NMC Act objections

In covering letter, it is mentioned that document is prepared in accordance with Section 27, 30, 31 and 57 of National Medical Commission Act (2019) (for short NMC Act). The relevant Section 27 gives power to Ethical Medical Registration Board (EMRB) as follows:

27. (1) The Ethics and Medical Registration Board shall perform the following functions, namely:—

(a) maintain National Registers of all licensed medical practitioners in accordance with the provisions of section 31;

(b) regulate professional conduct and promote medical ethics in accordance with the regulations made under this Act:

Provided that the Ethics and Medical Registration Board shall ensure compliance of the code of professional and ethical conduct through the State Medical Council in a case where such State Medical Council has been conferred power to take disciplinary actions in respect of professional or ethical misconduct by medical practitioners under respective State Acts;

(c) develop mechanisms to have continuous interaction with State Medical Councils to effectively promote and regulate the conduct of medical practitioners and professionals;

(d) exercise appellate jurisdiction with respect to the actions taken by a State Medical Council under section 30.

(2) The Ethics and Medical Registration Board may, in the discharge of its duties, make such recommendations to, and seek such directions from, the Commission, as it deems necessary.

The power conferred under section 27(1) (b) is a power to implement the Regulation, and not of framing the Regulations. EMRB can make recommendations vide Section 27(2) in this regard to Commission but cannot substitute Commission as far as making of policy for professional ethics and framing of Regulations as provided in section 10(b), (h) and 57. All Regulation

making powers are vested in Commission by virtue of Section 10 & 57 of NMC Act and not in individual Boards. Commission and Autonomous Bards are separate legal and independent entities with well defined functions and duties ( see section 16) . It is trite in laws that an authority which has been vested with a legislative competence by virtue of delegated power; it cannot be further sub- delegated to any other authority. Hence, the power under Section 57 is not be exercisable by EMRB of its own accord. Clearly Section 27 is not the authority to frame the regulations.

The Regulation making power of Commission is stipulated clearly in Section 10 (h) of NMC Act, the reference of which is missing in the draft document. The Section 10 (h) states:

“(h) lay down policies and codes to ensure observance of professional ethics in medical profession and to promote ethical conduct during the provision of care by medical practitioners;’

It is evident that as initial step there is a need to lay down policies and codes to ensure observance of professional ethics in medical profession to promote ethical conduct. And it has to be laid down by Commission. It is only after this step is taken with policy document readied by National Commission, that now the task of drafting regulation can be undertaken. This step seems to have been completely omitted. Without this policy document in place, the EMRB board has prepared a draft for public comments. The first step as per law was paramount as the Commission is a truly representative body that includes the elected members also.

This total avoidance of priming by laying down of a policy by Commission at the formative stage is unruly and unfair. A circulation of draft to public /

stakeholders can only make sense if it has been ensured that the draft is guided by a policy, in accordance with Section 10(b) and 10(h). All other sections mentioned in the document deal with the execution part and not with the delegated legislative power in the NMC Act. Therefore regulation making power with respect to professional conduct as enshrined in section 10(b), 10(h) and 57 (zd) (zh) & (zi) cannot be sub-delegated to EMRB, which should perform its function of implementing regulation as per section 27. As per section 16 of NMC Act, EMRB is totally autonomous board. It can only perform functions strictly assigned by the Act.

Regulation no 2: Definitions:

There was absolutely no need to have definitions in draft Regulations. There was no clause of Definitions in Regulations, 2002 either. The Regulations are subordinate legislation and the definitions therein cannot override the definitions given in main Act. There are few definitions in the draft Regulations which are self explanatory in their generic meaning and did not merit a specific exposition. Any digression in the definition of any term which is already stated in the Act makes such definition in draft Regulations a nullity. There was no need to redefine “Modern Medicine’ or “Allopathy” when the definition is already legislated by parliament in Section 2(j) of NMC Act. The term ‘medicine’ includes modern scientific medicine with all specialties as per definition in the main Act and any modification or additions to it by way of making of Regulations are null and void.

