Report of the Committee on NMC Draft Regulations

National Medical Commission Registered Medical Practitioner (Professional conduct) Regulations, 2022 having put into public domain by the National Medical Commission for suggestions and comments to be made known to them on or before 22nd June, 2022.

National President, IMA constituted a Committee under the Chairmanship of Dr. Vedprakash Mishra, Dean, IMA Academic and Accreditation Board in terms of a communication dt. 30th May 2022 for furnishing “Observations on the said Draft Regulations for consideration of IMA and its onward submission to the NMC.

Accordingly, the Draft Regulations has been critically evaluated and analysed and upon the same following observations are brought out:

1. ThecommunicationunderthesignatureofDr.AchalGulati,President,Ethics and Registration Board of NMC dt. 23.5.2022 has brought out that the Draft Regulations have been put in public domain inviting comments thereon which is in accordance with Section 27, 30, 31 and 57 of the NMC Act 2019.

The preamble of the Draft Regulation brings out that it has been worked out in exercise of the powers conferred by Section 27(1) (b), read with Sections 10 (b) (f), 16 (2) and 57 (2) (zh) of the NMC Act 2019 (Number 13 of 2019). However, it does not bring out taking recourse to Section 30 of the NMC Act 2019. Under Section 41 seriatim 7 categorically brings out as under:

“Award monetary penalty to aggrieved party as it deems fit as per Section 30 of NMC Act 2017 can be given by EMRB only as and when required”.

The material dichotomy being that when Preamble does not refer to availing of Section 30, an operative clause making use of the same is contradictory and more so if it is quoted as Section 30 of NMC Act 2017 which is palpably erroneously because the preamble itself refers to NMC Act 2019 (No.30 of 2019) without any reference to ‘2017’ in any manner.

2. NMCintermsofauthorityvestedunderSection57oftheNMCAct2019has powered to make regulations consistent with the said Act and the Rules made thereunder to carry out provisions of this Act.

In accordance with the said powered Section 57(2) prescribes that “in particular, and without prejudice to the generality of the forgoing powers such regulations may provide for all or any of the following matters, namely –

Thereunder Sub Section (zh), it is proved that a Regulation may be made for “the manner of taking disciplinary action by a State Medical Council for professional or ethical misconduct of Registered Medical Practitioners or Professional and the procedure for receiving complaints and grievances by Ethics and Medical Registration Board Under sub section 2 of Section 30.

Further at sub Section (zi), it is stipulated that by Regulation it may be provided pertaining to “the Act of Commission or omission which amounts to professional or Ethical misconduct under Clause (b) of the explanation to Section 30.

Without any reference to Section 57 (1) (zi) what is stipulated therein has been incorporated in the Draft Regulation which is a huge omission.

3. In Chapter 1, Title Preliminary under the Head Short Title and commencement at seriatim (A), it is stated that “these Regulations may be called the National Medical Commission Registered Medical Practitioner (Professional Conduct), Regulation 2022. This brings out that the name of the Regulation also is not in the domain of ‘surity’ in as much as the framers are not sure as to whether it would be named so or it may be named so. As such, the word ‘may’ should have been replaced by the word “shall”.

4. In the very chapter, in chapter 1, under Article l2 at seriatim 6, the definition is given for “Modern Medicine” and at Sub Section B, it is brought out that ‘the words and expressions used herein and not defined but defined in the Act shall have the same meanings as assigned to them in the Act” and the word “Act” is defined at seriatim (a) as “Act means the NMC Act , 2019 (No. 30 of 2019).

At Section 2 of the NMC Act 2019 at seriatim (J) word ‘Medicine is defined as “Medicine means modern scientific medicine in all its branches and includes Surgery and Obstetrician, but does not include veterinary surgery”.

The word defined in the act is “Medicine” explicitly with reference to its nomenclature, ambit and coverage. However, the Draft regulation at seriatim E, defines “Modern Medicine or Allopathy” which is neither in tune nor in tandem with the definition of the word “Medicine” in the NMC Act 2019.

Needless to state that a Regulation which is a subordinate Legislation cannot define a word which is already defined in the parent Act in any manner difference from the one which is depicted in the Act. To that extent the Draft Regulation suffers from a gross infirmity.

Further, under definition at Section 2 at seriatim G, Registered Medical Practitioner is defined as “RMP means a person whose name is either in the State Medical Register or Indian Medical Register or the National Medical Register unless otherwise specified”

As such, the definition specifically and explicitly refers to 3 Registers namely: – ‘State Medical Register’, ‘Indian Medical Register’ and ‘National Medical Register’ respectively. However, under the definition at Seriatim F, ‘National Register’ is defined and not ‘National Medical Register’. Similarly, at seriatim J, ‘State Register’ is defined but not ‘State Medical Register’. Further, ‘Indian Medical Register’ is not defined at all.

It may be noted that NMC Act under Section 2 (m) defines “National Register and at seriatim (V) defines State Register respectively. In that context, reference to – National Medical Register and State Medical Register is superfluous as the nomenclature defines is National Register and State Register respectively. However, reference to Indian Medical Register in the definition of Registered Medical Practitioner without being defined in the parent Act and Draft Regulation is grossly untenable and impressible.

5. Inthebackdropoftheaforesaidobservations,hereafterobservationsarebeing made clause-wise and theme-wise on the Draft Regulations in a tabular form titled Table I :

CLAU CLAUSE

SE NO.

CHAP PRELIMINARY TER 1

PENA SUGGESTIONS LTY

Table I

These regulations may be called the National Medical Commission

Registered Medical Practitioner (Professional Conduct) Regulations, 2022

(B) They shall come into force on the date of their publication in the Official Gazette.

Replace ‘may’ with ‘shall’

2(e)

“Modern medicine” or “Allopathy” is a healthcare discipline that involves a scientific understanding of disease processes and uses rational and evidence-based treatment methods. This system of medicine views disease as a biological abnormality in the function or structure of organs or organ systems, with effects on organs and the body as a whole. Animal experiments may be used to understand disease processes and the efficacy of therapeutic measures. Medical research using blinded studies and statistical analyses informs all aspects of diagnosis, testing, treatment, and disease prevention. Modern medicine has international uniformity in theory and practice. It has found universal acceptance in India and is currently practiced and taught in Government and Private hospitals and medical colleges governed/regulated and accredited by the National Medical Commission, Government of India.

AYUSH system does not include modern medicine and should not overlap Modern medicine not defined

Definition altered.

As such definition should be as brought out in NMC Act 2019 at Section 2 (J0 thereat.

2(g)

Registered Medical Practitioner” or “RMP” means a person whose name is either in the State Medical Register or the Indian Medical Register or the National Medical Register unless otherwise specified.

