Express Pharma

‘Make in India’ initiative could be huge re-branding opportunity

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Pharma cos need people who are Indian at heart, with global expertise in tech ops says Ian Wilcox, Global Managing Director, Life Sciences, HayGroup as he spells out some growth strategies to Viveka Roychowdhury

Adhering to global standards, be it GMP or GCP, has been a recurring concern in India. How are managements of pharmaceutical companies addressing this issue?

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Ian Wilcox

Scrutiny of global regulators like the US FDA has increased and we are seeing an increasing number of warning letters. Over the last 10 years, FDA activity has increased noticeably. The FDA issued more than six times the number of warning letters for manufacturing in 2014 (19) than it issued in 2005 (three).

But this spike in warning letters doesn’t tell the whole story. According to various media reports, between 2010 and 2011, field alert reports nearly doubled from approximately 800 to slightly less than 1600. In that same period, OTC recalls rose from 336 to 652, while prescription drug recalls rose from 479 to 605. Drug shortages also climbed: from 178 shortages in 2010 and 251 in 2011. In this same period, shortages of sterile injectables more than doubled, from 74 to 183. These figures are for all FDA activity, not just FDA activity related to India specifically.

As I see it, the ‘Make in India’ initiative could be a huge re-branding opportunity for the Indian pharmaceutical industry. As for how managements of pharma companies are addressing this issue, I think they should do it at three levels. Firstly, they should ensure that they have professionals with sound technical operations (tech ops) skills of the pharma manufacturing processes at the board level. This immediately sends out a strong signal to global regulators like the US FDA that the company has sound tech ops expertise, right at the top level.

Secondly, they should hire professionals with these tech ops skill sets like Sigma 6, Total Quality Management, ISO 9001, or Company-Wide Quality Control from global companies which have gone through manufacturing change of this nature. For instance, they should hire from companies like Boehringer Ingelhiem, Novartis, Sandoz.

Thirdly, the approach to quality should change. The pharma industry still sees quality as a cost, which is why quality suffers during cost cutting measures. Pharma sees quality as an afterthought where as in industries like automobiles, it is seen as a strategic asset. The pharma industry is beginning to view quality as a means to achieve cost efficiencies but they are still not seeing it as a key strategic asset. In fact, many of the bigger contract manufacturing organisations (CMOs) do a better job and have a better approach to quality than pharma companies.

What advice do you give to global companies who have acquired Indian companies and are strategising to bring India operations in line with global practices, be it GMP or GCP, etc?

It is both an attitude and skill set issue. On the attitude front, managements of acquiring companies cannot come in with an expat strategy. It should be a shared process, with the senior management of the acquired company on board and completely part of the process.

An attitude of shared accountability has to be built in all the way down the line, to the manufacturing shop floor, packaging lines etc. This requires a mindset that tracks key quality parameters like ‘getting it right the first time, on time’, reducing error rates, reducing deviations from good manufacturing practices, ensuring the integrity of test data, and ensuring sufficient environmental monitoring. Each and every employee has to own it and take shared accountability. This requires companies to hire people with the best skill set as well as the right attitude, that (quality) is not just a part of the job but a part of the shared accountability. Pharma companies need to find people who are Indian at heart, with global expertise in tech ops.

Regarding the second issue of skill sets, India does have a dearth of talent on the pharma tech ops side but this can be met by locating manufacturing plants close to talent pools. In fact, I would say that the Indian pharma industry has so far missed the opportunity to take leadership in identifying talent early and partnering with engineering schools to build a feeder pool of the skill sets they require. Again, the auto industry has done well on this front. For instance, take the General Motors Institute in the US. Globally, the biotechnology industry has done this better and there are many industry-academia partnerships.

Within the pharma industry too there are some companies which have gone this route. Examples of industry/ academia partnerships tend to be R&D rather than manufacturing focused. For example, the University of Limerick in Ireland’s Synthesis & Solid State Pharmaceutical Centre (SSPC) has collaborated with industry to optimise pharmaceutical processes. GSK took masters students in Biomedicine or Medical Biotechnology students at Lancaster University to its Ulverston site to learn more about the manufacturing process of medicines. Bayer has partnered with Peking University to create a joint research center at the school called the Bayer HealthCare/Peking University Center of Translational Research for Drug Discovery. Boehringer Ingelheim teamed up with the Duke Clinical Research Institute, an academic affiliate of the Duke University School of Medicine, to better understand the progression of the idiopathic pulmonary fibrosis (IPF). Teva in Israel has a partnership with the UK Cancer Research Institute. Sanofi has committed $2.4 million per year to seven top academic centers, including Johns Hopkins, Brigham and Women’s Hospital, and Columbia, to fund about 20-25 seed projects annually, with no strings attached and a wide-open scope.

It is clear from the recent moves of Sun Pharma to acquire Novartis’ brands in Japan or Dr Reddy’s Laboratories acquisition of some of UCB’s brands, Strides Arcolab buying local J&J brands that some of the bigger Indian pharma players are looking at topping the charts as global branded generics players. What are the starting blocks they need to put in place now, so that by 2020 they would have evolved to the next level?

To become truly innovative, Indian pharma companies will need to hire talent with this experience. This may not be possible for all companies, but it is definitely possible for some of the bigger top players.

The pharma sector in India has seen significant growth over the last few years but it remains generics-focused. What strategies can they employ to evolve up the value chain?

Within the Indian pharma sector, there are two strategies that I’d like to discuss: firstly, focusing on underserved areas of the world, and secondly, continuing to strengthen India’s position as a logistics hub.

With respect to India’s continuing focus on underserved areas of the world, it should develop core competencies in disease areas that meet a broad population need. Example areas are respiratory, HIV/ AIDS, and anti-infectives.

With respect to strengthening India’s position as a logistics hub, India sits, geographically, at the crossroads of the world and therefore should continue to invest in infrastructure. Companies should make logistics excellence a priority, because logistics supports another core competitive advantage for India: manufacturing. India needs to continue to work for excellence in manufacturing as it carries out a strategy of delivering medicines to underserved areas. India should continue to be a platform for manufacturing APIs and generics, and to be sure, will continue to address the quality issues that have bedeviled this critical sector.

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