Indian Pharma companies are in constant touch with the US FDA: DG Shah, India Pharmaceutical Alliance

In a chat with ET Now, DG Shah, Secretary General of Indian Pharmaceutical Alliance, says it would take another two to three years to resolve the issues with FDA. 

ET Now: Problems for Indian pharma companies started a year-and-a-half ago. FDA issues keep on cropping up now and then. How do companies tackle this? Why is it happening? 

DG Shah: There are three major issues as far as the US FDA is concerned and companies have been working on this for the last one year. They formed a quality forum and are in constant dialogue with US FDA. The actions that needs to be taken is with regard to data reliability, culture and best practices. Changing all this and implementing in each company is a long drawn out process. But we are working constantly on a time-bound action plan with the US FDA. We are hopeful that in the next two to three years, the results of the effort being put in by the major companies will start showing. 

ET Now: Indian companies are completely aware of the US generic terrain. They have been successfully exporting to the US markets for more than two decades now. But, the communication from the US FDA has come only over the last 12 to 18 months. It is like saying that US FDA has discovered a lot of problems over the last year and a half whereas these had existed earlier also. At that time, they seemed to have ignored them. 

DG Shah: That is not true. If you look globally, warning letters for such matters have been issued to companies all over the world including foreign multinationals. The bar has been raised and the implementation has changed. Since, the number of inspections have gone up so much all over the world and not just India, the industry is facing a problem in getting skilled and trained manpower. FDA also faces the problem of getting skilled and trained inspectors and this is where sub jectivity has crept in. FDA is fully aware of this and they are also addressing this issue. So, we believe that together we should be able to resolve because FDA is not interested in discontinuing the supply. It hurts the US citizens, because nobody can match the prices that India offers. I do not see that as a problem but it has cropped up and the way FDA is inspecting now is different from how it was being done 12 or 18 months ago. So, we need to take all that into account and work not only on what is now, but we should anticipate what would be the future trend in this and address all those issues and that is what we have started doing. 

ET Now: How much of the current US communication is typical US election rhetoric? Last time when there were US presidential elections, there was a lot of hue and cry about the IT industry and outsourcing. This time it is about outsourcing and US healthcare market. Do you think this is just posturing, ahead of presidential elections? 

DG Shah: Now, we take this more seriously, because the US government itself is interested in containing its healthcare cost and therefore this is not just posturing. Simultaneously, we can also say that to allay any such reaction, the Indian industry is making significant investment in the US and creating jobs there. There is a total commitment from the top management and they spend a lot of time on addressing issues and all that FDA wanted is senior managements' commitment to quality and we have demonstrated that. This is not something that can be resolved overnight. It is a culture issue. We need to provide training, development and bring attitudinal changes. This would all take two to three years before we can resolve these issues. But remember this is being addressed to a group of companies at the moment. There would be another group of companies which are also exporting to the US and they will have to be covered. So, the total process would take much longer to cover all the companies in India. 

ET Now: Do you think large companies like Wockhardt, Sun Pharma, Lupin, Ipca which are currently facing problems because of US FDA issue have the understanding and wherewithal to get over the US FDA problem? 

DG Shah: These large companies have come together and formed a quality forum and we are taking the best available consultants in the world including the regulators both MHRA/EDQM and US FDA to address these issues. There are several industries we need to look at. Take steel, automobile, airline which have been ranked as complying with the best quality standards, so it is not that that we do not have capability or we cannot do it. It is a question of focus and that focus has come back about 12 months ago and the results will take some more time. So, I am absolutely confident and determined that we will resolve these issues. For some companies it maybe earlier, for some it may take a little longer. But the market is the US and nobody would want to leave that market. 

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