There are no ‘Schedules’ attached to this draft of Regulations, as mentioned in its clause (h) of Regulation No 2.

The definition of Commission, EMRB , National Register, State Register , Medicine, , State Medical Council, etc are all given in the main Act

and nothing in the Regulations can alter the definitions given in the Act. The definition legislated in the main Act shall prevail in derogation of definitions hazarded in these draft Regulations. This futile exercise may be best omitted in toto as it serves no purpose at all but may lead to certain misgivings.

Regulation No. 8: Prescribing Generic Medicine:

This regulation captioned ‘Prescribing Generic Medicine’ is to be read with Guidelines-1 which deals with the same subject. It is strange that all the instructions regarding the prescriptions are only directory/ persuasive, but its non -compliance attracts L1 & L2 penalties. Therefore even if it is worded in the manner as if it was only an expectation, yet it has been made mandatory indirectly by prescribing penalties for its non-compliance.

One may appeal and persuade that branded generic medicine may be avoided, but its total ban on prescriptions by RMP shall be violative of patient autonomy on one hand and professional autonomy of RMP on the other. Some patients may prefer and feel safer (for right or wrong reasons) to take branded generic medicine, rather than non-branded generic medicine. Those patients who can afford and prefer to take branded generic medicines, the doctors cannot deny them the exercise of their choice. It is not the question whether skepticism of some patients regarding the non-branded generic is right or wrong. The question is whether it shall be proper to deny them their autonomous preference for branded generic medicines. By making a regulation, one cannot force doctors to insist on prescription of generic medicines, even if the patient does not want so.

On many occasions the issue of judicious use of fixed drug combination is matter of opinion. The NMC should not ban use of any branded

generic or fixed dose combination which have not been banned by appropriate authorities and is legally marketed in the country after due permissions from appropriate regulatory authorities. A lawful; activity cannot be banned by the operation of Regulations. EMRB/NMC cannot assume a delegated authority which trespasses into the domain of other plenary legislations and operate at cross purpose with the objectives of those legislations. If the use of these medicines was harmful for the society, then in very first place, the regulatory authorities should have banned these medicines, and make them unavailable for any type of sale.

Hence NMC should only give general persuasive suggestion in this regard and prescribe no penalty for breach of this purely directory clause.

Regulation No. 13: Medical Record

1) Regulation 13 (A) is distinctly discriminatory as follows:

A. 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) (L2)

It is selective and arbitrary because only ‘self-employed’ RMP shall be required to maintain the Medical Record, thus excluding the RMP’s in any kind of employment—private or public. Also, the bigger hospitals run by non-RMP entrepreneurs, stand excluded from this obligation. All RMP.s in bigger hospitals are ‘employed’ and the responsibility of Medical Record is in the hands of some hospital administrator. Hence, the bigger hospitals and institutions (including public hospitals) are excluded from its ambit. The requirement of keeping Medical Record is only for ‘self-employed’

RMP’s running small-to-medium -sized nursing homes and clinics. Such a discriminatory clause is out rightly unconstitutional because of lack of intelligible differentia.

Actually, the safe-keeping of the Medical Records is a function of a medical establishment rather than that of an individual RMP working therein. Any regulation qua Medical Record is subject matter of clinical establishment rather than one of professional conduct. This aspect needs to be regulated by plenary legislations on hospital industry i.e. Clinical Establishment Act or Nursing Home Acts are already in force in different states. EMRB has erred in including record keeping in ambit of professional conduct. It is for this reason that discriminatory regulation came to be formulated in the draft. EMRB has travelled beyond the objective of regulating professional conduct by making Medical Record related regulation and ended up excluding employed RMP’s & non-RMP health providers from obligation while self-employed RMP’s got selectively included. The laws pertaining to obligations of medical establishments vis a vis Medical Record are already in force in all states and provide for non discriminatory impositions in this regard. It cannot pass the muster, as it clearly unconstitutional and violative of Article 14 of Constitution in multiple ways.

