PPA ISSUE

Yogesh Kumar Sharma

                      Advocate & Counselor-at-law

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IN YEAR 2005 PPA (PHENYL PROPANOL AMINE) WAS BANNED BY FDA (USA) SINCE IT WAS ESTABLISHED THAT CHEMICAL USED IN COUGH SYRUP AND ANTI-COLD TABLET LEAD TO STROKE, BUT BECAUSE OF WEAK LEGISLATION INDIAN MARKET WAS EASY FOR PHARMACETICAL COMPANY.

ENUMERATED LETTER OF NOTICE –ON BEHALF OF PHILANTHROPHIST ORGANIZATION aSMITA (REGISTERED NGO) TO LEADING PHARMACEUTICAL COMPANIES RESULTED IN WITHDRAWL OF PPA BY SUCH COMPANIES FROM INDIAN MARKET AS WELL.

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February 26^th, year 2005

By Registered post, acknowledgement due

Asking  you people to kindly pass it along to CEO, P&G and Country Manager {India}, if got through to you; As they are virtually inaccessible through their e-mails for us. {Company's website do not show their ID/address}

ADRESSEE IDENTITY IS DELIBERATELY SCREENED

For personal attention :- CEO, Parent Company :

 If you do not present the reply in proper right to deniability background – we would be left with a vacant air of bewilderment. Resultantly, our imagination could conjure no set of circumstances that could explain your behaviour. And also in absence of any direction to your Country-Manager {India} you, would be, in our eyes, like a lazy parent who found it easier to acquiesce' to the whims of spoiled child then to stand firm and teach values. The higher the authority, the higher is the level of sensitivity and responsibility expected from it. To seek  shelter between the technicalities of law is  to let loose forces which would lower the moral tones of the society, may it be in America or India. Since there was no denial from you Pharmaceutical Companies on the news about stroke induced drugs of yours, it had assumed it was true. The allegation may have been untrue, the tragedy is it is so believable.

Other Pharmaceutical companies  {accused} have also by their silence endorsed the P&G' view. Further it unable to refute factually , in future also would relate itself as current to previous acts of controversial acts. You yourselves as have it conformity.

Dear Sirs

On behalf of asmita -- a philanthropist organization duly registered under the Societies Registration Act {1860} and is engaged in taking up various common problems of people for securing redressal thereof; this epistle  aims to strive to call your attention to very sensitive subject which appeared in recent news items of Times of India. It has indeed caused great surprise and serious concerns and is obviously matter of great importance of public interest --We would like to notify you as under :-

1.  THAT ab initio – right at the outset of this legal epistle – though it may look odd to someone – we would like to put prefatory remarks for our this legal notice paraphrased from, with an apology  for Joel Feinberg & Hyman Cross, Philosophy of Law {Page 306}: Critical judgments about  what people do occupy a very large place in our daily life. Philosophers want to make sure that these judgments are valid and so seek principles under which the judgments may, in turn, themselves be criticized. There are urgent practical reasons for making sure that our criticism of conduct is sound. We live our lives in a community of persons each of whom pursues his own interests, yet each is required to respect the interests of others in order to make possible the benefits of life in a civilized society. Since disinterested benevolence is not a regular feature of social life, people must be encouraged to avoid harming others as they seek their own ends. When harm is done, it is important that acceptable remedies be applied to undo the harm as much as possible. It is also important to take steps that will reduce the likelihood of harm being done in future. This requires holding to account those [and only those] who properly are accountable when something untoward occurs. It is a matter of some importance also that those [and only those] who are entitled to recognition for good work receive it, so that encouragement of socially valuable activities is provided. What we need, then are ways of criticizing conduct that are rational and fair. Moreover having read Tagore that 'There should never be any compromise with injustice, whether to one's self or others "Tolerance of injustice is bad as suffering it";

2.  THAT an qualified doctor-member of ours says : There was a time when we had sick patients. All we could only do was to provide support, then stand aside and hope. There was so many disease for which doctor had no weapons to fight, it used to be frustrating. But now this is not true. There is a whole arsenal of drugs to fight with and to cure; and credit goes to Pharmaceutical industry who provided them. We wish credit only when credit is due.

3.  THAT, Doctor-member further said, take hypertension quarter to century ago, there were a few, limited ways to treat it. Often they did not work, lots of times, hypertension was a killer. Now treatment through drugs is unlimited and sure. The incidence of STROKE, which hypertension caused, is down by half, and dropping. Drugs are preventing heart attacks. They have stopped most tuberculosis and ulcers, improved the diabetic patient's life. In every other field of medicine the same is true. So many drugs. That the point is that the successful, useful drugs outnumbered losers. And it is not just the drug makers who are gainer. The big winners are people – those who have health instead of sickness, those who live instead of die. Precisely what is to be said – with all its faults, despite its criticism – This industry is provide a benefaction for mankind.

