During Covid-19 lockdown, Messe Muenchen India, the organiser of leading trade fairs like analytica Anacon India, India Lab Expo and Pharma Pro & Pack Expo in association with Indian Pharma Machinery Manufacturers Association (IPMMA) has organised a serious of webinars focused on the challenges faced by the pharmaceutical industry.

The webinar held on 16th April 2020 deliberated on the topic “Time to collaborate, co-operate and innovate to face challenges in pharma industry”, and was well attended by over 400+ participants from not only India but also countries like Germany, Italy, UAE and Nepal. The webinar was also supported by IAIA (Indian Analytical Instruments Association).

The panel included names such as Dr. Viranchi Shah, Senior Vice President pan India & Chairman for Gujarat State board of Indian Drug Manufacturers Association, and Director of Saga Labs; Mr. Paresh Chawla, Chairman for MP State Board of Indian Drug Manufacturers Association, and MD of Alpa Laboratories Ltd; and Mr. Shirish Belapure, Senior Technical Advisor at IPA; and was moderated by Mr. Kaushik Desai (Advisor at IPMMA).

The webinar shed light on the current challenges faced by the pharmaceutical industry in the light of the pandemic and gave expert insights on what to expect in the future and viable ways for the industry to brave these challenges.

The pharmaceutical industry has been evolving continuously to ensure that there is minimum disruption and uninterrupted supply chain. This pandemic has given rise to many innovative means of communication, policies for ease of doing business, newer approaches in managing manufacturing operations, supply chain management and patient centric regulatory pathways.

It is said that necessity is the mother of invention, and the pharmaceutical industry is not behind. In the webinar, the experts shared their insights, thought-provoking ideas, and discussed the industry preparedness to fight this challenge.

‘Unique challenge calls for unique solutions’

Dr. Viranchi Shah

“Let me set one thing right, this is a unique challenge and it comes with a unique set of situations that nobody in the world has ever seen. So I think the first thing that every industry needs to do is take things day by day, because that is not too much that you can plan. However, if you see this challenge, this is a pandemic that has affected almost all the industries across the globe, and all sizes, whether it is small, medium or large, or whether you are in a healthcare space or in an automobile space. In whichever space you are, this pandemic has a very direct effect on you. This is a unique challenge, and it calls for unique solutions to manage.

There are disruptions in manufacturing and supply chain. But, I believe, when we say we are the global pharmacy we will bounce back in a short time, because there is definitely a need for our pharmaceuticals everywhere across the globe.

On the manufacturing side, most of our members have reported presence of almost 30 to 35 percent of their workforce, even when we are working during the lockdown. This translates into an efficiency of around 30 percent for most of the manufacturing units. This is something that needs to be rectified, because if you do not rectify this we will probably see more disruptions in essential medicines or in the supply chain in the coming years.

Let me reiterate that this particular epidemic is unique; nobody has ever seen something of this scale at least in our lifetimes. It comes with unique challenges, very, very big challenges. But the pharmaceutical industry is quite robust, we have whatever it takes to surpass this challenge, and when we are through this phase, when we pass this phase, we will prevail and the Indian pharma industry will prevail.

‘New challenge to the mankind’

“I think it’s a new challenge to the mankind. I have never seen such a thing happening to the whole country or to the whole world in the last 67 years of my life. Thousands of health professionals are battling this virus, putting their own lives at the risk. Governments and industries are working together to understand and address this challenge. Currently, we don’t know what will be the outcome of this situation. We need to support the victims and their families and communities, and search for treatments and vaccines. In that regard, I think, India is also in the forefront. I know at least two Indian companies which are looking for vaccine manufacturing. There are multinational companies as well.

Now the Government of India has enlisted pharmaceutical manufacturing as an essential service. We need to act swiftly and promptly to ensure continuity of medical supplies to avoid drug shortages. At the same time, we have to ensure the safety of the workforce in the manufacturing facilities. It’s absolutely critical. 

