The Indian Pharmaceutical Association will organise the 6th Symposium on Nasal and Pulmonary Drug Delivery, which will be held in Mumbai on October 24 and 25, 2013. The theme for the symposium is ‘Global Regulatory Trends.’ The two-day scientific symposium will be tailored specifically to nasal and pulmonary drug delivery and will reportedly welcome a panel of highly renowned scientists and technical experts for sharing knowledge about orally inhaled and nasal drug products (OINDPs).
The Indian pharmaceutical industry is showing increasing interest in developing orally inhaled and nasal products compared to conventional dosage forms as they provide significant benefits to patients including minimal systemic exposure, faster onset of action and broader options for disease management. Nasal and pulmonary drug delivery is used for local and systemic treatment of diseases such as asthma, chronic obstructive pulmonary disease (COPD), rhinitis, migraine and many more. New inhalation products are also being developed for non-respiratory disease indications, e.g diabetes, which would allow patients to avoid more intrusive medical treatments.
Inhalation science and technology is a rapidly growing field. In the US, for many years, the industry had no formal guidance for OINDP. However, between October 1998 and June 1999, the FDA issued three draft guidances and the industry commended the FDA’s efforts in preparing these drafts. However, in recent times, the regulatory hurdles facing OINDP developers have become more stringent as the global marketplace has extended the impact of the US FDA.
Patents are expiring at an accelerated rate without a compensating flow of new innovations, allowing cheaper generics to expand their reach in the US and Europe. By 2015, many of the products will go off patent in the US and the launch of generics would result in the brand drug sales to decrease by 60 per cent. The developed markets are forecasted to be characterised by low growth, a stricter regulatory environment and increasing levels of patent litigation. The pressure to reduce drug prices would be even more pronounced in Europe due to high government deficits. Most of the pharma companies are, therefore, seeing emerging markets as the key to their growth.
Most emerging markets are in a far better financial condition, with rising personal incomes, minimal entitlement exposures and lower levels of public debt. Rising levels of healthcare access and funding as well as the changing mix between generic and innovative products are contributing to market realignment.
Alongside the importance of emerging markets as sources of revenue growth, over the past decade several of them have also become major providers of low-cost contract R&D resources, spanning the full breadth of activities, from discovery chemistry and biology to API manufacture and clinical trial management.
The winners in the emerging markets, therefore, would be those companies that know how to balance their global competences with tailored approaches for local markets.
EP News Bureau – Mumbai
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