2) The second objection in Regulation 13(A), is the need to maintain outpatients’ Medical Record. Unlike inpatients Medical Record, the patient always gets the first (and sometimes only) copy of outpatient Medical Record. Therefore it should be expected that he/she shall keep the outpatient record with himself/herself for as long as the patient feels the need. Many a times, investigations are outsourced by RMP, and the only copy of which is

in the custody of patient. Normally, the patient claims his outpatient record immediately and it remains in his custody all through. Many patients take consultations from multiple RMP’s and it shall lead to multiplicity of effort by RMP’s. The patient himself should be responsible for the safe keeping of his OPD record.

3) Regulation 13 (B) says that if request is made for Medical Record by patient, his authorized attendant or legal authorities, the RMP should give a copy of the Medical Record within 5 days. Five days is a very short period. A self-employed RMP’s, due to several limitations and constraints, may not be able to furnish Medical Record in five days. The example of law dealing with liability to provide information passed by our parliament is RTI act (2005). It is paradoxical that in RTI Act (2005), the Public Information Officer, who is dedicated to job of furnishing copy of document is given 30 days to do so. On the other hand, a self employed RMP is obligated to furnish the copy of a document i.e. Medical Record in five days. The time allowed for providing information or copy of document by RMP to patient should have some degree of parity with RTI Act. It is a mockery of fundamental liberties of RMP’s. This regulatory clause is absolutely arbitrary in present form and should never have mentioned less than 30 days on the lines of RTI Act (2005).

4) As required in Regulation No. 13C the Medical Record should be furnished on same day in case of medical emergency. The Regulation 13 (C) is ambiguous in its language. It is difficult to understand the context of medical emergency with the Medical Record. It may be assumed is one of medical emergency that has landed in other hospital, where as initial treatment was given by RMP in his establishment at an earlier time.

A ‘self-employed’ RMP has to live up to his commitments with respect to other serious patients also. Surgeons have to operate for long hours, sometimes throughout the day. It is too much to expect from an RMP to apply himself to delivering Medical Record of one patient in exclusion of all his other professional commitments. It is his duty to prioritize his obligations according to bioethics. Such regulations lead to unrealistic expectation from the RMP’s and contribute to increased hostility and violence against medical profession.

5) Moreover, once the patient or any person on his behalf has initiated any legal proceeding against the RMP then the transaction, production and discovery of any type of document (including Medical Record) shall be in accordance with procedural law applicable to so initiated legal proceeding. In this situation the right to defense of doctor shall be guided by the procedural law i.e. Civil Procedure code or Criminal Procedure Code, as the case may be, and rival litigant party ( erstwhile patient) cannot by pass the procedural law passed by parliament and claim the copy of Medical Record by resorting to these regulations, which at best are subordinate legislation and cannot override the procedural laws mentioned above. When a patient or his representative has agitated the court and the erstwhile patient has become a rival litigant, At this juncture, the doctor patient relationship has extinguished and replaced by adversarial relation of rival litigants. The obligation of litigants can no longer be governed by any subordinate legislation ( i.e. Regulations) in derogation of procedural law passed by parliament shall take precedence.

6) Regarding need to digitize the record, it should even after three years it should not be made mandatory. The portion of regulation that it should comply with provisions of IT Act is ambiguous and needs further clarification. Many

RMP’s are self-employed and it is tall order for them to digitize all of their patient data with observance of plethora of laws. Most of the RMP’S earn their bread by having to give service to large number of patients in their everyday routine. Every record keeping carries some cost in terms of money and time. For digitization to be useful and accessible, it has to be uploaded on a common portal with resulting concerns of security and confidentiality of data. All these areas remain nebulous insofar as the draft of this regulation is concerned. The norms in the west should not be extrapolated blindly as the working conditions in our country are not same. The clerical work of RMP should not be increased, lest he should be distracted from performing his core clinical work.