‘Trend is negative, but positive signs too’

Mr. Paresh Chawla, Chairman for MP State Board of Indian Drug Manufacturers Association, and MD of Alpa Laboratories Ltd

 “The Indian pharma industry has been the world leader in generics both in global as well as in domestic market. You all know that our industry is significantly contributing to the global demand for generics. Now this pandemic has clearly shown as to how the entire world is dependent on India and why we are called pharmacy of the world. Even the President of the US, the most powerful nation of the world, had to request India to lift the ban on hydroxychloroquine. I feel this is a very big feather in our cap that the world has started looking towards India with a lot of expectations. India has now definitely become a focus country when it comes to the new development or the supply of existing drugs. So I see a very positive side of this pandemic. Of course, everybody has their own set of problems in the industry in dealing with situation. Although the trend is negative, all these things are coming as positive signs to the industry.

Although pharmaceutical manufacturing is exempted from the lockdown, the supply chain disruptions are becoming evident. The non-availability of labour, lack of clarity over transportation of ingredients like packing materials, physical distancing, all these have bottlenecked the production volumes. Also there is a production slowdown due to raw materials and ancillaries not reaching the factories. 

IWould like to express my gratitude to the entrepreneurs of pharma companies who are operating their companies amidst all these, and taking a big risk. Nobody at this time would like to go to the company and would like to work. So, definitely, we should be grateful to all our fellow members, our staff and everybody else.

Another biggest challenge in front of the industry is how to manage the supply chain, how to keep the staff motivated, how the risk can be mitigated, and how you can keep your labour safe. This will be a very big thing in times to come, because I don’t see this pandemic to end very soon. So it’s very important that we keep our staff and people working in the industry safe.

Another thing which is coming up during this pandemic is that we need to finish our dependency for raw material imports from China. We need to come up, and we need to have our own pharmaceutical API industry. The packages announced by the government are definitely going to help.

On the innovation and collaboration, which is the topic of this discussion, we need to innovate and we need to collaborate for the times to come, because this pandemic is going to change everything – the way we look at things, the marketing, the manufacturing, the handling of materials, staff and everything. So, definitely, each and every company needs to find out the ways to collaborate and innovate.

“Another thing which is coming up during this pandemic is that we need to finish our dependency for raw material imports from China. We need to come up, and we need to have our own pharmaceutical API industry. – Mr. Paresh Chawla

Q. What are the operating challenges and how are we managing with limited resources?

Dr. Viranchi Shah: Once the lockdown was announced in March, the first challenge that everybody had was that nobody knew how the pharma industry was expected to work. We were knowing that we were an essential industry, and in the interest of the society and the nation we had to work and make sure that all the medicines were available, not only to the population of India, but across the globe who have been depending on us for medicines for decades all together. So the first challenge was understanding the dynamics, and how things work. As an association and industry, we did a lot of efforts talking to the government and trying to open up the channels where the people can travel, and materials and products can be transported. In my opinion, currently the biggest operating challenge that we as an industry have is the availability of the manpower. We have been collecting data from across India from various manufacturers, and the summery that I have is that almost the entire India is working, on an average, with around 30-35 percent of their manpower. There could be exceptions, but this is the major figure that I have.

When you are working with limited manpower, obviously there are limited number of activities that you can do. So you need to prioritize your activities in such a way that you continue to manufacture at least the essential portion of your drugs. On the other hand, since you are a part of GMP there are certain things you don’t want to deviate. So certain basic things, for example, your maintenance has to go on, and there are certain other activities. Prioritizing them on the manufacturing front is actually a very big challenge.

When we started talking to the employees, there are several reasons why employees could not turn up. One of the things that came up was that many had travelled back to their hometowns and there was no way they could come back. There’s a challenge bringing them back. Many of the people who are in the close proximity have reported to work, while others are not reporting either due to family issues or in many cases the chairmen or secretaries of their housing societies do not want them to go out every day and comeback, probably, with some infection. So there are these kinds of challenges to overcome.