Whoever is registered with SMC automatically goes on IMR (Indian Medical Register).

Is there a plan to have a separate National Medical Register now? What would be the process of formation of said separate NMR?

CHAP TER 2 CLAU SE 4

Prefix, Suffix and Modern Medicine:

4(A)

Only those RMPs who are registered under NMC Act, 2019, can use Medical Doctor (Med Dr.) as a prefix before their names. Every self- employed RMP shall display the unique registration ID assigned to her/him by EMRB in his/her prescription, certificate, and money receipts given to patients. Employed RMP shall get a seal made by the employer for displaying the unique registration number below the RMP’s signatures. (Guideline for prescription)

A. Prefix Not acceptable. Use prefix for all other doctors of other systems, e.g Phd Dr. for non- medical doctors, Hom Dr. for Homeopathic and so on and so forth.

B. Details of Unique reg no. – will it be different from SMC reg no.

C. will other system doctors also be given URI? Is the current registration number issued by SMC not unique registration number? What is the need to have a new number? In addition to SMC reg. no.

4(B)

The RMP shall display as suffix to his/her name only NMC recognized and accredited medical degrees/diplomas as provided in the nomenclature of the regulations and listed on the NMC website. (List of such Degrees and Diplomas will be on the website and updated regularly)RMPs qualified abroad and seeking registration to practice after clearing FMGE/NEXT must use NMC-approved equivalent Medical prefixes and suffixes to provide clarity to patients and the public at large.

Is this prospective or retrospective?

If retrospective, will the RMP no longer hold the specialisation and will have to stop practicing?

Apart from degree and diploma, there are other qualifications such as fellowships, certifications, etc. which should be permitted.

4(C)

A RMP shall not claim to be a clinical specialist unless he/she has NMC recognized training and qualification in that specific

L1,L2

Is this prospective or retrospective?

branch of modern medicine (The list of recognized post-graduation and super- specialization degrees/diplomas will be available on the NMC website)

How will NMC recognise qualifications of those practising from so many years in chosen speciality, in which there is no qualification in our country?

CEA has already allowed for training for at least 6 months in the speciality without any qualification. Army hospitals also have the system of Qualified specialists and Graded classifieds specialists This clause needs to be modified to allow those who have specialised by way of years of hands on experience.

4(D)

Every RMP shall practice the system of medicine in which he/she has trained and certified (for this purpose referred to as modern medicine* or allopathic medicine) and shall not associate professionally with any unqualified person to perform any treatment, procedure, or operation.

Define unqualified? Are doctors of other

systems included in unqualified category?

4(E)

A RMP shall not employ in connection with his/her professional practice any healthcare professional who is neither registered nor trained under the relevant Medical Acts in force related to the practice of modern medicine. Provided that having employed any other assistants in the practice, the ultimate responsibility rests on the self-employed RMP or the RMP responsible for administration and recruitment in case of hospital practice.

While it is very important to maintain quality of healthcare delivery and for skill development, currently there is already a shortage of manpower. This clause should be deleted, as there is dire need for full-time or part time employees to manage the hospitals and nursing homes.

To continue their services, will new module of training and registration be planned?

If not, and if this clause is applied retrospectively, how will the manpower deficiency be taken care of.

4(F)

A person qualified in more than one system of medicine should decide which system he wants to practice. Once licensed to practice Modern medicine under NMC Act, he shall not practice another system of medicine simultaneously. Short courses in other systems of medicine do not qualify a practitioner to practice and prescribe in that system of medicine.

If this clause has to be applied, Similar parallel restriction MUST be imposed on other systems doctors, if modern medicine has to practice only one pathy.

Continuing Professional Development Program: A RMP should attend continuing professional development programs regularly each year, totaling at least 30 credit hours every five years. Only recognized medical colleges and health institutions or medical societies accredited or authorized by EMRB/State medical Councils can offer training and credit hours for this purpose. Credit hours awarded shall be updated online against the Unique Registration Number of RMP on the EMRB- NMC website. Renewal of License to practice should be done every 5 years (from the publication of the Gazette notification), after submitting documentation of CPD credit hours. The license renewal form will allow updates of details like specialization, place of work, address, contact details, or any other detail specified by EMRB/NMC. RMPs who wish to practice in another State (due to transfer of work of residence) should inform that State Medical Council and apply for License to practice in that State. State will have to mandatorily provide license to practice charging appropriate fee within 7 days. (CPD guidelines)

Regarding application of RMP for registration with SMC on transfer is valid.

On short term basis, there are multiple other scenarios wherein RMP would be operating or giving services in another state such as that happens in operative workshops, visiting professors demonstrating unique techniques, as invited faculty for difficult or complicated conditions, etc. where it is a short term assignment. This should be specified in this clause and no application for registration to the state of temporary assignment should be required

Details in sheet 1

Right to remuneration of A RMP:

Consultation fees should be made known to the patient before examination or treatment of the patient. A reasonable estimation of the cost of surgery or treatment should be provided to the patient to enable an informed decision. A RMP can refuse to continue to treat a patient if the

The details have to be added in this clause – Patient refuses to pay and also refuses to go to another hospital, creates an unpleasant situation, and/or violence occurs.

fees, as indicated, are not paid. This does not apply to doctors in Government service or emergencies and the doctor must ensure that the patient is not abandoned.

There should be a mechanism of complaint by RMP to NMC/SMC where the rights of RMP are safeguarded.

Other rights should be included in the regulations such as:

> Right to safe work environment including right to be protected by employer

> Right to limit working hours as per individual preference

> Right to proper hearing and justice

> Right to practise profession unhindered without over regulation and/or judicial adventurism

> Right to abandon the patient if he threatens, assaults, or indulges in violence

> Right to self defence >Right to privacy

> Right to protest peacefully

> Right to freedom of expression and speech

> Right not to be arrested in a routine manner for allegations of negligence (Jacob Mathew vs State of punjab)

> Right to equality and non-discrimination

> Right to cross examine in person those who have filled affidavits, expert witnesses, medical board persons, CMO’s PM reports

Prohibiting Soliciting of Patients: A RMP shall not solicit patients directly or indirectly or as a part of the group of RMPs, or institutions or organizations or hospitals or nursing homes, or corporate hospitals established, owned, controlled, or maintained by the appropriate Government, local authority, trust, whether private or public, corporation, co-operative society, organization or any other entity or person.

what is meant by soliciting of patients?

Not defined or specified in any manner what so ever.

Prescribing Generic Medicine: Every RMP is expected to prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.

