Milan Patel, President, Gujarat State Board Chapter, IDMA, and Joint Managing Director, Troikaa Pharmaceuticals Ltd spoke to Prathiba Raju on how the segment is focusing more on automation and getting data driven. Pivotal role heading the state chapter will be on laying emphasis on the current regulatory landscape, compliance issues, raise their level of understanding and implementing international norms of cGMP.
Q What are the main dynamics you are witnessing in the pharma manufacturing sector in India for the past one year? What about the country’s positioning in terms of R&D? How do you see its future prospects?
My perception is that the pharma manufacturing sector has a realization that focussing more on automation, having a more system-oriented and data-driven organization is the way forward. Companies that are in exports have turned the past one-year pandemic into a huge opportunity since the whole world is looking at India as the pharmacy to the world. Whereas domestic sales have obviously dropped except for a few therapeutic segments viz. vitamins and drugs they used to manage, due to COVID-19. Overall, it’s a mixed basket, but if the industry realigns its efforts in the right direction of the market demand, I am sure the majority of manufacturers will come out stronger.
Q How do you see the pandemic impact on Indian drug
Manufacturing? Do you think Indian companies have managed to turn this into an opportunity by using these ingredients to supply medicines at reasonable prices while reducing their production costs and R&D spend?
Indian medicines have always been reasonably priced, and hence I already mentioned that exports of our products in certain segments have gone up substantially.
Production cost has in fact gone higher, but still, the industry has done well in exports. I don’t think the reduction in R&D has any connection with the pandemic. R&D is an integral part of the growth of any company and in fact, it fuels the growth. The last one year was the pandemic year and the impact of the same is there on domestic sales, rise in input costs, manpower shortages, and other supply chain uncertainties. The silver lining is the export demand and the resilience and adaptability of the Indian pharma entrepreneur.
Q What is Gujarat IDMA’s current mandate? Can you let us know the milestones and achievements you are looking up for the chapter?
My focus and effort are to make the IDMA, Gujarat members to be more and more aware of the current regulatory landscape, compliance issues, raise their level of understanding, and implementing international norms of cGMP. I firmly believe that our country being pharmacy to the world, we all manufacturers should be able to be internationally compliant in all aspects. My focus will be on how to make the members of the chapter grow to the next level. Various webinars and interactions have been conducted and more will be done in the future.
Q What is the biggest concern for IDMA members during this pandemic period?
Rising costs of all inputs across all segments including API and packaging materials have raised the cost of production and are unable to get a corresponding price rise in the product. Adding to this problem is the supply chain unsurity and non-availability of many starting materials. This has put a lot of pressure on the profits of the manufacturers.
Q What are IDMA’s main suggestions to update India’s regulatory environment and foster the local and international
Development of its member companies?
Indian regulatory environment is changing very fast. It is speedily catching up with the international cGMP norms. IDMA is always supporting the government in this issue. We as an association believe that Indian manufacturers have already created a worldwide image of being pharmacy to the world. If our regulatory environment matches the world standards, then it will give much more enhanced respectability and a wider international market to the Indian manufacturers.
Q What is your assessment of growing stringent regulations in foreign markets and the impact on generics export from Indian companies?
Indian companies will have to be compliant with international regulatory norms. We have a very good image as an affordable source of generics, but if we want to enhance our reputation we will need to also upgrade our regulatory compliance, which builds a lot of respect and confidence in the world and obviously will get a bigger market share at more value addition in the international market.
Q What is your assessment of the positioning that India should occupy when it comes to pharma manufacturing?
The positioning is very obvious considering our current strengths of being a source of affordability, high quality, and reliability of generics. We also have a huge technically qualified human resource and the ability to develop generics at very high efficiency due to this advantage.