Most of the industry entrepreneurs or people who run the industry have been talking to their employees, their key team leaders, and trying to explain that as an essential industry our role is to make sure that there is no shortage of drugs, and the supply chain remains intact. In my experience, if you put the right safety mechanisms in your plant like temperature mapping and ensuring that everybody has proper masks, gloves, and sanitizers are available, and if you try to explain the situation, handle the team with compassion and patience, then probably you will have the number of people coming to the plants increasing. And probably in the coming time, we would be able to see this challenge going down and would have people to undertake our operations in a much better way.

“In my experience, if you put the right safety mechanisms in your plant, like temperature mapping and ensuring that everybody has proper masks, gloves, and sanitizers, and if you try to explain the situation, handle the team with compassion and patience, then probably you will have the number of people coming to the plants increasing. – Dr. Viranchi Shah

Q. What are the risk assessments and the mitigation strategies that can be adopted or are adopted?

Mr. Shirish Belapure: For risk mitigation, first we need to identify the risks and then adopt the mitigation strategies. The two risks mentioned here are: the supply is being hit, and the absenteeism of the employees. These two risks have to be mitigated. I am sure that most of you must have seen “Creation of Emergency Plan”, the FDA guidance which had come out in 2011. It talks about the guidance for the industry, planning for the effects of high absenteeism to ensure availability of the medically necessary drug products. If you look at this document, it actually talks about the things that we need to do to mitigate the risk of not supplying the medicines, and it is taking about creating an emergency plan where the things that can be avoided during the period when absenteeism is high, and particularly when the absenteeism in the quality control is hurting in a big way, compared to even the manufacturing.

Some of the non-critical activities can be reduced like production equipment routine maintenance; utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air); environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production; stability testing for certain drug products and components; and periodic examinations of data and of reserve samples. You can actually extend this list to avoid the problems and the stoppage of your activities.

We can even reduce testing of packaging materials, testing of raw materials, etc. So this is one way of mitigating the risk. We need to have this emergency plan. Write down the things which are required to be done during this period, and how you are going to handle without impacting the quality of the product. Every regulatory authority today, be it European or American or our own, understand the current situation and they are ready to help us in this regard.

“We need to have the emergency plan in place. Write down the things which are required to be done during this period, and how you are going to handle without impacting the quality of the product. – Mr. Shirish Belapure

Q. What are your experiences on managing the supply chain issues?

Dr. Viranchi Shah: The supply chain of the incoming materials was the first challenge that we faced when the industry started working. When the lockdown was announced IDMA and all other industry associations were talking to the state and central governments almost on a day to day basis. The first thing we took was to address the supply chain issue, because we realized that unless the materials could come in, unless our finished products could go out seamlessly, the entire exercise of keeping your plants open would be futile. Ultimately there would be shortage of medicines in the market.

So the first task all the associations took was talking to the government to make sure that our employees could come, materials could move, and the transportation could open up, especially the interstate transport, as the API industry is concentrated around Hyderabad, and the formulation industry is concentrated in Gujarat and North India. So we had to make sure that the materials would come, and the government was very active in listening to us, and they promptly responded and we made sure that the channels were opened up. There were issues of opening the ancillary industries like the printing industry, the bottle making industry, the shippers, etc. Many things were needed to take things forward and the government on our request did immediately react and gave permission to open up these industries. Now most of the ancillary industries are working, the transportation is working, and the industry is working. But yet, I still repeat, the major challenge is the people who are not coming in. That’s why probably we are not able to execute it the way we want it.

Q. What are the collaborative and innovative practices that can be adopted?

Mr. Paresh Chawla: As I said in my opening remarks, this is the real time to innovate and collaborate. First of all, we need to work upon the user expectations. We need to shift our focus from product-centric to user-centric, and discover the ways to innovate. We need to define our goals and prepare a prototype as to what should be innovated and how to be innovated.