L1,L2

List of generic medicine

available in each city and

state as well as Jan

Prohibition of Fee Splitting/Commissions: A RMP shall not directly or indirectly participate in any act of division, transfer, assignment, subordination, rebating, splitting, or refunding of any fee for diagnostic, scanning, medical, surgical, or other treatment. These provisions shall apply with equal force to the referring, recommending, or procuring by a RMP of any patient, specimen, or material for diagnostic purposes or other studies/work. However, nothing in this section shall prohibit payment of salaries by a qualified RMP to another duly qualified person rendering medical care under his/her supervision. RMP shall not use online forums or agents for procuring patients.

Aushadhi Kendra list

including rates should be

provided for each

prescription to be

honored so that patient

does not have to run

around and be hassled

DISCLAIMER

Prohibition of endorsement of the product or a person:

10A

A RMP individually or as part of an organization/association/society shall not give to any person or to any companies or to any products or to software/platforms, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report, or statement concerning any drug, medicine, nostrum remedy,

There are many situations such as medical or surgical camps, clinical research, etc. where the name and other information about

surgical, or therapeutic article, apparatus or appliance or any commercial product or article with respect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through any mode.

the doctors are bound to be given. This clause needs to be therefore suitably modified.

10B

ARMPshallnotissuecertificatesofproficiencyinmode rnmedicinetounqualifiedornon- medical persons. This does not restrict the proper training and instruction of bonafide students, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants & therapy assistants under the personal supervision of RMPs. (L2). Every certificate must contain the details regarding experience, skills and competency obtained, duration of the training, and kind of work done during training. The onus of the veracity of the certificates lies with the RMP.

A standard format with details of objective assessment of skills and competencies for issuing certificate is needed.

11 Restriction on Advertisement:

11A

A RMP is permitted to make a formal announcement in any media (print, electronic or social) within 3 months regarding the following: (1) On starting practice (2) On change of type of practice (3) On changing address (4) On temporary absence from duty (5) On resumption of practice (6) On succeeding to another practice (7) Public declaration of charges.

Is there any restriction for advertisement on any other professional within the ambit of CPA?

11B

A RMP or any other person including corporate hospitals, running a maternity home, nursing home, private hospital, rehabilitation center, or any type of medical training institution, etc. may place announcements in the lay press, but these should not contain anything more than the name of the institution, type of patients admitted, kind of training and other facilities offered and the fees. (Guidelines on social media conduct)

L1,L2

11C

A RMP is allowed to do public education through media without soliciting patients for himself or the institution

Responsibility of RMP regarding the sale of drugs

12A

A RMP shall not run an open shop to sell medicine prescribed by RMPs other than himself or for the sale of medical or surgical appliances. They are allowed to sell medication to his/her own patients.

12B

RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by a RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug.

12C

ARMPshallnotdispenseorprescribesecretremedialag entsofwhichhedoesnotknow the composition or action in the body. The manufacture or promotion or use of these remedies is prohibited.

Responsibility of RMP regarding the Medical Records:

13A

Every self-employed RMP shall maintain medical records of patients (outpatients or inpatients) for 3 years from the date of the last contact with the patient for treatment, in a standard proforma laid down by the NMC. (Guideline)

Difficult to store all outpatients records, should be deleted.

NMC should provide the platform for electronic storage of records and it should not be the responsibility of RMP if any untoward incident happens after storage of records

13B

If any request is made for medical records to a RMP responsible for patient records in a hospital or healthcare institution either by the patients / authorized attendant or legal authorities involved, the same may be duly acknowledged and documents shall be supplied within 5 working days.

Only certified photocopies to be given, especially to health insurers, which should suffice.

13C In case of medical emergencies, the medical records L2 should be made available on the same day.

13D

Efforts shall be made to computerize patient’s medical records for quick retrieval and security. Within 3 years from the date of publication of these regulations, the RMP shall fully digitize records,

L1,L2

Preferably, digital platform to be provided by NMC/MOHFW

abiding by the provisions of the IT Act, Data protection and privacy laws, or any other applicable laws, rules, and regulations notified from time to time for protecting the privacy of patient data.

13E

RMPsareincertaincasesboundbylawtogiveormayfro mtimetotimebecalledupon to give certificates, notifications, reports, and other documents of similar character, signed by them in their professional capacity for subsequent use in the courts or administrative or other purposes. Such reports, certificates, or documents should not be untrue, misleading, or improper. A self-employed RMP shall maintain a Register giving full details of such certificates issued by him/her.

A RMP shall cooperate in the investigation against incompetent, corrupt or dishonest conduct of other members of the profession without fear or favor.

The RMP shall not aid or abet torture, nor shall he be a party to either infliction of mental or physical trauma or concealment of torture inflicted by another person or agency in clear violation of human rights.

Practicing euthanasia shall constitute unethical conduct. However, in some instances, the question of withdrawing life-supporting devices or measures even after brain death shall be decided following the provisions of the Transplantation of Human Organ Act, 1994. (End of Life Guidelines) …..

NOT MEN TION ED

It should be as per guidelines prescribed by Hon. SC in Common cause society vs Union of India in 2018

The RMP should respect the boundaries of the doctor-patient relationship and not exploit the patient for personal, social, and business reasons (L2) and in particular, avoid sexual boundary violations. (L4)

L2, L4

RMP shall not refuse on religious grounds alone to assist in or conduct of sterility, birth control, circumcision, and medical termination of Pregnancy when there is a medical indication. (L3)

RMP’s have a right to refuse treatment except in emergencies, hence this clause should be deleted or suitably modified

INFORMED CONSENT

19A

Before performing any clinical procedure, diagnostic or therapeutic, or operation, the RMP should obtain the documented informed consent of the patient. In case the patient is unable to give consent, the consent of the legal guardian or family member must be taken. The name of the operating surgeon must be mentioned in the medical records. In an operation that may result in sterility, the consent of both husband and wife is required. In case of an emergency, the doctor should try to obtain consent, but if this is not possible, he must act in the best interest of the patient. The medical records should describe the basis of decisions taken in an emergency No act of in- vitro fertilization or artificial insemination shall be undertaken without the informed written consent of the female patient and her spouse as well as the donor.

In India, informed consent is not mandatory as per Law. Details in Sheet 3

(Consent Guidelines)

19B

A RMP shall not publish photographs or case reports of patients without their permission in any medical or another journal in a manner by which their identity could be revealed. (L1)

19C

Clinical drug trials or other research involving patients or volunteers must comply with ICMR guidelines and the New Drugs and Clinical Trials Rules, 2018. Consent taken from the patient or participants for the trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct. (Research Guidelines)

L2-4

Conduct of RMP on Social/Electronic and Print Media shall follow the prescribed guidelines (Social Media Guidelines)

RMP should take due care in practice and exercise reasonable skills as expected, to preserve the life and health of the patient and follow the guidelines (Guidelines on Reasonable Care and Skill)

CHAP TER 3 22

DUTIES OF RMPS TOWARDS THEIR PATIENT

KEEPING APPOINTMENTS

22A

An RMP shall endeavor to be prompt in attending to patients and should keep in time with appointments or visiting/consultation hours. If the RMP is delayed for a valid reason, the patient should be informed.

