As Indian pharma companies now move towards AI and automation and even connected manufacturing, what talent gaps are you seeing emerging at the plant level and are companies struggling more to find digital skills or professionals who can combine the pharmaceutical knowledge with technology?
With this emerging AI, automation, industrial internet of things, the entire pharma industry landscape is changing very rapidly. This change is happening not just at manufacturing level, but it is taking place at every stage of the entire product life cycle that is at the research and development, drug discovery, manufacturing, quality control, in process quality control, supply chain and further regulatory guidelines or regulatory compliances. Obviously the things are being done in much shorter time with more precision and more accuracy.
When we talk about industry, it is all data driven. Earlier also conventionally a lot of data was getting generated, because equipment is running, they are being monitored for various parameters. So data is getting generated, then there is a quality control happening, in process quality control happening, then supply chain the product is being delivered.
Everywhere there are logs, maintenance logs, batch manufacturing records, master files, data has been always getting generated. But in the past the approach was about using that data to understand whether the product complies with the required standard and what went wrong, but that was a kind of reactive type of approach. But now the industry has been changing rapidly and now industry is making the right use of AI, machine learning, internet of thing for more kind of predictive approach, responsive approach.
It is not only about AI or digital knowledge which will sustain or only the technical knowledge which will sustain, because AI has a lot of role to enhance your decision making, to expedite the efficiency of your work. So it is going to complement your skill, it is not going to substitute your skill. So every person has to have a very strong scientific knowledge, there cannot be a substitute for scientific knowledge, but AI is going to help you in a number of ways like the data is being studied by AI and it is helping you in decision making, informed decision making.
People should have digital literacy, AI literacy. Once the data is being analysed by the system and it is showing you some kind of results, you should have an ability to interpret those results and arrive at some decision. So if you are not able to observe it carefully, critically analyse it further and arrive at some informed decision, then somewhere there will be a gap in your efficiency as well as your delivery of the output.
The industry now requires a person who not only has a very good in depth knowledge when it comes to science, but also he has a very good smart way to work by adopting the technology and arriving at a right decision by using the technology and these decisions because they are based on data, there will be more accuracy, there would not be just the assumptions, but there is an evidence based decision that is possible.
Industry is moving in that way, in that direction and this person has the requirement of a person who has both science based knowledge as well as digital literacy to convert that knowledge into informed decisions.
Pharma 4.0 as I see it is bringing production, engineering, quality, IT and data functions together. How far should a pharma manufacturing professional be expected to work beyond their traditional domain and which capabilities will increasingly be required to nurture that specialised talent?
When we are talking about 4.0, it is all about automation, it is about digitalisation, it is about continuous manufacturing, it is about smart ways of handling the product and delivering the results. The industry when it is moving ahead with these skills, the personnel also should align themselves with all these requisites.
When you said that it is a blend of technology, engineering, this engineering is also very much important because these equipments that are being designed, they are not an equipment which have all controls and these controls are also generating lot of data, there are sensors, we call it as industrial internet of things.
These sensors are giving you red flags, they are predicting that there is something going wrong and you are able to understand that there is a beginning of something going wrong and you need to stop the operation at that stage and take some corrective action. So, all these red flags you are able to get because of that 4.0 and 4.2 talks about continuous manufacturing. Now, in India and abroad also more commonly it is seen in manufacturing of oral solid dosage forms like tablets.
This is the entire pipeline operation, it starts from raw material and then the mixing, then milling, then granulation, then again milling, then blending with lubrication and then compression and then further levelling, packaging, levelling everything is happening on a single line.
There is something called process analytical technology which is developing very fast. So, we have NIR near infrared Raman where those probes are able to at entire pipeline everywhere they are able to understand, they are able to monitor the micro changes in the pipeline, what is going to be the bottleneck, where these micro changes are happening, what is the trade of changes taking place and bridge pad will be able to tell you whether everything is going on well and there is a go status or no go status, there is some micro change happening, there is some kind of missing of some kind of required specification.
This is how development happens where a lot of core engineering knowledge is required. So, for designing these equipment and installing those sensors, the displays, the PLC boards. This is what is the integration of engineering with the science and pharmaceutical technology and that is only giving us a lot of data.
Data logs are getting generated and so when it comes to regulations, regulation is becoming very easy because earlier may be conventionally, traditionally whenever there is an inspection people used to run around and generate the data, but there is no such need every minute you are ready for any kind of regulatory compliances or audits because you have a data logs and there is a very high degree of data integrity because everything is available digitally.
You cannot manually say there is no intervention except that you have to read it and interpret it and take the decisions that are the intervention, but otherwise data integrity is going on very well, the trained analysis is possible, audit trails are available. That is how industries benefited a lot due to this 4.0 developments and automations.
As AI and digital systems enter regulated manufacturing environments, how should the industry balance digital capabilities with fundamentals like GMP and data integrity, validation and mostly cyber security? Is the current talent pool equipped to manage this convergence?
I am an educationist. I would like to share with you that the Pharmacy Council of India is an apex body for pharma programs in all India and now in this year 26-27 academic year they have come up with a revised syllabus and that revised syllabus is introducing AI and ML at almost every semester.