Regulation No. 19: Informed Consent:

The full bench of Hon’ble Supreme Court in Samira Kolhi Vs Pratibha Chand clearly laid down that for our country, a ‘real’ consent or ‘valid’ consent is more suitable than an ‘informed consent’. This landmark judgment is law of land under Article 141 of Constitution of India. In exercise of a sub-delegated authority Ethics Medical Registration Board (EMRB), should not have overruled the decision of Full Bench of Supreme Court. In para 26 of this judgment the Hon’ble Court clearly stipulated the following:

“26. In India, majority of citizens requiring medical care and treatment fall below the poverty line. Most of them are illiterate or semi-literate. They cannot comprehend medical terms, concepts, and treatment procedures. They cannot understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures. Poor patients lying in the corridors of hospitals after admission for want of beds or patients waiting for days on the roadside for an admission or a mere examination, is a common sight. For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms and doctor’s experience or intuition is acceptable and welcome so long as it is free or cheap; and whatever the doctor decides as being in their interest, is usually unquestioningly accepted. They are a passive, ignorant

and uninvolved in treatment procedures. The poor and needy face a hostile medical environment – inadequacy in the number of hospitals and beds, non- availability of adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness and apathy. Many poor patients with serious ailments (eg. heart patients and cancer patients) have to wait for months for their turn even for diagnosis, and due to limited treatment facilities, many die even before their turn comes for treatment. What choice do these poor patients have? Any treatment of whatever degree, is a boon or a favour, for them. The stark reality is that for a vast majority in the country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance.

The position of doctors in Government and charitable hospitals, who treat them, is also unenviable. They are overworked, understaffed, with little or no diagnostic or surgical facilities and limited choice of medicines and treatment procedures. They have to improvise with virtual non-existent facilities and limited dubious medicines. They are required to be committed, service oriented and non-commercial in outlook. What choice of treatment can these doctors give to the poor patients? What informed consent they can take from them?”

And consequently the Hon’ble Supreme court laid down following law in its final conclusion:

32. We may now summarize principles relating to consent as follows :

(i) A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’ (the term ‘treatment’ includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.

(ii) The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should ———————————————.

(iii) Consent given only for a diagnostic procedure, ——————.

(iv) There can be a common consent for diagnostic and operative procedures where —————————

(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as

normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.

Hence not the ‘informed consent’ but it is the ‘real consent’ which should have been adopted in the draft regulation. It may be further noted that this landmark judgment holds the field till today. On this issue, there was no need for NMC/EMRB to make a regulation on ‘informed consent’ on lines of a foreign judgment i.e. Montgomery Vs Larnakshire Health Board, as mentioned in Guidelines-5. The standard of disclosure of risk is different in ‘informed consent’ and ‘real consent’. Hence the imposition of ‘informed consent’ of type and manner in Montgomery (supra) is contrary to law on this issue vide Article 141 of Constitution of India.

(2) In Regulation 19(A), it is mandated that for all procedures ‘clinical or diagnostic’ a documented consent is required. It would imply that those investigations which are non-procedural in nature, the documented informed- consent is not required.

However Guidelines-5 required taking of informed consent in all ‘investigations’. The distinction between procedural and non procedural investigation is not made out here. This discrepancy needs to be corrected. There should be no ambiguity in this respect as the punishment of breach of this sub-regulation is severe i.e. L4.

(B) The wordings of Clause (B) of Regulation 19 is vague. Does it mean that consent of patient is required only when his or her data is published in any journal and the identity of patient gets revealed? Or does it mean that RMP can

never publish patient’s data wherein the identity of patient is revealed, and in other situations only by consent of patients?

Regulation No. 26: Patient Care

An RMP should be free to choose all the time, which patient he will treat in all circumstances including in case of life threatening emergency. If RMP does not have required skill, expertise, capability, facilities, staff etc. to deal adequately with life threatening emergency, he should immediately direct the patient to appropriate center after initial screening. Law Commission 201st Report has clarified adequately on this point on similar lines. Making it mandatory that every RMP must manage every life threatening emergency, regardless of availability of required facilities and capability, can lead to disastrous consequences.

If a change of RMP is needed because the patient needs a procedure to be done by another RMP, it is absolutely preposterous to expect the referring RMP to obtain consent in advance even before the referral The prerogative as well as obligation to obtain consent is of RMP to who the case is being referred. (see Guidelines-5). So this clause is contradictory and confusing.