22B

A RMP may also advise referral when necessary to another RMP who is specialized in the treatment of the patient’s ailment.

22C

In case of emergency (life and limb saving procedure) an RMP shall provide first aid and other services to the patient according to his expertise and the available resources before referral.

Incapacity: A Registered Medical Practitioner having any incapacity (induced or otherwise) detrimental to the patient or professional practice, which can affect his decision-making or skill in treating the patient is not permitted to practice his profession for the period of incapacity. Use of Alcohol or other intoxicants during duty or off duty which can affect professional practice will constitute misconduct. (L3, L4)

L3,L4

Off-duty to be deleted

NMC should protect the junior doctors/residents from working more than 24 hours at a stretch by prescribing mandatory working hours.

Confidentiality: Every communication between RMP and patients shall be kept confidential. Such communication, whether personal, or related to health and treatment, shall not be revealed unless required by the laws of the state, or if non- disclosure may itself be detrimental to the health of the patient or another human being. (L2, L3)

L2,L3

a. Medical records of patients asked by insurance

b. Telerecorded communication – A caveat should be provided to ensure that the Technology Platforms through which teleconsultation is provided by the RMPs can have access to such conversation and communication in order to ensure the quality of the teleconsultation, to understand the experience of the

patients, to address grievances of the patients and to conduct enquiry upon receipt of a complaint from a patient and any other relevant purpose. The Technology Platforms, shall however, inform the patients about the access and shall obtain a prior consent from the patients in accordance with applicable laws. The Technology Platforms shall also endeavour to take all steps and security measures and follow all precautions to ensure the safety and security of the data of the patients and to always ensure confidentiality

C. Patients/relatives recording conversation without consent not permissible

Truth-telling: The RMP should neither exaggerate nor minimize the gravity of a patient’s condition. He/ She shall ensure that the patient or legally appointed representative has such knowledge of the patient’s condition that can assist in making decisions that will best serve the interests of the patient. (L1)

Patient care: A RMP is free to choose whom he will serve, except in case of a life- threatening emergency. Having accepted a case, the RMP should neither neglect the patient nor withdraw from the case without giving adequate notice to the patient and his family. If a change of RMP is needed (for example, the patient needs a procedure done by another RMP), consent should be obtained from the patient himself or the guardian. The RMP who attends to the patient will be fully

L2-L4

‘Adequate word’ does not provide enough information. It should be changed to a particular period of 24-48 hours

For an abusive, violent or unruly patient, why should the RMP who refuses to treat, refer this patient to another RMP?

accountable for his actions and entitled to the appropriate fees. In case of abusive, unruly, and violent patients or relatives, the RMP can document and report the behavior and refuse to treat the patient. Such patients should be referred for further treatment elsewhere. (L2- L4)

if one RMP has refused, it is upto the patient to find another RMP. Moreover, NMC MUST insulate its RMP’s from acts of violence by describing in detail the process of reporting these patients, the authority to whom reporting has to be done, etc.

Referral: Only such Follow up consultation should be planned as required by the patient. Likewise, laboratory investigations ordered for the patient should be justified. An update/summary of the clinical condition and reasons for referral must be documented and provided at the referral. Specialist referral must be sought to benefit only the patient and duly justified in medical documents (L2)

The RMP should decide the ‘followup’ based on the condition of the patient.

Joint decision making should be emphasized where patient understands his health related issues and co- operates with the RMP for his own well-being

Signatures: All signatures in the notes, prescriptions, certificates, orders, referral summaries etc, should carry the RMP’s Name and NMC Registration number. Electronic generation of orders/prescriptions may help automation of this information. (L1, L2)

L1,L2

Consultation by Telemedicine: Consultation through Telemedicine by the Registered Medical Practitioner shall be permissible following the Telemedicine Practice Guidelines (Telemedicine Guideline) (L1, L2)

L1,L2

CHAP TER 4

RESPONSIBILITIES OF RMPS TO EACH OTHER

Professional Integrity: In consultations, professional rivalry should not be indulged in. All due respect is owed to the RMP in charge of the case, and no derogatory statement or remark be made which would impair the confidence reposed in him by the patient. For this purpose, professional discussions should not take place in the presence of the patient or family or legally appointed representative. The

L1,L2

specialist must provide the clinical opinion only to the RMP who referred the patient. Every discussion/opinion regarding the patient should be kept confidential. If a referral is sought by an RMP, it should be clarified if the specialist will take over the care of the patient or if the patient will remain with the primary RMP. (L1, L2)

RMP as Locum: Whenever a RMP requests another RMP to attend to his patients during his temporary absence from his practice, professional courtesy requires the acceptance of such appointment only when the RMP can discharge the additional responsibility along with his /her other duties. The RMP acting under such an appointment should give the utmost consideration to the interests and reputation of the absent RMP and all such patients should be restored to the care of the latter upon his/her return. (L1, L2)

L1,L2

Reporting and Inspection: When it becomes the duty of a RMP occupying an official position to inspect and report on an illness or injury, he should communicate this to the RMP in attendance to give him the option of being present. The RMP occupying an official position should avoid making any derogatory remarks regarding the diagnosis or the treatment plan adopted. (L1, L2)

L1,L2

And also keep it confidential

CHAP TER 5

DUTIES OF RMPs TOWARDS THE PUBLIC AND ALLIED HEALTHCARE PROFESSIONALS

33 Public Education and Awareness

33B RMP should enlighten the public concerning L1,L2 quarantine regulations and measures for the

33A

RMPs, as good citizens, have a responsibility to disseminate scientific advice on public health issues in the public interest without self- promotion. They should particularly co-operate with the authorities in the administration of sanitary/public health laws and regulations. (L1)

prevention of epidemics and communicable diseases. At all times the RMP should notify the constituted public health authorities of every case of notifiable disease under his care, following the laws, rules, and regulations of the health authorities. RMP needs to involve in public education and awareness activities without involving in the advertisement. When an epidemic occurs, a RMP provided with all the necessary medical protection and his own health permitting should not abandon his duty for fear of contracting the disease himself. (L1, L2)

RMP as a team leader, should recognize the importance of teamwork and respect the practice of different paramedical services. (L1)

RMPs and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fee or honorariums, or access to entertainment or recreation from pharmaceutical companies, commercial healthcare establishments, medical device companies, or corporate hospitals. However, this does not include salaries and benefits that RMPs may receive as employees of these organizations. Also, RMPs should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector.RMP should be aware of the conflict of interest situations that may arise. The nature of these relationships should be in the public domain and should not be in contravention of any law, rule, or regulation in force. An RMP himself or as part of any society, organization, association, trust, etc. should be transparent regarding the relationship with the pharmaceutical and allied health sector industry. (L3)

A RMP may charge a consultancy fee or honorarium for service rendered in the form of medical camps, profession advice as an Advisor to a company. To prohibit the same may be legally unsustainable, unless it’s a fraud and indirect gifting by a pharma company. Almost all educational activities involve sponsorship by pharma or corporates or hospitals

Regarding educational activity, funding of these activities by pharma companies is a very important aspect and must be permitted.

