancy facility but when you go inside and talk to your people, talk to the operators, look at the facilities, look at the manufacturing equipment, look at the analytical instruments you realise how nothing…

Chandrachur Datta - Inside it's all false.

Dr. Rajiv Desai - So, this is something that you know always comes in most of the observations.

Chandrachur Datta - So, why do you think this is more and more important for companies to adopt this mindset. So there are still people like you said there are still people who think that the whole quality thing is to you know pass that day of inspection. So why do you think it is important for companies to, specifically for Indian companies to change the mindset and go to a perpetual quality mindset.

Dr. Rajiv Desai - It's important that when you have that kind of mindset of ensuring that your facilities are of the right quality, of the right requirement, obviously you don't have to prepare for anything. Everyday is like you come to your work and what I say is it doesn't take time and effort or even for the amount of money to keep something in a very proper condition, but the moment you say I'll prepare for the inspection I'll spend time, I'll whitewash everything, I'll clean up everything that doesn't help you because somewhere or the other you're going to be caught. And this is what has been realised and most important is that the pharma, even though it's a business it's an industry you have to make money so the moment some companies who have gone through this process and not been able to meet the expectations of the regulatory agencies and have been cited and they have not been able to you know meet the expectations they have been cited they have been given warning letters obviously the business has suffered.

Chandrachur Datta - Correct. It has an implication on your business as well.

Dr. Rajiv Desai - Exactly. So there's no point in spending money on remediation, spend money on the right at the right places with the facility, with the equipment with the people I think that will go a long way in your business also.

Chandrachur Datta - Correct. So two things because you talked about money. So, people think that if I have to put a quality process, that is perpetually taking care of my, you know as a culture I have to change something. It will be a costly affair compared to if I just prepare for the inspection. Do you think that is right? I already get from you that it is not right but still.

Dr. Rajiv Desai - It's not correct. I mean people feel that spending money on quality spending money on your infrastructure will be expensive but in the long run it definitely helps.

Chandrachur Datta - Correct.

Dr. Rajiv Desai - This is something that everybody should realise. I can understand that you know, unless you have proper control on the things and you should have people to manage those things also, then only you'll be able to make sure that it meets the requirements.

Chandrachur Datta - Correct. So, we always try to convince our clients that the cost of quality is something that has implication on lives of people as well as on your business so you really cannot evaluate it just by comparing – ‘I am buying four machines vis-à-vis, I'm training people vis-à-vis ok, if I don't do this and just manage the inspection - how to do it’. So, I thank you, you are pointing me to that direction itself by the way doing this does this change anything significantly in the day-to-day life of the manufacturing and QC people, if I have to adopt such a mindset will it change something drastically inside?

Dr. Rajiv Desai - I don't think so. See the quality culture as they call it is a top down impact. And when the top management says or the leadership says that this is what we want I think everybody follows. Nobody does anything by themselves unless you have people who create that kind of a creativeness of doing some shortcuts. But if you have a very clear mindset about what should be done and you should be looking at the patient first then your quality standards go on a very high standards.

Chandrachur Datta - But does not change anything significantly for the day-to-day operations vis-à-vis the analysis.

Dr. Rajiv Desai - In fact it becomes more easier.

Chandrachur Datta - You don't have to hide anything.

Dr. Rajiv Desai - You don't to hide and people are more free to say and the moment you have that kind of attitude in the company that you're free to speak a mind, free to give inputs, you'll always be improvising. That improvisation happens with the people giving you inputs from the shop floor also.

Chandrachur Datta - Correct

Dr. Rajiv Desai - And I have my personal experience that I always make the shop floor people, the operators and workers to speak and I can tell you some of the best of the solutions have come from them.

Chandrachur Datta - I completely agree.

Dr. Rajiv Desai - You can't get solutions sitting the boardroom and the conference rooms.

Chandrachur Datta - They know the solution intrinsically only thing is no one asks them, so they don't tell and even if they tell I have found that people know - be put under the rug, ‘et's not discuss this’ and all that. So if we can you know drive quality as a mindset I think everybody will be open to give their inputs.

Dr. Rajiv Desai - You should give that openness to the people that's very important.

