“We are working on introducing new ways of serving our customers, making the supply chain smoother and logistics easier by selecting the right partners & exploring new channels and partnerships to increase our market reach,” said Falgun Jani, Head of Sales, Freudenberg Medical India, in conversation with Hemant Arora, Group Director, Pharma Industrial India. Mr. Jani also discussed about the company’s investment and expansion plans for India, key challenges faced, government policies, etc. 

Question: Briefly tell us about Freudenberg Medical in India. 

Answer: India is one of the fastest-growing markets in the APAC region. Freudenberg group has held ties with customers in India since 1920. Anticipating our customer’s needs is the foundation of Freudenberg Medical’s success and a reinforcement of our commitment to continuously innovate and enhance the value for our customers. Freudenberg Medical’s foray into India by offering local support in India is a decisive step and proof of our commitment to providing the best solutions to the growing needs of India’s pharmaceutical market.  

Utilising our innovation, R&D and 11 global manufacturing locations, we are currently working very closely with our India customers at every stage of new product development life-cycle, right from concepts, designing, material selection, and lean manufacturing processes, etc., to help them to introduce new and improved medical device products for India and global markets. Along with new products and technologies, we are also working on introducing new ways of serving our customers, making the supply chain smoother and logistics easier by selecting the right partners. We are also exploring new channels and partnerships to increase our market reach. 

Question: Tell us about your products and solutions range for the pharmaceutical industry.  

Answer: Freudenberg Medical is a global contract manufacturer with a 100 per cent focus on solutions that address the complex challenges of the medical device and pharmaceutical industry. 

Freudenberg plans to introduce several new products this year and beyond in the fluid handling space for biopharma. These include extensions of the current PharmaFocus Premium product line plus a New Product Line. In this month (June) itself, we have launched a new product, ‘HelixTCTM’. This is a new range of over-moulded Tri-Clamp ends with in-built gaskets for silicone tubing that serve as a safe & unique alternative to conventional barbed TC connections. ‘HelixTCTM’ can become an ideal choice for critical fluid transfer applications in the pharmaceutical and bioprocess operations as it greatly reduces bioburden entrapment and leakage situations associated with conventional barb-type TC fittings. HelixTCTM ends are manufactured in a certified clean room with material certification and a lot of traceability and are available in standard and custom sizes.  

Question: In your view, what are the key challenges in the pharma sector in India? Is there a possible solution? 

Answer: The Indian pharmaceutical companies have faced several challenges on various fronts. These are: A lack of a stable pricing and policy environment- The challenge created by unexpected and frequent domestic pricing policy changes in India. Lack of capabilities in the innovation space- The government needs to invest in research initiatives and talent to grow India’s innovation. The government should support the clinical trials and subjectivity in certain regulatory decision-making. 

Challenges in the generics export market- Due to price attrition, increased buyer consolidation and higher competition, the success of generic exports to the US has started to plateau. Influence of external markets-Certain reports comments that India is heavily dependent on other countries for active pharmaceutical ingredients (API) and other intermediates. Eighty per cent of the APIs are imported from China. So, India is at the mercy of supply disruptions and unpredictable price fluctuations. The import dependence of APIs and intermediates is particularly high for many of the low-value, high-volume and off-patent essential medicines that are used widely by the Indian population. According to data maintained by the Directorate General of Commercial Intelligence and Statistics, India has imported APIs worth $3.8 billion in FY 2020-21. Exports were worth $4.42 billion 

Quality compliance Audits- India has undergone the highest number of Food and Drug Administration (FDA) inspections since 2009; therefore, continuous investment for upgrading quality standards will distract the capital away from other areas of development and growth is reduced. 

During the COVID-19 pandemic, almost every major Indian pharmaceutical company has seen challenges and historical disruption in the supply chain of critical components and ingredients required to manufacture life-saving drugs and vaccines. Like many global pharmaceutical companies, Indian companies have also understood the importance of sustainability and security of supplies of these components and ingredients, which has resulted in exploring and evaluating multiple options and newer ways of supply-chain and logistics. 

Freudenberg Medical can support customers worldwide from its two like-for-like manufacturing sites outfitted with the same top-of-the-line manufacturing equipment, software and quality systems along with easy & faster availability of standard and braided silicone tubing from our off-the-shelf ready stocks. 

The Indian Government has undertaken structural and sustained reforms to strengthen the healthcare sector and has also announced conducive policies for encouraging FDI. The Aatmanirbhar Bharat Abhiyaan packages include several short-term and longer-term measures for the health system, including Production-Linked Incentive (PLI) schemes for boosting domestic manufacturing of pharmaceuticals (APIs) and medical devices.  

Seeking to permanently address India's dependence on China for active pharmaceutical ingredients (APIs), the Department of Pharmaceuticals has drawn up a list of 56 APIs to prioritize them for the Make-in-India initiative. Due to the steps taken by the Indian Government, India's import dependence on raw materials (API) to manufacture essential drugs is likely to reduce by 25 per cent by 2024. 

Indian pharma companies must take bold strategic steps to overcome the challenges. Improving communication and understanding amongst the industry stakeholders and regulators would be advantageous for the future. Drugmaker Cipla has launched an 'API re-imagination programme looking to expand its manufacturing capacities using recent government incentives. 

Question: What are the company’s business targets in the next two to three years? 

Answer: The Asia Pacific is one of the focussed areas for Freudenberg Medical. Recently, we have invested in human resources for India and China. This has resulted in the much-needed day-to-day engagement and close coordination with the customers for their current and future projects. Along with new products and technologies, we are also working on introducing new ways of serving our customers, making the supply chain smoother and logistics easier by selecting the right partners. We are also exploring new channels and partnerships to increase our market reach.  

As I mentioned earlier, as India and APAC are on a growth path, we will continue our efforts to nourish and nurture the diverse and unique needs of medical device and pharmaceutical markets in these regions. We will continue to invest in human resources, innovation, product development and supply chain areas. Depending on the specific needs of India and APAC markets, we are already working on certain projects which will result in the launch of many new products by our end customers in the coming three to five years.