The lone operational criteria should be

absence of conflict of interest.

RMPs may be required to file an affidavit regarding their financial earnings and or benefits received in the past 5 past years from any pharmaceutical companies or allied health sector. (L3)

What is the purpose of this clause is not clearly spelt out.

RMP’s are filing Income tax and all financial details are already there with the Government. This clause must be deleted.

Power to Draft guidelines: EMRB will draft the guidelines/codes etc on Generic Drugs and Prescription, CPD guidelines and accreditation of organizations, Telemedicine Guidelines, Code of Ethics, Guidelines on Penalties for Misconduct including the monetary penalty, Advertisement Guidelines, End of Life guidelines, Consent in Medical Practice, Guidelines on Research by RMPs, Guidelines on Social Media Conduct of RMPs, Guidelines on Reasonable care, skill and Guidelines on Interaction with Pharmaceuticals, as and when required and amended from time to time by EMRB.

CHAP

PROFESSIONAL MISCONDUCT

TER 6

Professional Misconduct: Any violation of these regulations, or other applicable Acts related to medical practice which are in force, shall constitute professional misconduct. By issuing these regulations, the EMRB, NMC, and the State Medical Councils are in no way precluded from considering and dealing with any other form of professional misconduct by registered medical practitioners which do not fall under any of the categories mentioned in the regulations or guidelines or codes appended. RMPs bound by these regulations will not engage in any activities which violate these regulations and should not enter into any employment or other contract that engages in activities in violation of any of these regulations. Conviction of RMP in cases of a

cognizable offence involving moral turpitude may result in the suspension of license to practice.

Procedure for a complaint of professional misconduct

39A

The aggrieved person will file the complaint to the State Medical council through the website portal/offline, ordinarily within 2 years of the cause of action. (The complaint will be lodged in the SMC where RMP is located at the time of cause of action, both in teleconsultation or in person consultation)

39B

Where the aggrieved person is unable to make a complaint on account of physical or mental incapacity, a complaint may be filed by —

a. afamily member or relativeorfriend;or

b. theguardianorauthorityunderwhosecaretreatmen twasreceived

c. the legal heir or guardian in case of death of the patient

Friend to be deleted

39C

The EMRB or state medical council can initiate a suo-moto case against any RMP taking cognizance of gross misconduct. The suo-moto complaint will be taken up if a simple majority of the EMRB or State medical council members agrees to proceed against the RMP

What amount to ‘Gross misconduct’ is not explicitly brought out.

40 Manner of Inquiry into the complaint

40A

At the time of filing the complaint, the complainant shall submit to the EMRB or state medical council five copies or for offline applications (till the whole process is made online) of the complaint along with supporting documents and the names and addresses of the witnesses.

40B

On receipt of the complaint, the council shall send one of the copies received to the respondent within 15 working days. For online complaints, the State Medical Council/EMRB/NMC will send an e- copy/physical copy of the complaint to the respondent.

40C

The respondent shall file his reply to the complaint along with his list of documents, and names and addresses of witnesses, within a period not exceeding 15 working days from the date of receipt of the documented complaint

40D

The state medical council or EMRB/NMC shall conduct an inquiry into the complaint following the principles of natural justice.

40E

On receipt of the complaint, the State Medical Council shall refer the case for review to the designated committee, with assistance from a panel of experts, if required, specifically formed for this purpose in the stipulated time.

40F

If more than one hearing is required, The /State Medical Councilor EMRB/NMC shall have the right to terminate the inquiry proceedings or to give an ex-parte decision on the complaint if the complainant or respondent fails, without sufficient cause, to present herself or himself for two consecutive hearings or three hearings in total convened by the /SMC or EMRB/NMC. In such situations, the termination or ex-parte order may not be passed without giving a notice fifteen days in advance to the party concerned.

40G

The parties shall not be allowed to bring in any lawyer to represent them in their case at any stage of the proceedings before the state medical council or EMRB/NMC.

Lawyer should be permitted wherever warranted and desired by any or both the parties.

40H

In conducting the inquiry, a quorum shall be ensured.

details required regarding the quorum as well as participants of quorum need to be defined.

40I

No new documents or certificates or evidence or witness will be entertained from either of the parties once the proceedings are initiated (meaning -after the parties have been called for a hearing) unless its admission is cleared by the majority of the members. The complaint cannot be withdrawn after it is admitted by the SMC or EMRB/NMC.

Withdrawal of complaint must be permitted if either party does not want to pursue the matter

40J

The State Medical Council or EMRB/NMC may either of its motion or on an application made by either of the parties have the power to change the subject matter experts, if appointed, by providing a valid reason.

Disposal of the complaints: The State Medical Council or EMRB/NMCafter giving the parties concerned an opportunity of being heard, may make any of the following recommendations: 1) dismiss the complaint

2) reprimand or warn the RMP

3) recommend counseling to the RMP

4) an alternative penalty can be considered

5) may restrain the RMP from performing the clinical procedure(s) or examination as deemed fit. Holding Suspension i.e. restraining RMP from practice until the case is decided- only with full consensus

6) Suspend the RMP from practice for a temporary period as it may deem fit by removing the name of the RMP temporarily from the National Medical Register

7) Award monetary penalty to aggrieved party as it deems fit as per Section 30 of the NMC Act, 2017 can be given by EMRB only as and when required.

8) SMC can charge monetary penalty up to 10 times of the license fee in case it is found during misconduct complaint case that the RMP has not taken license to practice in that state.

9) May direct the RMP to undertake specific training courses related to the misconduct/some certificate course/ethics sensitization etc. 10)Punishment of Permanent removal from NMR under exceptional circumstances by SMC must be ratified by EMRB.

(Guidelines for alternative penalties can

be given by EMRB as and when

required)

Point 5 should be deleted

For point 8

what about casual practice in other states e.g. camps/ workshops/ consulting during travel/ telemedicine etc.

Timeframe for disposal of complaint should not be exceeding 3 months from the date of submission of all replies and documents which must be clearly spelt out.