Chandrachur Datta - And that improves the quality throughout. Thank you.

Chandrachur Datta - So, next question is to implement this perpetual quality readiness what do you think will be the challenges that we'll face, anything that comes to your mind?

Dr. Desai - Challenges, as I the said if you have some activities which are being done in a not so correct manner to change them, you may have people who would say that no this cannot be done, that cannot be done because we have been doing it for so long, so you should make sure that you really eliminate such people.

Chandrachur Datta - So, basically the shift will be very difficult, the change management would be difficult.

Dr. Rajiv Desai - It is not difficult it is only the mindset of certain people I know that not everybody has that kind of an intention.

Chandrachur Datta - Okay.

Dr. Desai - But you'll have some people in the company who say no, this cannot be done.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - And that will be like an infectious mindset which cascades down the line.

Chandrachur Datta - Okay.

Dr. Rajiv Desai - And then they say ‘my boss is saying so, so I cannot do it’ but the bosses should have that kind of a courage and conviction that things can be done.

Chandrachur Datta - Yeah, like you said it's a top down approach.

Dr. Rajiv Desai - It's a top down approach.

Chandrachur Datta - The people at the top must give, must create that environment of fearlessness ‘you do the correct thing, don't worry I'll protect you’.

Dr. Rajiv Desai - I can tell you that we are talking about these changes of facilities and changes of equipment also. People have been you know by and large you know feel the comfort level of using the same kind of a facilities, same kind of a you know system and they don't want to change. Most important is when technologies come in I found that people are not ready to imbibe or at least adopt those changes the reason is the - fear of failure. And if we have people who have that kind of mindset things will never work.

Chandrachur Datta - Okay. In general what are the common quality incidents that happen in the plant, in the sense what should we focus on improving. If we need to improve the quality as such, shifting the topic a little - from the perpetual quality readiness to what is happening in the plant today. So what are the kind of problems that they face and what are the preventive actions that you think we should take first?

Dr. Rajiv Desai - See most of the activities and the work that is done it's still manual.

Chandrachur Datta - Correct.

Dr. Rajiv Desai - And, it's all dependent on the physical activities. So look at ways of how to make things smarter, make sure that you know you minimise the errors. I mean we talk about a lot about this human error okay, why will human error happen the reason is the process have been in such a manner that they, don't give a thought about how can it be improvised, how can it be made simpler. And documentation wise also I mean we feel that more and more documentation is good for the company, but there are new techniques technologies of electronic documentation.

Chandrachur Datta - Yes

Dr. Rajiv Desai - This is not something expensive. I mean people are used to it. Now tell me even the youngsters or anybody for that matter how many of us use a pen outside the factory, okay we hardly use a pen.

Chandrachur Datta - And there we are making them write pages after pages.

Dr. Rajiv Desai - That's right. In fact it goes to the extent of telling what kind of colour should be there. and that's the only place they use a pen and the moment they miss out something, we penalise them. We you know, find faults in them. But in our day-to-day activities, we got these apps, we got the smartphones okay which are so very easy for us now.

Chandrachur Datta - And everybody's so used to it.

Dr. Rajiv Desai - So, the fact remains that they have adopted this, I mean we didn't know what we want but we were told that these are things available so the same things are coming in the plants also. So the technology is so good now that the documentation can become electronic and there are some very good technologies which are available both Indian and overseas which can be adopted for the facilities and companies should really encourage to implement them.

Chandrachur Datta - So, if I have to make a theme out of whatever you are saying so make the lives of the analysts simpler.

Dr. Rajiv Desai - Everybody.

Chandrachur Datta - Don't make them do things which they probably don't need to do that can be done by someone else so let someone else do it or if we can take help from technology we should take help from technology at all times.

Dr. Rajiv Desai - I can tell you there's a study which has been done where a five minutes activity requires 15 minutes of documentation.

Chandrachur Datta - Yes.

Dr. Rajiv Desai - Okay, where you supposed to record in some document, some log books, some registers. And somewhere anybody makes mistake the physical activity is forgotten and people start looking at the documentation mistakes also. So look at how you can consolidate them. There are many initiatives by the companies we talk about simplifying the SOPs. Under the name of simplification they become more bulkier, okay.

