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: superior growth. Companies are buoyed by the fact that there is a strong possibility of the NDDS-based formulations introduced after 2005 getting ‘patented’ in India, under the provisions of the 2005 Patent Act enactment.

That’s not all. Indian companies have strong product development skills and a record of successfully being able to make ‘copies’ of internationally available delivery systems-based products in areas such as controlled release. Novel and complex drug delivery systems are ways of modifying delivery of a medication in order to make it simpler to administer, easier for the patient to take, or make it more effective or safer, says Amit Patel, vice-president (corporate development and strategic planning), Dr Reddy’s Laboratories. They could also help Indian drug companies evolve to the next stage by creating delivery systems that can be licensed out or used to bring products to the market.

“It is a win-win situation for all the stakeholders—patients, industry and the clinicians,” says Sanjeev Dani, senior vice-president and regional director (Asia & CIS), Ranbaxy Ltd. NDDS products represent the first significant step towards innovation. They can improve therapy by increasing the efficacy and duration of drug activity. Some can increase patient compliance through decreased dosing frequency and convenient routes of administration. Others can improve targeting for a specific site to reduce unwanted side effects. Ultimately, the product life cycle gets extended, Dani insists.

Ranbaxy occupies a leading market position in the NDDS arena with a basket of over 30 products already on the shelves in the country. It’s technological breakthrough came in 1999, when Bayer AG of Germany, signed an agreement with Ranbaxy to obtain exclusive development and worldwide marketing rights to an oral, once-daily formulation of Ciprofloxacin, originally developed by Ranbaxy. Cipro has been Bayer AG’s blockbuster drug and one of the world’s leading antibiotics. This new once-daily or extended-release oral formulation of Ciprofloxacin, developed by Ranbaxy, offers the twin benefits of improved patient convenience and enhanced compliance.

Similarly, Biocon’s research focus in this space is anchored on the premise that it has a new molecular entity that allows for a novel route of administration, namely, oral, compared to the existing injectable medium.

“Our focus is currently on a molecule, IN105, which is an insulin-conjugate optimised for oral delivery as a tablet. We have already completed Phase I trials of IN-105 in India,” says Arun Chandavarkar, chief operating officer, Biocon Ltd.