[Biraj]

Originally Posted by dkaile

This is all a plot from many big US based Pharma giants to discredit and finish off local Indian manufacturers. And Ranbaxy can also be pawn in that. If they can discredit a big player like Ranbaxy then what hope do 100's of small drug manufacturers like us have?

Just to fuel the conspiracy theory, Gleevec's patent was rejected by Supreme Court in April and we see this report in May.

Many of the points made by you are extremely valid and there is certainly a need for reform in infrastructure and governance before FDA rules are implemented. However, I am sure you will agree that not all drug manufacturing companies are adhering to the code of ethics. Greed has got the better of them.

My job requires me to interact with opinion leaders and policy makers in Healthcare industry and I have heard instances where a leading pharmaceutical company that got the license by showing manufacturing unit in Himalayas was getting its drugs manufactured in slums of Dharavi. I have even heard of a drug manufactured by a very reputed generic manufacturer which doesn't dissolve inside the body and the patient will excrete the tablet as is, next day. So, where's the quality management and self regulation?

I am all for generics and I understand how important generics are, especially for economies like ours. However, it's extremely important that our government takes lives of people seriously and ensures that there is proper governance in pharmaceutical industry. Till that day, I will prefer to purchase branded drugs for my family.

[amitoj]

Originally Posted by dkaile

I can proudly say the SSI sector in general produces fantastic drug quality at fraction of the cost of these giants.

All that is fine but what data do you have to back that up? Why would i trust your statement instead of an FDA approval?

Would you buy a helmet that is manufactured locally or one that has at least an ISI approval even if local manufacturers claim their helmets to be as strong if not more without equivalent test data to back them up?

[dkaile]

Originally Posted by Biraj

I have heard instances where a leading pharmaceutical company that got the license by showing manufacturing unit in Himalayas was getting its drugs manufactured in slums of Dharavi. I have even heard of a drug manufactured by a very reputed generic manufacturer which doesn't dissolve inside the body and the patient will excrete the tablet as is, next day. So, where's the quality management and self regulation?

Till that day, I will prefer to purchase branded drugs for my family.

And are you 100% sure that the so called 'branded' drug manufacturer has not 'bribed' your prescribing doctor by 'sponsoring' his US holiday in the name of drug research meet so that he can prescribe you the 10 times costlier 'branded' drug to your 'perceived' receiving of better quality?

And who is responsible for people setting the units in Himalayan states? The flawed Government policy of providing excise, income tax and VAT benefits for such states at the cost of genuine small manufacturers in non subsidy states suffering the brunt. Not 100% producers are genuine but in the name of few exceptions to implement a policy affecting 99% genuine manufacturers, is that fair too?

Originally Posted by amitoj

Why would i trust your statement instead of an FDA approval?

I think you are unaware that the pharma industry whether in SSI or otherwise is one of the few "licensed" raj industries still going on. We CANNOT manufacture drugs without FDA approval, period. How did you perceive that I was talking of manufacturing drugs without FDA approval?

My point was that 'Indian' FDA standards should not be blindly following the 'US' FDA standards without realising the ground realities, which it is not in recent years.

[Biraj]

Originally Posted by dkaile

And are you 100% sure that the so called 'branded' drug manufacturer has not 'bribed' your prescribing doctor by 'sponsoring' his US holiday in the name of drug research meet so that he can prescribe you the 10 times costlier 'branded' drug to your 'perceived' receiving of better quality?

Not 100% producers are genuine but in the name of few exceptions to implement a policy affecting 99% genuine manufacturers, is that fair too?

Just for the sake of clarification, when I say 'branded' I mean the research molecule not branded generic. I agree that large corporations have enough money and greed to corrupt anyone. Everyone in the system wants to make extra money be it the manufacturer, physician or the pharmacists. Even pharmacists stock/place products based on the commission they earn. I am fine as long as it stays to extra profit. The moment it stretches into a zone where human life is being risked, I find it unacceptable.

I really wish that 99% of all drug manufacturers are genuine and work with the same earnestness as you do. Unfortunately, most of the people I speak with in the industry believe that the percentage of genuine manufacturers is way too less than 99%. Maybe I should have done better sampling.

[amitoj]

Originally Posted by dkaile

I think you are unaware that the pharma industry whether in SSI or otherwise is one of the few 'licensed" raj industries still going on. We CANNOT manufacture drugs without FDA approval, period. How did you perceive that I was talking of manufacturing drugs without FDA approval?

My point was that 'Indian' FDA standards should not be blindly following the 'US' FDA standards without realising the ground realities, which it is not in recent years.

More stringent guidelines are often met with resistance. I would expect similar reaction from the ISI stamped helmet manufacturers too if the government tried to make Snell certification mandatory. Similar resistance would come from car companies too if ARAI adopted Euro NCAP style crash testing. In both cases, the products do go through some sort of testing but is that enough?

You see all i am hearing so far from you are these vague statements like "blindly following US standards without realising ground realities"
or
"SSI industry would never be really able to implement the high cost involved in many unnecessary regulations in context of our country"
or
"Where the government is NOT ready to provide us US level of infrastructure and corruption free environment BUT still wants manufacturing facilities, drug trials and unnecessary research studies of US levels."

What are these guidelines and standards that the government is imposing that are unnecessary according to you? It is a sincere question I am asking in order to better understand your point.

