Indian drug makers are now more aware and appreciative of compliance issues in global markets, Frances Zipp, CEO at Lachman Consultants, one of the most sought-after global consultants, tells ET Prime’s Vikas Dandekar. Edited excerpts:
How do you see things shaping up in India on drug manufacturing side?
India is a critical source of drugs for the global markets. There is now a lot of transparency in the worldwide supply of drugs. We have seen open, genuine discussions on issues faced by the industry. In my opinion, one of the unique opportunities for the industry to come out on scientific and safe manner is to engage closely on the latest developments in the industry.
What critical changes have you seen from the Indian companies?
In the last couple of years there has been a heightened appreciation and awareness on both science and compliance requirements. Importantly, there are no differences between any of the markets. The items and issues seen in India exists all over the world and the Indian pharmaceutical companies are aware now more than ever on how critical they are for global supplies. Hence, they are coming up with robust solutions that are based on technology and maintain good compliance standards.
Complexities involved in making drugs have changed — we now have cell-based therapies, biotech, etc. How do smaller generic companies make the change in this swiftly evolving landscape? Why are Indian companies getting regular citations?
There are significant observations and warning letters around the world. In my role, we look closely at the distribution. You must see the percentage of distribution of drugs. The Indian and Chinese markets have a lot of generics. There are so many biosimilars. In the eighties and nineties, it was not there. I can tell you people here in India are highly sophisticated in their knowledge. It’s just about matching the knowledge to the compliance issues. That is very critical.
People say a lot of the compliance deficiencies are related to the cultural issues in India?
It is, and many times I have seen it around the world. The onus is on the companies that if you want to be big in the markets being tapped, you must follow the rules. There is no other alternative. And the rules are very clear. It is a learning curve.
What are your thought on issues such as data integrity?
Firstly, there is a lot of awareness on this at present. Five or ten years ago, people really were not necessarily aware of the requirements of the overall data governance. I always say that people come to work to do a good job and that is true everywhere. Regulators have showed data that acknowledge reduction in data lapses and that is because of training, education and awareness that filters into the whole industry. I don’t see any difference between India and any other part of the world on that. We work with global companies and most of it comes down to understanding of the issues and education. It is important to know that the daily inputs of the staff has a direct impact on the product that affects the heath of the patient.
One of the points raised at the conference is about the leadership not so well trained to understand the shop floor issues. Your comments?
I think the missing link was the overall word of the management. No matter what, the management is responsible, management has the tools to help the people do their jobs right, and we heard a lot of examples where people were found to not have the time or the skill set to do their work. It is here that the management should be available. Companies around the globe have gone through this. In India, this has come into play in the last few years. If there is a regulatory citation, the senior management’s name is on that document. It’s not the guy at the shop floor. It is the top person.
What about the latest advances in artificial intelligence coming into manufacturing?
AI is gaining importance, but I think it all goes back to the basic. The feedback received from AI is great for improvements. People come to work knowing what they need to do, have the tools to do their job that is the best. When we fully automate and take away as much human intervention as you can, that’s wonderful. But all that needs to be set up by someone. It all goes to personal integrity and giving value to that end goal. Everything we do every day has an impact on the patient — that is the bottom line.
How do you see the role of the Chinese in the drug industry and the impact of the Indian companies?
I did look at the data and have my own experience. Now there is more than just China that are becoming important in the region that are keen to enter the US market. The Indian advantage is that they have been here for long, they have the expertise and they know the market dynamics. But competition is fierce, with US helping get more generics in the market. You see South Korean, Indonesian, Taiwanese, Thailand and Singapore companies coming into the field in a big way and learning from the mistakes of American, European and Indian companies. Competition will keep increasing on generics (and just because they are generics, it does not mean that they are easy to make), biosimilars and branded drugs. India is doing very well on reaching a global scale, and that’s the best way to learn and do things in an open manner. It is not about low-cost generics, now a lot of technology is coming in to play.
How do you see the increasing cost of remediation for the generic drug industry versus the pressure from the US government to keep healthcare costs low? Even the US FDA has taken steps in that direction...
This is a controversial point. But the costs of doing things right is so much cheaper than going wrong. Everything in this goes back to personal integrity, the integrity that you get from your family, social situation and education. There might be many regulatory complexities that we deal with, but if we do it right the first time, the cost is so much lower than remediation. The message to every industry is that as soon as you get external experts involved, be it the regulators or the consultants, it’s going to cost more, from delayed approvals and changes required to remediation. The learning however is that companies are on the path of sustainable compliance.
When do you think Indian drug makers will get out of these problems?
I think this is a cycle. I don’t think one can ever stop learning. People are becoming vigilant, communication quality with the employees are becoming better. Also, this is across the board and not just in India — I repeat. I think every time a new regulation comes out, we again start to learn new things. There isn’t anyone part of the world that can stay we are very stable.
Resourse: //economictimes.indiatimes.com/articleshow/66484779.cms