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Firstly, apologies for not blogging regularly. No excuses, but have a new resolution to be more frequently at the keyboard.

The one issue which has forced me out of my cocoon will be debated in the coming months: often in hushed tones in the medical and pharmaceutical circles. That is the newly renewed guidelines to the medical doctors about their relationship with the pharmaceutical industry. The text of the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 – Part-I” (Ref: No.MCI-211(1)/2009(Ethics)/55667) is available in the Indian Gazette, but I first read it here and gratefully acknowledge the author of the blog.

The summary guidelines say:

“In dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below.”

a. Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives.

b. Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME program etc as a delegate.

c. Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.

d. Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.

e. Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-
(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities.
(ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies.
(iii) Ensure that it fulfils all the legal requirements prescribed for medical research.
(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself.
(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s).
(vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way.
(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment.

f. Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his / her own professional autonomy and / or with the autonomy and freedom of the medical institution.

g. Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:
(i) Ensure that his professional integrity and freedom are maintained.
(ii) Ensure that patient’s interests are not compromised in any way.
(iii) Ensure that such affiliations are within the law.
(iv) Ensure that such affiliations / employments are fully transparent and disclosed.

h. Endorsement: A medical practitioner shall not endorse any drug or product of the industry publicly. Any study conducted on the efficacy or otherwise of such products shall be presented to and / or through appropriate scientific bodies or published in appropriate scientific journals in a proper way.

It was time that these guidelines were issued and adhered to. Medical profession has too much into disrepute because of the various enticements the drug companies offered and are accepted. The freebies include gifts ranging from pens to motorcars, local and foreign trips to local and international destinations often thinly disguised as academic tours (“conference”), cash and sundry other goodies. A very innovative medical company once offered to start an SIP in my name in return to what they called an ‘exclusive support’ to one of their products.

I have no doubts that any sane person, which includes most doctors, would welcome these restrictions, but I have a couple of points to make:

  1. Along with all the greedy, unscrupulous medical practitioners, genuine academicians have been needlessly restricted by these guidelines. For instance, in my own field of interventional cardiology, the premier academic conferences which propagate new techniques and technologies are held in Europe and the United States. In the absence of any structured training or opportunity to dabble with emerging technologies, this restriction will now condemn us to archaical practices. Of course, since I’m in private practice and because of the pressures of learning new technologies I personally will fund my own training abroad. But with typical conference expenditure between Rs 150,000 to Rs 200,000, how does a typical cardiology faculty member from AIIMS or PGI manage to go to these conferences? True, the government sponsors few faculty members with lots of limit on the expenditure, no of days of attendance, no of times one could go attending conferences, but that kind of scanty attendance would hardly suffice for learning on a large scale. Moreover, governmental funding, already abysmal on research will further fall because huge increases in conference funding.
  2. While the guidelines exhort the doctors to stick to ethical conduct, there doesn’t seem to be any directive towards the pharmaceutical industry. The New Year has started and I am already tired of refusing gifts and overseas conference offers. Representatives of various companies go around asking doctors as to which conference they would like to attend ‘this year’ so that their companies can plan their ‘annual budgets’. Strangely, they don’t seem to acknowledge the existence of these fresh laws to the doctors. So many doctors who are unaware of the laws may accept gifts or conference invitations and may be later on punished.
  3. Despite the MCI formally coming up with the guidelines, the average neighborhood doctor is unlikely to be aware of the existence of the rules and the type of reprimand or punishment they are likely to face in the event of a violation. These laws were reported in some sections of the media. I personally am not aware if the MCI is making any attempt to make doctors aware of these laws. It should. If it has already done it, then there should be more visibility of the awareness program.

Comments are welcome.

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48 Comments

  1. I am an upcoming Surgeon & not aware of these offers given by companies about the offers that are being sited as examples. I would certainly be happy if such practises as getting a car/SIP as gift be strongly condemned. But as most of them have pointed out,i will not be in a position to sponsor myself for conferences.
    I am not citing others mistakes as my opportunity,but in other countries these companies must be helping out the practitioners. Afterall our culture is now more or less a copy culture & i am sure that this is also copied from other countries.
    Before implementing our MCI must have looked into what other countries have been doing.