4.  THAT this is with reference to a by-line news item in The Times of India on January 29^th, 2005 – "Anti-cold pills recipe for STROKE". The details in the news item were "Popping that pill from your first-aid box every time you get the sniffles could be fatal. Commonly used cough and cold pills and syrups such as D'cold, Vicks Action 500, Actified, Coldrain contain phenyl propanolamine {PPA}, an ingredient that could rapidly lead to stroke. In the west, pharmaceutical companies had quickly recalled drugs using the particular ingredient when reports of their fatal side effects emerged  about three years ago. However, in India most cough & cold preparation continue to use PPA. Professor and Head of Cardiology at All India Institute of Medical Science, Dr K Srinath Reddy, says : Almost 50% of the currently available cough medicine contains PPA. Doctors continue to prescribe them even when there are safer alternative available. But the number of people who suffered the fatal side-effects would hardly ever be known. "Even when person suffers a stroke, no one will  relate it with the cough syrup" says Reddy, "What is causing concern among expert is that these are not some rare side-effects of a drug. Trials reported in the New England journal of medicine have pointed out that this ingredient alone could be listed as an independent risk  factor for stroke." "Commonly used cough & cold pills and syrups such as D'Cold, Vicks Action 500,Actified or Coldarin contain phenylpropanolamine, an ingredient that could lead to stroke. 'The Haemorrhagic Stroke Project' conducted by Yale University School over a five year period, first came out with damning evidences against the ingredient. The risk of stroke was found to be higher in women compared with men. The ingredient was found to lead to strokes on healthy people even on recommended doses and with single use. The US Food and Drug Administration asked for recall of the drug. C M Gulati, Editor of MIMS India, a monthly medical index, says in India, the medicine is used for all kinds of  unrelated disorders such as bodyache and headache. It can also aggravate diabetes, glaucoma and prostrate enlargement. He says certain brands are available with safer alternative in the west, but in India they are sold with the offending ingredient.";

5.     THAT also to facilitate your better understanding and to jog your memory, we are here-in [this para] incorporating the letter of FDA, USA to all CEOs of pharmaceutical companies which market the drugs containing PPA, downloaded from the internet bulletin board of their websites.

This manuscript claims as under :-

FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

November 3, 2000

Food and Drug Administration Rockville MD 20857

Dear CEO or President:

This letter concerns drug products containing phenylpropanolamine and its salts marketed by prescription or over-the-counter (OTC), which are now or have previously been manufactured, relabeled, repacked, or distributed by your firm. Phenylpropanolamine is currently available by prescription and OTC as a nasal decongestant, and OTC for weight control. Your firm is receiving this letter based on information in the Food and Drug Administration's (FDA) Drug Listing System or because you have a new drug application (NDA) or abbreviated new drug application (ANDA) for a product containing phenylpropanolamine.

This letter is to inform you of recent developments relating to phenylpropanolarnine. Earlier this year, FDA received a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project" from scientists at Yale University School of Medicine. This report, which is on display in Docket No. 81N-0022 in the FDA Dockets Management Branch, states that the data suggest that phenylpropanolamine increases the risk for hemorrhagic stroke.

On October 19, 2000, the Agency's Nonprescription Drugs Advisory Committee (NDAC) discussed this report and other information on phenylpropanolamine. NDAC determined that there is an association between phenylpropanolamine and hemorrhagic stroke and recommended that phenylpropanolamine not be considered generally recognized as safe for OTC use as a nasal decongestant or for weight control. 1

Based on these recent developments, FDA intends to initiate rulemaking to classify phenylpropanolamine as nonmonograph (not generally recognized as safe and effective) for OTC use. Based on the recent research findings, FDA also has significant concerns about the continued use ofphenylpropanolamine in prescription drug products. FDA also intends to take action to remove phenylpropanolamine from prescription drug products. FDA plans to issue a Public Health Advisory on phenylpropanolamine to alert consumers and health professionals about the report.

I In the mid-1970s, phenylpropanolamine was classified as Category I (safe and effective) by two OTC drug advisory review panels. The Cough-Cold Panel's recommendations on phenylpropanolamine as a nasal decongestant appeared in the FEDERAL REGISTER of September 9, 1976 (41 FR 38312) and the Miscellaneous Internal Panel's recommendations for weight control use appeared on February 26, 1982 (47 FR 8466). However, FDA deferred its classification of phenylpropanolamine because of subsequent safety issues that were raised, pending completion of additional studies.


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FDA also believes that, as an interim measure to protect the public health, you should voluntarily discontinue marketing any drug products containing phenylpropanolamine. If applicable, you may reformulate such products to remove the phenylpropanolamine ingredient.

If you have any questions or want additional information, including information about options for reformulating products that contain phenylpropanolamine, please contact Jerry Rachanow or Robert Sherman at 301-827-2241.

Your cooperation and prompt attention to this matter will be appreciated.