Prohibition of review of the order: SMC or EMRB/NMC will not have the power to review its order, and the order will be executed only after the expiry of the period of appeal.

Power of the SMC/EMRB. The SMC and EMRB/NMC shall have the same powers as are vested in a civil court under the Code of Civil Procedure, 1908 while trying a complaint against an RMP in respect of the following matters, namely: —

1) the summoning and enforcing the attendance of any defendant or witness and examining the witness on oath.

2) requiringthediscoveryandproductionofanydo cumentorothermaterialobjectas evidence.

3) receiving evidence on affidavits.

4) therequisitioningofthereportoftheconcerneda nalysisortestfromtheappropriate laboratory or any other relevant source.

5) issuing of commissions for the examination of any witness, or document; and any other matter which may be prescribed by the Central Government.

6) penalty so awarded and confirmed to the RMP by State Medical Council or EMRB/NMC shall be publicized widely on its website and other platforms as they deem fit and communicated to the employer, the hospital /healthcare institution of the RMP and respective Medical Associations/Societies/Bodies.

Delay in decision: Where the EMRB is informed that any complaint against a RMP has not been decided by a State Medical Council within six months from the date of the complaint, and the EMRB has reason to believe that there is no justified reason for not deciding the complaint within the said prescribed period, then EMRB can direct the SMC to hear the case daily until the case is closed. The reasons for not deciding the case within the stipulated time shall be mentioned in the order of the SMC or withdraw the complaint pending with the concerned State Medical Council immediately.

Appeal

1) A RMP who is aggrieved by the decision of the State Medical Council shall have the right to file an appeal to the Ethics and Medical

Registration Board (EMRB) within 60 days from the date of receipt of the order passed by the said State Medical Council: Provided that the Ethics and Medical Registration Board may if it is satisfied that the appellant was prevented by sufficient cause from presenting the appeal within the aforesaid period of 60 days, allow it to be presented within a further period of 60 days.

2)A RMP who is aggrieved by the decision of the Ethics and Medical Registration Board may prefer an appeal before the National Medical Commission within 60 days from the date of passing of an order by the EMRB.

3) Order of SMC will become operational after the expiry of the period of appeal (60days+60days). Once in appeal, the order of SMC will be deemed stayed unless decided otherwise by EMRB/NMC.

GUIDELINES

GUIDE LINE 1 GUIDE LINE 2 GUIDE LINE 3 GUIDE LINE 4 GUIDE LINE 5 GUIDE LINE 6 GUIDE LINE 7 GUIDE LINE 8 GUIDE LINE 9

Generic medicine and prescription Guidelines Template for writing prescriptions rationally NMC Code of Medical ethics

Penalties

Informed consent in clinical practice Conduct of RMP on Social Media

Template of certificate recommended for leave/extension, etc.

Format for medical record

Lists of certificates/reports/notifications, etc issued by doctors

GUIDE LINE 10

Continuous Professional Development Guidelines

GUIDE LINE 11

Guidelines for practice of Telemedicine in India

ANNEXURES

ANNE XURE 1

Drugs list

List O, List a, List B, List of Prohibited drugs

ANNE XURE 2

Sample prescription format

ANNE XURE 3

Sample patient information sheet

ANNE XURE 4

Sample informed consent format

Patient explicit consent for teleconsultation

SHEET 1

GUIDELINE 10 – CPD

As per sheet 1

a. Why registration required to SMC as well as EMRB/NMC

b. Discrepancy in points 5a and 9e for Advance application which state one month and 2

months respectively. Since application is online, advance application of 15 days must be

followed

c. Credit points for various activities is too low, and needs to rectified as follows:

Table 1: Framework for accreditation –EMRB

S Description CPD activities No

Category 1 (Accredited Group Learning) (70 % of credit hours)

Credit Rating

+1 credit hours

+0.75

credit hours

+1 credit hours

+0.5 Credit

hours

SUGGESTIONS

• Conferences, symposia, seminars, and workshops

• Online synchronous OR blended learning activities

0.25 credits/hour of active learning

0.5credits/hour

+ 1 credit hour

Activities that have been deemed

to meet a set of administrative,

educational and ethical standards

established by the EMRB/State

Medical Council. Only recognized (National/International) bodies will be considered. Invited Speaker (State) (Activity organized by

Pharma/drug companies/vendors Oral Presentation for equipment/ commercial lab are

Invited Speaker

ineligible)

Poster Presentation

Category 2 (Accredited Group Learning- General Professional) (30% of Credit Hours)

Activities provide individual, or groups of healthcare practitioners, or inter- professional health teams, with knowledge, competence, or performance in General Professional Development. All accredited assessment programs, activities, or instruments must meet the standards established by the EMRB

Group activity through simulation, exercises, demonstrations on: Research and Biostatistics Epidemiology

NMC Code of Ethics

Hospital Management Tele-Health and Tele-Medicine Communication Skills

General Practice/Family doctor Quality Improvement (QI/QC) Clinical Audits

0.25 credits/hour of active learning

0.5

Self-learning activities are planned and implemented by a health care practitioner to:

Address needs related to clinical practice/Educational needs/Research/Quality Improvement

Completing self-learning modules Webcasts/Podcasts

Attending online webinar

As per predefined by the organizers (Usually 0.1 to 0.25 credit hours) Self- paced

Category 3 – Self-Directed Learning Activities (Not more than 50% of Credits) *

Publications (RMP has shown Editor of Journal of recognized

1 credit hour

0.5 credit hour

2 credit

hours

0.25 credit hours

their scholarly work published in Association/Society/Organization that year)

Book through Standard Publishers Author (for one book only one chapter will be considered)

Journals

Original article in journals recommended by NMC

Systematic review/Meta-analysis

Original article in Pubmed indexed

with IF>2

Reviews/Letter to Editor/Commentary

CLAUSE

Fees of 25,000Rs for accreditation of organisation/institute to NMC (page 52) every 5 years

In form 1 – registration with charity commissioner and report of last audit

SUBMISSION portal for publications of articles as well as chapters in books

List of NMC recognised/recommended journals, specialty wise

Faculty taking more than one lecture/talk in any one CPD should be granted credit hours for all

Faculty attending entire CPD should get credit points for attendance too

Extra Credit hours for organisers, additional credit for being organizer+faculty

2(a) organisations who can deliver cpd programs – to add district

What will be the minimum credit hours given by SMC/NMC? Can a CPD be organized for one hour and 0.25 credit points be granted?

If SMC accreditation is done, why should the process be duplicated with NMC

SUGGESTION

Should be reduced to 5000Rs.

