tête-à-tête with the Leader Dr Kumar Kurumaddali
Dr Kumar Kurumaddali Visionary Leadership in Pharma
In the vanguard of pharmaceutical innovation and leadership stands Dr. Ramachandra Kumar Kurumaddali, a luminary whose stewardship as Managing Director has been pivotal to the ascent of Chemo India Formulation Pvt. Ltd. Since its inception on August 13, 2015 in Hyderabad, Dr. Kurumaddali’s unwavering dedication has not only propelled the company to the forefront of the industry but also cemented his status as an indispensable beacon of excellence and innovation.
A sage in the realm of pharmaceutical sciences, Dr. Kurumaddali’s profound acumen spans the intricate tapestry of the industry, from rigorous quality assurance to the avant-garde of research and development. His tenure at Chemo India Formulation Pvt. Ltd is marked by a relentless pursuit of excellence, steering the company with an astute vision that harmonizes stringent standards with astonishing innovation.
Beyond the confines of Chemo India, Dr. Kurumaddali’s influence radiates through his directorial roles in various other enterprises, a testament to his versatile expertise and a broad spectrum of skills that transcend the conventional boundaries of pharmaceutical leadership.
As we delve into the insights and visions of Dr. Kurumaddali, we not only uncover the strategic foresight behind Chemo India Formulation Pvt. Ltd’s triumphs but also glimpse the future contours of the pharmaceutical industry shaped by his indelible contributions. Join NSH, as our interview with him explored the narrative of a visionary whose dedication to excellence continues to forge new paradigms in the quest for scientific discovery and healthcare advancement.
Can you share your journey in the pharmaceutical industry and how it led you to your current role as the Managing Director of Chemo India Formulation Pvt. Ltd?
I completed my schooling up to the twelfth grade in Machilipatnam, my hometown. Following this, I attended Andhra University to pursue my B.Pharmacy and M.Pharmacy degrees. My academic journey then took me to the United States, where I earned my PhD from Albany University in Alabama.
My professional journey began in Atlanta, Georgia, where I worked as a research scientist at Pfeiffer Pharmaceuticals for approximately four and a half years. I then transitioned to Perrigo Co in Michigan, where I initially served as a research scientist before being promoted to a manager of R&D.
In January 2001, I returned to India and settled in Hyderabad. Upon my return, I facilitated the expansion of Perrigo to Hyderabad, initially establishing it as a sourcing center. Given the success of this venture, I was tasked with building an R&D center for Perrigo in Hyderabad. This led to the establishment of the first R&D center in the Kompally area of Hyderabad. I managed Perrigo’s operations in India for about five years, from 2001 to 2006.
Seeking to contribute to an Indian company, I joined Granules India as the Chief Scientific Officer. Over the course of three years, I worked in various functions including R&D, quality assurance, quality control, and regulatory affairs.
Following this, I felt a strong entrepreneurial urge to establish an R&D company in Genome Valley, Hyderabad. This led to the creation of FinosoPharmaPvt. Ltd. We undertook foundational work for various clients around the world, including those in the US, Canada, Australia, New Zealand, and Southeast Asia. This allowed us to expand our footprint from US-based development to global-based development.
After successfully running the company for four years, we sold it to another pharmaceutical company based in Hyderabad. Upon fulfilling my obligations under the agreement, I embarked on a new venture and founded Chemo India in May of 2015.
As the Managing Director, what are your key responsibilities and how do you ensure the smooth functioning of the company?
In the initial stages, I was solely responsible for the company’s formation, including handling legalities and setting up bank accounts. Our next step was to acquire land in Genome Valley through TSIIC. I worked closely with engineers from Spain and India, as well as local engineering consultants, to design our facilities.
The construction of our building began in 2016, and by September 2017, we inaugurated the Chemo India facilities. With this, a new company was born, equipped with full-fledged facilities for R&D, manufacturing, and study. These three functional roles marked the beginning of our operations.