Sincerely,
Director
Center for Drug Evaluation and Research

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6.  THAT this much we know that a drug, any drug, is an alien chemical in the human body. When it is put there – usually when a doctor prescribe it – with the aim of curing something that's wrong in the body. But as well as doing good, it may also do harm. The harmful part is called side-effect, though there can be harmless side-effects too. Keeping in view this, drug makers has to judge – while making a drug – whether the risk of using a  particular drug is worth taking in order to get results that he and patient want. And that is known as "risk versus benefit" factor i.e. the benefits over-weigh their risks -to decide whether a drug which had been made should be marketed or not . At this point of decision making no pharmaceutical company could afford to decide "Let the cure may be worse than disease". Usually this thing always came in to the notice of drug makers before or after submission of their NDA & ANDA to regulatory agencies for approval to brought in the market for sale. The mandatory regulatory agency is also supplied to find out about risk - What they are and how bad.

7.  THAT let us again come to the news item and surprisingly we find that here-to-fore any rebuttals occurred with these news items report is absent. If it is true that silence of good people is more dangerous than the deeds of sinister.So the 'no-comment' situation  from the PROs of those alleged pharmaceutical companies is intriguing and a diligent person can only think that – their unspoken words in this regard are to be so obvious that – we might as well have said them  aloud : "We do not care";

8.  THAT we  do believe that JUSTICE is a contract of expediency, entered upon to prevent man harming or being harmed but it is also beyond comprehension as how we could afford to overlook tenet of rule of law, that no one should be condemned unheard. And for that purpose let us hear it from us and see it yourselves by entering the hall of mirrors {facts} and see whether you find distortions and your caricatures, and then if the pharmaceutical companies related with (accused with)  PPA contained drugs think that the allegations are true than it is quite BAD. But if the accusations being made all-over & in the newspapers are not true it is EQUALLY BAD cuz the newspaper will then have permitted falsehood to be repeated and allowed companies to be falsely accused;

9. THAT stroke is one of the commonest neurological emergencies. It is third most important cause after cancer and heart-attack, of morbidity and mortality in elderly population of any nation .Atherosclerosis with thromboembolism is the commonest cause of the stroke. Stroke is one of the important cause of severe disability in the society. Stroke patients, as against heart attack patients, rarely return to their jobs and social positions. No possible treatment is foreseen in the terrible description term – Vegetable– when it is also due to drug induced and/or unregulated mix of chemicals in the human body. Amounted to 'criminally' violated his/her human right to life, crippled his manner of living, denied his pursuit of peaceful existence – in essence, destroyed him. Justice Field had said in US in 1877 – "How the right to life means not just a right to animal existence but to a life of dignity & fulfillment";

10.   THAT when we simply enquired from a fellow attorney & counselor-at-law in USA– an American lawyer who had spent much of his life as litigator for & against pharmaceutical companies ,he told us, as he was trying to quickly give us, standard academic sketch of the accepted Pharmaceutical Companies' history & way of working. What we are now what we were narrating as under, though it may not carry his exact words,  otherwise this is going by all accounts, the substance of what he wanted to say/purported to convey its information:

              i.      "There was a time when corporate sector including big pharmaceutical companies in USA were being called a 'national treasurer' but now that MNCs, if you believe the claims of anti-globalationists from Sealtle to Carcun, are the ugly face of capitalism. Not only are they   as despoilers of the environment and member of sweet-shop but they are fickle too. They have no commitment either to the countries in which they are based or those in which they invest. They move jobs from one country to another purely on the basis of cold calculations, only seeking lavish subsidies to pursue them to invest or to stay. Jhon Kerry, American Democratic Presidential candidate, in recent election had labeled companies that switch production overseas as "Benedict Arnold" firms. After traitor in American revolutionary wars";

         ii.      "To see why these pharmaceutical companies are now blamed for their – excessive avarice, incompetence, indifference, carelessness, duplicity , callousness,, greed & cover-up skills – all of which sins are at times committed  by pharmaceutical companies, whose bottom line is PROFIT; We have to peep in their working ethos & culture. It is also true that in USA, despite a guardian of public health, FDA, we come across with cases of mass tort litigations. But the drug maker always have some 'Mr O.C. Fixit', the initials denoting out of court. Even that amount of compensation which drug makers pay for settlement are from the victims' pocket too, as the premium for product liability insurance is also being part of drugs cost – which the pharmaceutical companies had already took from them to make the victim ill. Sometimes we wonder who is serving whom ? In our experience Man go to far greater length to avoid what they fear then to obtain what they desire";

