Mr Bob Rhoades, VP, Quality and Compliance of Quintiles Consulting
Q: Please tell us about your clients and activities in India? What are the opportunities that exist in India?
Being in confidential agreements with our clients, we cannot reveal the names but they are among the prominent names here. Companies approach us for resolving their issues with the FDA. Since clients seek remedies from us, we basically have expertise in rescue and remediation. Generally those who have been served warning letters, higher level of enforcement activity approach us. We try to help them in making amends to their existing processes and documentation habits.
If the market forces would have moved to Tanzania, everybody has been there but that is not the case. India continues to be in focus and that is why people talk about it. There are more than 200 USFDA (United States Food and Drug Administration) approved manufacturing set ups in India. However, next focus is China and that can prove competitive for India to deal with. Although big opportunity lies in the biologics, these pose a great challenge too. We have a great team that is working in the area. Also, I think biosimilars are complex and it is not going to be easy for the FDA to accept these.
Q: With growing challenges in quality control and compliance, how mature is the Indian industry and its regulatory system?
There have been few controversies but it is hard to say that the loopholes exist across the whole industry. Lot of the key inspections happen and there are just few headlines. Therefore, it is not exactly true that all the companies are the same. It is on company to company basis. Two years ago we had just one client here in India and today we have five. It is inappropriate to brand entire community or paint all with one brush. Today 42 percent of finished products and 80 percent of active drug ingredients (API) are coming from China and India. It is the regulator's job to find issues and things that can be potentially risky if entering their country. It is wrong to label India as bad while the FDA inspectors who are tasked to do their job, find any issues in few cases. India is still being talked about positively.
Q: In the backdrop of few examples where Indian companies were fined by USFDA, How could they ignore the basic quality parameters?