Should be deleted

has to be created and added in the regulations

To be provided by NMC To be added in regulations

To be added in regulations To be added in regulations

To be added in regulations For further clarification

For further clarification

CPD delivery – COMPLEX

CPD programmes may take the form of face-to-face (Category 1 and 2), Not more than 50% of

CPD shall be online/virtual/hybrid

(Category 3)- online/self-paced or hybrid forms, depending on the nature of the CPD. 28

IN NON-PANDEMIC SITUATIONS(to be added).

Following National Mission on Education through Information and Communication Technology (NMEICT) can be utilized, and credit points mentioned against them.

a. National Digital Library of India (NDLI)

b. SWAYAM (Study Webs of Active Learning for Young Aspiring Minds)

c. e-PG Pathshala

d. Swayam Prabha: 32 DTH channels

e. E-Shodh-Sindhu

f. National Programme on Technology Enhanced Learning (NPTEL)

g. Virtual Labs

h. To add – all Virtual platforms available

4) Accreditation Framework

The accreditation will be offered in the respective fields at three broad levels of Professional Bodies, Conferences and Individuals and are listed below:

a. Professional Bodies

i. National, recognized – REGISTERED ?

ii. State, recognized REGISTERED? VAGUE

iii. Unrecognized, others UNREGISTERED SHEET 2

GUIDELINE 6: SOCIAL MEDIA

S.NO SUBCLAUSE

1 RMPs can provide information and

announcement on social media.

3 RMPs should not post patients’ photographs or scan images (ct/pet scans) on social media. Once an image is posted in social media, it becomes

SUGGESTIONS

RMPs should avoid discussing the treatment of patients on public social media or prescribing medicine to patients on the public social media platform. If a patient approaches doctors through public social media, the doctor should guide the patient toward a telemedicine consultation or in- person consultation as the situation warrants.

data that is owned by the social media company or the general public.

RMPs should not directly or indirectly indulge in the practice of purchasing “likes” , “followers” , or paying money so that search algorithms lead to their name being listed at the top or registering on software programs (apps) that charge fees for higher ratings or soliciting patients.

RMPs should not request or share patients ’testimonials or recommendations or endorsements or reviews in social media.

Positive reviews are permitted in all settings, why not for healthcare industry, and hence this clause should be deleted.

The CPA under which Healthcare services are covered gives advantage to the patient as a consumer with right to be informed about the quality, quantity, potency, purity, standard and price of goods and services as per section 2(9) (ii).

If this clause is to be accepted, then there has to be restriction on patients also to share any kind of review, positive or negative .

It has be spelt out that in view of the

contradiction between the two clauses (Section 2 (9) (ii) of the Right to Information which one will have the supervening or over-riding effect.

Soliciting of patients directly or indirectly through social media is unethical

Define soliciting in healthcare setting?

What is indirect soliciting?

What are the methods to ascertain indirect soliciting?

What is the penalty?

SHEET 3

GUIDELINE 5: Consent

S.N SUBCLAUSE

1 informed consent

SUGGESTIONS

Legality of informed consent

The information should include all that the patient would need to know to make the decision(Montgomery vs L Health Board)

Bolam’s consent principle instead of Montgomery, what is the legal procedure to shift? Can it be done just by preparing the guidelines?

The information shared must be that which any reasonable man would want to know, particularly the most common side effects or complications that can arise

Reasonable man is vague term which may bespelt out appropriately.

Pre-printed procedure specific consent can be made available after prior approval from SMC or EMRB but the responsibility of administering the informed consent is on the primary physician

This entire sentence is incongruent as it is not possible for taking prior approval from SMC/EMRB while the responsibility lies on physician. SMC/EMRB should provide standard consent form for all conditions and situations which can then be used by all surgeons, so the need to take permission will not arise.

In major surgeries, it is in the interest of the patient to execute an advanced directive nominating a legal representative who can give consent on their behalf if required for further procedures during surgery when the patient is incapacitated

If patient is so incapacitated how will he nominate a legal representative?

In emergencies, consent for treatment should be taken from patients whenever possible or from legal representatives (wherever available) when the patient is unable to give consent

If legal representative is not available, who will provide consent?

A patient undergoing two separate elective procedures (example: cholecystectomy and appendicectomy) needs to give consent for each operations

does this mean multiple consent forms are to be filled? Or consent can be taken for multiple surgeries in one form? This needs clarity.

Similarly, fresh consent must be taken for every new procedure planned for the patient. Consent must be taken separately for surgery and anesthesia because the

Blood transfusion to be added

nature of these procedures as well as the complications, is different

The elderly, marginalized, illiterate and other vulnerable patients may require additional time and efforts at communication prior to consent

Witness as a relative of the patient to be present in such cases to explain to the patient and signature of witness mandatory

In the case of operative procedures which may result in permanent sterilization, it is prudent to take informed consent from both the patient and the spouse unless denial of consent could put the life of patients in danger.

MTP may also lead to permanent sterilisation, but for MTP only consent of patient is required, so this clause is questionable.

Patients have the right to refuse treatment, and this right should be respected. RMP should communicate all possible outcomes of the refusal to be treated especially in emergency and acute conditions. It is important to document the patient’s refusal to be treated and the reasons given for the refusal.

Patient should sign the refusal consent. Also, if he refuses to sign the refusal to treatment, it should be documented in the medical records and signatures of treating doctor and witness should be taken

Under no circumstances will the patient’s data be posted on social media

this is a new feature and indicates that even with consent data cannot be posted on social media

N.B:- For the purposes of discerning clarity, it is pertinent to note that t

Montgomery v Lanarkshire Health Board

concerning the duty of doctors on disclosure of information to patients regarding risks. The law now requires a doctor to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. Are doctors totally removed from the protective shield even if the practice is accepted by a reasonable body of medical opinion previously laid down by ‘Bolam’ with the recent Supreme Court decision in the ‘Montgomery’ case? This paper questions whether the ‘Bolam’ principle needs to be discarded or re-interpreted in the modern context of health care. Adopting ‘patient-centred’ care to unfold the ‘significant risks’ attached to patients would align with the evolving changes in medical law. It should

he Supreme Court

judgement in ‘

’ has caused a change in the law

be the changing context of health care driving the evolving change of law.

