Medical profession is essentially self-regulated, since historical times. The doctors were considered healers, demi Gods. Kautilya's artha shastra, which gives a glimpse of ancient system of medicine, holds the physician accountable both to the state and the patient. Failing to provide proper information to patient, committing mistakes due to negligence were said to be punishable.^1,2

An unwritten social contract existed between medicine and society. In return for a physician's commitment to altruistic service, a guarantee of professional competence, the demonstration of morality and integrity in their activities, and their agreement to address issues of social concern, society has granted considerable autonomy in practice to medical profession, apart from a special status in the community. The exemplary behaviour, attitude, along with the myths about cure, physicians convinced society that science-based medicine was superior to alternative therapies and that their profession represented a trustworthy moral enterprise.^1,2,3 Complexity of the knowledge base and skills required, especially as technology advanced, would make regulation by nonprofessionals difficult^1,3 and it was thought that the profession could be trusted to carry out this necessary activity.

In this view, a search of Pubmed/Medline and Google database was made for relevant articles focusing mainly on Indian scenario with key words as ‘regulation of medical profession’, ‘ethical issues in medicine’ and ‘doctor-patient relationship’. We also constructed relevant information from textbooks to provide an overview.

Self-regulation of the medical profession is complex and involves multilaminar, clairvoyant oversight aimed at guaranteeing the competence of the practicing physician. Some of the activities that have been initiated and continue to be carried out with skill and rigour include accreditation of medical colleges with the affiliated hospitals and training programmes, licensure and certification. Conferences, continuing medical education (CME) programmes, workshops, seminars, web telecast of live interactions, wet labs and hands on workshops are some of the self-evaluation and upgradation activities that have become very popular. While there is a scope for improvement always, in general, the self-regulation activities have performed well and have achieved their objectives to a surprising degree over the past half century.^3,4,5

The major obstacles for credible self-regulation that have been identified and documented include: providing assurance that those in practice maintain their competence;⁴ taking appropriate action once a problem with an individual practitioner has been identified ^3,5 and regulating conflicts of interest.⁶ From the time when, as medical students, they are offered food and goodies supplied by a pharmaceutical company at CME programmes, to until they retire from practice. Physicians are exposed to a plethora of potential and real conflicts, and not all of these conflicts originate from outside of the profession.

It is very easy to understand as to why a doctor as an individual while pursuing a profession in his own interests can slip away from their altruistic ethical behaviour. Professionalism balanced against ethics calls for a high degree of personal integrity, which cannot be expected in all doctors. Conflict is inherent in a profession in which individuals are expected to be altruistic, while, as human beings, still pursue their own interests.^3,5 As long as the profession remained in high esteem, outside observers presumed that altruism would prevail and that the patient's needs would come first.⁷ Negative events have overtaken those relatively simple days, however, and the situation medicine now faces are different. Trust must be continuously earned from a skeptical public who are very aware of the opportunities for its abuse in a highly competitive, market-oriented health-care system that encourages and rewards entrepreneurial behaviour.⁸

In the 20^th and 21^st century, the privilege of self-regulation of medical profession has gradually made way to establishment of licensing laws worldwide.¹ By the latter part of the 20^th century, many social scientists observed that the medical profession had abused its privileged status and public trust, and that its regulatory procedures were seriously flawed.^3,5,17 Standards were considered to be weak, variable and inconsistently applied, and physicians were further accused of using collegiality as a means of shielding poorly performing peers. A lot of criticism was directed to the medical profession for its lack of openness and transparency in regulatory procedures and for the absence of public involvement in them. Many of these criticisms proved to be accurate and had an impact on both public policy and on the level of trust that the profession enjoyed. In effect, the system appeared to lack accountability, and it was suggested that an informed public should participate in medicine's regulation. Nevertheless, public demands for assured competence are both present and growing, virtually guaranteeing a future for the processes of re-licensure and recertification. Identifying problem physicians and taking appropriate disciplinary action against them can be a complex situation and can tarnish the reputation of the entire medical profession.¹⁸

1. The Indian Medical Council (IMC) Act 1956: The Medical Council of India was first established in 1934 under the IMC Act, 1933. The Council was later reconstituted under the IMC Act, 1956, that replaced the earlier act. The Indian medical register, the right of persons possessing qualifications to be enrolled, removal of names from the register, code of ethics, professional conduct and guideline for state medical councils, etc., are some of the topics where guidelines are prescribed.¹⁹