Students are going to start from basics of Python and its application and then they are going to also study data analysis, further they are going to study AI and ML and then application of AI in clinical research, pharma for vigilance, regulatory and healthcare. So, students will be definitely getting equipped with all these skills required with the new syllabus that has emerged. That does not mean the previous students who have stepped into the corporate are not equipped with that.
We always had a platform called Swayam. That is the government of India created MOOCs platform, Massive Online Open Courses. So, through that platform our students were studying all these AI and ML related subjects through self-study and completing some certificate courses.
Also there are number of online educational edtech companies like Coursera, UpGrad which has given many such programs our students and when I talked about VES College of Pharmacy and my role as a chairman of board of studies of Pharmacy of University of Mumbai, four years back I had designed one course on AI in healthcare which was a value added course for University of Mumbai affiliated pharmacy colleges.
Almost every college offers a value added course. In our college every year we offer it and we integrate it or we collaborate with our engineering college, VES Institute of Technology and their faculty members come and deliver that course.
That is how we are trying to train our students to get adapted to these new trends because that is important.
When you talk about cyber security, the government of Maharashtra also takes lot of initiatives and they always insist that our institutions should also conduct the programs on cyber security because students are now more available online because online resources are huge in number.
There are chances that while using digital transactions and on accessing online data somewhere their mails can get hacked, their data can get hacked or if they are working for their organisation there also such threat is always there of hacking of the data.
It is very important that students are aware about how to protect your data, what should be revealed, what should not be revealed, how you can have security measures and what are those measures, how you have to encrypt your files, password protected.
That kind of education is also equally important because we know that when we are travelling somewhere the Google comes to know where we are and Google starts giving us the information about the shopping malls, theatres and everything in that area. That means whatever we are doing on WhatsApp or online through any kind of online platform it is getting recorded and AI is able to understand your whereabouts.
Students should know. We also keep telling students when you are generating a research paper or you are using chat GPT for example, for redrafting or paraphrasing your research publication it is you should be careful you cannot directly put your entire abstract there or a lot of very big length of article there because once you put it in the AI chat GPT has also captured it as a data.
Sometimes your own data will be shown as plagiarised because chat GPT has captured it.
These are the threats also when the technology is moving on and everything is available through smart means that data somewhere is getting generated. So, protection of data becomes very important and we know that there is an act about privacy of data.
Even industry and employers are worried about what data of your employee or your organisation should be revealed and what should not be revealed, what comes under the umbrella of disclosure allowed, what should not be allowed for instance Aadhaar number you are not supposed to disclose.
Cyber security when it comes to this is a challenge to everybody, the employer, the employee, the student, the educational institutions, the management and we need to be careful about it and digital literacy that is indispensable and we need to train students and our syllabus is now framed. So, their students will be completely updated by the time they graduate.
India is no longer looking only to strengthen its manufacturing base, but also trying to enhance its capabilities in innovation and product development. What kind of talent will this shift require and is the current industry academia ecosystem equipped to prepare professionals who can contribute both to manufacturing and innovation?
Innovation since last 4, 5 years I can say that innovation has become a very important component in the educational systems.
Especially so, when our government of India and Honorable Prime Minister promoted Make in India, start up India policies and the Ministry of Education also incorporated Institution Innovation Council, Ministry of Education’s Innovation Council.
Through that Innovation Council every institution was required to set up their own institutional innovation cell and not just that to promote that kind of activity. The Ministry of Education earlier it was MHID, now it is the Ministry of Education. So, they also encouraged colleges to take part in the ranking framework based on your Institutional Innovation Council activity that is called IIC short form.
Every institution including our institution we are taking part every year in the IIC activities ranking framework. So, through that framework every institution conducts a lot of programs to encourage students to think differently.
Entrepreneurship related programs, design thinking then we invite people having their own start ups and how. So, how commercial adaptability is important, how do you convert the prototype into a commercially viable product, that kind of training is being given the entire business canvas is being taught to students while they are graduating and that is how innovation is innovative.
For entrepreneurship the skills and the kind of knowledge that you need that institutions are providing.
Now, when it comes to innovation as an attitude, we know that it is not taught in the classroom, but it is all about the kind of spark that you have about creativity, critical thinking, and problem solving. You are always very creative when it comes to thinking out of the box.
Students are deliberately made to think about the community based problems, what is going around and based on that do you find out some unmet need that society is facing and for which solution is right now not available and it need not be very hi-fi thing because at first year and second year level what advanced research you can think about.
It need not be about genomics, proteomics or bioinformatics. It can be about small small things like some kind of smart watch which has an alarm which takes up your vital and gives you some kind of indication like there is something wrong with tachycardia.
So, you need to consult a doctor or in my college I developed one film which was just a plain film of a polymer, but it was water insoluble and it was a peelable and biodegradable polymer.
Our idea was just to apply the film and then go into and do the work where you have to deal with some detergents or some for the agricultural community, some fertilizers, manure, soil. So, your hands will be protected and it is not a glove, but it is just a film which is mixing with your skin.
