The Supreme Court will hear a PIL on Tuesday seeking a ban on Ranbaxy drugs. The petitioner cited the pharma giant's case in the US where Ranbaxy USA admitted to selling substandard and adulterated drugs. The pharma giant has been asked to pay a fine of 500 million dollars. Ranbaxy has been facing the heat even in India with a few hospitals banning its drugs. Pharmaceutical industry expert Vikas Dandekar joined IBNLive readers for an interaction on the issue.
Q. Is Ranbaxy selling substandard and untested drugs? Asked by: Anuj
A. In India, there is no conclusive evidence to prove Ranbaxy is selling untested drugs...In the US, it did involve in backdating and manipulating product filings...But the US FDA had not issued any product recalls, etc. or warned that Ranbaxy drugs sold at that time were unsafe...I think the Import Alert of Sept. 2008 was probably a precaution.
Q. Is a fine of 500 K enough for a thing like this when profits of selling substandard drugs are many times more and companies will only be induced by all this so it is like forgetting Bhopal tragedy for 20 crores? Asked by: Ravi
A. Agree...but I have no idea on what basis the amount was arrived...In many other settlements, the fines have gone much higher...Pharma across the globe is known for profits...That is a different point of debate in itself...And most important, there is no price that can compensate for loss of human lives.
Q. i think in India generic medicines are being sold adulterated coz the more the treatment will go, the more medicines will be sold. may be I am wrong but can I have your observations. otherwise at so many instances doctors prescribed me for simple throat infection or soar throat 1000-1500 mg three times a day for 5 days. is it a jest? this only means that medicines are not effective enough? Asked by: pc
A. Tighter quality controls is a must. India has been speaking about a regulatory overhaul, etc. but the fact remains the Indian regulator is short staffed and at times less qualified to deal with QA/QC issues related to new generation drugs..Having said that, I don't agree that all generic medicines in India are adulterated...That is a sweeping statement.
Q. Is Ranbaxy just interested in profits rather then the people's healthcare? Asked by: kiran
A. Ideally, healthcare should come as a foremost goal for drug companies...As is said, find cure for patients, profits will follow. I am not sure if that has just remained a statement.
Q. Why are Ranbaxy's top management or its executives be allowed to go scot-free with fat pay cheques or stock options when it is indulging in all these practices? Asked by: Sanjay
A. I think you are referencing the U.S. episode...Great question but I have no answers for that...I think it was beyond the Justice Department to book charges against individuals. But I am not very sure about the legal aspects on that. Also I am not well informed about the fat pay cheques or stock options - so no comments on that.
Q. Today, with what information we have,if for a critical illness your doctor prescribed a Ranbaxy drug, would you take it? Asked by: Deepak J Singh
A. Yes, why not ! Is there a clinching evidence to suggest that Ranbaxy drugs sold in India are killing patients? I will also look at the price and hope it is not sold at 3x of other rivals.
Q. Would this sales of substandard drugs come to light in India as Indian regulatory practices are corrupt and political patronage is massive for corporates like Ranbaxy? Asked by: Arvind
A. Great point! We can only hope that truth is told. No company and specially a drug company can survive with its credibility eroded.
Q. Is the pharma industry adulterating drugs? Asked by: Jyoti
A. This again is a sweeping statement...Unless we know that drug firms are producing drugs in non-GMP settings, it will be wrong to say drugs are adulterated or sub-standard...Personally I feel a thorough investigation as being told by the DCGI should put things in the right perspective. The disturbing part is that most people have started assuming that all drugs made in India are substandard or adulterated...That's not right.
Q. Sir, I give you a very simple example. I took this anti allergic medicine bought from USA. And taking one medicine, I was completely feeling better.The same medicine being generic drug manufactured in India I took 5 for 5 days, there was no change in my condition. this is just one eg. you go and try the generic version and the original version manufactured in US or EU, hell lot of difference you will find. so I am not surprised if Ranbaxy selling untested drugs. your observation! Asked by: pc
A. I value your inputs but think of this part...All drugs sold in the U.S. are approved by the toughest regulators...Therefore they should all be giving the same benefits to the patients. So far as drugs sold in India is concerned, ideally there should be no difference between a drug sold in India or anywhere...Your point could be true if the drug maker in question is really having manufacturing practices that are shoddy..Can you name the drug maker and the medicines, if you remember?
Q. Is the Ranbaxy episode an example where profits and stock value is every thing and business ethics and govt norms are meant to be flouted at the cost of common man as the company had nothing to do with research or sound drug manufacturing practices Asked by: Hitesh
A. I have answered the part about profits...In terms of stock value, I don't think in the last 5 years, the stock has gained greatly in value..ask Ranbaxy shareholders, they will know better than me.
Q. Is it fair to be blaming Ranbaxy at this time when it has lost control over the company to Japanese firm and is minority shareholder Asked by: Ravi
A. Rather than seeing the episode as a blame, it makes sense to see what good comes out for the generic industry...tighter controls, unquestionable quality and value for patients - beyond these three points, nothing is more important at the moment.
Q. Is it proper to raise aspersion on Ranbaxy when it has been doing business in US for so long and has been selling economical drugs like lipitor in their generic form so can an isolated case effect it in any way Asked by: Manav
A. A different kind of question !! I think previous Ranbaxy management take things for granted for too long - no denying that and there is evidence of that ! The road ahead should be spotless - as already the damage to its credibility has been immense.
Q. Does Ranbaxy example show that other drug manufacturers in India are also selling inferior products as Indian administration as far as inspection and regulation are corrupt? Asked by: Hitesh
A. Unless we see facts, it will be unfair to make these assumptions.
Q. Are Indians over-blowing the situation when in past FDA has picked certain drugs of Merck and Pfizer for not meeting norms so big firms also have to go through stiff tests so best thing for Ranbaxy is to stop making excuses and improve its compliance norms. Asked by: Manush
A. Regulatory investigations are conducted across companies..I agree with you..Ranbaxy should improve on compliance - no doubts.
Q. See. again and again I am repeating this. We are seeing new influx of money in the last 1 decade. so the point is, a person getting a good package and so called fake image in the society follow the mob and do what others are doing. So how can you expect honesty from that person. else this kind of embarrassment what India has seen in USA by getting their homeland company charged with such a case, wouldn't have happened. You are pushing freshers and youngsters to this fake society image that they only bother to care about themselves if you throw a good package on their face. they will keep mum and will never fight for truth.candle light walk is just a sham. Asked by: pc aka @jpchat9
A. Sorry, I am not sure about this question.
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