Usha Sharma – Mumbai
Chronic obstructive pulmonary disease (COPD) is one of the most serious health concerns in India. In a bid to discuss ways and means to handle this disease, Indian Pharmaceutical Association and Aptar Pharma recently organised the sixth symposium on Nasal and Pulmonary Drug Delivery in Mumbai on the theme Global Regulatory Trends. The conference is a biennial scientific meeting in India to share knowledge about orally inhaled and nasal drug products (OINDPs).
SD Joag, General Secretary, Indian Pharmaceutical Association said, “This is our flagship programme from IPA and it is being held for the sixth year in a row. It is constantly evolving and becoming more successful. Today, nasal spray is finding fast acceptance in the society, many and many pharma companies are getting into this business. Our aim is to keep the industry updated on all aspects related to regulations and other changes as well as advancements in the business. Through this forum we are educating the industry.”
Dr B Suresh, Vice Chancellor, JSS University commented that drug discovery is a challenging job and today industry-driven drug discovery and developments are also taking place. This in turn is becoming challenging to the regulatory authorities. He also stated that they are finding it difficult to not only set up new regulations but also adhere to it going forward. He said, “Today, the major difficulty faced by the regulators is data incompletion, companies are not revealing the entire process data to the authority while applying for the patent and unless the complete data is shared with the industry the outcome is not complete. Hence, I emphasise to the industry that they should share the data in detail because the final result may be the same but process varies from each process.”
Mark Copley, Sales Director, Copley Scientific presents his view, “India has a well established and advanced pharma industry that has considerable experience in the development of inhaled generic products for both domestic and international markets. Currently, India’s rate of development of generic products outstrips much of the rest of the world. Until now focused conferences on inhaled product development have been centered around Europe and the US where much of the inhaled originator products were developed. However, as India rapidly ascends and begins to tackle highly lucrative and yet highly regulated Western markets it is important that the key Indian stakeholders have access to the latest information and developments in this area. Therefore a conference such as this (which is now well established as the primary conference for inhaled products in India) should continue to grow in future years.”
Dr Tim Noakes, Medical and Specialty Products Commercial Manager, Mexichem commented, “The symposium brings together a vibrant local pharma industry with international experts representing most of the phases of development and manufacture of inhaled medications. The interactions between the experts of the now substantial local industry, and visiting experts, is really starting to bear fruit. At the first symposium, ideas and concepts discussed were much simpler, and the gulf between Indian inhaled medication manufacture and some Western manufacturers was all too obvious.”
Copley shares his experience during the event and mentions, “International expert speakers delivered topics that were diverse and of a high quality covering a range of technology around inhaled and nasal products. There was a strong focus on regulatory aspects (European, US, Brazilian and others) especially with regard to generic bioequivalence, which is particularly relevant to emerging markets. The talks were up-to-date and covered the very latest thinking; there was considerable debate as a result.”