It is almost invisible. You do not have a feeling here you are wearing something, but your hands are completely protected and after work is over and you do not have to now deal with the hasardous material just peel it off and it is biodisposable.
Such types of innovations have a lot of concepts that are strong, but the work can be very simple: just dissolve, mix and make a solution. So, these kinds of innovations we are asking students to think about.
That is what is called design thinking. We are trying to create them about finding out some problem statement for which solution is available and what can be that solution, that solution oriented approach that is being taught to students by giving various examples, the contemporary examples in day to day life like food products, nutraceuticals, formulations, drugs, medicines, devices.
Innovation, We know that when there is necessity there is an invention, but we are going beyond that like we are trying to tell them that you have to whatever is your idea you just try to experiment it do not just neglect it.
That is what a tinkerer’s lab is. We are giving them the platform, we give you chemicals, we give you equipment, you just do it and see whether you are able to convert it into a product or you are able to convert it into some prototype which can be seen as this is how it will work.
We have heard about digital twins right, what is a digital twin? It is a mock or prototype of the simulated model which before physically we make it that digital twin tells you that this is how the process will appear, this is how the product will appear and this is how it will work.
We are also trying to tell them you make a twin which is in the form of a prototype and then later on maybe in the phases we have our own incubation centre Hashu Advani Business Technology Incubation Centre where you can incubate and we can convert it into a viable solution.
That is how institutions are encouraging innovation, VES College of Pharmacy has our own institution innovation council, we conduct many sessions, we invite speakers who have their own startups, we also conduct workshops on design thinking and we nurture that innovation thought.
Our second year student recently when we had a design thinking workshop she came up with the idea of a digital watch and she is saying in that digital watch we will have a strips blister pack of the anti asthma drug like salbutamol and it will also have a kind of sensor.
So when a person is having bronchospasm because of an allergen to which he or she has been exposed to, the sensor will be able to capture that anatomical change and it will show a red brick.
The person who is allergic to certain things will come to know, okay I am going to land up in an asthma attack.
So I will just dial the next dose and I will inhale it through the asthma digital valve. So the idea was so good that we took her to the Tinkerer lab and also we introduced her to some other engineering college students of VES and we found a team and we would now tell them, now go ahead and try to design a certain type of watch.
That is how we are encouraging students.
As India seeks to strengthen its position as a global pharma manufacturing hub, could talent become a constraint to the adoption of smart manufacturing and what should industry and academia start doing to ensure that the talent pipeline keeps pace with its transition?
Very good question. The Pharmacy Council of India is telling us, it is making it mandatory that every institution should have 10 MOUs with the industry and hospitals.
Out of that 10, at least 5 should be with the industry. Now these MOUs should not be just the on paper record, but it should be an active MOU.
My suggestion is that industry should adopt at least 3 to 4 colleges, may be based on geographical location or may be because of the, based on the research interest that these institutions are having and their research forte and then industry should hand hold these academia.
Each industry if it adopts 2 or 3 institutions and they hand hold them, it is like a sharing of the expertise, sharing of the facilities, sharing of the knowledge and that can become a very good collaborative model.
Because we know abroad in the US, so many products, so many vaccines, even for example Covishield vaccine that was, that has emerged from one institutional research. Institutions have got a lot of creativity.
Institutional faculty members have got a lot of new ideas, but they lack its commercial translation into commercial products, whereas industry has expertise in commercialising it.
What I feel is that industry should set up the industry training center in the colleges and they can identify one such college in the cluster of 10 colleges and then this training center should give training to all the students available in that cluster.
The host institute may be considered based on its location and its overall expertise and the trainers available with their experience in research and in that institution the industry can invest through their CSR funding or any other source and install all industry compliant CSR compliant equipment, having all digital monitors, sensors, then PLC controls.
So that it is not the primitive machine or equipment that academic institutions can afford to have, but it is actually GMP CSR compliant equipment that industry uses.
But this training should be provided while the student is studying here. So that is what hands on training.
Merely going for an industry visit will not help in fulfilling that requirement. But if you have such type of center and it is catering to 10 nearby institutions, students can be visiting to this host institute for some 2 days workshops, additional their work for which this center can cater to their need for scaling up, for giving them better product with proper log and proper data which is printed and available as a digital copy.
While they are studying they come to know what are the industry practices and industry also should talk about QMS.
Academic institutions should set up the quality management system through their instrument rooms, pilot plant. So in our college we have already consulted Mr. Sunil Putkar who is a regulatory auditor and under his guidance we are setting up QMS systems, quality management systems in our instrumentation and pilot plant and record keeping.
Then we are going to ask students to maintain it.
These are industrial practices. So in the college level itself they should come to know how the records are maintained, documents are made, done, then common technical data, CDDs, files are made. So everything should be trained.
How SOPs are made, standard operating procedures. So that training is required plus hands on training to handle the equipment because the industry has set up that kind of training.
My vision is that in our college there should be a translational research and development center.
This center will cater to translating your research into commercially viable products. That is one thing for which we are working on.
And second thing is that industry training center where we can tie up with the company and we can provide this facility for the nearby colleges.
We can volunteer to train them. That is what my vision is.
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