    iii.      The pharmaceutical industry is in some ways still too close to its roots in early origins. They started off, not all that-- long ago, selling snake-oil at country fairs and fertility potions, and a pill to cure everything from headache to cancer. The salesman who sold those things did not care what they claimed or promised. All they wanted was sales. They would guarantee any results to get them. Often such nostrums and folk remedies were marketed by families. It was some of same families who opened early drugstores. Latter, still their decedents continued the family traditions and built drug manufacturing  firms which as years went by, became big, scientific and respectable. As it all happens, the crude early selling methods changed and became more respectable. Surely, there can't be many families left that controls big drug companies. No many, though some the original families control large blocks of stocks. But what has persisted, even with paid executives running the companies, is the out-of-date, less-than-ethical hard sell much of it happens when some detail men call on doctors to tell them about new drugs";

         iv.      To continue further–"as you know, some salesman – not all – but still too many – will say anything, even lie, to get doctors to prescribe the drugs they are selling. And although drug companies will not tell you officially, they do not condone it – cryptic double talk, they know it goes on. Also we have read stories  from doctors – about patients being ill or even dying after taking drugs, all because salesmen gave false information about drugs, which the doctors believed. Then there is a drug company advertising, Doctors are delude with it, but a lot of advertising does not tell a physician that he ought to know – especially about side-effects of drugs., including dangerous ones. May it be misplaced concretion but LEONARDO DA VINCI' quote : "Many have made a trade of delusion and false miracles, deceiving the stupid multitude". The thing is, when doctors are busy, with patients to see  and a lot of other problems on their mind, it's hard to believe that someone from a drug company, or the company itself, is deliberately deceiving doctors";

              v.      He further said : "I guess lawyers alone haven't evolved much new over the centuries. But, it is also true that drugmakers also have a system, the system to develop new drugs {For name sake} from old drugs, making use of organic chemistry. Beginning with existing active component, the drug's chemistry was modified, then modified again………. And again…….., and again…….if necessary to infinity. Always the search was for a new effective drugs, derived from the old, with no, or low toxicity. It is called "me-too" drugs by copying the successful drugs of your competitor – which is probably no better or worse than half a dozen others already available – by simply playing molecular roulette by changing them just enough so that can't be sued for infringing  someone's patent also by camouflaging it with lucrative alluring misleading advertisement with information minimizing or even ignoring to show dangerous side-effects. They use devious means to attain their ends";

         vi.      He further said : "It is unfortunate aspect of this industry  that they never tell the customers about the so-called cold remedies can also do some harm. As a matter of fact, a lot of them are harmful, some dangerous. In trying to cure a  cold, they may make other, more serious things that are wrong with you a whole lot worse. It is in the knowledge of pharmaceutical firms. At least for three decades, that in most cold remedies there is a mish mash of ingredients. One is a chemical called phenylephrine, it's in what are advertised as decongestants to relieve stuffy nose. Whereas the fact is that mostly, phenylephrine  does not work – there isn't enough used to be effective – but it does raise blood pressure, which is harmful for anyone, and dangerous for those who have the tendency of high blood pressure already. See the irony where drug makers earn profit from effecting cause & also from after their effect also. Where inferences are made from both cause & effect and from effect to cause, the term caused must be used in the sense of "necessary & sufficient conditions". Legitimately infer effect from cause only and in the sense of sufficient conditions. And the inference that one event is the cause of another from mere fact that the first occurs earlier than second i.e. temporal succession does establish a casual connection. A plain simple aspirin , just about all medical researchers agree, is the best thing for a cold. But there are aspirins substitutes, heavily advertised and brought, which contain a chemical, phenacetin. It can cause kidney damage, may be irreversible damages, if taken too often and too long. Then there are antihistamines in cold tablets – there  shouldn't be, they increase mucus in the lungs. There are nose drops and nasal sprays more harmful than good. What it come down to is that the pharmaceutical companies have saturation advertising, that can make people believe anything to buy anything";

    vii.      He further said : "Unfortunately for customers and fortunately for drug makers above narrated drugs are available not by prescription but they are over-the-counter {OTC} drugs. O-T-C territory concerned solely with non-prescription products. There was a time when big pharmaceutical firms erected a wall between the prescription drug portion of its business, which was considered prestigious, and its O-T-C activities which frequently were not. On each side of wall, all activities were separate. Each side had its own administrative, research staff and sales force. Mostly O-T-C learn to care about cough remedies, haemorrhoid ointments & shampoos. Also O-T-C is part of the whole drug scene – a big part and it makes a bundle of money. The O-T-C is mostly hype. Prescription drugs costs millions to research and takes five, six years before it  is ready for selling. Whereas with an O-T-C item,  you need only six months or less to formulate the stuff. The big money goes for packaging, advertising & sales. O-T-C drugs sales are shooting up & up like a goddam rocket, cuz it is what people wants. People who have got some thing wrong with them – mostly something minor which time would take care of, if they had the sense to leave it alone – those people want to treat themselves. They like playing doctor, and that's where drug companies come in; "Blinding ignorance does mislead us. O! wretched mortals, open your eyes" {LEONARDO DA VINCI}. And Pharmaceutical companies reaped the benefits";

viii.      "We come across with prevailing trend in drug industries - which can be catalogued shameful failure of American and other Pharmaceutical Companies doing business in Latin America, Africa and even developing countries like India - to supply warning about adverse side-effects of their prescription drugs – let alone O-T-C drugs. The warning required by Law in more sophisticated countries. If you bought this in USA there would be a published warning about possible side effects. But is there a printed warning say so on the same drug but selling in India ?