    • @ Dr Arun,
      Thanks for your comment.
      Indeed it will be a lot difficult for many of us to get on to conferences on our own.
      In the west, especially in the US there used to be a strong practice of ‘soliciting’ by the medical companies whereby meal tickets, goodies and trips were all given out to the doctors by the pharma companies. But all that is a thing of the past. Out there now the law is extremely stringent and in fact, the new MCI directives are actually somewhat based on the US model.
      As you said the practice of bribes must be eradicated and we have to find a way to keep the academics intact.
      Cheers

  2. In my opinion , this new guidelines will definitely hamper the learning process and knowledge sharing for the academically oriented and in turn halting the progress in medical treatment.

    how about MCI approving a few agencies who can deal and coordinate such events ?

    While maintaining ethics, why compromise on knowledge development and learning ?

    • @Niel M,
      I entirely agree that in a country where a large majority of doctors, especially those in government service, cannot afford conferences and it would hamper learning.
      IMHO, MCI approving few agencies to co-ordinate events will open the floodgates for corruption. The guys who control the agency will be offered bribes by both parties! 🙂
      Having said that I think your idea is in the right direction: we should find our own way to legally do what is required for furthering continued medical education. In my institution we are planning an educational grant co-sponsored by the pharma industry and the hospital management. Such funding is not directed to specific doctors and the hospital can have a neutral committee to decide as to which doctors will learn most from which conferences etc.
      I’m sure there are many legal methods to do this. There are illegal ones too: unfortunately this may trigger off a huge amount of unaccounted money being used as enticement to the doctors. That is the flip side of this law.
      Thanks for your comment
      Cheers

  3. These laws are definitely good and it will help patients also as many times just because of these gifts,Few drs.Prescribe those companies medicines which are not up to the standards and there should be one more thing that a ban should be on medical stores inside the nursing homes or hospitals but something should be done for these CME`s

    • @ abhishek Dixit,
      Valid points.
      However, chemist stores and pharmacies being inside hospitals is plain horsesense. Patient convenience is immense because of this. I don’t think there is an inherent harm in such a pharmacy as long as it is run independent of the doctors’ or nursing home’s personal interests in mind. A large part of hospital profits come from the pharmacy and it is unlikely that there is going to be a ban.

    • K.Chandrasekharan
    • Posted February 11, 2010 at 10:50 am
    • Permalink
    • Reply

    First of all a welcome move. But there are two aspects. In a country where the people who formulate such rules themselves have been found wanting in following rules – they go to foreign country for treatment at tax payer money – the question to be asked is have they applied their minds totally? Prescribe generics – Good principle – will you dare to do it for the president and Prime minister – You will import it from USA. If pharma companies are making the doctors corrupt – why not develop the governmental system so strong it attract people – hence the private practioners and private hospitals can become reduntant. And why bring it out without taking anybody in to confidence – have not the politicians and the top doctors who drafted it taken any freebies from the pharma companies at all? Instead of focussing energy more on setting up a good health care system which will help common man we are probably focussing on minor issues.

  4. Lets be honest. If pharma companies will be allowed to sponsor CMEs they will certainly expect a return favour. One just can’t deny that. Hence i am against partial ammendments of the directives.

    If someone has to fund it. It has to be the government. Agreed it cant fund all. But possibly one from every district every year (or something like that) Remember school scholarships?

    Also the web arena has opened up so widely. possibly CDS / wecasts of the CMEs can be shared.

    What say?

  5. First, govt should explain the policy of CME’s and also about the Academic Conferences, so that the drs can keep them up to date in ERA of CPA..if govt. is seriously thinking about the wellfare of patients, it should take of all the pharma companies, taxes should be reduced which are imposed of the companies so that cheaper drugs can be provided, govt should give handsome amount of allownces to every govt and private practitioners so that they can provide best and latest treatment, govt should conduct compulsary and informative CME’s for the drs free of cost to update them, their should be no politics for drs and patients if u want it in true senses..