Although under normal circumstances, the RMP who attends the patient is fully responsible. But in an emergency situation, if he is obligated to give a particular emergency service, then the implied contract of service between doctor and patient is vitiated because of lack of voluntariness on part of RMP. Under such circumstances, an RMP cannot be held fully accountable for his actions undertaken by him due to a statutory obligation.

In case of abusive, unruly and violent patients or relatives, it is provided that the RMP can document and report the behavior. But it is obscure to which authority the RMP can report the behavior and what are consequential obligations of that particular authority to protect the RMP who has fallen victim to unruly and violent patients and their attendants. In fact, a refusal of treatment by RMP, when the patients and his attendants are agitated, can increase the probability of eruption of violence. Just by providing for a right to refusal to treat the violent patients with a right to inform the ‘unspecified authority’, the problem of medical violence is not solved. It is strange that the subject of protection and security of RMP, who is facing violence, has been completely sidelined.

On a breach of any of the clause in Regulation No. 26 the punishment is harsh (L2-L4). The Regulation No. 26 lacks the precision which is necessary for penal provision.

Regulation No. 27: Referrals:

This regulation is directory in nature and there is scope of difference of opinion as regards the indication of referrals for laboratory investigations and specialist referrals. L2 punishment is harsh for any clause which can not be precisely defined and is directory in its draft. Only in extreme cases L1 punishment is justifiable.

Regulation No. 28: Signatures on Documents

Such clerical omissions should not be subject to harsh punishment of L2 levels. The documents created in situations of emergencies, mass casualties or other type of exigencies should be exempted from this clause.

Regulation No. 35: Prohibition on favors from Pharma Co etc.

It is desirable goal that the Pharma & other commercial companies do not shower favors and gratifications on RMF to prevent a conflict of interest. However it cannot be extended to ban on any kind of lawful payment to RMP by the Pharma & other commercial organization. The legitimate earning of RMP from Pharma companies in the form of consultation services or rendering of any service would not come in the purview of this Regulation 35, Not only salaries and benefits of an RMP employed with these companies stand exempted from the impact of this Regulation, but also the consultation service or services rendered to these companies in any professional or contractual relation should be excluded from the operation of this regulation.

An exception should also be made regarding the sponsorship of Academic activities of the RMP’s. Considering there would be enhanced requirement of academic activities in wake of new regulations of CPD programs, the funding of such activities shall be facilitated if scuh misconceived austerity is not extended to Associations of RMP’s. A distinction should be made between the financial favors to individual RMP and sponsorship of academic activities of Associations and Societies of RMP’s. It is too far-fetched that a courtesy extended to an Association for sponsoring their academic programs, creates a conflict of interest on individual basis. If such rigorous austerity is extended to other spheres of commercial activities, it shall lead to total ban on advertisements of every kind.

Regulation No. 37: Power to Draft Guidelines

The guidelines are part of Regulations. Any kind of regulation is to be made by National Commission and not by EMRB according to the main Act..

The guidelines being part of regulations, the power to draft guidelines is co- axial with power to make regulations. Hence Regulation No. 37 conferring EMRB with another genre of authority to frame guidelines as an alibi to regulation making power of NMC under section 57 , is not supportable and maintainable as per main Act.[ Read Section 10 (b) & (h) and section 57 2 ( zd, zh & zi) of main Act]

Regulation No. 38: Professional Misconduct

The Regulation No. 38 gravely suffers from vice of going beyond the scope and meaning of the term ‘professional misconduct’ as explained in the main Act. The professional misconduct has been given a very wide sweep in the Regualtion no 38, as follows:-

“38. 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.”

As one can see from above draft, the meaning of term ‘Professional Misconduct’ in the draft of regulations travels much beyond the meaning explained in the main Act. The real meaning of the word ‘ Professional

misconduct has already been explained in the main Acr as follows in last two lines of Section 30 of NMC Act:

30. (1) The State Government shall, within three years of the commencement of this Act, take necessary steps to establish a State Medical Council if no such Council exists in that State.