Not on you life !

Who cares if a few people suffer or die here because they haven't been cautioned ?

After all, its only India, a long way from USA. Why should those companies care ?

The fact that people, in these countries, could buy them, 5 years after they should have been withdrawn simultaneously; as it had already been withdrawn, recalled and destructed in that country where the parent company first researched and then marketed such drugs in that country. People of these nations can buy other dangerous drugs marketed here without proper warning cuz there are no government agencies to insist on adequate labeling, and so it is a typical of the "don't-give-a-damn-attitude" of American drug firms";

         ix.      He further said : "Many drugs, when in action in the human body and as part of their metabolism, generated free radicals. These are the elements harmful to healthy tissues, and the cause of the adverse side-effects and sometime  death and the most immoral segment of this business is, precisely sales, these companies over-sell-grossly, cynically, wickedly. It is a natural phenomenon that one takes what are essentially reasonable drugs necessary, though with limited medical uses. But  these over recruited force of salesman through massive, ruthless sales campaigns {pushy sale} have those drugs prescribed for countless people who either don't need, can't afford, or shouldn't have them – sometimes all three. This precious industry had to be taken over the head with the regulation before it would publish proper warnings about the dangers of its drugs. Even now, it fights for minimum warning and usually wins. Not only that, after a new drug goes on sale, adverse effects are hidden, conveniently, callously, buried in company files";

              x.      Lastly he remarked : "We fought the illusion with every logical shred of intellect we had, if we did become unbalanced when emphasizing the pharmaceutical industry's negative aspects while ignoring the many positive, humanitarian contributions to science and health industry had provided;pharmaceutical companies should see that this is not only our theory, its being around for a long  time. We are simply building on it";

11.   THAT we think there is only one way – for drug makers – to serve customer interest – the just way. Now let us again come back to the front page by line story in the Times of India, January 29^th, 2005 "Anti-cold pills recipe for stroke" in which it has been said that Professor & Head of Cardiology at AIIMS Dr K Srinath Reddy said :"…….. But the number of people who suffered the fatal side-effect would hardly ever be known……." Fortunately for ensuing crusaders  for common cause for 'safer medicine' we found three unfortunate victim of alleged PPA induced stroke who – still suffers from locomotors disability or cerebral palsy.One came to us as soon as he read that news item. Apparently his conscience did not allow him to seek refuge for a moment in silence. He legitimately feels that he has a basic right to live healthy, which has been permanently render non-exercisable {for} no fault of him;

12.         THAT if the O-T-C drug firm P&G – which according to our knowledge seldom had  achieved a merited reputation for high quality prescription product , may be making some of off patented drugs {generic} – has any qualms of conscience for ethical merchandising . Read : here  is the first person account of paralytic patient reached in this condition due to your half-baked truth advertised pill ' Vicks Action 500' - a describing attempt to pin responsibility on this pill of yours.

He said : as he recalled {It gave him gooseflesh, we were feeling gooseflesh too}:-

a.    "Grief did strange things, even sometimes producing a parody of grief ….. my profession does not allow us to afford a running nose before Bench. Hence, as it always gave me a relief in severe bad cold to bring around, on that fateful day also, I took a pill of Vicks Action 500. In taking medicine like this, trust was the sina qua non as its side effect was unbeknownst to me and thinking what a myth it is, as it being said, if anyone had a cold and treat it properly it will last seven  days, if they don't, it will last a week". It seemed he was forensically reconstructing the incident's events – and after marshalling the facts in his mind he said  :"I was sitting in my office alone and started to feel some relief and reading  an article"…..'after a battery of tests, a specialist finally found the answer the disease was Huntington' chorea a hereditary disease that strikes the brain and central nervous system. In time, it results in loss of brain tissues, an inability to control muscles, an ultimately death…….'. "At that moment, as happens so often in the real world the next move came where I least expected it, precisely, I became aware of sudden breathlessness, my pulse was erratic & my breathing shallow, a cold chill went through  me, a fluttering in my chest, as if a bird was inside, beating its wings and trying to get out. The sensation frighten me. My forehead was dripping with sweat. I felt queasy, my clothes sodden with perspiration. I sweated with the some kind of fear as I was just reading about the ultimate death by Huntington's chorea, and at that time, I knew it was the  fear of death. I knew, too, I was having some kind of attack and needed help. I began thinking in a detached way : I would telephone and whoever come and whatever was done, I would ask them to send my wife cuz there was something I wanted to tell her. I was not sure exactly what, but if she come the words would find themselves. The trouble was, when I made up my mind to reach for the telephone, I discovered I no longer had the power to move. Something strange was happening to my body. On the left side there was no feeling any more; It seemed I have no arm or leg, or any idea where either was. I discovered I did have some feeling and power of movement in my right side. I tried to get-up, using my right arm as a lever, but the rest of my body failed me and I slid to the floor between the desk and the chair."

