"We have a competitive edge based on the diversity we present in our portfolio"

Rahul Dev
Vice President India
Datwyler Sealing
Datwyler Sealing Solutions has been providing state-of-the-art solutions for pharma packaging and recently made news on expansion of the Pune facility, which is one of the key steps for Datwyler in strengthening and growing business activities in India. Rahul Dev, Vice President India, Datwyler Sealing Solutions in an interview with Mahesh Kallayil discusses more on this.

Going by the presence of Datwyler in the global markets, how has the company performed so far? How is the company positioned in the Indian and global pharma market?

Datwyler has performed very well globally in the last years. In the first half of 2017, business grew by 3.9 per cent, adjusted for currency and acquisition by 2.2 per cent. Particularly the Sealing Solutions division performed very well and is one of the growth drivers for the company.

In India, Datwyler is positioned as major player in the health care industry supplying the ten most important pharma companies with its products.

In the Pune factory, Datwyler manufactures components in the field of container closures, eg. for (glass) vials, syringes and pre-filled syringes, and components for diagnostic devices.

In 2017, close to four billion components were manufactured in India.

What is the standing of Indian Pharma Packaging Industry in international market?

The Indian Pharma Packaging Industry is gaining importance in the international market. Currently, the Indian market is quite focused on generic medication, but also has the highest number of FDA approved products worldwide. This development towards more high-end products also means investments in Research & Development which will push the Indian market even further.

As a global player in pharmaceutical packaging, what developments would you like to see Indian pharmaceutical market?

We are happy to see a more R&D focused approach in the Indian pharmaceutical market and are sure that companies can only profit from this development. More high-end manufacturing methods like cleanroom manufacturing is something we as Datwyler actively push with our factory extension which will incorporate our highest manufacturing standard First Line for production in cleanroom environments.

What are the emerging trends in packaging technologies?

The emerging trends that are relevant to us are certainly the continued rise in biologics and biosimilars, which require specialized packaging. This is particularly important when it comes to coatings as a source of extractables and leachables such as silicon oils, which can potentially contaminate the medication and endanger patient safety. Requests for coated products such as cartridge components or pen packaging are rising. High value products will be an essential driving factor for growth.

Specialization is certainly important, so that medication can be packaged according to the specific needs of the pharmaceutical product and the customer alike.

In this fiercely competitive market, it seems that you have a competitive edge over others. How do you perceive it?

We do think that, as a company, we have a competitive edge based on the diversity we present in our portfolio. We are always looking at the next step we need to take to strengthen and expand our position as one of the major players in the global market. As a globally acting company in the pharma industry, we need to anticipate any upcoming future trend. There are several developments at the moment which we consider to be important and interdependent trends in the pharma market. The future of injectables and the provided possibilities for administration, for example. Closely connected are also the developments in the sector of self-administration and what the field of digital health can contribute to the issue. These kinds of new health care solutions are a main focus in our research and development efforts. We see partnerships as the way forward and a competitive edge, which is why we established partnerships with the Interuniversity Microelectronics Center (IMEC) Institute in Belgium and the Holst Center in the Netherlands to do research in the wearables sector.

Kindly brief us about Datwyler's GMP principles in production and control of pharma packaging materials within organization.

The production standard First Line is dedicated to guaranteeing the highest levels of quality and safety for pharmaceutical rubber components. The First Line production operates in a fully integrated good manufacturing practice (GMP) environment using innovative automated processes and conforming to the highest industry standards. Each zone has been meticulously designed and constructed to prevent bio-contamination and is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. The process flow, gowning protocols, personnel and material flow, and state-of-the-art automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. The new clean room also incorporates the latest generation of camera inspection techniques. The entire facility incorporates rational and lean production flows in accordance with the Six Sigma methodology. The First Line manufacturing concept exceeds the most stringent quality standards of regulatory authorities and is certified to ISO 15378. It is designed to operate under a zero-defect philosophy.

Datwyler recently completed expansion of its facility in Pune. Could you please tell more on this? How is it going to meet the requirements of India's domestic pharmaceutical packaging market?

The expansion of the Pune facility is one of the key steps for Datwyler in strengthening and growing business activities in India. The facility will manufacture according to the First Line standard (please see question 10 for details). Therefore, it will provide state-of-the-art components and packaging solutions which will cater to customers who are looking to manufacture advanced and high-end pharmaceutical products. With the facility and its First Line aligned expansion, we will not only be able to better cater to customers and companies with operations in the region, but can also concentrate more on our Indian customers, who make up a quite substantial market share for us.

The same applies to our facilities in Europe and the United States which are either already manufacturing according to the First Line Standard or will open later this year (2018).

How do you see Indian pharma packaging sector vis--vis the "Vision 2020"?

Due to its healthy growth development and high potential for new business, we believe that the Indian pharma market will play an important part in future global health care. One of the most important factors is the Indian population, which is growing at an estimated 5-7 per cent per year. The living standard is continuously improving, and so is the health care sector. We see bigger efforts by the government to ma tch this development with investments in health care. As a result, health care services and medication are much better accessible for the population and the quality of life is improving. Quite frankly, we are looking at a fast-growing market with lots of opportunities.

What are company's future plans?

The most important development will certainly be the expansion of our Pune facility and the start of production to full capacity. This will also have positive effects on our employee structure: while we are currently employing more than 400 people, we should be closing on 500 employees by the end of 2018.

It is important to us that we staff the majority of all positions with local and regional workforce. We also place high value on social and environmental engagements, such as the construction of a local school and efforts in terms of water quality and resources.

Datwyler is a growth-oriented company. In the last couple of years, we have been investing very heavily for two reasons. The first reason is to be globally present in different geographical regions, which enables us to supply regional and global market players. The second reason is to further strengthen our customers' confidence in the high quality of our products.

Presently, we are investing in India and have strong confidence in this market and its opportunities.