There’s a very good concept which has come up now. It’s called design thinking. I think all the pharma entrepreneurs should now have some sort of learning on design thinking. This will help us in planning, and we can predict and it is a personalized sort of plan.

Another big thing which needs innovation is in the segment of marketing. During the lockdown the marketing is dead. Everything needs to be online now. So we all need to go digital. We need to find out ways of, may be, a medical representative giving presentation to the doctor online.

Another thing which is very important now is to do internal collaboration in our organisation, by getting all the functional heads together. We need to talk to them and interact with them to bring about innovation. We need to get them in the boardroom now. The people who were earlier focussing on their particular job now need to do internal cross-collaboration, which will bring out very good results.

We need to work on reducing the process time of our batches. How fast you can put the raw materials into processing and how fast the product can be moved out of your company. Earlier if you were processing a batch in 15 days or 20 days, you now have to innovate ways, within all the regulatory purview, on how the period can be shortened. This will definitely help the industry as well as the end users in this pandemic period. Innovation should happen in a lot of areas, not just in manufacturing or marketing. We need to innovate on how we can handle our materials, and more importantly, how we can handle our people, because the primary concern at this time is the safety of the people. If they don’t have this feeling that the organization they are working in is managing for their adequate safety, they will not be ready to come to work. So we need to innovate on each and every front.

Q. Could you elaborate on IPA’s guidance document on best practices for employees safety?

Mr. Shirish Belapure: When Covid-19 struck us, we were not aware what safety precautions needed to be taken for the safety of employees. They are actually taking risk by coming to the factory, so they should not get infected. That was our prime concerns and prime responsibilities as factory managers or owners. So we collated information from different companies and also from the US and WHO,  and created a document on the best practices for protecting staff in pharmaceutical manufacturing facilities in relation to Covid-19.

The need for communication is one of the important things it talks about. We can’t bring lots of people together and talk to them in current situation. So the communication has to be virtual, and at the same time you have to ensure that it reaches everybody. Employees should also communicate to the employer about their condition and of their family members and neighbours, so that other people are not affected. So both ways of communication are important.

Employee segregation is another very important thing. You have to divide the workforce into essential and non-essential categories. Non-essential staff like those in planning,  purchase, regulatory, etc. can work from home. Those who are required to be on the job are production and quality control people, and may be the supporting staff for housekeeping, running canteen, etc.

We also have to look at which medically necessary products are to be manufactured, and employees should work in small groups, so that one doesn’t impact the other. The staff buses should run in fifty percent capacity, keeping sufficient distance between the seats.  These are essential things to be done in addition to sanitation, hygiene, masks, etc. to ensure the safety of the employees.

Q. What more is expected from the government for the smooth running of the plant and uninterrupted supply chain?

Mr. Paresh Chawla: The government is definitely trying to extend all its support. We expect government to come out with special incentives for the pharma as it is an essential industry. Measures to promote bulk drugs manufacturing in India is a step in the right direction. Not just the bulk drugs, but even the formulation industry needs incentives.

The government should give special focus on R&D. If we have a very strong base of R&D, we will be able to innovate more products and become number one in terms of value as well, not just in volumes.  

Dr. Viranchi Shah: When we talk of the government, I had a very good experience with the government. Whatever interactions the associations had with the government, either it is central, state or local, the government has been earful of whatever we had to say,  and have supported us in whatever requests we had come up with. But there are certain basic fundamental things that need to be done as a nation. The most fundamental thing is addressing the API deficit. The good thing is that the government has recently come out with a package of almost Rs. 10,000 crore to strengthen our API industry, especially those based on fermentation and those kind of industries that we do not have in India. We have some strength in synthetic APIs, but in things like fermentation we are very badly dependent on China and some other countries. So this is one area where the government have initiated a very good package. The industry and government will continue to work forward and make sure that our dependence on other nations, especially China could be reduced. So that our industry become self-sufficient and we are in a better position to serve the world. I think this is one of the most important messages that has come out of this pandemic.