Since then, the company has been steadily growing, undertaking numerous activities primarily for capital consumption for our global company, InsudPharma. This marks my journey in the pharmaceutical industry for the last 32 years, ever since I graduated with my PhD from the US. It has been an incredible journey that is still ongoing, and we continue to add many new initiatives, which I will discuss in the next segment of this interview.
Chemo India Formulation Pvt. Ltd is known for its commitment to quality and safety. How do you maintain these standards across all operations?
From the very beginning, we established three fundamental pillars for our company: quality, teamwork, and integrity. These pillars are integral to our company’s commitment to quality. I firmly believe that quality begins at the top and permeates through every level of the organization, from department heads and team leaders to senior scientists and all other employees.
We emphasize the importance of quality in every aspect of our business. We remind our employees daily that quality is of paramount importance. At least once a year, if not more frequently, we reiterate to our entire workforce that our business cannot exist without a steadfast commitment to quality. We uphold the principles of quality at every step of the way.
From the outset, we have been conducting monthly quality review meetings. All functional teams come together to review the quality aspects of our business and make necessary course corrections. This approach ensures that everyone understands the paramount importance of quality and practices it at every step of the way.
In terms of safety, we emphasize the importance of adhering to good safety practices. We hold monthly safety committee meetings involving all departments, where any issues are raised. If any unsafe practice is identified, we immediately address it and ensure that all safe practices are followed. We provide all employees with protective gear, including safety goggles and shoes. I am proud to say that, to date, we have not had a single accident in the company’s history.
Can you discuss some of the major achievements of Chemo India Formulation Pvt. Ltd under your leadership?
Upon our inception, we began with the production of solid pharmaceuticals. Given the success of this venture, our company decided to expand into the production of injectable pharmaceuticals as well. This marked a significant addition to our product line.
The manufacturing of solid pharmaceuticals is carried out in Cambodia and at our sites in Spain, which has led to an improvement in their application across these sites. However, the manufacturing of injectables is exclusively carried out in Spain due to the availability of specialized facilities there.
We started our global stability operations with barely 20 samples a month. Today, this number has grown to 800 samples a month, marking a significant improvement. We receive designs from all our global sites and ensure their timely processing to avoid any backlog in stability.
Furthermore, we have recently established two new laboratories. One is dedicated to the production of microspheres for injectable facilities, and the other is a brand-new oligonucleotide center in India. This center is the first of its kind in India, dedicated to the commercial production of oligonucleotides. Although it is still a work in progress, we are making significant strides in this area.
Chemo India Formulation Pvt. Ltd operates in various divisions (APIs & FDFs, CMO, OTC, Vetpharma). How do you ensure synergy and collaboration across these divisions?
Our primary operations are in the Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) divisions. Our API division continuously supplies APIs for our R&D development and manufacturing purposes. We maintain regular interaction with our API teams to ensure a steady supply of APIs. We collaborate with them on technical aspects such as polymorphic issues, particle size issues, and impurities, among others. This exchange of information helps us improve our services.
Our finished products go through manufacturing and then to regulatory effects. These are the two divisions that fall under Contract Manufacturing Organization (CMO). We also have other divisions in the company like mAbxience and Exeltis, which we can discuss later.
In terms of CMOs, our facilities in Spain have a large customer base for CMO business. Recently, we have been receiving increasing interest in the Chemo India facility as a CMO, as we have approvals from the USFDA and European authorities. As a result, more customers are showing interest, and we are capitalizing on this opportunity.
How does Chemo India Formulation Pvt. Ltd stay ahead in the rapidly evolving pharmaceutical industry?
At Chemo India Formulation Pvt. Ltd, we strive to stay ahead of the curve in the rapidly evolving pharmaceutical industry. Our primary focus is on maintaining quality at all costs. When facing regulatory audits or customer audits, we ensure that all our systems meet the satisfaction of both regulatory bodies and customers. We have successfully completed our first ever FDRA with zero observations, a significant achievement. Over a period of four years, we have also completed two Spanish audits, all with positive outcomes. Additionally, we have undergone numerous successful customer audits.