[mroptimist]

Originally Posted by amitoj

All that is fine but what data do you have to back that up? Why would i trust your statement instead of an FDA approval?

Would you buy a helmet that is manufactured locally or one that has at least an ISI approval even if local manufacturers claim their helmets to be as strong if not more without equivalent test data to back them up?

Disclaimer: I am M.D in pharmacology, a teaching pharmacologist with a medical college with a deep understanding of the subject being discussed. Still I don't consider myself competent enough to talk on every aspect of Pharma industry.

amitoj where do you stay? If you are in India why are we talking about FDA? Do you think FDA approval has any thing to do with India?

I have time and again stated with all humility you cannot discuss sensitive policy issues on this forum which do not concern the auto industry.

I urge the moderators to lock this thread because it is promoting panic among readers and unnecessary heat is being generated which is absolutely unwarranted.

What we must try to avoid is medication by the media or prescription by politicians.

P.S: Even Ranbaxy is not considered part of Big Pharma.

[amitoj]

Originally Posted by mroptimist

amitoj where do you stay? If you are in India why are we talking about FDA? Do you think FDA approval has any thing to do with India?

You are right. FDA has no jurisdiction in India. Perhaps I should have said the following: "Why would i trust your statement instead of data from extensive tests and research?"

As for locking the thread, I'd let the moderators be the judge of that. I don't see any harm in having a civil discussion though.

[AltoLXI]

Originally Posted by mroptimist

I have time and again stated with all humility you cannot discuss sensitive policy issues on this forum which do not concern the auto industry.

I personally do not see anything wrong in having meaningful discussions about the issues which affects the people and society.

Originally Posted by mroptimist

I urge the moderators to lock this thread because it is promoting panic among readers and unnecessary heat is being generated which is absolutely unwarranted.

No sir, there is no panic promoted. With information already available in the public domain, ignorance need not be bliss.

Originally Posted by mroptimist

What we must try to avoid is medication by the media or prescription by politicians.

It still helps to know what prescription the politicians are writing and what medications the media is handing out.

[BoneCollector]

Looks like another one is brewing up.
Wockhardt shares dive after US import alert
http://toi.in/FSxYHb

I guess till the time healthcare is not taken as a priority by politicians, it'll be difficult to root out such problems. I read in papers that there are so many pharma companies owned by politicians, how can there be any check on those? You just cant do anything to it. In India, anything can be sold if you show the money to people responsible for maintaining its quality control. I feel that the FDA is doing a good job till the concerned people wake up here. Most of the companies when they come to market their product over emphasise on FDA approval of their products so if FDA says that the drugs are sub-standard, I'll accept it without any pinch of salt. At the end, its for the doctors to judiciously decide on medications. But again, in India, its difficult to keep tab on sub-standard drugs and over medication, because every Tom-Dick-Harry is a medicine prescriber here, even your next door grocery shop chap will do that.

[dkaile]

Originally Posted by amitoj

What are these guidelines and standards that the government is imposing that are unnecessary according to you? It is a sincere question I am asking in order to better understand your point.

I would definitely like to discuss this but it is not such a simple matter and I believe this is not the proper forum for the same. Unless you have a deep understanding of the pharma sector, I would mostly be banging my head on the wall trying to make our issues properly through to laymans. It is imprudent to equate a helmet certification with a drug one. Safety is paramour but there are routes to reach that without killing domestic industry, is all I would like to end my side of the story with.

[NetfreakBombay]

Originally Posted by mroptimist

Do you think FDA approval has any thing to do with India?

In 2008, Ranbaxy was being probed by FDA as well as Indian regulators. FDA continued its investigation and Ranbaxy pleaded guilty to criminal charges.

At the same time, Indian regulators did not find anything wrong in the same case. After this debacle, they reopened investigations.

If Indian regulators were doing their job, things would not have reached this level.

Originally Posted by mroptimist

because it is promoting panic among readers and unnecessary heat is being generated which is absolutely unwarranted.

I do not think it is unnecessary. Though I am not part of Pharma industry, things* that I have seen have convinced me of need for stronger regulations.

*As a engineering student, I worked on few projects for MIS of a company that used to do contract manufacturing for tablets.We got to see the plants to understand some MIS processes. In that industrial belt, drugs were being mixed in containers and we students were standing right next to it wearing our own shoes, no worker was wearing any mask or cap and in general it was clear even to us that this is not good. Too many possibilities of contamination.

This was the case with most companies there.

Shockingly, Ranbaxy was one of the better ones. No one could casually wonder around in the plant and things were much more controlled.

So, if Ranbaxy is being convicted, what would be the level of those smaller companies?

[AltoLXI]

Originally Posted by dkaile

Safety is paramour but there are routes to reach that without killing domestic industry

Safety cannot be paramour.

[dkaile]

Originally Posted by AltoLXI

Safety cannot be paramour.

paramount

[latentpotential]

Amazing web of deceit formed by Ranbaxy. It is a bigger surprise that Indian Media is ignoring this topic, and such a detailed article completely.

[BoneCollector]

Originally Posted by latentpotential

Amazing web of deceit formed by Ranbaxy. It is a bigger surprise that Indian Media is ignoring this topic, and such a detailed article completely.

I tweeted to some media big shots for a response, no one replied. Only Suhail Seth replied and he too was asking the same question, Why is media silent? I guess there's much more happening than what meets the eye. There are rules but then, it needs to be implemented. As it is, our country is dumping ground for so many things.