Chandrachur Datta - More elaborate.

Dr. Rajiv Desai - And that simplification has to be very smartly done. Involve people, as I said, they'll be able to give us more ideas about what should be done in a better manner.

Chandrachur Datta - Because they are facing it every day they already have the solutions in their mind. Why are the approving bodies like we discussed so every time a mistake happens in the lab we generally have to do an investigation for it. But mostly what we have also experienced that the approving bodies like USFDA they're not very happy with the Root Cause Analysis (RCA) done for these incidents or invalid OOSs that happen in the lab. Why do you think they are consistently unhappy with the way we approach these errors?

Dr. Rajiv Desai - As I said in the beginning, mistakes can happen.

Chandrachur Datta - Correct. Unavoidable.

Dr. Rajiv Desai - Unavoidable means, yeah, they are mostly happening because your process is such that they tend to, you know, tend for the people make mistakes, either intentionally or unintentionally so we have to be very clear about how to do the fault finding also. Secondly, the SOP says that we have to complete the investigation or close this part within <30 days, that's the standard thing in the industry. Now in the process you really miss out what was the real cause and because of the fear the people involved in the actual activity do not come out with the facts. And, the team, the so-called team which is formed to do the investigation try to look at some ideas or creative reasons of saying that why it could have happened.

Chandrachur Datta - Could have happened

Dr. Rajiv Desai - And then you create a document of your investigation, you create a Corrective And Preventive Action (CAPA) and close a chapter that's done. Fast forward to the inspection, now this event has happened, say one year back or two years back, you have an inspection, the event gets pulled out as part of the investigation and somebody's telling what exactly, so the most common thing is ‘walk me through this investigation’, so you have bulk of documents sitting over there saying that this is what happened the person who's explaining has absolutely no clue of what has happened one year back.

Chandrachur Datta - Right

Dr. Rajiv Desai - Okay, and he's fumbling or she's fumbling about explaining what exactly happened now one is that the invest the investigator doesn't have time to go through your 100 page document, okay, they want to understand in two minutes, five minutes what exactly was the issue. How it was handled and how did you correct it and how do you make sure that it doesn't repeat again these are the four fundamental questions that they will ask. Now if any of the question is not answered properly you had it.

Chandrachur Datta - And by the way when you have filled up these many documents answering these four simple questions should not be rocket science. One should be able to answer them.

Dr. Rajiv Desai - So, that’s why I tell create a one page summary of the investigation. What happens is even if the persons involved can read after one year that one page summary immediately you recollect back what exactly happened

Chandrachur Datta - instead of reading through the whole thing.

Dr. Rajiv Desai - Exactly.

Dr. Rajiv Desai - And most important is that when you are trying to explain something you should be able to very clearly articulate what exactly happened and how you were able to handle this. Now with the whole confusion during the inspection that they're not able to explain properly and you should be very, you should know that the inspectors are highly trained people. They may or may not be subject matter experts but, they look at the way the person is talking whether the person is really you know genuine and is able to explain the things correctly and if it is not happening and they start asking questions and they're not answered and then you find that the observation gets cited and then afterwards when the inspection is completed you got a 483 then you have all the things coming up and you keep on claiming that ‘oh this particular question was already there in the investigation report’, but who why were you not able to show at that at that time.

Chandrachur Datta - Or answer him.

Dr. Rajiv Desai - Or answer. So if you know that a particular manufacturing quality or any deviation which happened or incident happens there's a logic behind it, there's a logic of reason of why it happened. Now if you're not written it in the same manner of what somebody would look at and you start giving a totally different creative reason for it you are bound to be caught.

Chandrachur Datta - Of course. So, Dr Desai we are talking about root cause analysis and you explained it beautifully now can you tell us how to connect these two topics if I do the root cause analysis properly how can I achieve Perpetual Quality Readiness how are these two things linked.

