The Delhi High Court has quashed a March 10 notification, banning 344 Fixed Dose Combination (FDC) drugs. The drugs can be brought back to the market following the decision.
However, Kewal Handa, Industry Expert and Former MD, Pfizer
says bringing back the banned drugs may not be very ethical for the pharma companies and they may avoid doing so. He was of the view that the pharma companies will most likely rebrand the drugs and introduce them back into the market.
There is no evidence that all FDC drugs have an irrational combination, says Habil Khorakiwala, Chairman of Wockhardt
. He says the drugs were in markets for more than a decade, and were not a cause for concern for all those years. This is a very appropriate decision from the Delhi High Court.
The government had banned the FDC medicines including popular names like Corex cough syrup, Vicks and D-cold on March 10 terming them a 'risk' to humans. Below is the transcript of Habil Khorakiwala and Kewal Handa’s interview to Ekta Batra on CNBC-TV18. Q: What are you making of the news that the Delhi High Court has in fact quashed the March 10 notification banning 344 fixed dose combination (FDC) drugs?
Khorakiwala: What Delhi High Court is very appropriate because these are basically a decision taken very arbitrarily and not a full appreciation of mine. Additionally, it is a committee which just recommended a drug. So, from a scientific rationale to understand each of these drugs from the industry, why is it so and why is it banned because many of these drugs were in the market for the last 10-20 years and there are no evidence whatsoever that it is irrational, combination all of them.
Second, in the Indian context, one must recognise the compliance of medicine. When it is in the combination, the cost of medicines are lower and there are better chances that the patient will use the drug. Instead of taking three drugs or two drugs at a time, if you have a single pill available, the chances that the compliance and there is enough evidence worldwide. Q: The point is taken about compliance where one particular strip of drugs will allow you to access multiple drugs at the same time. But the problem with FDC as a while in India is that these many drugs are not actually sold globally in other developing markets as well. India is particular in terms of the high amount of FDCs that we do manage to sell. So from that perspective, do you think that it is that important to rationalise it?
Khorakiwala: The question is just because it is not available elsewhere and it was available here, it is an arbitrary decision actually, because in the western countries, it is not a medical rationale. It is not because, there is not evidence, critical trials and others have not been taken to get those drug approved. And the need for various drugs to combine depending on the disease profile are not necessarily identical. Now the very fact that drug is in the market, it has been there for 10-20 years, there is no adverse effect and the physicians are prescribing and using the drug. So, from that context, what government is actually doing is the treatment for the patient is making two things, one is more expensive and second they are doing is compliance is suffering. So, I am not saying that irrational drug should be in the market, but a proper scientific approach is not taken to do that. And to do 344 drugs in one go obviously, the science has not been applied. It is a very arbitrary decision. Q: But there is the Kokate Committee which actually went through this whole list of drugs and that is when it was decided that 344 would be banned in March. But your point is taken in terms of the queries that you have. But in terms of Wockhardt, which are the drugs which would come under FDC and would you putting as much effort in terms of branding and marketing those drugs as you were, pre-March, 2016?
Khorakiwala: We have a few drugs which do come under that, but it is not a very significant part of our portfolio basically. So, from a personal point of view, it is making some impact like all companies, but none of our big brands or anything covers under this FDC issue. Q: How much of the percentage of sales would it be, sub-5 percent?
Khorakiwala: It would be sub-5 percent. Q: Are drug companies making rational efforts on their own because we just heard from Pfizer, this week, that they are discontinuing the Corex brand, but there will be line extensions which will come out under the Corex brand. They have already introduced Corex Dx which is Rs 40-50 crore in terms of sales. So, there is rationalisation which is taking place by drug companies already. Your thoughts in terms of whether this was enough of a reason for them to do that.
Khorakiwala: All the companies were developing a plan ‘B’. The plan ‘B’ is that you keep the brand and what the drug administration wants, based on that, develop a formula and reintroduce those products. So, a cough syrup is always a multi-brand activity. So, it is one of the drugs which they found there are issues like Codeine containing drugs and some of the combination they have and a rational issue. So, from that context, companies revising the formulation. And I think that is an industry practice. Q: Mr Handa, your thoughts?
Handa: The decision by the court was mainly because the process was not properly followed. But I do agree with the government point of view that there are certain FDCs which are irrational completely. There are certain which are ethical forming drugs which are being misused. So, there is definitely a case for the government to pursue it. But the manner they went about doing it in a wholesale way has actually, they lost the case at the supreme court. But there are companies who have also realised that some of them are really irrational, they have changed it. Some of them also stopped some of the drugs which are Codeine based and therefore, there has been a realisation amongst the companies that these types of drugs cannot be sold like quantities in the market.
I guess, now going forward, whether these companies will come back with the old products and sell in the market, that would be unethical to my mind. You have taken a decision to stop these products and then come back and start selling it just because of the order of the courts, certainly unethical. As far as the government is concerned, they should actually do more research, more trial and present it in a better manner so that the case is strengthened.