Our second major initiative is the digitalization of our programs. We have implemented library limbs in our QC laboratories, resulting in a paperless lab. This is a first-of-its-kind initiative in the Institute of Pharma group and places us among the top companies that have fully digitalized their QC labs. We have also implemented TrackWise for our Quality Management System (QMS), document management system, and loading management system.
On the engineering side, we have implemented a calibration management system, building management system, and SCADA system for water. Wherever possible, we have automated processes to reduce manual errors.
These improvements have allowed us to stay ahead of the curve. Regulatory auditors have appreciated our efforts, noting that there are no data integrity issues in our company. They have confirmed that everything is as per the system, and we are following the systems very thoroughly, leading to their high level of satisfaction.
How do you feel about the inauguration of the Oligonucleotides Centre in Hyderabad, and what are its implications for the pharmaceutical industry?
The inauguration of the Oligonucleotides Science Research Centre in Hyderabad was a significant event. Mr. KTR, the then minister for Telangana state, was proud to inaugurate an Oligonucleotides facility, which is the first of its kind in India.
While research on Peptide molecules has been ongoing, Oligonucleotides represent a new area of research, which is considered the next level to peptides. Our company, in collaboration with a European company, has conducted all the R&D work. Following this, we transferred the technology to our facility in Hyderabad.
We are currently in the process of manufacturing batches of new substances. We also have a unique opportunity to be the first to file an Abbreviated New Drug Application (ANDA) in the US market due to the advancements in technology that we have made.
Our company is quite pleased with these developments and we are making significant progress in moving forward with the manufacturing of Nusinersen API. This represents a major stride in our commitment to innovation and excellence in the pharmaceutical industry.
What are the challenges and opportunities of producing Nusinersen, a novel antisense oligonucleotide for the treatment of Spinal Muscular Atrophy (SMA)?
Indeed, Nusinersen is a novel antisense oligonucleotide used for the treatment of Spinal Muscular Atrophy (SMA), a condition that affects children at a very young age, around 4-5 years. The treatment for this condition is extremely costly, which presents a significant challenge.
Therefore, it is crucial that we develop alternatives to the brand-name drug, which could potentially lower the cost of the medication. This would hopefully make the treatment more affordable for patients, enabling them to access the medication they need to manage their disease.
Nusinersen is just one of the molecules we are working on. We have plans to introduce three or four other molecules for various other rare diseases. These diseases can only be targeted and treated with oligonucleotides, which can attack the harmful cells and cure the disease.
We are working diligently to ensure that we bring more and more of these molecules to the market in the coming months and years. This represents both a challenge and an opportunity for us, as we strive to make a significant impact in the pharmaceutical industry.
How do you collaborate with other brands of InsudPharma, such as Exeltis and mAbxience about which you were already referred to? What are the synergies and advantages of being part of a global pharmaceutical group?
InsudPharma is composed of four main divisions. The Chemo Division, where we belong, is primarily focused on active pharmaceutical ingredients (APIs) and chemical products.
The second division, mAbxience, specializes in biopharmaceuticals, particularly biosimilars. We have initiated the biosimilar market in Argentina and Spain, and we are gradually expanding to South and Central America as well as certain European markets.
Xiromed, the third division, is primarily based in North America and Northern Europe. They function as a marketing and distribution arm, with products supplied from the Chemo division, including from Chemo India. We continuously collaborate with Xiromed to ensure that their customer requirements are met from the Chemo division, both in India and Spain.
The fourth division, Exeltis, deals with branded generics. These branded generics are present in many countries, including India, Indonesia, Turkey, Mexico, Guatemala, and several others. There is occasional collaboration between these two divisions regarding product selection. If a product from the Chemo division is suitable for their distribution, we are more than willing to manufacture it further.
At times, they may have some ideas that they share with our R&D team. We can then work on the R&D and develop and manufacture the product for them. This intense collaboration between the divisions helps us catalyze synergies wherever possible. Being part of a global pharmaceutical group like InsudPharma provides us with a wide range of opportunities for collaboration and innovation.
How do you measure the social impact and value of the products and services that Chemo India Formulation Pvt. Ltd offers, and what are the feedback mechanisms that you use to improve them?