Dr. Rajiv Desai - Well it's an easy question and a complicated question also I would say that. One is that I would say you know have that kind of confidence of finding what has gone wrong. Okay. And the moment you have that kind of a mindset in the company you'll definitely make sure that the root cause is rightly found right so it's a very simple thing you know why to beat around the bush. Okay. And as I said in the beginning that it's all about making sure you are commercially viable. Okay. Specially in formulation if there's a failure you can't do anything, you have to just throw the product, throw the batch out.

Chandrachur Datta - There's no other way out.

Dr. Rajiv Desai - Okay. So, can you afford it? The answer is no.

Chandrachur Datta - Not every time. Of course.

Dr. Rajiv Desai - Not every time. I mean no matter if you say my failure rate is just about 1%, that 1% itself is a huge cost. So why can't you reduce that. So when it's possible because if you have that mindset of identifying the real reason, then you hit the nail about how can you minimise it happening again. Okay. It can be anything your facility equipment people then focus on those areas now if you done it correctly I think the regulatory agencies will also know that you have that kind of attitude in the company. Most important is that, as I said in the formulations you directly sell the products or gets distributed to the patient. The patient gets it there's nobody else in between, its only the distributor or pharmacist. But when it comes to API and if the API is done in the right manner it goes to the formulation the formulator is actually believing and relying on the quality standard of the API. And if there is something wrong which could not be identified and I can tell you…

Chandrachur Datta - At the API stage.

Dr. Rajiv Desai - At the API stage. The challenge is that not all methods of analysis will be able to tell you what is the impurity or what has gone wrong in the process, because that is never challenged as part of the development work. And the biggest problem is that if you find the process not going well your methods are not able to detect, identify, quantify those impurities, they get transferred to the formulation, and ultimately who suffers the patients. So you should have that kind of a mindset saying that ‘I will find a reason I'll make sure that it is taken to the logical conclusion and making sure that my product will be considered throughout the life cycle’.

Chandrachur Datta - Our observation has also been that when you have done a proper RCA (Root Cause Analysis) the CAPA is, it's not just another checklist, let's just put it that way because I have seen that many in many cases the CAPA is just training of the people or just a checklist, add one more round of checklist and things like. And the checklist grows from 10 points to a 100 pointer checklist which is again a useless document that we prepare. So, if the RCA is done properly then the issue, the actual error will not happen again, I'm talking about more about the invalids the invalid errors not the lab errors rather if those are correctly identified then, when an investigator or an auditor is coming like you're saying I can answer fearlessly what exactly happened and what actions I have taken if I know that if I don't know what exactly happened I have just taken a checklist or an analyst training as a CAPA then my answer will not be as fearless or as confident. Do I understand it correctly.

Dr. Rajiv Desai - That's true.

Dr. Rajiv Desai - See, as I said first of all the root cause analysis should be properly done – openness, making sure that you bring in the right people at the right place, not doing the investigation sitting in the conference room. Go to the shop floor. That's why they talk about Gemba walk, they talk about you know talking to the operators, looking at what exactly happened, the clues behind this failures. Secondly if you are able to identify the root cause then your corrective action is obviously going to be the right thing. You also mentioned about training, training should not be the only corrective action.

Chandrachur Datta - Correct. I’m completely…

Dr. Rajiv Desai - it can be one of them. But I invariably find that training becomes a very common corrective action okay and most…

Chandrachur Datta - Without correcting anything.

Dr. Desai - So, you just blame the person. You just blame the person saying that he did it wrong, that's why. And not only that you train him, you train the others in his group, in his team. So it just creates a document. And most important is that I've seen, the inspectors coming and saying that ‘oh you had a training so let's look at the record’, so the companies try to create those records and also saying ‘oh see this is the record’

Chandrachur Datta - Who all attended

Dr. Rajiv Desai - Who all attended, the attendance record. So what was trained that is not there. At least there should be some sort of a module which says that what were you trained on you find a fault you know that the people are trained for what, there's no record of that…

Chandrachur Datta - Correct

Dr. Rajiv Desai - And mind you after one year or two years nobody realise, remember what was done.

Chandrachur Datta - That is a bigger challenge actually.

Dr. Rajiv Desai - And why should you not be penalised for these kind of activities.