(2) Where a State Act confers power upon the State Medical Council to take disciplinary actions in respect of any professional or ethical misconduct by a registered medical practitioner or professional, the State Medical Council shall act in accordance with the regulations made, and the guidelines framed, under this Act:

Provided that till such time as a State Medical Council is established in a State, the Ethics and Medical Registration Board shall receive the complaints and grievances relating to any professional or ethical misconduct against a registered medical practitioner or professional in that State in accordance with such procedure as may be specified by the regulations:

Provided further that the Ethics and Medical Registration Board or, as the case may be, the State Medical Council shall give an opportunity of hearing to the medical practitioner or professional concerned before taking any action, including imposition of any monetary penalty against such person.

(3) A medical practitioner or professional who is aggrieved by any action taken by a State Medical Council under sub-section (2) may prefer an appeal to the Ethics and Medical Registration Board against such action, and the decision, if any, of the Ethics and Medical Registration Board thereupon shall be binding on the State Medical Council, unless a second appeal is preferred under sub-section (4).

(4) A medical practitioner or professional who is aggrieved by the decision of the Ethics and Medical Registration Board may prefer an appeal to the Commission within sixty days of communication of such decision.

Explanation.—For the purposes of this Act,—

(a) “State” includes Union territory and the expressions “State Government” and “State Medical Council”, in relation to a Union territory, shall respectively mean the “Central Government” and “Union territory Medical Council”;

(b) the expression “professional or ethical misconduct” includes any act of commission or omission as may be specified by the regulations.

Hence only those acts of commission or omission which are ‘specified’ as ‘misconduct or unethical conduct’ with levels of punishment indicated therewith in draft of Regulations can be construed as Professional Misconduct, and nothing more. No Regulation can increase the ambit of nay explanation given in the main Act, especially when it carries a penalty. The legislative bodies have already prescribed penalties and punishments with respect to infringements as per other Acts, in at par with any other citizen. Those Acts which are punishable by common law cannot be included with in definition of Professional Misconduct unless the same is specifically mentioned in regulation as per section 30(b) of NMC Act. Therefore a general allusion to Acts punishable by other parliamentary laws, or any other unspecified act of omission and commission cannot be included in the definition of Professional Misconduct in draft of Regulation no 38

Such arbitrary widening of the sweep of punitive clauses directly impacts the fundamental rights RMP’s. The Regulation No. 38 has to be re- drafted and rephrased by purging the inaccuracies. It must be kept in mind that the meaning of terms like professional misconduct must tally with the meaning given in the main Act, or else it is likely to be set aside in a judicial review.

Regulation No. 39: Procedure for Complaint:

(A)A period of limitation of 2 years for filing complaint after the cause of action is overly permissive. The unscrupulous patient having a weak case, take to arm twisting and blackmail innocent RMP’s until the limitation period is over. A

genuine complainant has no reason to wait for 2 years before making a complaint in a jurisdiction which is not beset with any formalities and technicalities.

(B)Where an aggrieved person is incapacitated, the complaint may be made by any other person authorized on that behalf by a power of attorney, The complainant must be given on an affidavit duly notarized so that 193 IPC can be invoked by the RMP in case of falsities and deceptions in the affidavit.

(C)If EMRB/or SMC can initiate a suo moto case against any RMP , a reciprocal right should be bestowed upon any individual RMP or Association thereof, to implead in any matter, which any RMP or Association thinks can lead to a detrimental precedent. This right to implead /intervene should be available in appellate proceedings before EMRB also, even if the RMP seeking impleadment/intervention was not a party before SMC.

Regulation No 40 :Manner of Inquiry into the Complaint:

(A) It may be reiterated that the complaint must be on affidavit, duly notarized with solemn affirmation under oath of all declarations.

(B) It should be a true copy attested by the patient on each document and a typed copy is desirable wherever the copy of document is not eminently readable. If the copy is incomplete in any respect and additional time is used up in assuring an acceptable copy, then the period allowed for filing reply shall not deemed to have commenced until a complete copy of complaint and documents have been received by the RMP.

