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pharmaceutical ingredient (API) is the same and by varying the formulation, one can modify the pharmacokinetics without necessarily altering the route of administration. This allows for extended release or reduced frequency of dosing. This strategy is often used by innovator companies as part of their life cycle management for existing products and also by generic companies who wish to find a niche for entering with differentiated formulation, using an abbreviated regulatory pathway.

Numerous studies conducted by various drug companies on the medical fraternity’s experience suggest that there is high level of poor compliance to the medications by patients. One such study based on daily dosage frequency in Indian patients has shown that those who fail to comply with prescribed treatment usually range from 30% to 60%, with some figures as high as 90%. In other words, non-compliance is fast becoming the most significant reason for failed therapy. Also, studies show that a better compliance is there with medications having once-a-day or twice-a-day dosage guideline.

No wonder, getting a suitable drug delivery form is almost as important as the drug itself. And, the true significance of drug delivery technologies lies in their ability to improve the safety, efficacy and medical utility of several drugs.

The NDDS segment is being driven by the twin trends of declining number of approvals of innovative drugs along with blockbusters going off-patent, says Utkarsh Palnitkar, head of life sciences practice, Ernst & Young (India). Pharma companies are able to give ‘newness’ to the product by introducing a new technology into old products. This fetches them a higher price valuation. Furthermore, companies are ‘tinkering around’ with the structure of the original drug, by extending the structure to a NDDS platform, to try to arrive at ‘new molecules’, sometimes targeted at newer indications.

Uday Baldota, vice-president (investor relations, Sun Pharmaceuticals Ltd, says, “We have to evolve to the next stage, that is, create ‘new to the world’ delivery systems that can be licensed out or used to bring products to market. Once these ‘novel’ technologies are patented in India, then copying even these will become difficult,” he insists.

However, NDDS need not always be the succour that the industry is looking for. Sensational failures—inhaled insulin is a case in point—highlight the need for successful technology platforms as an enabler of commercial success.