CRAMS industry needed to focus on innovation, quality and compliance

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With the slowdown in the growth of Indian Contract Research and Manufacturing Service (CRAMS) industry from an envious 35 per cent in 2009 to 15 per cent in 2012, companies are now driven with a strong need to focus on innovation, quality and compliance in the current global regulatory environment.

“The global regulatory environment is changing rapidly and industry is grappling with re-tooling itself to meet quality expectations,” said Hitesh Windlass, co-founder and CEO at Windlas Healthcare Pvt Ltd., a pharmaceutical formulations manufacturer for oral solids for regulated markets and Alumni of University of Chicago Booth School of Business.

“The earlier model of vertical integration is also quickly giving way to strategic partnerships on joint product development and even co-marketing. We at Windlas are actively building a portfolio of value added generics and investing in R&D to target different patient segments – paediatrics, geriatrics. R&D resources with focus on nutraceuticals and cosmeceuticals is one of the main thrusts at our company,” says Hitesh.

He further explains, “We wanted to expand our presence as a CMO (contract manufacturing organisation) in the Indian market for the developed countries like the US, Europe and Australia. Windlas was started with this view and we are well on our way to achieve this goal. Today our facilities are approved by five of the top six pharma companies of the world. We are in the process of registering products in our target markets and take pride in providing high quality and innovative products to our customer.”

We invest almost 50 per cent of our profits in research and development. We have two R&D labs and are looking at enhancing molecules for targeted group of patients, products used in clinical nutrition and complex generics. Our R&D has been segmented into basic systems, nano systems, probiotics, prebiotics, modified release concepts and taste enhancement and are also looking at ignored areas like anti malarials. We closely work with National Institute of Pharmaceutical Education and Research (NIPER) in areas of pre-formulation studies. We have also been benefited by the subsidy programme of the Department of Scientific and Industrial Research (DSIR).

Talking about market opportunities and challenges in India, Hitesh pinpoints that a lot of growth in the Indian market was driven earlier by the launch of new products i.e. fixed dose combination products. It has come to a grinding halt now. Looking from a patient’s perspective, this might not be a bad thing. We see certain product segments like nutraceuticals, cosmeceuticals, etc. growing at a rapid pace and we have recently augmented our production facilities to specifically target these market segments. We also see renewed emphasis on innovative approaches to old products. Since we develop the formulations ourselves, we help our customers bring these innovations to market and thereby building their brand presence.

Our greatest challenge is to find the right talent. Identifying innovations and executing the development program within defined timeframes. Capital cost has also gone up in view of the economic and fiscal environment in India.

Many players who are operating on the fringes of quality will therefore be weeded out gradually. A case in point is that Chinese regulators have downed shutters of manufacturing units on the quality issue over the past few years. Similar actions have been observed by the US FDA and many of the European regulatory agencies. Cost of production in pharma sector is going higher as it is linked to manpower, infrastructure and electricity cost. Thus, when you have R&D and innovation as your primary differentiation strategies, it becomes more and more difficult because the higher operating expenses squeezes out the R&D budget.

Globally, it is evident that the cost advantage that India has as a formulation manufacturing hub is becoming smaller. Industry will soon need to compete on quality with other world class players. The cost advantage will no longer be enough to bring home the customer. These challenges exist for all players. We need to be faster at making decisions and smarter about picking our battles. “The competitive landscape was earlier determined by capacity, today innovation, quality and regulatory compliance have become the winning factors,” Hitesh further said.

Source: PharmaBiz

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