(C) Fifteen days is a very short period for filing reply as the RMP’s have a busy routine. RMP should get a level playing field. A complainant gets 2 years to file complaint after the cause of action has arisen. The RMP should get a

time of at least 30 days to file reply extendable to 90 days as provided in Order 8, Rule 1 of Civil Procedure Code. It should be also remembered that the RMP shall have to draft it himself as these Regulations deny the right of legal assistance from a legal counsel also { cf draft Regulations 40 (G)}.

(D) If complaint is found to be completely frivolous and false at the stage of initial inquiry, the SMC should incorporate some mechanism of deterrence to discourage harassment to doctors by wily patients,

(E) The designated Committee should be sent the case for review only after receiving the reply from the respondent.

(F) A complainant must make pecuniary compensation to RMP for his absence on any hearing date.

(G) A ban on legal assistance is not acceptable. Any of the parties should have full liberty to follow any lawful means to make his case. An may feel that he cannot cope with the pressures of a legal proceeding all by himself. Sometimes RMP is so engrossed in his critical clinical work that he can not extricate himself for the proceedings. His absence or distraction from critical clinical work may be harmful for the patients under his care. This complete prohibition of legal assistance is blatantly unconstitutional. Legal assistance should include an authorized agent or power of attorney, pleading on behalf of any party.

(H) The quorum needs to be specified further.

(I) The complaint should be allowed to be withdrawn if there is prima facie no

professional misconduct.

(J) The wording ‘subject matter experts’ is ambiguous.

Regulation No 41: Disposal of Complaint:

Under clause (5) it is provided that RMP may be restrained from practice until the case is decided. It is a very harsh measure and the RMP may be harmed immeasurably even if later he is found innocent. It is mentioned herein that the suspension before final decision can be undertaken with full consensus only. . But only this precaution is not adequate. Such a harsh measure should be confined to those rarest of the rare situations where it is evident ex-facie that the violation of professional conduct is so aggravating that the continuation of practice by RMP is an obvious threat to health of his patients.

Guidelines- 5: Informed Consent

The Pre-printed consent- forms are allowed subject to a condition that the approval of State Medical Council (SMC) or EMRB has to be first obtained.. It may be noted that in its order dt. 06.07. 2020, in Vinod Khanna Vs R.G. Stone Urology and Laparoscopy Hospital & Oths, the National Commission held that the ‘pre-printed consent forms’ as unfair trade practice. This order was stayed by Hon’ble Supreme Court. If an order of Commission has been put on hold that directly means that the Supreme Court has taken prima facie view that the use of pre-printed consent forms is not unacceptable. Hence such a regulation which puts an embargo on use of Pre-printed consent forms should not have been considered. In the likelihood of Supreme Court finding preprinted consent forms unobjectionable, this Regulation shall stand overruled by the judgment.

A fully hand-written exhaustive consent in the language of patient is extremely arduous, longish and impractical proposition. Pre-printed forms are necessary as these save lot of time and labour of writing those points which are repetitive. There cannot be any objection to preprinted Consent Forms as long

as the merit and genuineness of the consent process is not compromised. Both time and energy are at premium in the daily functioning of an average RMP. His time and energy should be optimized so that best part of it is available for the actual medical care of the patient, and is not frittered away in needless clerical work. This instruction shall have to be modified or withdrawn. In no healthcare system of any other country this kind of provision (of banning pre- consent forms), has been put into force

Secondly, the sanction from SMC/EMRB may take long time before the Pre-printed consent formats shall become available to RMP for use. It is expected that many hospitals and individual doctors shall apply for such approvals, and it may lead to unmanageable workload for SMC/EMRB and considerable delays in such approvals For that reason, SMC/SMRB should issue their own formats of procedure specific consent forms, so that RMP’s are not unnecessarily blamed for leaving out any important ingredient of Consent. Moreover, a reasonable time limit must be mentioned by which SMC and EMRB must respond and approve, failing which the proposed form should be deemed as ‘approved’.

The important aspect in administering informed consent is the language which should not contain difficult medical terms and should be in terms and words that patient understands. It does not matter if such information is partly conveyed by preprinted forms. The preprinted forms should be freely allowed and such consents should be considered valid, if other requirements are fulfilled.