    Thanking you
    Regards
    Dr. Gajraj Kaushik
    MD. Medicine
    Haryana

    • I think the answer to both above comments is the same. Today there is no mechanisms for CMEs to be independent of pharma companies and it would be foolish to expect that the companies would sponsor doctors unselfishly as Sarvesh has said. At the same time it is not possible for either government or individual practitioners, esp GPs, practitioners with lower revenues to shoulder the burden on ongoing education to doctors.
      What we have to evolve is a transparent mechanism where the profits of pharma companies is used to fund CMEs without expectation of a return favour. One mechanism is that companies give unrestricted (rider-less) educational grants to hospitals, IMAs, conference organisers who in turn are pressured to include most if not all practioners by rota over a period of time.
      Even administratively this looks like a humongous task and sincerely I don’t think anybody has that kind of intention in the first place. So all this might remain a pipe dream.

      By the way MCI has now prescribed the penalties for various kinds of violation of the gazette notification. So the time for doctors to be careful is NOW: Big brother is watching

  6. We are anaesthesiologists doing private practice in mumbai since the last 3 decades.Conferences are held in mumbai annually every alternate year by our forum.Surprisingly this year,sponsorship has not been forthcoming to us by the pharma companies to hold the conference cititng MCI rules against sponsorship.
    I would be really grateful if you could let us know of our locu sstandi regarding sponsorships from pharma companies?are they right in refusing sponsorship to us?

    • The MCI guidelines are applicable to individuals as the notification specifically mentions the word individuals. However, the main challenge for the organizations will be: how do you get delegates to attend the conference. No delegate is allowed to take sponsorship for travel, accommodation, food or registration. SO though, as an organization you can get sponsors to organize events for you at venues, you won’t have delegates, unless the delegates pay for their own participation.
      There are two possible ways out:
      1. The pharma companies donate money to the institutions like medical colleges and hospitals, who in turn sponsor their employee doctors to the conference.
      2. Pharma companies make unrestricted educational grants to the conference secreteriat who in turn can send out complimentary air-tickets, hotel accommodations, meal coupons and conference registrations to delegates.

      You can imagine that both these methods have huge scope for manipulations, corruption etc. But if properly used, these techniques can achieve MCI’s purpose, i.e., dissociate sponsorships from prescription practice of doctors.

  7. MCI itself is a corrupt body. Will the chief explain how he gives permissions to so many medical colleges with scant facilities? It is openly reported in the media that even Govt medical colleges transfer doctors on a regular basis prior to ” inspection” by the MCI.
    Instead of doctors being defensive about such practices they should take the war to the MCI itself. It is just a situation where the MCI has called everyone else a thief first so that no one will accuse it!! Plain old tactic!

  8. ALL HONEST DRS ACCEPT THIS AND BRIBED DRS WILL OPPOSE THIS.MEDICINE PRICE,AND QUALITY WII BE IMPROVED FOR THIS ACT,

  9. BUT DO YOU THINK MCI GUIDELINES WILL HELP IN REDUCING THIS MENACE? CERTAINLY NOT!. BECAUSE THERE ARE MANY PROPAGANDA CUM DISTRIBUTION COMPANIES, WHO ARE OFFERING 30% CASH ON M R P OF THE PRICE TO THE DOCTORS, WHO PRESCRIBE THEIR BRANDS. THE BRANDS ARE OF DOUBTFUL QUALITY & HIGHER PRICE WHEN COMPARED TO STANDARD BRANDS. SO WHAT MCI CAN DO ,IF ALL THE DOCTORS DO THIS.

  10. what about the Propoganda companies offering huge discounts on mrp to Drs or 30% of the business given to that company also those Drs practicing with Nursing home asking for discounts in the retail shop of there nursing home.
    Few big corporate hospital purchases medicine on discount on MRP and these hospitals are not passing the same benefit to patients, why MCI is not thinking for the benefit of Patients. If they want to bring such things in control they should reduce the price of drugs so less that pharma companies could not be able to provide sponsorships for anything.

  11. Sir, It is my suggestion that if we know that one doctor is taking sponsorship or any other gift from any company then how we can report this news to MCI?Then there should be a particular contact number or any e=mail id by which we can inform to MCI regarding the particular matter and about particular doctor also.so kindly do the needful as quick as possible to make our nation healthy and corruption free.