What a tale of unpoetic injustice with a horrible premonition – he feared he would be done in by the disease he was reading about. What an irony of fate he was thanking the demon who was going to be responsible for his worse than death disease;

b.    "Memory was like a film of sharply focused images, the set arranged and brightly lit, the characters formally disposed, the dialogue learned and unchanged but with no linking passages. I remember the doctor's exact words as he read the reports as that was my death sentence. The doctor said quietly to my son :'Your father's chances of any substantial recovery are nil. My prognosis is that he will be a hemi-pelagic invalid as long as he lives, with complete loss of power on the left side. I'm dreadfully sorry, but I'm afraid there is no way to break this to you gently'.";

c.    "Time had lost all meaning for me. There was no beginning and no end, and the days & nights flowed into one hand or other in a seamless rhythm.  First the hospital then my room become my whole life, the outside world was a foreign, a far way planet";

d.    He further said : "The disease has been a big strain on my father. That is often the way it is harder on the family than the patient". My 80 years old father said at that time :'My son could never feel himself unaided, bathe himself, attended to basic sanitary requirements, open a door, hold a woman in his arms, or even write his name'. Could this truly be the way it happened ? This prosaic formal, minor key accompaniment to deepest tragedy; Were these petty Pecksniffian phrase the best that could be found to signal the sudden grievance ending of a lifetime's work, a once dedicated man's career ?"

e.    "I had built an emotional fortress around myself, and I was determined that no one would ever breach it. Outwardly, I seemed fine. Inside I was sunk in an abyss of deep, with scattered accumulated wisdom, for which we as court-officer are known, desperate loneliness. Even when I was surrounded by people I sat in a lonely chair in a lonely room, in a lonely house, in a lonely world; loneliness can be corrosive, eating away at the spirit. Everyone needs to share joy and glory & pain. Though I never loses faith in law, but tragically loses faith in virtually everything else, perhaps its because  of my basic integrity to and great love for the law";

f.    "But whatever else I might be, I was a pragmatist. I long ago recognized that in life there was gambit which you won, others you lost. Sometimes the loss was sudden and illogically not due to your fault. A chance, a quirk, a nettle in grass, could turn an almost-grasped success in to mortifying  defeat. Fortunately, for me the reverse was some thing true;"

g.    "What that happened, when you left the mainstream for whatever reason, you were apt to be forgotten quickly; and latter, even if you want to, sometimes you never did get back. It was the reason that I started less important pro bono jobs, or doing it less well; as an Advocate, I knew I was as good as ever, probably better. But the big contribution which I had once seemed likely to make no longer was in view";

13.        THAT if we turn over eyes away, it swells, we continue to look other way, it explodes. Gravamen of this case is that the empirical evidences is that the alleged drug containing PPA with various brand names by various pharmaceutical companies has allegedly been withdrawn, as they say, voluntarily in USA but not from India and elsewhere. Therefore, if in the USA PPA contained drugs was understood to be dangerous by these firms. In India and elsewhere is fortiori dangerous. And as such we are at loss to understand which spawns a series of puzzles, why these pharmaceutical companies are reluctant to withdraw these PPA contained drugs from these nations. Any journalist of Wall Street Journal or New York Times may with his much conventional  wisdom can describe it very easily as terrorist forces made to be run away by USA from Afganistan are still striking with their nefarious aim in India. In an interesting, though not for you, resemblance had come out for modus operandi {MO} which had always been magnets for terrorist and drugmakers alike. For those who are still marketing the PPA contained drugs. Taken together, the two MO fit a classic pattern. The drug store/Medical Stores and even general store' shelves full of these PPA contained drugs are for in discriminatory use and see the parity terrorist also fire indiscriminatingly. Ironically, in vernacularly both are called 'Goli'. Kaldiscopially we try to see it with other way, both terrorist's explosive material and these O-T-C drugs having an attractive packaging as lying to be picked-up. Result in both way : one death another worse than death. Both –MO- contain deliberated,cold blooded, pre-mediated with knowingly intent & content. The day will come when someone will bring this whole subject out into the open may be by TV Journalist and in that case it would be a fundamental irony – use of televisionist advertisement to your advantage & disadvantage – a little both, he has to simply approach to any popular vernacular {Hindi} TV Channel, where after a while, with media trial, wrong becomes right usually; with a proposal for "making medicine safe" documentary in which he wants to expose the explosive story of stroke induced drugs to a mainstream television audience. The TV Channel producer will love this hot premise, and for its reasons, and its credibility he would solicit three  or four cameos from respected research institutes from around the Asia; In our and/or your experience, most people would jump at the opportunity to see their name and face on the screen, all of whom, it, would corroborate the stunning nature of the PPA secret with their own research, and this would be become a pleasure for network which might end up in enhancing its reputation for quality journalism but this would be shocking and stunning news for your customers and that would put you in negative light. And if the momentum of this case lest be snowballed by high jacking it by 'Swadeshi movement organizations' or some so blamed fundamentalist or pseudo-fundamentalist organizations in this volatile democratic nation like RSS & Shivsaniks {Mumbai} if you are not aware to their  zeal  for nationalism, ask it from your country-manager, with simply deducible only logical conclusion that would muster that if this PPA contained drugs had been said to be voluntarily withdrawn by the same pharmaceutical companies in America after receiving the reports of adverse reaction from these drugs why not in India. Further they may go upto the extent that because in America as there is no report of adverse effect from tests on animals that is why it had not been yet withdrawn for them. So Indians are supposed to be animals as they were being treated by Britishers also : "Dogs are not allowed" syndrome. At that time this whole episode might turn to become  'Quit India' Movement for your other harmless products too, if they are so, naturally your Indian competitors would provide a proxy sponsorship to all this ugly ending. But fortunately our philanthropist NGO is staunch follower of ancient Indian Justice Culture by which we judge man's civility not by his compassion for his friends, but by his compassion for his adversaries. So we are salivate at thought of extending our helping hand to you pharmaceutical companies to render our fullest cooperation for  withdrawal, recall and destruction of these PPA contained drugs –if you are ready to do it on your  own. Law is the embodiment of the moral sentiment of the people;

