Christophe Boulanger, Managing Director, NNE Pharmaplan India,in an interview with Usha Sharma, speaks about the company’s future plans for the Indian market
How long you have been associated with the Indian pharma market and what have been your learning experiences?
NNE Pharmaplan is a business partner to the pharmaceutical and biotech industries and is one of the leading engineering and consulting companies within the field. NNE Pharmaplan started its operations in 1996 in India and has been providing engineering consulting services to the pharma and biotech sector over the past 18 years.
Personally, I have been associated with the global pharma industry for more than 20 years now. During the past eight years, I have been involved in various global positions within NNE Pharmaplan which has given me insights into the Indian pharma industry.
The Indian pharma market, along with the markets of China, Brazil and Russia, will spearhead growth in the pharma industry in the coming years. The Indian market has some unique characteristics: First, branded generics dominate, making up for 70 to 80 per cent of the retail market. Second, local players have enjoyed a dominant position driven by formulation development capabilities and early investments. Third, price levels are low, driven by intense competition.
However, the industry will need to strengthen three sets of commercial capabilities: marketing excellence, sales force excellence and commercial operations. In addition, players will need to put in place two enablers: strengthen the organisation to be able to sustain performance and manage rising complexity; and collaborate with stakeholders within and outside the industry to drive access and shape the market. NNE Pharmaplan is aligning itself to cater to these requirements and help the industry players to strengthen their operations by providing first-class consulting services driven by technology leadership.
Tell us about the company’s ongoing activities and the major projects which it is working on?
In India, we focus on vaccines, OSD and injectables as well as the latest trends and technologies such as single-use systems. To support this, we have established a consulting department focused on high-level business support, which is headed by Aeby Thomas. Aeby comes with a rich global experience in production and consulting, and has been with NNE Pharmaplan for more than seven years. Supporting him, we have local experts in India. At the same time, we are also utilising our global consulting department to look into critical domains such as containment, oncology and continuous processing.
Our focus has always been to create value for our customers across the world. We strive to deliver a similar experience for our customers irrespective of where they choose to work with us.
Our goal is to increase the quality of our deliveries while focusing on our core of pharma and biotech customers. We are currently engaged in the following domains in India:
- Biopharmaceuticals and mAbs
- Containment within API and OSD
Unfortunately, I cannot share the precise customer and project details with you due to confidentiality agreements.
There have been regulatory compliance issues with many Indian manufacturing facilities. How critical are these challenges? What steps do you follow to overcome these issues?
It’s important to note that many Indian companies understand and adhere to current good manufacturing practices (cGMPs). The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing. These include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing and product adulteration or contamination. While some Indian companies operate state-of-the-art facilities and meet cGMPs, others do encounter problems and operational challenges.
Not only is quality critical to public health, but also the basis of the public’s confidence in pharma. Overcoming these issues requires a willingness to change and a pro-active approach to looking into other high technology industries, investigate their practices and adopt these selectively so as to achieve the goals of transparency, traceability and therefore quality.
When designing facilities, we have our GMP experts review the layout of the facility. Our GMP experts are up-to-date with latest guidelines and regulations laid down by FDA which helps us to design facilities in accordance with current guidelines. NNE Pharmaplan has devised internal tools called ‘Our model and our Wiki’ which are global platforms for sharing knowledge about latest trends and technological solutions available across the globe and for sharing best practises within the organisation. If a customer wants to check whether their facility is in compliance with latest guidelines, NNE Pharmaplan can provide GMP review and assessment studies and make a review report with recommendations of corrective actions.
Why should multinational pharma companies invest in India? Particularly in the Asia-Pacific region, which market do you feel have a huge business potential and why?
India is expected to rank amongst the top three pharma markets in terms of incremental growth by 2020. Within APAC, NNE Pharmaplan has offices in India, Malaysia and China and we have the required muscle to support even the biggest and most complex projects in this region.
However, I still believe that India has an advantage in these markets, primarily due to the following reasons:
Workforce: India possesses a skillful workforce with high managerial and technical competences.
Cost-effective chemical synthesis: The track record for development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent.
Legal and financial framework: India is a democratic country with a solid legal framework and strong financial markets. There is already an established international industry and business community.
Globalisation: The country is committed to a free market economy and globalisation, which is constantly increasing.
Approval time for new facilities has been drastically reduced.
India’s cost of production is significantly lower than that of the US and almost half of that of Europe.
What will the consultant keep in mind while setting up new units?
NNE Pharmaplan keeps in mind the following things while designing for new facilities:
- The facility should be cGMP compliant and adhere to international regulatory guidelines relevant to the customer’s target market
- The CAPEX and OPEX should be stabilised, driven by our rich knowledge database and technology leaders
- Effective space management and efficient utilisation of site dimensions are ensured through use of 3D Revit where it is possible to visualise the entire facility before it is built
- The facility set up should be designed to allow for future expansion. NNE Pharmaplan adopts a modular engineering approach which enables expansion of operations without disturbing existing production. This is secured by having regular constructability reviews during the design stages of the facility.
How many people are associated with the group and out of them how many are technical experts?
NNE Pharmaplan has a resource pool of 2,000 resources at more than 25 locations around the world. The resources are divided into two categories: operational and non-operational. The operational resources are the technical resources that are involved in designing and engineering consultancy for pharma and biotech domains.
Around 80 per cent of our employees are billable/ operational. They are supported by 20 per cent non-billable/non-operational employees involved in IT, HR, sales etc.
NNE Pharmaplan also has a pool of senior technology partners (STP) who are high level technical specialists within their own respective fields. We currently have STPs within vaccines, sterile and aseptic fill and finish, regulatory compliance, OSD, biopharmaceuticals, medical devices and drug delivery systems. Most of our STPs are technology leaders within their domains and work to provide innovative solutions to our customers globally.
Tell us about the company’s future plans.
NNE Pharmaplan has set out on a journey to build long-term relationships with strategic customers based on a role as trusted advisor. We believe that we can deliver the right solutions through deep insight and understanding of our customers’ challenges and opportunities.
So to say, our New Year’s resolution is to be more focused on our key customers, understand their pains, deliver customised solutions, move towards focused pharma engineering, attract the right talent and distinguishing ourselves from other players on the market by providing high value for our customers.
We are on the right path of sustainable growth and we are entering the new year with a good pipeline.