  12. @ Sadananda g patki & vaibhav,
    First, MCI is a body that deals with the code of conduct for doctors. So MCI cannot and will not lay down rules for the pharmaceuticals. The pharmaceuticals themselves have a body known as OPPI which has attempted lay down a code of conduct which they are supposed to follow

    As far as any private discounts or 30% kick-back to doctors, this MCI guideline eminently covers it. If any doctor is found accepting these they are liable to be punished

  13. It had been long practice of taking support from the pharma and healthcare industries and now new guideline will be a difficult propositions as to continue.
    some kind of sponsorship is required for academic purpose.Thanks

  14. pl send me new post regulair

  15. @ K Chandrashekharan
    Absolutely valid points. Health reforms are needed badly. Prescription practices should not be interfered with by the govt. The practitioner decides generic or otherwise. Still this legislation is welcome because it aims at minimizing a certain type of malpractice.

  16. its a good move by MCI , doctors should not be spared if they accept any thing from pharma companies .They should be treated like corrupts. The rules should be applicable to all levels of doctors ,however senior he might be he should be punished and banned from practise ,and they should not be allowed seeing patients even in emergencies.

  17. what kind of nonsense discussions are going on , am a diabetic patient and am seeing him from past 5 yrs and am quite happy with his treatment and many of our colony people are quite happy with him . Am least botherd what he takes from pharmaceutical companies . if suddenly u creat some rule and ban that fellow where should we all go .Am sure pharma companies are only back of some popular doctors who are very busy , if MCI puts a ban on them we will be left up with honest doctors who dont know how to treat .

  18. How long do u prepose to talk with a holier than tough attitude. How many doctors write a unnessary medication to fill a bill against how many of the doctors earn enough to continue a decent life.
    Perks in IT is welcome as they would work better but for holy doctors its a sin?
    even rural nursing homes have industrial EB. and water tax, ever increasing pays across all catogories but holy hospitals cant earn by having chemist shop.
    We Should trow out our holy cloak ask a fresher struggling to make end meet to frame rules and follow them

  19. These rules which are made my MCI should be strictly applied to doctors.Tough Punishment for those who doesnot follow.There shouldnot be corruption within the MCI

  20. Yeh it’s good and it will be a history in Indian Healthcare Industry. But if those companies starts giving CASH to their customes then who wil. monitor those activity.Bcoz customers will not keep any records in pen & papers……

    • Some physicians might think that this is true. Strictly, you can never escape the long arms of law. Remember, the unscrupulous pharma companies will have to generate huge amounts of black money to give to the physicians. Companies, by law, cannot withdraw large amounts of cash. Even if they manage to do, some kind of book keeping happens so that the companies can track their money. If there is an IT or similar raid on the companies, these books will have the details of the money received by various doctors. Though this won’t be proof of corruption by doctors, this kind of evidence can attract IT attention!

        • PARTHA
        • Posted April 24, 2010 at 11:03 am
        • Permalink

        Yeh
        Thanks.it can be done.
        But now a days some companies are giving good no of bonus to some perticular products from there profit some % cash retailers/Stokist/Company personel giving to the doctor & some local companie ( promition cum distributors ) also doing this.
        If MCI/DCGI not take any action against this unethical marketing i belive this activity may go up…

  21. In ref. to new guidelines some practical points need to be addressed.conferences and CMEs are must for all academic orinted doctors to keep updated and it is also a bitter fact that average clinician cannot afford these at own expenses. There should be a way out that sponsorship and ethics move side by side. MCI itself should comeout with solution if they are concerned about academics of us.

  22. Wat does the guidelines say abt accepting journals or CIMS from representattives….Is it allowed ??

    • @vineethwaitin4u Inasmuch as journals and CIMS being gifts, technically one is not supposed to receive it. However, I have certain personal observations: If a journal or CIMS is printed or reprinted by a pharma company in large numbers and distributed freely among the medical community, it is expected that such journals carry the advertisements of drugs manufactured by the company. In that sense they are just promotional material and can be easily accepted.

      If however, journals are specifically subscribed for in your name and paid for by the pharma company, that is certainly not allowed. The only way that becomes acceptable is when the pharma company donates subscriptions in the name of your hospital or your department.