14.         THAT pharmaceutical science had clearly been cautious and complete as human care could make it. But you've also learned along the way that there are obstacles and practicalities which IDEALISM won't ever conquer, so you ease up on ideals. But then it is also true, clever people often did foolish things. There are choices we are obliged to make, which give us pain, but afterwards we know they were best and wiser. We agree to your difficulty to accept against the advice of your lawyers that if you make the withdrawls on your own, it could be an admission of error and therefore of liability. But we have been poised on a needle point : A life is sacred or it is not. We can't adjust what we believe just cuz it cause us pain. So long that we are used to crises as a daily habit. But eventually there comes a point beyond we think we are close to it now. Every problem requires decision. We know you may think to defend this case by mocking at the system .

But we assure you  : DO NOT UNDERESTIMATE THE LEGAL                       SYSTEM OF INDIA.                 It is a curious system but one which works remarkably well provided that your first priority was the protection  of the innocent rather than the conviction of the guilty. It wasn't designed – How could be ? Not to elicit the truth, the whole truth & nothing but truth. We are trying to persuade you to our own convictions : That a new breath of outlook had developed, that beliefs and ideas once held immutable had been examined and found false, that as what younger people despised was not the morality of their parent's generation, but a façade of morality with duplicity behind, not old standards in  themselves, but hypocrisy and self-deception which, all too often, the so-called standards shielded. In fact, it was a time of questioning, of exciting intellectual experiment from which mankind could only gain. Why does corporate cultural lock-in occur ? The heart of the problem is the formation of hidden sets of rules, or mental models, that once formed are extremely difficult to change. Mental models are the core concepts of the corporation, the beliefs and the assumptions, the cause & the  effect relationships, the guidelines for interpreting  the languages and signals, the stories repeats within the corporate walls. When a company's mental models become out of sync with reality, management makes forecasting errors as well as poor decisions. Mental models are invisible in the corporation. They are neither explicit nor examined, but they are pervasive. Unfortunately, control system can also create "defensive routines" in organizations, including the failure to encourage a diversity of opinions, the failure to disagree with superiors {there by displeasing them}, communicating in ambiguous and inconsistent ways, and making these failures, even when know, "un-discussable" change becomes impossible .

15.         THAT now it is up to you people whether you are interested – in the author & creator of the fish-bowl principle ; Professor Shoji Shiba –'to become a fish is to get into the bowl' or as "Essay concerning human understanding" John Locke's view : 'error is not a fault of our knowledge, but a mistake of our judgment…… those who cannot carry a train of consequences in their heads, nor weigh exactly the pre-ponderance of contrary proofs & testimonies ….. may be easily misled to assent to positions that are  not probable'. Ergo we appeal to please - withdraw, recall and destruct these drugs pronoto. We are ready to extend our fullest cooperation in this regard as and when required by you. Any reluctance in this proposal would set a un-precedented example for venality greed and perfidy which would remain unparalleled in the history of the civilized world.