We measure the social impact and value of our products and services at Chemo India Formulation Pvt. Ltd through various initiatives and feedback mechanisms.
Every year, we organize a charity run called the Chagas Run in our company. This event is in commemoration of our fight against Chagas disease with exclusive medication. For every kilometer run by our employees, the company makes a donation to a charitable organization. InsudPharma runs a charitable organization called Mundo Sano, which carries out extensive charitable work in less developed countries and in South and Central American countries like Argentina, Chile, Uruguay, Paraguay, and Guatemala. They are also working to expand their presence into African countries where help is needed.
At Chemo India, we also contribute by participating in and making donations. During the coronavirus pandemic, we donated a cheque of 10 lakh to the Chief Minister’s relief fund.
We have a collaboration with the AkshayaPatra Foundation for underprivileged children. We collect donations from employees, and for every rupee donated by an employee, the company matches that amount. We donate the total amount to AkshayaPatra once a year as part of our social responsibility.
The feedback we receive has been very positive. AkshayaPatra always appreciates our contribution, which goes towards the good cause of helping underprivileged children who may not have parents, for their school education and meals. This kind of donation money goes to their betterment.
These initiatives and feedback mechanisms help us improve our products and services, and ensure that we are making a positive impact on society.
How do you ensure the environmental care and sustainability of your operations, and what are the best practices and techniques that you follow?
At Chemo India, we operate a zero-discharge facility, ensuring that we take good care of our air, water, and soil quality. We do not discharge any effluents through the drain process. Instead, all effluents are collected. Solid effluent is collected once a week or once a month, depending on the volume. A dedicated truck from Ramky, an authorized waste handler in Hyderabad, collects our solid waste. They analyze it and incinerate it in a safe manner.
Similarly, we collect all the liquid waste. We have a fluid treatment plant where we process the waste, adjust the pH, and remove all unwanted substances. The treated waste is then given to JMTM, Jeeva Metal Fluid Treatment Plant, which is authorized by the government. A tanker comes once a week or once in two weeks to collect the liquid waste. They process it further and convert it into sludge, which is then taken for incineration.
This approach ensures that we follow safe practices and do not pollute our surrounding areas, be it soil, water, or air.
In addition to this, about 10-12% of our power consumption is contributed through renewable energy like solar. We have also planted quite a few trees around the facility to create a green environment and absorb any pollutants.
We conduct safety trial sessions for our employees and environmental awareness programs every year to ensure that we are responsible citizens towards the environment. This comprehensive approach helps us ensure the environmental care and sustainability of our operations.
Lastly, what advice would you give to young professionals aspiring to build a career in the pharmaceutical industry?
My advice to young professionals aspiring to build a career in the pharmaceutical industry is to continue progressing in their academic journey. A Bachelor’s degree serves as a foundational program where you learn about various theoretical aspects such as pharmaceutical chemistry, pharmacology, pharmacognosy, medicinal chemistry, physical pharmacy, and pharmaceutical technology.
I would recommend pursuing a Master’s degree in pharmacy at a minimum, given the highly competitive nature of the market in India. Some individuals may choose to further their education by obtaining a PhD, which allows them to specialize in a particular field.
Another piece of advice is to undertake an industry internship, either during your Bachelor’s or definitely during your Master’s. An internship of at least 6 to 9 months can provide real-world industry experience and learning opportunities. If you demonstrate talent, companies may offer you a permanent position.
In addition to technical skills, companies value good communication skills, leadership ability, and the capacity to grasp things quickly. These are key skills to develop at the beginning of your career.
As you progress in your career, I would advise diversifying into 2-3 different areas. For instance, if you are a formulator in formulation development, try to understand analytical development, analytical method validations, and testing. Gain knowledge in areas such as quality assurance, quality control, production, engineering, and various aspects of entrepreneurship in business. The more you know, the more valuable you become to a company. Companies always value good employees, and you will experience proper growth throughout your career. This is the advice I would give to all young people aspiring to build a career in the pharmaceutical industry.
