How do you look at India growth story? With the new government in place and focus on Make in India, is that really translating into positivity at global level?
Kate: Currently the narrative is that India is lacking a compliance culture. Problems with clinical data and compensation issues are adding to that. Whatever the new government is doing, at least on the international front there is no change in the conversation. There are warning letters adding more to this perception of not being compliance friendly.
I think the ‘Make in India' initiative is a right one and India does have tremendous potential. However, at the same time, the Indian firms will have to use more will power to tackle the issues that have stunted the growth. Indian industry has to be creative about changing the perceptions. Governance, self regulation is very necessary but all the stakeholders have to contribute. Small molecules, biological and overall generics have a great future here. I am much hopeful about India's growth story but at the same time it will take real efforts and investments. It will not grow by itself.
David: Regulatory changes are a game throughout the world. One of the challenges for biosimilar industry is to manage these diverse regulatory pathways. Even in Europe there is a pathway that continues to evolve. The US FDA is continuing to issue guidances on the development of biosimilars. Indian contract manufacturing is mostly for finished dosage products or APIs. Indian government and companies will have to effectively manage the global regulatory landscape to ensure that the global image and perceptions remain positive.
Is quality control and compliance a major issue for Indian industry? What are the specific steps to be taken in this direction?