Spotlight

Moving Northwards

NDDS has always been an integral part of drug discovery. Today, there are very few pure players in India catering to this niche segment. Ethypharm India, a wholly owned subsidiary of Ethypharm SA, France is one of them. Vanessa Mahapatra tracks the journey of this focused player.

With the goal to be a preferred partner to pharmaceutical companies, Ethypharm SA, a France-based company began its India operations, after establishing its presence in Europe, US, Africa and Japan.

So far, Indian companies have been developing drug delivery mechanisms in-house at a pretty high cost. The concept of going to an expert for such specialised work did not exist earlier in India. Yet Ethypharm India was set up by the parent French company with the idea of bringing in expertise and core competency in specialised drug delivery solutions and making it readily available in this geography at an optimal cost. However the journey was a hurdle race for the company.

"We would like to take a leadership role in promoting drug delivery systems in India and the other emerging markets too" - Ajey Kumar CEO Ethypharm

"Setting up in India was certainly not easy as ours was an international company with low exposure to the local market, to the local mindset and the government's policies and regulations," muses Ajey Kumar, CEO, Ethypharm. Ethypharm's entry into the Indian market was marked by its acquisition of Lloyds Laboratories in 1998. "Acquiring an existing company was an easier route at that time given the then FDI rules," he justifies. But even this was definitely not a trouble-free way out, or rather a smooth ride in. Lloyds' business model as entirely different from that of Ethypharm's. Everything had to be realigned to meet the requirements of an R&D driven company that chose to be in the business of making platform technologies available for drug delivery.

Two-pronged strategy

Survival in any country translates into customisation of the business model to suit the PEST requirements there. Ethypharm's business model in India has two aspects. On one hand, it out-licenses its products to be marketed by other companies with either royalty or profit sharing along with a one-time licensing fee and on the other hand the company collaborates with leading pharma companies to bring to market innovative products using its platform technologies. For instance, Ethypharm India recently out-licensed the marketing rights of Tramadol Flashtab to Ranbaxy.

Additionally, the company set up a new R&D centre and a factory and went on to receive WHO GMP approval for the new manufacturing site between 2001 and 2003. Also, in order to make the organisation more competitive and productive, the factory and the R&D centre are being scaled up for EUGMP and USFDA accreditation in 2006-07. "The entire exercise of setting up new factories and R&D setups was an arduous task," says Kumar.

Small steps, giant strides

Success comes in small measures. It did for Ethypharm. The company's small successes have made them big. Ethypharm India initially received the WHO GMP certification. This complemented the increase in demand and production it has achieved over the years. Today the company is in the process of further scaling up its facilities to meet new challenges and demands from the developed markets. Ethypharm India is one of those few focussed MNCs in India, whose core competency lies in drug delivery solutions.

Conquering new lands

Being a king in just one territory is not enough for Ethypharm. Hence, in addition to strengthening its presence in the existing markets, Ethypharm India is also gearing up to supply to newer territories in the Western world.

Ethypharm India’s reach has widened to encompass the Indian subcontinent, East and West Africa, the Middle East, South and Latin America, Russia, Ukraine, CIS and Baltic Nations. Yet the journey has just began as Kumar says, "We would like to take a leadership role in promoting drug delivery systems in India and the other emerging markets too." Other than successfully catering to its markets, Ethypharm covers a range of operations that include clinical evaluation, product formulation, API sourcing, manufacturing, contract research and clinical services for its group companies worldwide.

Armed force

However, a wide reach alone does not make a company successful. In order to stand out in the crowd, it requires a strong and unique product portfolio, which needs to be expanded so as to sustain the growth with time. This is something that has made Ethypharm India a successful name in drug delivery. About their product range Kumar says, "We go across multiple molecules, wherever we see the need of an optimal drug delivery solution, regardless of the therapeutic segment." The company boasts of a wide range of products that span diverse therapeutic segments like pain management, cardiovascular, diabetes, gastrointestinal, neurological and inflammatory disorders.

Kumar sees a strong potential for drug delivery system products in India and emerging markets, "Drug delivery systems form 15 percent of the total pharma market worldwide. However, in India and emerging markets the drug delivery products form only around three to four percent of the total market. There is an obvious gap here." Thus Ethypharm India has armed itself with technologies like oral disintegration, taste masking, sustained release, enhanced absorption and site-specific delivery. The company is also in the process of developing newer products based on high-end technologies which will help convert injectables into oral dosage forms. Extensions like taste masking have also been added to various products for paediatric and geriatric patients.

Ethypharm India is also trying to develop cost-effective technologies for the Indian and emerging markets in order to increase the accessibility to high-end products and decrease dependence on expensive imported technologies in these markets. In line with this Ethypharm India has also filed some innovative patents recently, which include areas of gastro retentive technology and taste masking technology. It has also filed applications for DSIR accreditation.

Last words

With the impact of WTO, the Indian industrial sector will mark a shift from a multi-tasking business model to one that focuses on clearly identified core competency. Considering this and looking above and ahead, Kumar says, "Ethypharm India intends to remain a focused player in drug delivery solutions. The idea is to push the drug delivery systems concept in India and also take a leadership role in the growth of this segment here and in the relevant export markets."