Apparent difference between ‘Bolam’ and ‘Montgomery’

The ‘Bolam’ principle has long been the traditional test governing how much information is necessary to avoid liability in negligence. The principle is that ‘A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible

body of medical men skilled in that particular art’.7 Doctors would rely on their professional judgement to determine the amount of information to be disclosed. The ‘Montgomery’ case has called upon us to consider ‘material risk or significant risk’ and the doctor would need to give the fullest possible information or all possible options.3 What a reasonable person would want to know in order to make an informed choice, the ‘prudent patient’ standard in lieu of professional judgement, now becomes the yardstick of standard of care.8 Patients would consequently receive detailed information on comparatively uncommon as well as rarer serious complications with only a remote risk.9 It is not uncommon to find over 100 pages describing possible drug interactions in the drug formulary. Paradoxically, this might result in a patient’s refusal to take a reasonably safe treatment. Is this a desirable outcome of the change in medical law? Tort law offers little guidance to professionals like doctors. Analysis of judicial decisions from ‘Bolam’ to other subsequent cases leading up to ‘Montgomery’ would dissect the factual, evidential and legal perspectives regarding standard of care. Does good medical practice now become the legal standard rather than ethical guidance?

GUIDELINE 11: TELEMEDICINE

S.N SUBCLAUSE O

SUGGESTION

A Registered Medical Practitioner (RMP) is eligible to provide telemedicine consultation to patients from any part of India. In case of any complaints of misconduct, the complaint will be lodged in the State Medical Council of the State, where the RMP is located at the time of providing teleconsultation.

Why not in the state where RMP is registered?

What jurisdiction does other state medical council have over RMP who is not registered with them?

Some UT’s do not have state medical council, so what shall be the process in that situation?

If case is filed in consumer court would need to be filed in the court with jurisdiction where doctor is residing and practicing

For example: Telephone, Video, devices connected over LAN, WAN, Internet, Mobile or Landline phones, Chat Platforms like WhatsApp, Facebook Messenger etc., or Mobile Apps or Internet based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc.

This is in contradiction to previous subclause of guideline 6 – on social media

Explicit consent must be recorded in any form. Electronic media can be used to provide information as in the written in-person informed consent process. Consent can be administered and documented using electronic formats such as text, graphics, audio, video, podcasts or interactive websites to explain information related to a study and to document informed assent/consent from a

Is consent required for telemedicine? Can teleconsultation happen unless the patient comes online on selected platform?

participant or Legally Appointed Representative. The RMP must retain this in his patient records.

5.2

RMPs shall not participate in telemedicine platforms that provide ratings by patient or others including reviews, advertisements, and promotions of RMPs any means. (manipulation of algorithms/search engines etc). Advertising of RMPs is not allowed by anybody under any pretext.

5.6

In the event of non-compliance with these guidelines or infringement of the existing laws applicable to the provision of services provided by the Technology Platform, or if complaints against the Technology Platform are received by the NMC, appropriate action including legal action may be initiated against the Technology Platform by the NMC.

NMC can specify of the digital platforms and issue directives to SMC’s for only those platforms to be utilised state-wise

5.7

Technology platforms based on Artificial Intelligence/Machine Learning are not allowed to counsel the patients or prescribe any drugs to a patient. Only RMPs are entitled to counsel or prescribe and have to communicate directly with the patients in this regard. While new technologies such as Artificial Intelligence, Internet of Things, advanced data science- based decision support systems etc. could assist and support the RMP on patient

Compliance & Dispute Resolution (Technology Platforms)

Page – 88 (Point – 5.6)

applicable to the provision of services provided by These clauses provide for legal action and / or blacklisting “In the event of non-compliance with these of technology platforms. However, they do not provide for guidelines or infringement of the existing laws e-guidelines seem arbitrary/unfair and are completely the

Technology Platform, or if complaints against silent about the Technology Platform are received by the NMC, a) the mode in which any such complaints will be made.

We suggest that the provisions be modified accordingly to incorporate a detailed process in relation to the enquiry of the complaints and the options available to the Technology Platforms to defend themselves in accordance with the principles of natural justice. An appeal or redressal mechanism should also be instituted.

Appropriate action including legal action may be registered;

a) initiated against the Technology Platform by the

b) any warning mechanism;

c) opportunity to defend and file responses;

d) leading evidence;

e) oral hearings; “In case any specific Technology Platform is found

f) requirement of speaking orders;

g) timelines associated with the process; existing laws applicable to them, the

EMRB/NMC may designate the Technology Platform as appeal against orders, blacklisted, and no RMP may then use that platform to provide telemedicine.”

These are the observations which have been appropriately put across against the relevant Clauses incorporated in the Draft Regulations. As such, it is evident that the proposed Draft not only suffer from self-evident contradictions but also from palpable inadequacies and infirmities whereby it falls short on the corner stone of ‘specificity and clarity’ in unison.

Regulations have to be aiming at ‘Reformatory Approach’ rather than availing ‘Punitive Approach’. It is this very context, which evidently seems to have been lost in terms of emphasis in the present Draft Regulations.

It is worthwhile to note that Constitution of India evokes principle of “Federalism which is evidence from Article 1 of Constitution itself which reads “India/Bharat is a Union of States” It is in this vein scheduled lists came to be worked out pertaining to the subjects vested with the authority of the appropriate Governments namely : Central Government and State Governments respectively. This list of subjects vested with the Central Govt. go to constitute a separate schedule, likewise subjects vested with the State Govt. constitute schedule of State subjects and those within the ambit of both end up in constituting concurrent list of subjects.

Health is a state subject included in the scheduled of State subjects, therefore is the onus and responsibility of the state Govts. State Medical Councils are created vide state legislative enactments. As such, States through State Medical Councils have the primary jurisdiction on the RMP included in the State Register. As such, in the fitness of things in true spirit of federalism, a warranted discussion inter-alea consultation with the State Medical Councils pertaining to the proposed Regulations turns out to be inevitable necessity. Hence, State Medical Councils need to be consulted by the NMC through its EMRB for invocation of the proposed Regulations pertaining to Registered Medical Practitioners.

It is therefore concludingly suggested that a fresh look at the entire Regulation needs to be undertaken so as to make it legally tenable, legislatively appropriate and catering to the cause of augmentation of professional competence and resultant dispensation thereto so that it is viewed as a legislatively worth adherence rather

than it falling short on the tenets of fulfilling the doctrine of fulfilment of legitimacy of the expectations of the RMP.

The observations that have been made by the Committee can not be taken as the last words on the same. They may be critically appraised and then availed to the extent deemed appropriate may be adopted to be made known to the authorities in the NMC before the notified cut out date so that they are taken required note for their meritorious consideration.

The Committee records it thankful gratitude to the National President, IMA for bestowing his faith and trust in the Committee which has been its guiding spirit for the Committee to dispense its assigned task in a time bound manner.

This could not have been accomplished without the able and timely assistance rendered by Mrs. Meena Singh, Chief Manager, IMA to the Committee even on non- working day.

Report submitted to National President, IMA for such action as he may deem necessary.

Place : New Delhi Date : 19.06.2022

Dr. Vedprakash Mishra Chairman For and on behalf of the Committee