Chandrachur Datta - if somebody is fabricating it's very difficult to remember what all and…

Dr. Rajiv Desai - When you start getting these probing questions okay and the people who are sitting in the conference room explaining it it's a quite a challenge and obviously you are bound to get observations.

Chandrachur Datta - Okay. So can you share any success stories or examples of companies who have successfully implemented this approach towards quality that there will be Perpetual Quality - I’m not working for inspection readiness only any examples

Dr. Rajiv Desai - I’ll not name the companies but I can tell you that, so as normally said no that with mistakes you learn. Okay. In pharma you should not make mistakes you should learn from others mistakes.

Chandrachur Datta - Correct

Dr. Rajiv Desai - Okay. And there's umpteen information available in the public domain on the 483s and the mistakes and the observations which have been cited. That itself is a big learning you know school for you. Now companies they don't have a deep pockets, smaller companies, medium size companies, so what they say is ‘I have to survive, I have to be in the market, I to be in the niche market I will not try to do anything wrong which will jeopardise my business also. So I want to make sure that my work is so good that I will strive to make sure that my product is consistent, no failures, no recalls, no deviations or minimum deviations, but do a proper investigation. And that kind of investment will be far reaching compared to what you do spend on the remediation. And we have seen that the amount of remediation cost that goes through in the bigger companies is far higher compared to the small the medium size and small companies just can't afford it

Chandrachur Datta - Okay

Dr. Rajiv Desai - So they say we can afford maintaining my quality. I can afford maintaining my consistency I’ll spend time in training I’ll spend time in ensuring that my equipment are well, you know, taken care of facilities are up to date, not doing something fancy, but making sure it meets the requirement and the confidence of the people till the lowest level of that operator should be seen. And ,I've seen some of the places where the inspectors go so they ask whom should I talk and the senior person says, ‘you can talk to anybody’.

Chandrachur Datta - That's what we are trying to do

Dr. Rajiv Desai - And, when you have that kind of confidence of people saying that they can talk to anybody, of course we also make sure that when some question is asked to person, if that question is not relevant to you, please direct it to somebody else who knows it. So that the right answer is given.

Chandrachur Datta - Don't expose a person who does not

Dr. Rajiv Desai - No, not necessarily expose I mean it can be let them walk to any place. Now many times, you know it's a typical mindset of our Indian way of working. When the boss is speaking I'll just keep quiet, okay, the boss is the administrator, he may not know the nitty-gritties of the activities which are going on in his department, not necessary.

Chandrachur Datta - Absolutely

Dr. Rajiv Desai - Okay. He's there to manage the things. So if he's asked something very you know vital thing about a laboratory about plant, he can very well say confidently, say ‘I'm the administrator that's not my day-to-day activity but, Mr XYZ he's the one he can answer’ the moment you say that shows the confidence of that department of the person saying that the quality does not end or start or begin or end there it goes right to the end of the hierarchy.

Chandrachur Datta - And you were saying these kind of companies are existing in India as absolutely there are people working like this.

Dr. Rajiv Desai - Absolutely

Chandrachur Datta - And you are also saying that they got forced to work like this because they don't have you know access to excess funds, maybe.

Dr. Rajiv Desai - It's like as I said know they want to make sure that they invest in the right manner not in the remediation, making sure that they, see there are medium sized companies who are ready to invest on software. I can tell you most of the technocrats who have started the companies, they themselves have worked in bigger companies, come out of them started companies, now they're looking at not only software’s, they're asking is there anything that I can do in terms of Artificial Intelligence (AI), Machine Learning (ML). So they're ready, and what they want is ‘if I do it right in my beginning the moment I grow my system will also grow accordingly, rather than I grow and then try to implement something’ which is very difficult

Chandrachur Datta - Understood. So in light of this that the new technologies are coming, people are changing their mindset, in terms of you know when they're small in that stage itself they're trying to build something which will support them or sustain them even when they're bigger so how do you see the future of quality readiness evolving in the pharmaceutical industry in India.

