An alliance or partnership or relationship of IAP with Pharma Industries is inevitable. This is necessary to create a healthy atmosphere for steady and uninterrupted growth of mankind. In accordance with this Concept, IAP and Pharma Industries both should ensure that, the foundation of this alliance is based on the principle that, "interest of the consumer (patient) will not be compromised in any way". Patient is supreme. While creating this healthy beautiful relationship, ethics must be observed in letter and spirit.

It is understandable that the basic tenet of Industries is to profit through Commerce and not Charity. The profit must reflect need rather than greed. It should be generated through healthy competition in the market. The regular insinuations into the moral values of the medical fraternity must stop. The persons and procedures (from Industry), who try to influence members of the Academy and try to lure them with material gains, must be desisted in doing so.

In view of this context the following principles are being enunciated for everyone in the IAP.

There has been a cordial relationship between the Academy and the Industry since long time. They are the basic and stable wheels of the cart to deliver health care. The most important common factor for both is the patient. For the benefit of the sick and infirm, this cooperation must continue and even furthered to drug research, clinical trials and continued medical education. The cooperative effort must also continue for Workshops and Conference; wherein immense exchange and updating of knowledge occurs.

The term ‘Industry’ means – all commercial establishments related to preven-tion and management of diseases for e.g., Pharmaceutical houses, Vaccine manufac-turers and suppliers, Medical equipment manufacturers, Diagnostic houses, Corporate hospitals, Food or IMS or Micronutrient manufacturers, etc.

The term ‘Academy’ denoted the Indian Academy of Pediatrics.

(1) Medical Colleges

Formation of ethical committees: Each Medical College should form an ethical committee. The committee should supervise research work, drug trials, funding of various projects and also look after ethical and rational therapy. The teachers and the staff must follow guidelines detailed in clinical medicine. Clinical diagnosis based on history and examination of the patient should be established by relevant investigations rather than a battery of modern gadget based and un-indicated investigations, putting the health care system or the patient to avoidable loss of time, energy resources and financial ruining of the patient and his relations. The Ethical Committee should be a ‘Guardian of Ethical Practice’ within the Medical Community.

The value and qualities of the teachers descend vertically onto their students. The students are a direct reflection of the character portrayed by their mentors. The teachers must thus have a transparent behavior, integrity of the highest order, autonomy in clinical medicine and research, sublime character with ethical values.

There should be adequate exposure in ethics. Reputed and respected public figures in judiciary, law, religion, media and ‘NGOs’ must form the basis of such culture cultivation. The tender mind of the student must be moulded, so that he follows ethics all along his career.

The triangle of the Patient-Doctor-Industry must work in liaison to benefit the mankind. To protect the Interest of his Patient, a doctor’s management (diagnostic, investigative and therapeutic modalities) must be rational. Transparency and ethical actions shall keep the trust of Patient intact. Professional secrecy with regard to patient data must be maintained.

The doctor must maintain professional autonomy; integrity; independence and work scientifically to improve the health status of the patient. This will promote a healthy patient-doctor relationship and will help to avoid unnecessary litigations.

The industry should also follow pro-fessional ethics as laid down by their bodies from time to time.

(a) Approval

Every research and drug trial project must be approval by the concerned ethical committee, with the aim to protect the interests of the patient. The design, methods, results should be scientific, and transparent.

(b) Patient interest is supreme

The interest of the Patient should be supreme. The funding agency should bear the costs of all investigations, investigative materials, treatment, supply of equipments and chemicals required for Research, Drug trial, Drug assessment and/or Drug evaluation, including their increasing cost. This economic burden should not be born by the institute or hospital or Patient.

(c) Funding

Funding should be done by the Industry. It should include funding of all aspects of research involved in the Research or Drug Trials e.g., pilot projects, stationary, paper-work, materials, and payments of Assistant Research Officers. The funding should be dermal and properly budgeted in advance.

A team of medical and financial advisors should audit funding of all researches and drug trials and other critical scientific evaluation. The concerned ethical committee should scrutinize the audited report, so that the money approval is also critically evaluated.

The remunerations should be as per time, energy, level of involvement and secretarial assistance, but never exhorbitant, so as to influence the results, conclusions and recommendations.

Presentation of the paper may be sponsored in a seminar or conference by the agency. Grant extended for the purpose should provide comforts rather than luxuries.

(d) Indemnity to researchers

The funding industry must provide indemnity to IAP members, Pediatricians, Patients and others engaged in Research or Drug Trial, so that they are not victimized in any manner, due to the known and unknown problems, occuring during the conduct of such Research or Drug Trial immediately (which can be directly or indirectly attributed to the Research or Drug Trial) and in future.

(e) Research and drug reports

The Research Project report should be available to all those who are interested in the subject, except for, where ever it has commercial implications. The results, conclu-sions and recommendations should also be discussed in detail before publication. The Research Paper should be published in a peer-credited journal rather than in one published by the industry.

A Drug trial is important to evaluate the drug fully, before launching in the market for human use in accordance to the laws of the land. Post marketing surveillance studies are equally important. Doctors must participate in these activities. It should be double blind controlled trial to maintain a fair interest of Patient. An informed written consent should be taken, whenever and wherever the trial involved human participation. The industry should bear the cost accuring from any adverse reactions, side effects or complica-tions in the trial. A patient should have the basic right to quit the trial whenever he desires.

(a) Personal sponsorship

The esteemed members should desist from being sponsored to attend these events with industry funding.

There should be no support in any form what so ever from IMS (Infant Milks and Infant Foods) manufacturers, as per IAP principle, resolution and commitment, to follow the ‘Infant milk substitutes, Infant foods and feeding bottles Act 1992’ of Government of India.

