2016: Onward and Upward, India!

Nick Mitchell, Managing Director, Phenomenex India, opines that the pharma and biotech industry within India, need to develop a series of short-term goals and targets to accelerate progress

2015 marks the mid-point of the second decade of the 21st century. A good time for reflection and critical analysis of what has been accomplished, and what has yet to be done. Prime Minister Narendra Modi summarises one of our toughest moments, on July 27th this year, “India mourns the loss of a great scientist, a wonderful President and above all an inspiring individual. RIP Dr APJ Abdul Kalam”. And in his death we should recall some of his incredibly forward-looking works, written and published before we even crossed into the new millennium, challenging all of us to think about India – 2020.

In the early 1990’s, Kalam offered India a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis for the nation and a strategic vision looking over 20 years into the future. One example was recognising India’s incredible agriculture production potential, but identifying the weaknesses such as cold storage solutions, lack of roadways, and rapid transportation from rural areas to the heavily populated metros across the country.

In the pharmaceutical and biotech industry within India, now might be an opportune time to develop a series of goals and targets that we can work toward over the next five years, the decade which will take us to 2025, or perhaps as far out as 2030. For those of you responsible for goal-setting within your organisations, we all know that mid and long-term goals can be very challenging to set and might only be achieved with a strong focus on clearly defined short-term goals.

A recent meeting in September of a number of UN-member nations in New York, brought government leaders together for an exercise to develop a series of global goals, across number of categories. The meeting concluded with the finalisation of seventeen global goals. These goals have short-term metrics, and will drive the stakeholder nations to achieve the objectives.

If world leaders can come together and develop a set of goals with such tremendous scope, then surely we in the Indian pharma, biotech and life sciences space can take inspiration and challenge ourselves to do something similar in our niche arena, wouldn’t you agree?

To further the parallel of this analysis, let’s go back to 1990 and review the progress made on one of the UN’s Millennium Development Goals. In 1990, the percentage of the global population below the poverty line was 36 per cent. The goal was to reduce this number by 50 per cent by 2015. By 2010 (five years early), the percentage was decreased by half (18 per cent), and by 2015 this number has reached 12 per cent (http://www.bbc.com/ news/business-32082968). It’s interesting to note that the establishment of the original goal was coincidentally incredibly close to India’s economic liberalisation which officially began in 1991.

Let’s consider India’s pharma market development over the same time frame. Although the industry began as early as the 1950’s and 1960’s, there was incredible momentum created during the economic liberalisation of the early 1990’s. This development, coupled with India’s unique position on intellectual property considerations during this same time period, fuelled the rapid growth of the active pharmaceutical ingredient (API) and generic drug manufacturing within the country.

Transitioning to a world class research and development nation within the fields of pharma and biotech pharma requires a conscientious decision on all stakeholders. It requires a commitment from the academic institutions to develop educational models that are focused on delivering the latest content, and delivered by leading academics publishing research in the most reputable journals worldwide. It requires a commitment from industry to invest in the latest analytical technology platforms to perform their testing protocols, and the leaders of these organisations must recognise that the increase in expense of these platforms is a long-term investment to increase the quality of testing results across the entire spectrum. And ultimately, an increased risk tolerance has to be accepted by those that develop the financial models to support these development objectives.

The short-term impetus to moving in this direction is very clear, it is re-establishing India’s place at the front of generic pharma manufacturing market; head to head with our immediate rival, China. As a nation we must regain the trust of the international community, specifically the regulated markets of the West, by agreeing to accept this initiative and not falter on 100 per cent compliance. The mid to long-term position will be to effectively move into the rapidly developing bioequivalents and biosimilars market.

The Make in India initiative is establishing a communication platform to bring industry stakeholders together in early January 2016 (http://makeinindia.com/sector/ pharmaceuticals/). If the homework is done now, this meeting could act as a catalyst for the change that the industry must undergo. With this forum as a backdrop, there needs to be a coordination between policy makers and players across the value chain for meaningful change to take place.

The suggestion of a plan for migration further up the value chain with a fifteen year timeline between 2015 and 2030 is more than reasonable. It will afford ample time to drive all stakeholders to comply. It also offers the opportunity for those organisations that are already serving the Western markets to re-affirm their position, as well as offer their support to those companies which are currently struggling. Finally, it would permit a timeline toward a zero tolerance initiative that the Indian pharma community must accept as they integrate into the global community and recognise a single global standard.

India is an emerging market, and emerging markets are very cost conscious. However, low cost products are not the panacea to all of the dilemmas we are facing within our sector today. On the contrary, the commitment to significant investments are required across the sector to increase the level of quality as well as to confirm the quality of the processes and their final products that the Indian pharma and biopharma companies are manufacturing.

A final thought to borrow from another vertical in India that has done very well over the last two decades, namely business process outsourcing and IT consulting. In this space, there have been incredibly strong training programmes for the graduates of India’s strongest engineering schools. Companies like Infosys, Wipro, and Tech Mahindra to name a few, have training programmes that can last anywhere from four to six weeks, six months, or even a full year. These programmes take the brightest of students and put them through rigorous sets of protocols, where deviance cannot be accepted, else dismissal is the end game. Ironically enough in visiting a few of these institutions over my years of living in India, I have never heard of “jugaad IT innovation”. There cannot be cutting corners, there is a compliance to “off’s” and “on’s” (“0’s and 1’s”). And it is this compliance, and the respect of this compliance that has turned this industry into a multi-billion dollar one across India. I think our pharma and biopharma companies can learn a lot from the companies in a high technology industry right next door to ours’.

Over the last month of 2015, take the time to consider, how will I do my part to take my organisation to the pinnacle of success globally? Phenomenex India is so interested in supporting our clients globally that strive to reach new heights. Our products and services are recognised by the US-FDA, the European Pharmacopeia, and are in hundreds of validated methods around the world. We manufacture all our products under the strictest of ISO guidelines, and we are always deeply committed to reach positive resolutions to all of your chromatographic challenges. We take this opportunity to wish you a strong finish to 2015, and best wishes for a fantastic 2016, during which we will celebrate our official “Five Years in India” at the end of April 2016. We look forward to you sharing in our celebrations. And lastly, thank you to all of our customers that have worked closely with us toward advancing the frontiers of separation science, here in India and across the globe. We sincerely appreciate your support and we look forward to working more closely with you in 2016 and the years ahead.