The extent of the spread of unethical practices across the length, breadth and height of society determines the quality of life enjoyed by it at any given period of time. Today, unethical practices have become so much a norm that the definition of ethics needs a re-look. The Pharma fraternity cannot escape such ravages of time and de-generation of society. Maybe it is re-generation! The Pharma technocrat is already used to revising standards if the actual performance does not meet with the previous standards. We have been programmed to think like the regulators. What are the specs? Do you have a SOP? Are you adhering to the SOP? Do you have records to prove that the SOP was adhered to? Do the records show that you comply with the specs?Once these questions have been answered, everything is fine. Not many want to investigate how the specs were arrived at. So in quite a few cases, it is better to "revise" the standards "on paper" and claim "success". We can thus re-define "ethics" and be "ethical".

In the pharmaceutical industry, today, the focus has shifted from "patient" to "market share" and "share market". Success is defined by these two shares, and any method that meets this end, is lauded and applauded. It is lauded within the organization and applauded at public fora such as seminars and award functions. The ability to write documents has therefore become a skill that is acknowledged and rewarded readily by Corporate. The ability to "manufacture" medicines is not rewarded as much because "what's the big deal in manufacturing?". "Most workers are undergraduates and any ordinary B. Sc. can become a production supervisor"; words of wisdom from some hugely "successful" organizations. "Manufacturing" documents is much more important than manufacturing medicines.If the amount of attention paid to documentation was transferred to manufacturing we would have far superior medicines. Actually "fabrication" would be an apt word to describe maintaining records, but somehow one suspects that the word is taboo. The "Copy-Paste" artist is more in demand than an experienced production chemist. Organizations have sprung up to cater to this "demand" of manufactured documents. Some Ph. D. scientists have found it lucrative to invent documents and prefer to manufacture them over drugs.

We have become the most sought after country for BA/BE studies (bio-availability and bio-equivalence, though BABE is not a bad subject as such). Why? Because it allows a few immaculately dressed, portly Vice Presidents of hugely successful companies to look at you wisely over their gold-rimmed glasses from a podium in a 5 star hotel and tell you at length about the "gene pool" diversity in a densely populated country - a definite plus compared to China. It allows them to pat each other for producing "world-class" scientists who can now do any "research" in "world-class" laboratories in which "colleague" corporate houses have invested "crores" and put India on the World Pharmaceutical Map. It gives them a chance to wax eloquent about India's capability to match the "best in the world" and be "second to none". How many of the documents are "genuine" and how many are "manufactured" is interesting to know. A colleague says that it is a myth that only the small or medium scale manufacturer is out in the market to "buy" documents. He claims to have witnessed a deal between a leading Pharmaceutical manufacturer and a medical professional, wherein data collected and collated from "here and there" was composed by one of the many "compiling" organizations. This data was then printed out neatly with some of the brilliant products of IT technology. The data is then bound into a neat docket. Now our esteemed Medical Doctor smirks and puffs up his chest and assures the pharmaceutical giant that he will get the signature of an eminent scientist from the Big Apple, for a fee of course. For this brilliant piece of "Research and Manufacture", the pharmaceutical giant is willing to "invest" lakhs of Rupees because it opens up the doors to the prestigious markets of the first world once this "original-work document" is accepted by regulators of the first world. Amusingly, the Medical Doctor also says: "We are honest about our records. We don't create documents like these commercial organizations that have sprung up all over the country". He "justifies" that by saying that he charges a professional fee for services rendered and one of his associate organizations will give an official invoice with a registered Service Tax number. When asked why he does not present his own invoice with his own registration number, he looks at you as if you have sent your thinking faculties on privilege leave and says that he cannot sign the documents since the experiment is not "actually" done and he wouldn't like to risk his name in the event of a future scrutiny. The colleague swears that he saw a look of indignation on the doctor's face.

A different but related story is of a statistically oriented colleague who used to bring clippings from newspapers that have a penchant for some peculiar statistics.One such newspaper used to publish statistics about "the most corrupt country in the world".An African nation that used to feature in the top-three list on a regular basis, used to be one of the prime export markets for every small-scale entrepreneurs. Why? Because the prestigious exports from a growing economy to the hapless, impoverished country comprised 475 mg of Paracetamol tablets labeled as 500 mg, or 1000 tablet packs filled with 800 tablets. USP type III glass vials used for Chloroquine Phosphate 30 ml injection. Second hand vials purchased from hospital scrap used for injectable preparations. Turmeric powder used in Riboflavin or Tetracycline solid oral dosage forms …"Qualified" owners of such businesses had "valid" explanations. Pharmacopoeia says 95 to 105%. 475 mg is 95% of 500 mg so we are not cheating. We are very honest and ethical people. Chloroquine Phosphate solution is stable at alkaline pH. Type III glass leaches alkalies. So we are in fact stabilizing the product. While we make a life saving product, we should also look at the affordability of the nation's populace. Otherwise, the patient may be saved by the expensive drug but will die of poverty and hunger. So we are preserving life by making affordable medicines. What the take was on the Turmeric powder is not yet known but one shouldn't be surprised if one hears that Turmeric is a better anti-infective agent than Tetracycline.