Q What are the learnings from this pandemic?

Mr. Shirish Belapure: I think we have learned a lot of things, both on the personal level and as an industry. We now know what working from home really means. The industry has learned that automation and digitalization will be the way of work for the future. There will be lot of changes in the way we are working. I think majority of the work which are currently being done from the home will continue to be done from home. Woking from home will be a normal thing in future.

We have also learned the skill of prioritization; prioritizing the product, prioritizing the employees who are important, etc. I think these are the main areas where the learning has taken place.

Dr. Viranchi Shah: I think one of the important learnings that we have is that every industry has to have a very robust business continuity plan. Unless you have a very robust business continuity plan in pandemic situations like this, when the whole axis on which we have been working for several years or decades suddenly changes, it is very difficult to comprehend the path forward. So the need to have a very robust and very strong business continuity plan is something that everybody has learned.

People had business continuity plan, but I don’t think very rarely there could be a company who has been able to continue the work based on the plan they already had. Because what happened now is something massive. Therefore, it is important to learn that in order to continue our businesses in such emergencies we need to have a very elaborate and a very robust business continuity plan,  where we could obviously include automation, digitalization, prioritization working in limited resources, etc. If you suddenly find yourself left alone in a jungle, how do you survive? We all need to develop such survival tactics.

Another important learning I can share is that until now the global research was mostly focused on the chronic segment, especially diabetes, cancer and cardiovascular. The nations who invested in research never felt the need to invest into infections and infectious diseases or bacterial or viral infections. Suddenly this perspective has now changed. So I believe one of the lessons that the world has to learn is that we also need to invest in acute diseases, because this kind of situations wouldn’t go so easily. There are chances of recurrence, it may come out next year in a new form, and we don’t know how it is going to play out. So we, as a nation or world, need to invest in infectious diseases.

And the last thing I feel is that this particular pandemic will bring a lot of strengthening of healthcare systems across the world. All the countries will have to heavily invest in their healthcare spending in developing the infrastructure and maintaining a large pool of medications and essential medicines. This will actually result in a lot of investment and a lot of focus on the pharma industry as well. Therefore, I believe that this industry has a lot to do and there are tremendous growth opportunities in the coming years.

Mr. Paresh Chawla: Definitely, this pandemic has taught us that we shouldn’t be a single source dependent company, be it raw materials or packing materials. In contract manufacturing there are companies who ask your risk mitigation plan as to how you plan to mitigate these type of risks. It is a part of their agreement. Now each and every company needs to have a disaster management plan or team or a committee who constantly evolve new ideas so that the business can stay as robust as it can be.

Q. What are the critical factors you feel most important for collaboration and cooperation to overcome this challenge?

Mr. Shirish Belapure: I have become a safety man after spending forty years in manufacturing. So for me safety of the employees is most critical. For that collaboration between the industry, employees, health officials, associations and the government is very important. Secondly, we have found that we are fighting this pandemic together. There is a lot of cooperation between each section of the society, that is one of the critical things which I feel very important in emergencies like this. I am sure we will come out of it, and let us have patience until then.

Mr. Paresh Chawla: I completely agree that we need to collaborate internally for the safety of our people. It’s most important, and especially in situations like this. Your employees are the ones who are actually driving the company. So the employee safety needs a big collaboration amongst our internal team. And definitely collaboration is required on the marketing side as well, to put our products across the market. 

Dr. Viranchi Shah: I think collaboration and innovation are very important outcomes of this particular pandemic management. We have seen car companies making ventilators and sugar companies making hand sanitizers. So collaboration has come from between the industries. We have the state governments, the central government, the industry associations, the NGOs, the police and everybody collaborating to deliver the good to the people.

In our own organization, I have seen people from different departments collaborating each other. I have seen collaboration between the teams within the organization, between the organizations, between nations, and between industries. I think this innovative way of collaboration is going to take us forward.