16.         THAT despite of our appeal to you. If you want to play Indians for a sucker as doing for so many years, and want to contest. You drug makers, are going to become a clown – in the pharmaceutical circus – at your wit's end about what to do – as the idiom apparently doesn't need to be translated. Who see the exercise of criminal wrong as means to an end. It always been the case that individuals must sacrifice to further the advance the civilization and his particular society. In that case, as we think it is necessary to give an opportunity to the rival parties to deny or admit facts set forth in writing without any delay and any rate within four weeks from the day of receipt  both in terms of content and intent. If there is no denial within a stipulated time period it would be treated that it had been accepted by you in toto. Further,it is here to be made clear that if any denial of any fact in the stipulated time period is not received by us then it would be reserved for action to be taken, when deem to be fit, on the basis of that again you are having nothing to say in this behalf. Behavioural patterns are limited but acceptable evidences;

17.         THAT we cannot remain mere mute spectator. When the system which provides us our pedestal is being ruined by a handful of businessmen , we would be in constraint to execute our plan for dealing with this type of case seeing its  civil aspect, PIL {Public Interest Litigations] apart from simultaneously criminal aspect after seeing whether you had followed  every section to the letter of various laws viz. the Pharmacy Act 1948 { 8 of 1948}; The Poison Act {12 of 1919}, The Drugs Act, 1940 {23 of 1940}; The Drug and Magic Remedies Act, 1954; The Narcotic drugs and Psychotropic Substance Act 1985 { 61 of 1985} and various related acts not as ordinary people, unschooled in the complexities of the legal system can't accept these principles of laws. We would also like to see the various sections of Indian Penal Code like 284, 299, 302, 304 A, 306, 307, 326, 328, etc which one and/or another shall be visited with any adverse or penal consequences whatever, by your companies. So far as the PIL is concerned in the case, we would like to inform you this much gist of that it fit  to knock for justice at the portals of our highest tribunals with Lord Denning's ingenious legal opinion :"it only meant that they will not allow the words, in which they happen to be phrased, to become tyrannical masters. Even if contract is absolute in terms, nevertheless if it is not absolute in intent, it will not be held absolute in effect";

18.         THAT also keep in mind where the offence is committed by a company, "every person" who, at the time of offence was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. And when it is proven that the offence has been committed "with the consent and connivance of, or is attributable to, any neglect on the part of any director, manager, or other officers of the company that person shall be liable for punishment laid down in the Indian Acts;

19.         That an employee and/or officer and/or agent  working for and/or on behalf of the above named pharmaceutical companies  neither in professional capacity nor in personal capacity nor in capacity as an employee can cause and promote such an irregularity which can hamper grossly to the public interest and shatter the basic fabric of public confidence . Thus, if established you are jointly and/or severely liable and responsible for intentional breach and willful violation of Indian laws and for flouting the judgments of Hon'ble apex court and various High Courts;

20.         THAT This legal epistel, is written on a privileged occasion the reason being that it is drawn & drafted by us without any indirect or improper motive, in the performance of duty, as also in the protection of public interest – at large  and in either case reciprocity was there – as Contemplated by Law.

21.         THAT the above facts and figures are being taken without prejudice to one another and  the undersignee craves leave to add to or amend the above grounds of malfeasance to stop to make legal the illegalities;

22.         THAT the present legal notice is being preferred  only to secure the interest of justice and in public  interest at large;

23.         THAT in the present scenario of judicial activism & legal clinics, I – being an Advocate, a minister of Justice – personally and staunchly believes that one must strive to overcome the various obstructions & impediments in the resolution dispute through ALTERNATE DISPUTE REDRESSAL MECHANISM {ADR}. In today's era where litigations have become nation's secular religion, ADR has become a substitute for traditional method of resolving dispute through litigations. It wears by now in this millennium an apron of fully conceptualized sort of conflict settlement devices.

24.   THAT Ostensibly these matters are of general public interest and we hope that there is no secrecy involved in relation to them. It is in this context that we have asked the required information. Matters of such nature continue to be pursued with the concerned authorities. Where replies are not received and the matter is considered to be of general importance, we examine the possibility of taking the matter to court for the redressal of public grievance at large.

25.   THAT We earnestly hope this communication  will receive immediate consideration by yours taking on the request embodied in this epistle within a four weeks. And also if you as an organized fraternity in distress interested, as we wish you should be, to reply to this legal notice of ours, kindly adduce explicit documented evidentiary facts – showing your innocence because where facts, lore, and misinformation would made to become so inter-wined that extracting a pristine truth is almost impossible e.g. have you got excellent safety data record deduced by a series of field tests on animals and volunteer humans in India before submission to regulatory agencies for approval of these PPA contained drugs; Without documents accompanying. If a 'line of reason' had ever existed, it would deem to be just crossed by you;

26.         THAT the undersignee will be constrained to opt for equally efficacious remedy in law for the cause of action being agitated in this legal notice after failing in its keen desire to resolve this dispute through ADR; with financial accruals afforded there-in;

Any attempt at this stage to pre-judge or prejudice the eventual task of the justice should be avoided by both of us.

Please pay heed and be well advised.
Without prejudice, per se

(Yogesh Kumar Sharma), Advocate
On behalf of 'asmita': the NGO