The bigwigs bend the norms because they see a "larger" picture which lesser mortals like us cannot see. Vision, uplift of the masses, social obligations, national healthcare, international acclaim, progress, growth and pride are some of the lofty ideals way beyond the imagination of "middle-class" or "working class" people. If changing some "specification" or redefining romantic words like "integrity" and "honesty" can help achieve these objectives, then so be it. And, if you think only entrepreneurs and business owners bend the norms, think again! The QC Manager bends the norms because the boss "ordered" it as an exception. Naturally, the "ordering" authority is also the appraising authority on whose recommendation/ approval, the merit increments of the QC Manager rest. The Production Manager bends the norms because he has to "meet a deadline" which will reflect in his appraisal and consequently his promotion/ increment. The Engineering Manager bends the norm because his is qualified in engineering and does not "understand" the jargon of GMP. The Administrative Manager bends the norm because the Excise Commissioner has promised to "look into the pending excise violation case" leniently. The Personnel Manager bends the norm because he has orders from the "top" to ensure peace and harmony so that the sales targets are not affected. All the top managers are bending norms because the onus of running the organization rests on their broadly sagging shoulders. The regulators bend the norms because the politician "forces" the bureaucrat to bend - or face the consequences of "transfers" to unwanted places. "Wanted" places of course come with a premium, and regulators who wish to invest have to queue up outside the ministries.

Then what can the executives do? They have to tow the line laid down by the bosses or get the sack. And what about the poor worker who is at the tail end portion? Be it blue collared or white collared, everyone is in a job for his own and his family's survival. Not following "instructions" which, though illegal, are couched so intelligently in the labyrinth of some convoluted logic that not following them amounts to insubordination. This might result in disciplinary action and finally termination of the source of livelihood. In effect, it is a chain reaction started at the top. Greed is just one human flaw at the base of it all. There are various other human weaknesses that prompt such blatant breach of ethics and it is easy to blame the smaller individual because his voice will never be heard unless there is a revolution or an uprising. Where does it leave the common man or the consumer? Battling the towering waves of corruption engulfing our society; Gasping to survive. Struggling to stay afloat and in the bargain ending up joining the mainstream of corruption in his small world. The rich become richer, the corrupt become more audacious, the powerful become tyrants and we become silent!

Silent spectators to all that we wish to rebel against, protest, catch by the scruff of the neck, punish in public so that others are deterred. Silent because we lack the courage to confront. Silent because we have lost the moral courage to cast the first stone. In our own ways we have also participated in the degeneration of society. Silent because we are also greedy in our own way, and are constantly trying to make hay while the sun shines.It is because of this that today we find ourselves enamored by the glitter of money, cowed down by the intimidation of power, and faithless about systems which we like to talk about especially in the small pharmaceutical community.

We measure success by wealth and power and not by knowledge, effort, or contribution. When honest knowledge, sincere effort, and genuine contribution fail to rake in honest money and honest power, we are tempted to try the "accepted" route. Almost all of us have witnessed the steady conversion of a relatively honest fiery, energetic, hungry, willing-to-sweat-it-out, just-out-of-college youth, into a thick-skinned, smooth-talking, non-working, politically savvy, jargon-spouting, street-smart executive or a Manager or a Vice President or the entrepreneur-owner. Most of us have definitely seen ourselves. How many freshers have had a rude shock to see their icons having feet of clay. How many aspirants of golden dreams have come face-to-face with the stark reality of the sleaze and slime of the business of healthcare.

One should not be surprised if one hears, in the not too distant future, of a course called PGDCM - Post Graduate Diploma in Corruption Management where they teach you how to bribe, how to accept bribes, how much to bribe. There will be tables like menu cards which give a bribe tariff depending on the government agency or the NGO and from the bottom dog to the top dog. You could have variants in various colleges going by the same acronym. Thus PGDCM could stand for a PGD in Corrupting Management, PGD for Corrupt Managers (refresher course). We could have variations in the title itself, such as PGDCC which could be PGD in Corporate Corruption or PGDFC which could stand for PGD in Functional Corruption.Though the names of these courses vary, the theme would essentially be the same - emphasizing the survival of the "corruptest". You could have Corruption for Clerical Staff, Corruption for Workers. Certificate courses, weekend courses could be added to rake in the moolah. The pinnacle will be reached when the IIMs start offering MBA in C. The faculty would never be a problem. Kantibhais reign supreme.

On occasions more than one, your author has been "advised" not to be blunt when expressing his views. He was privileged to work with one such "boss" in his humble career. An outrageously corrupt man, the boss once "advised"; its ok to call a spade a spade, but why should you call it a SPADE? Be gentle. The author has also been advised to avoid using strong words while writing articles. In deep contemplation and while struggling with the English language, several words were considered. In a silly moment, even considered the title "Ruption of Cor" not wanting to use the word corruption.
(The author is a pharmaceutical consultant and industry professional)