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 In a bid to revolutionize the pain management and addiction treatment landscape, Rusan Pharma has unveiled its state-of-the-art active pharmaceutical ingredient (API) facility in Pithampur, Madhya Pradesh. The new API facility marks a significant capacity enhancement for Rusan Pharma, increasing its manufacturing capability from 40 metric tonnes (MT) in Ankleshwar to an impressive 400 MT in Pithampur.
Dr. Kunal Saxena, managing director of Rusan Pharma, in an exclusive interview with Shardul Nautiyal gives an insight in to the facility's role in building a robust supply chain, ensuring affordability, and achieving backward integration to maintain quality control. Excerpts:
"Tell me something about the pain medicine market as a whole?
The global need for pain medicine is increasing day by day, with a staggering 5 billion people having little or no access to such medication. According to INCB estimates, 92% of morphine is consumed in countries where only 17% of the world's population resides like the United States, Canada, countries in Western Europe, Australia and New Zealand. The new API facility aims to address this gap, contributing to global pain management efforts.
Dr. Saxena further gives a low down on the untapped market potential and unmet medical needs in pain management, drug addiction, alcohol addiction, and tobacco addiction. He stressed the importance of awareness, accessibility, and affordability, particularly in developing countries like India.
What is the untapped market potential that Rusan is eyeing on the landscape of pain management and de-addiction treatment solutions in the country?
The global and Indian data of addiction for drug, alcohol and tobacco and pain management is alarmingly high. Awareness, Accessibility and Affordability are major concerns in developing countries including India.
Globally in 2021 alone, 296 million drug users were reported worldwide. Around 2.35 billion (43% of the global population) are current alcohol users and in 2016, 3 million deaths were reported due to harmful use of alcohol. There are 1.3 billion tobacco users. Tobacco kills more than 8 million people each year, including an estimated 1.3 million non-smokers who are exposed to second-hand smoke.
In India, in 2019, 23 million drug users were reported in India. Around 160 million people in India are current alcohol users and 57 million Indians need help for their alcohol use problems. In India, 266.8 million adults in India currently use tobacco.
Could you share more information about Rusan Pharma's recent milestones and achievements in the field of addiction treatment and pain management in India? Can you share some information about the market share of Rusan Pharma and the company’s turnover?
At Rusan Pharma, we've been pioneering advancements and offer a One-Stop-Solution in addiction treatment and critical pain management. One of our notable achievements, was the introduction of 'Buprenorphine sublingual & buprenorphine naloxone sublingual tablets' under the brand Addnok & Addnok-N in India, making us the first company to introduce advanced products for addiction treatment in the country. These medications have played a crucial role in tackling the opioid addiction crisis. Hence, we are the innovators and brand leaders of drug addiction treatment, where we cover about 60-70% of the Indian market in the private retail segment.
Moreover, our specialisation in manufacturing transdermal patches and launching indigenous formulations of fentanyl, buprenorphine, lidocaine, and nicotine patches in India, has been a source of accomplishment. These patches have made a substantial impact, significantly improving the quality of life for people dealing with chronic pain and nicotine addiction. Additionally, our commitment to research and development has led to groundbreaking solutions, especially in the realm of controlled substances like depot injections and implants. These continuous efforts underscore our dedication to advancing the field of addiction treatment and pain management.
Rusan Group of Companies' turnover in FY 2022-23 was Rs. 402 crore with a three-year CAGR of 16.9%. 56% of this turnover comes from exports, and 44% comes from the company's domestic sales. We are very much in line with the government’s ‘Make in India’ initiative, as our long-term aim has been to reduce our dependency on imports and ensure valuable export earnings. We have also set up front-end offices in the UK, Europe, Canada, Brazil, South Africa, Australia, and New Zealand, focusing on bringing affordable, quality medicines into addiction treatment and pain management.
What are the total investments made, and what is the next step the company is taking with the new API facility in Pithampur, Madhya Pradesh?
The three prominent reasons behind the facility in Pithampur, Madhya Pradesh, is capacity enhancement, i.e., a sharp increase from 40 MT in Ankhleshwar to 400 MT at Pithampur. The second prominent reason is to have a robust supply chain. The third reason is affordability. The third prominent reason is that the backward integration to the APIs allows us to not only have complete control of quality but also helps maintain prices, ensuring affordability for chronic diseases such as addiction treatment and pain management.
The API facility in Pithampur will now undergo many GMP inspections by stringent regulatory authorities. There are five modules in this facility, out of which we are now focussed on commercialising three of them, and the rest will be eventually done. Hence, the project is split up into two phases, where we have made a substantial investment of up to Rs.300 crores in these two phases.
How does the new API facility set it apart from competitors in the pharmaceutical industry?
At Rusan, we exemplify the government’s ‘Make in India’ initiative, where we have brought indigenous innovation through concept products for the Indian and global market. We have designed the facility keeping several parameters in mind. The facility spans over 24,000 square meters, leveraging significant technological advancements and automation in production alongside compliant software to achieve a paperless manufacturing approach. Our new plant boasts of five modular API manufacturing blocks with dedicated suites for finished API manufacturing. This grants us complete control over the quality of our products and reduces our dependency on imports, aligning perfectly with our commitment to excellence. The design showcases architectural excellence which utilises gravitational flow and the natural terrain for operational efficiency in the manufacturing process. Committed to environmental consciousness and a clean, sustainable, and safe design addresses the latent risks related to Environment Health Safety (EHS) and FIRE. Fire safety measures, including underground firewater tanks and a well-planned hydrant system, are integral components. A standout feature is our in-house design team, Rutech, which played a pivotal role in meticulously designing and executing the entire project. Drawing on insights from our existing API facility in Ankleshwar, Rutech gives us a distinctive edge, setting us apart from competitors who may rely on external resources for similar tasks.
Is the company currently exploring opportunities for international mergers and acquisitions?
As part of our growth strategy, Rusan is actively considering evaluating acquisition opportunities in its key focused markets.
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