Several pharmaceutical companies in India, big as well as small, are set to exploit the potential of novel drug delivery systems (NDDS) platform technology, as the market of NDDS products are expected to make a major leap in the near future.
According to the available data, NDDS market, which has been witnessing a drastic growth with the introduction of new techniques and routes of delivery, contributes nearly US $75 billion or 15 per cent to the global pharmaceutical industry. The segment contributes nearly four per cent to the country's pharmaceutical industry. Industry experts states that the growth, which the sector has been witnessing in the recent years, is mainly due to the increased R&D spending, competition and strong international market.
The pharmaceutical companies today consider the use of NDDS platform technology as an opportunity to strengthen their brands by making the products easier to administer, more patient friendly and effective. It is crucial in terms of the efficacy of a medicine, as drug compliance generally wanes off with multiple dosing or in case a drug needs to be taken continuously over a long period of time. Drug delivery companies are now at the forefront of innovation and is all set to leverage the global pharmaceutical industry.
As per industry experts, the robust trend, which has been happening in the global pharma industry, is visible in the Indian market too. It is expected that in the immediate future, NDDS drugs will continue to gain importance, as these formulations are patent friendly and represent an immense opportunity for the pharma companies for sharpening their competitive edge in an increasingly crowded market place.
Observing the scope of NDSS platform technology for the Indian firms, Rena Shukla, a healthcare analyst with Frost& Sullivan, said, "Companies like Ranbaxy, Ethypharm, Cipla, Wockhardt and Panacea Biotech have taken initial steps to develop offerings on NDDS platform. The market opportunity for India may look small in sheer numbers, that's due to limited focus on developing drug delivery systems for oral forms. Nevertheless, Indian companies have adopted the in-licensing model recently to introduce new forms of drug delivery."
Commenting on the same Ajay K Vij, CEO, Dabur Pharma said, "NDDS platform technologies have tremendous potential for Indian companies, especially for companies with oncology focus like Dabur Pharma, as many of the existing cancer therapies have significant side effects associated with their formulation. The key for any novel delivery system will continue to be delivery of the therapy to the target without harming the normal cells."
Ranbaxy to exploit NDDS segment
Ranbaxy Laboratories, one of the largest players in the domestic pharmaceutical industry and a leader in the NDDS segment, is set to further exploit this growing segment. The company had in 1999 licensed its once-a-day ciprofloxacin formulation on a worldwide basis to a multinational German firm Bayer. Its foray into NDDS has led to several proprietary know-how platform technologies resulting in many products under developmental and commercial stages.
Commenting on Ranbaxy's strength in this segment, the company spokesperson, said, "At Ranbaxy, research in NDDS represents an innovative and strategic activity focused on maximizing the overall therapeutic value of commonly prescribed pharmaceutical formulations by enhancing their performance and reducing their adverse event profile. Such innovation may also help to improve the overall quality and efficacy of the drugs and result in superior patient experience."
The company's NDDS focus, which has 40 novel products in its kitty, is mainly on the development of new drug applications (NDA) or abbreviated new drug applications (ANDAs) of oral controlled-release products for the regulated markets.
Ranbaxy's in-house NDDS programmes are primarily focused on the oral segment. Inhalation (patented devices) and trans-dermal (patented adhesive polymers) programmes are also being pursued through collaborations. In the oral NDDS space, Ranbaxy has already developed four platform technologies - gastro retentive, modified matrix, multiparticulate and AeroGel. The company has also successfully developed several products leveraging these technologies.
The company's major products in the segment are sporidex AF (cephalexin), cifran OD (ciprofloxacin), cifran TR (ferrrous sulpahte), desval ER (divalporex central), flotral (alfuzosin), minoz OD (minocycline) and raciper D (rabeprazole+domperidone). In the current year, Ranbaxy has further augmented its NDDS portfolio with the launch of six NDDS formulations with many of them being marketed for the first time. It includes neupent AF (Gabapentin SR), niftran (Nitrofurantoin ER), eligard (Depot Leuprolide inj) cardibeta (Metoprolol XR), stanlip (Fenofibrate) and cefdeil DT (Cefdinir 125mg).
Themis concentrates on NDDS pipeline
Themis Medicare is another Indian firm, which has been working on NDDS platform technologies. Currently, the company is working on two main technologies - clear gel and injectables. Dr Sachin D Patel, director, business development, Themis Medicare, said, "We can manufacture a gel, which is transparent in nature and it penetrates faster, as compared to other topical products available in the market. We are also working on designing an injectable formulation for lipophilic compound with our novel drug dissolving technology. We have designed more than five formulations with the help of this technology, and aceclofenac ready to use injection is one of the latest examples of this technology, which is the most widely accepted molecule after coxib tragedy."
Lupin to strengthen NDDS platform
Also, the Mumbai-based Lupin has proved its NDDS capability by launching ceff-ER, world's first once-a-day cephalexin tablet and odoxil OD, world's first once-a-day cefadroxil tablet. It is learnt that the company has filed seven patent applications for NDDS platforms in major areas.
Dabur goes nano way
Apart, in what can be termed as a significant development, Dabur Pharma launched nanoxel, a novel drug delivery system for the widely used anti-cancer drug paclitaxel, which is claimed to be as India's first indigenously developed nanotechnology based chemotherapy agent.
Referring to the development, Dr Rama Mukherjee, president, R&D, Dabur Research Foundation, said, "Owing to its water insolubility the widely used chemotherapy agent paclitaxel, which is known to have substantial anti-tumour activity, is now used with a castor oil based solvent, cremophor, which in turn is an agent for life threatening side effects."