  23. Do MCI Regulary check all the pharma companies, means checking their records and various investments to know to whom i.e who all doctors are benefited by that particular company, and do pharmac company themselves keep such records for years so that the particular doctor can be tracked anytime in lifetime by MCI ,if he/she accepted any benefit from that pharmac company…..plz reply…
    Dr.yash

    • MCI has the authority to ask a medical company to provide it’s books to track the doctors who received the gifts etc. However, I don’t know if MCI has the time and inclination to go into every company’s record. But if there is a specific complaint MCI will be obliged to investigate. Unfortunately, records are permanent. But then company representatives can write anything in their books as to whom they gave what. So some kind of proof that the gift was actually received should be there for prosecution I guess

  24. well it all starts with learning ,knowledge but latter all and goes towards recovering invested costs of dr. and goes inevitably to writing brands with high mrp and low supply rate products only.

    • @Mahul. I guess for some the temptation can turn into limitless greed. No doubt!

  25. plz let me know if a pharmaceutical company offer gift, money, cme, rail air ticket what action will be taken for them. avinash

    • I am not sure if MCI has any authority over the pharma industry. However, the pharma industry itself has defined a code of conduct and so they are supposed to follow that code. Still I don’t think there is any punishment for them. I may be wrong here though, so correct me if I am incorrect

  26. Ah its movement like ANNA Hazare’s movement in India. Imotions and reality are faces of coin. In this Adarsha era , how many feel this is possible ? The highest profit making Industry in India, have already started to find out many alternatives. Ask inocent medical rep. They are being pressued by both i.e. currupt management & much currupt many more private practioner drs.

    • @Surendra
      I agree. Unfortunately, the hapless MR has to follow the orders!

  27. now a days all doctors are taking money ,gifts,and tickets from pharma companies and doctoctors also demand for money from pharma executives. i am apharma executive

  28. I am a Medical Representative of a reputed company. Many company is following the MCI guidlines. I am really proud of my company because my company is not doing any unethical things for it own benefit. I want MCI should come up aggressively to prevent the unethical bussiness of many company and save the country. So that my country people can get the real treatment in a affordable price.

  29. I am a Medical representative in a reputed company .Many of the companies like H&H,SunPharma,Palsons,Lupin,MicroLabs,Intas,Ipca,Torrent,Unichem,Abott,Ranbaxy,Cipla,Novartis,Glenmark,Zydus,Zuventis,Gracewell,Dr.Reddys,Aristo,Macloids,Mankind,Systopic,MedManor,Biocon,Glowderma,Galderma,Canixa,Jhonson&Jhonson,Mylon, Elder,Hetro,MSD,Molecule,TalentIndia,Pfizer,GSK Alkem etc.There are unlimted of pharma companies which are corrupting Doctors like offering huge amount of money,foreignTrips,Flight tickets,5starHotel accomidation, local trips with family,Funds sponsoring for Doctors house construction,interiors,luxury furniture,plasmaTV, mobilephones,Shopping coupons,Food Coupons,Shopping ATM cards,CC cameras,Split Acs and so worst there are companies which are even providing women for a night to doctors in such the doctors are corrupted.
    It is a matter of time where all these can be stopped if Medical Counsel of India strictly take necessary actions and even the MCI should not even hesitate to cancel Doctors registration.

  30. I have very simple but effective solution which will reduce this practice. Like posters of female foetal killing. Create big posters of mci guidlines. And make it compulsory for dr to put it in his clinc visible to all.

  31. i have proof of pharma company name . United biotech pvt ltd. Is giving cash to dr’s and they are taking it company in not afride of mci. The compay say that mci . Can not do any thing . Because mci is also taking money from unitedbiotech pvt ldt. Is that true . Plz stop this compay i have proof. I can show to u. my cont. Number.09768887188

  32. and they are giving womens for night to sex with dr’s so plz take action on this compay. Unitedbiotech pvt ltd close this company it will make the india totaly waste. Plz

  33. My Dear all,.
    What ever rules and regulation come/formed to have a ethical practice by the Drs will not work , because even if the price of the drugs are less or more no one is bothered as Each and every individuals are covered under Health Insurance Policies……What ever amount the Bill is the patients claim it from the Health Insurance Company. so where come the name burden the patients.

  34. Please make it clear only registration for conferences without travel and lodging expenses allowed or not. Only registration nothing else.


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