2. The Drugs and Cosmetics Act 1940: An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.²⁰

3. The Dentists Act 1948: An act to regulate the profession of dentistry. It is expedient to make provision for the regulation of dentistry and for that purpose to constitute Dental Councils in India.²¹

4. The Pharmacy Act 1948: Act to regulate the profession of pharmacy. It is expedient to make better provision for the regulation of the profession and practice of pharmacy and for all that purpose to constitute Pharmacy Councils.²¹

5. The Indian Nursing Council Act 1947: An act to constitute an Indian Nursing Council. It is expedient to constitute an Indian Nursing Council in order to establish a uniform standard of training for nurses, midwives and health visitors and also to register.²¹

6. The Homeopathy Central Council Act 1973: An act to provide for the constitution of a central council of Homeopathy and maintenance of a central register of Homeopathy and for matters connected with the administration and regulation.²¹

7. The Indian Medicine Central Council Act 1970.²¹

8. The Clinical Establishments (Registration and Regulation) Act 2010: An act to provide for the registration and regulation of clinical establishments in country to prescribe for minimum standards of facilities and services.²²

9. The Transplantation of Human Organs Act 1994: An act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto.²³

10. Indian Contract Act 1872: Applicable in the present context.²⁴

11. Consumer Protect Act 1986: An Act to provide for better protection of the interests of consumers and for that purpose to make provision for the establishment of consumer councils and other authorities for the settlement of consumers’ disputes and for matters connected therewith. Extended to medical field in 1995.^25,26

12. Indian Penal Code 1860: Sections 52, 80, 88, 89, 92, 93,186, 269–278, 284–288, 304A, 312–318, 332–333, 336-38, 353, 376D.²³

13. Criminal Procedure Code 1973: Sections 133–136, 357.²³

14. Law of Torts 1993: The development of constitutional tort, which began in the early eighties and was cemented into judicial precedent in the last decade.²⁴

15. Medical Termination of Pregnancy (MTP) Act 1971: An act to provide for the termination of certain pregnancies by registered medical practitioners and for matters connected therewith or incidental thereto.^27,28

16. Pre-Conception and Pre-Natal Diagnostic Techniques Act (PCPNDT) Act 1994: The act banned prenatal sex determination; is a federal legislation enacted by the Parliament of India to stop female foeticides and arrest the declining sex ratio in India.²⁹

17. Biomedical Waste Management and Handling Rule, 1998: Ministry of Environment and Forests (MoEF), have included a set of new rules under the Environmental Protection Act.³⁰

18. Environment Protection Act 1986: An act to provide for the protection and improvement of environment and for matters connected herewith.³¹

19. Mental Health Act 1987: An act to consolidate and amend the law relating to the treatment and care of mentally ill persons, to make better provision with respect to their properly and affairs and for matters connected therewith or incidental thereto.³²

20. Last but not the least, The Constitution of India 1956.^19,21,23,25

These are some of the relevant information a doctor must acquire in order to have a safe and effective practice of the medical profession in India.

When the society becomes dissatisfied with the performance of the profession, changes the terms of the social contract and reclaim some of these powers, the medical profession's rights to self-regulation tends to decline. There will be more public input into the process of self-regulation. Licensing boards and professional associations will contain more public representatives, and methods of assuring greater accountability will be instituted. The Medical Council of India, the principal regulatory body, may have a majority of lay members, which would mean that the profession is no longer self-regulating. While this may sound remote, it is to be noted that such considerations are happening in the West.³³ Notwithstanding re-licensure, re-certification, the principle of self-regulation will be further questioned and the pressure for external regulation will grow.

Patients have a strong interest in the ethical aspects of good medical practice and doctors should not wait to become patients to take the same interest. Profession must accept greater accountability and should not hesitate to act on professional misconduct. Self-regulation is a privilege that can be maintained only with the public consent and trust. Ethics and good doctor-patient relationship should be put at the heart of medical practice. The present generation of doctors needs to adapt and accept the changing scenario and develop a scientific approach to achieve the lost glory.

The authors declare no conflict of interest.

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