Express Pharma

‘We support the Prime Minister’s Make in India call’

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Datwyler is planning a FirstLine plant in Satara, Maharashtra, the company’s first facility outside Europe. Rahul Dev, Vice President, Datwyler India, in an interaction with Usha Sharma, discloses the company’s corporate plans and strategies

Recently, Datwyler has announced to open its FirstLine production site in Satara. Tell us more about the plant, its  investments, production activities commencement, manpower etc.How is it going to cater to the domestic as well as international markets?

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Rahul Dev

The FirstLine production facility is specially designed to conform to the highest industry standards, exclusively producing components for healthcare applications. Datwyler manufactures pharmaceutical rubber components such as vial stoppers or syringe plungers in a fully integrated Good Manufacturing Practice (GMP) environment. The company’s most complex rubber components are vial and syringe components from the Omniflex family, which prevent any interaction with the drugs due to their total fluoropolymer coating. The first state-of-the-art FirstLine production site is in Alken, Belgium. The FirstLine plant in India will be the first facility outside Europe and simultaneously Datwyler’s most modern production site. Spread over an area of 24,000 sq metre, the facility will be integrated in the existing premise and will operate in 2017. The site will also offer additional 24,000 sq metre for future growth. The new facility is a major investment and part of the company’s commitment to India and the Asian markets.

How will this project work in line with PM Modi’s ‘Make in India’ initiative? The company has a record to grow inorganically and the Satara plant will be the first greenfield project. Do you plan to quit/ sideline the inorganic way to grow?

We support Modi’s ‘Make in India’ initiative, which is a very ambitious project. India’s pharma and biotech markets are evolving rapidly and they were able to gain traction from global manufacturers, suppliers and customers in the  last few years. The country is also being recognised as one of the global manufacturing destinations. Although we have always grown inorganically by way of mergers and acquisitions, we are open to new opportunities and are happy to invest in own operations if they are in line with our company strategy. With our new facility in Satara, we are underlining our commitment to India as we are looking at catering to global markets. The rubber components which are made in India are already distributed globally. 100 per cent is exported to Europe, the US and South East Asia. However, Datwyler Sealing Solutions also has a significant market share in India. We have been supplying our Indian customers from our global plants since the last 20 years. Currently, we have approximately 50 to 60 Indian customers.

Which new product areas you would like to explore and why?

Nowadays, drugs are becoming ever more complex and sensitive. As a result, pharma companies demand rubber components which are characterised by low extractables. Therefore, one of the areas we explore is the development of new rubber compounds and coatings with low levels of extractables. With our Omniflex family, we have already developed a series of products which meets these demands perfectly. This product line is exclusively manufactured in our FirstLine facilities, such as the new facility in Satara. In the Indian market, we are also focusing on high-end rubber formulations for products like plunger stoppers, Lyo, serum stoppers and customised rubber stoppers. As a leading partner to global pharma companies and the global number two for closure solutions for injectable medicines, we produce 15 billion components for healthcare products each year.

Tell us about Omniflex and which products will be manufactured from the new built facility in Satara. How it will be beneficial for the Indian pharma industry?

Omniflex is our premium product series and first coating to both provide barrier properties and eliminate the closure as a source of silicone oil-based subvisible particles (SbVPs) at the same time. The total coverage by the Omniflex coating offers the benefit of providing a complete barrier which is especially necessary for high-end drugs, mostly biotech drugs, that are very aggressive in nature and must not come in contact with the rubber compound. This coating technology was developed by Datwyler in Belgium and is one of the highest selling products. It meets one of the most important demands within the biologic drug packaging industry at the moment, the reduction or elimination of silicon oil to mitigate risks and reduce time-to-market. The Omniflex series will be produced at the new facility in Satara. Till date, in the Indian healthcare sector , we have been mainly supplying to the diagnostics market. Further, we are the major suppliers to all the syringe manufacturers. On a global level, we are the key supplier for pre-filled vials and syringes.

Today, the Indian pharma industry is facing quality issues in the global market and Indian regulators are encouraging the industry to adhere to  guidelines, Datwyler is a multinational company and have access to various markets. Share your views on the same.

Being in the pharma industry, tracking is one of the most important things that we apply. Transparent traceability is one of our major standards. We’ve set up a system where we are connected directly to the servers in Switzerland, i.e. each production step is coded, so we are able to trace hour, person and equipment that have been produced.

The government has mandated 2D barcoding on primary packaging line for all pharma exports. Which technology/ service have you planned for the Indian pharma companies?

We are into manufacturing of rubber and aluminium components. Datwyler has started imprinting UV coding systems to identify counterfeit. For rubber compounds we are more process related. So, one of the main reasons for the rules is counterfeiting. We will always adhere to government guidelines and follow international norms.

Which new technologies do you plan to bring from Switzerland and when?

We will bring in new technology and best practices not only from Switzerland but also from our plants based out of the US, Belgium, Germany and Italy. We also have a platform to share best practices from plants spread around the world. We are five years young here in India and are invested to bring in more manufacturing and technology to support the Prime Ministers ‘Make in India’call.

How large is your global manpower strength? What is the headcount in the domestic market? Are there any plans to increase the headcount?

We have a global manufacturing footprint on three continents and sell our products in over 100 countries. Globally, the division has a workforce of more than 5,600 employees.

What are the company’s corporate plans?

Presently, Datwyler is expanding in India. Datwyler Sealing Solutions has been present in India since 2010. With our operations, we are dedicated to guaranteeing the highest levels of quality and safety, and continue to make investments aimed at meeting global regulatory requirements.

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