Dr. Rajiv Desai - It's very bright I mean the youngsters are very much aware. And I can say that when some the youngsters are now coming into the industry or into their career. They want to they want to really prosper and grow. They don't want to be part of a failing company. Okay. They don't want to become you know somebody who is looking at quality way of working in a very different manner. So, it's very important for them to also work in an environment which gives them that kind of a, you know, I would say confidence and also that pleasure and also satisfaction.

Chandrachur Datta - Also maybe pride.

Dr. Rajiv Desai - It’s pride

Chandrachur Datta - Take pride in their work

Dr. Rajiv Desai - Absolutely. And I've seen that they if you give them the chance, I mean I can tell you the youngsters are the one who really are ready to implement technologies also. I personally had experience where when I wanted to bring in some technology, when I was taking care of quality as a Quality Head. The moment I put this across to some of the seniors, there's a bit of resistance apprehension whether it'll work or not. But the youngsters are there just a couple of layers below ‘Sir, we'll do it’ because that confidence and they're just waiting for that encouragement. The moment somebody says you do it success is mine failures is yours that doesn't work, you should be also ready to take that process together and then nobody, you know, works for failure.

Chandrachur Datta - And nobody can stop you also.

Dr. Rajiv Desai - Nobody can stop, and then they take pride. First of all you should be ready to give the credit to the people who are working.

Chandrachur Datta - Absolutely. Okay. Dr Desai what a enlightening conversation last question - what role do you think the regulatory bodies in India and the government of India their initiatives has to play with driving this change. Can they do something that you know kind of forces people to think in this way or you know brings the people who are you know digressing can bring them back to the line.

Dr. Rajiv Desai - The biggest change that has happened in this country, which was very much needed was the updated Schedule M, which is a guideline for the pharma industry for the country. Not that it was not fulfilling the requirement, but it had some of the areas which were missing and we brought it in and most important is the implementation part of it. And the Department of Pharmaceuticals which is under the Ministry of Chemicals and Fertilizer is really striving to make sure that the pharma industry really takes it up in a big manner. There are initiatives by the industry and the government to ensure that the industry as such grows. The bigger companies, the bigger generic companies, even though they may be fighting for business opportunities in the same market but when it comes to India as an industry they're all together.

Chandrachur Datta - That's great.

Dr. Rajiv Desai - And, they want to make sure that India should be able to meet up to the requirement of the outside world. And I can tell you that no company can work by themselves, they need support in terms of partners, in terms of vendors and these vendors are small companies medium size companies as we call them MSMEs. Okay, unless you upgrade the standards of these MSMEs you can't show reach a certain level. So obviously there's a big initiative by the top pharma companies to provide that kind of a encouragement, provide that kind of a support to upgrade the technology, upgrade the competency of these companies also

Chandrachur Datta - You can't run alone you have to take everybody along with you.

Dr. Rajiv Desai - Yes. And on the on the same lines, I'm sure that in the recent times we've heard a lot of this quality issues about some of the products which are sold from India to some countries. It is an embarrassing situation. It's not a good sign, but I can tell you it's not a industry-wide issue, maybe you know when they when any person or any organisation looks at business and they find that the business is lucrative everybody wants to come in that business. And what I can say that, there are lot of people who have come in this industry just for the sake of making money. And the ethics are compromised. Okay, and we want to weed them out, we want to make sure that the industry really looks at the ethical practices of the industry. As I said earlier also, that we are in a very dicey situation. If there is an issue with any product outside by X company…

Chandrachur Datta - Outside India

Dr. Rajiv Desai - outside India or wherever it's there. Tt's not the company which gets blamed, it's the country which gets blamed. And that is something quite embarrassing for us. Maybe I'm not the only one, but I have got so many of my colleagues and seniors, I mean we would never compromise on such things.

Chandrachur Datta - And as a as a representative of the industry it becomes an embarrassing situation

Dr. Rajiv Desai - But I can tell you that the same thing happens outside, if a multinational fails to meet the requirements and the patient product issue with the patient it's the it's the company which gets blamed not the country from where it comes. That's the irony for us.

Chandrachur Datta - That should be a learning point for all of us, that when we do something wrong, even if one of us is doing something wrong because we are from this part of the world the whole country might get blamed for it.

Thank you, Dr. Desai. This was super enlightening thank you very much.

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