In case of conflict the members are expected to declare the sponsorship.

(b) Selection of speaker

The responsibility of selection of speaker(s) should entirely rest with organizers.

The subject matter to be discussed at these meets should concern clinical medicine and not the drug(s). In case relevant research applicable to the clinical scenario is to be discussed, it should be the prerogative of the Scientific Committee, and should not be governed by the Industry. The financial help for such activities should be given into the official accounts of the organizers, preferably by a cheque/draft.

There should be no link between speaker(s) and the agency(ies) funding. Organizers should arrange for travel, local stay and hospitality. The company should not accompany the Speaker(s) in any case.

The speaker should deal with the subject scientifically and rationally.

The undue reference and importance to the drug(s) of the concerned company must not be given.

No mention of trade names of drugs or manufacturers should be referred to by the speaker in his disposition on technical subjects.

The speaker should declare any conflict of interest before the lecture.

A banner displaying the name of the company (Sponsoring a talk) may be displayed, but no drug(s) name should be displayed in such a banner. It may read, "This lecture/Symposium /Seminar etc. is sponsored by (name of the company).

(c) Lucky draws

Draw of lots, lucky numbers and other ways to attract doctors to their stall should be strongly discouraged by the Organising Committee.

(d) Venue

Today most of the conferences/seminars/symposia are hosted in costly values. The faculty of the medical colleges should be encouraged to organize these academic events in their college campus, with the help of local Organizing Committee of IAP. This will help IAP to reduce the cost of organizing such academic activities and also reduce the finan-cial burden on the Organizing Committee.

(e) Breakfast - Lunch - Dinners

The industry may sponsor these, but at the reasonable cost. Lunch should be simple. It should be a working lunch. Dinner also should be modest,liquor should not be allowed. Natural juices and soft drink may be encouraged.

(5) Drug samples

Drug samples are necessary to evaluate the efficacy of a drug, side effects, cost effectiveness, tolerance and development of resistance. Samples should not be in excess, but should be in appropriate quantities.

The doctor should use samples on patients without charging money for these drugs. Evaluation must be carried out on scientific basis. No over prescription should ever be done to favor the industry in order to get favors of any nature from the Industry. Careful disposal of outdated drugs should be undertaken.

Gifts should be avoided. Industry may donate to the Institute, materials that help in the patient care, such as books, stethoscopes, torches and materials related to the care of patient. These must not be expensive.

The Industry may try gift of a car, computers, household gifts, travel package and stay at five star resorts. This is unethical. It must be avoided.

Practice of cut system for prescribing certain brands of medicines must be abandoned forthwith.

The esteemed members of IAP should desist from being sponsored by industry for travel from the city to the place of conference/symposium/seminar.

The members and office bearers of IAP should voluntarily declare any visit tours and travels sponsored by Industry.

These should be considered as phar-maceutical products. No donations, sponsor-ship and any other help in cash and/or kind should be accepted from the Industry manufacturing them. Infant feeding formulae, milk substitutes, baby foods and weaning food manufactures should be out of bounds in all the conferences. No Pediatrician should prescribe these products unless specifically, medically indicated in an individual case. Same ethics and principles should apply to infant formulae and related products.

Some of the drug stores are owned by doctors or their relatives. Doctors should not ideally invest in pharmaceutical industry so long as they practice medicine.

A Pediatrician should write a rational prescription for the patient. Dispensing should be done if there are no drug and chemist stores in the vicinity. This situation will exist only in an area of 5 km or remote area where there is no doctor.

Peer selling occurs where a company sponsors a seminar or symposium, where only the product(s) of the company are focussed. For such events the company calls a group of doctors and spends heavily on them. This should be discouraged by the members of the Academy. The members of the Academy should not attend such events.

Ideally the organizers should select the topics, invite the speaker(s), look after the travel, accommodation, hospitality and control all the events. The industry should not have a say in these matters. All of us should follow the ethics laid down by IAP.

Academy should print its own journals. The layout, printing and paper are not as important as the content. Money spent on glossy paper and digital printing should be avoided. It should look like an academic presentation.

Practicing doctors and the industry have to maintain a cordial relationship. Doctors must have information about recent developments and the industry has to sell its products. We must follow the ethics of our respective professions.

Some consultants, pathologists, diagnosti-cians, and radiologists give kickbacks to referring doctors. It is the malpractice of first order and should be strongly discouraged.

Some companies and medical shop owners give printed letterheads and pads to Pediatrician with their name(s) printed on. This is a malpractice and should be strictly avoided as this may invite litigations.

The IAP members should be vigilant in reporting and stopping of surrogate advertis-ing and unfair and restrictive trade practices indulged by Industry.

Dr. Uday Bodhankar,
Ramdaspeth, Nagpur -440 010
E-mail: [email protected]

Dr. Yashwant Patil,
Anjuman Complex,
Sadar, Nagpur -440 001
E-mail: [email protected]

        Dr. Uday G. Bodhankar       Chairman            Dr. Yashwant Patil            Convenor
        Dr. C. P. Bansal                 Member              Dr. Panna Choudhury        Member
        S. R. Keshava Murthy         Member              Dr. M. R Lokeshwar          Member
        Dr. Dilip Mukherjee             Member              Dr. P. S. Patil                   Member
        Dr. Satish Pandya              Member              Dr. K Jayoji Rao                Member
        Dr. Rohit Agrawal               Member              Dr. Sailesh Gupta              Member

                 Dr. H. P. S. Sachdev         President IAP (Ex-officio)
                 Dr. M. K. C. Nair               President-Elect IAP (Ex-officio)
                 Dr. Nitin K Shah                Secretary General (Ex-officio)