Guidelines – 6: Code of Ethics:- All the clauses are discretionary persuasive except clause (3) & (7). The word ‘must’ has been used in context of

clause (7).The clause ‘7’ is objectionable as it imposes unwavering obligation to treat in emergency. It needs to be qualified that obligation to treat/assist even in emergency is subject to limitations of availability of expertise, skill, infrastructure, facilities and staff ( cf Law Commission 201st Report). A worthless treatment rendered under duress in a resource or expertise deficient manner can be detrimental in critical emergencies. It not only leads to erosion of Golden Hour, but also it can be dangerous for the patient because of forced therapeutic adventurism.

Guidelines-7 Medical certificate.

It requires that the identification marks of the patient should be specified on the medical certificate. It is totally un-necessary, wasteful and overdone precaution. The identity of the patient can be affirmed and recorded by attaching a copy of any photo ID e.g. Aadhar Card etc. It fulfills the need of making sure that the medical certificate is not misused by any person other than to who it has been issued.

Guidelines-9 List of Certificates :

It should be provided in Guidelines that an RMP may require that the patient (or any person authorized on that behalf) must apply in writing for procuring any kind of certification given in the list. The application must include all the facts that have to be necessarily mentioned in the certificate. The patient shall only be responsible for the veracity of such facts lest its falsity be discovered later by any authority. The Commission should also furnish a model format for the whole list of certificates listed in this guideline in much the same way as done for Guideline -8 ( Medical Certificate).

Guidelines -10: Continuing Professional Development Program:

The earlier system Continuing Medical Education is re-conceptualized as more comprehensive Continuing Professional Development. But it suffers from lack of clarity on funding and implementation. There are many grey areas and gaps. The fee for obtaining certificate of eligibility for conduction of CPD program is extortionate. A certification fee should commensurate with the administrative expenses to be borne for administration of that particular regulation and nothing more. It should not become a source of generation of revenue for other purposes. Such a disproportionately high fee is a form of indirect taxation on the medical professionals and is unconstitutional.

As the sponsorship of CPD is subject to strict regulations , the whole cost of CPD program is to be borne by the Organizations conducting CPD programs, The financial burden shall be ultimately passed on to the RMP and he shall pass on in part to poor patients. It shall result in high registration fee for CPD activities. Already the frequency of burn-out and drop-outs in medical profession is on the increase. An arduous, tedious and expensive CPD requirement coupled with high cost entailed in compliance of CPD program, may lead to early retirement of medical professionals.

Senior citizens should be allowed online completion of 100% credit points under Category -3 Activities. This indulgence is already recommended for RMP residing n the foreign country and the female RMP’s who are in the family way. In case of senior citizen, this permission should not predicate on any approval by the Committee as the factum of age of senior citizen is available on record (unlike other categories which might need approval). Most senior citizens continue their practice in old age only for sake

of rendering services to society, and not for making a living. By virtue of life- time learning and experience they can be relied to maintain the desired quality in their professional performance with self study. Due to reduced mobility and energy, some of the aged RMP may be put out of circulation, thus depriving the society of most experienced doctors. As such senior citizens are shown some indulgence in many other respects due to Article 41 of our Constitution, which is a Directive Principle of State Policy (DPSP).

The same relaxation of permission to complete their 100% credit points ought to be extended to physically challenged RMP’S and those having chronic ailments leading to physical incapacity.

The credit hours for each hour of learning activity is on a lower side. The accrual of credit points/hour of activity has to be augmented and rationalized. A frugal scoring makes the CPD a burdensome process. Each hour of active learning activity should yield 0.5 Credit points at least.

As mentioned earlier, the period of one month granted for the comments and objection was very short. So with in constraints of available time the objective of submitting objections is only partially fulfilled. These submissions are made without prejudice to supplementing it further in case of postponement of last date of submitting objections to draft Regulations.

Thanking you, and with utmost respect,

Yours sincerely,

( Dr Pradeep Arora)

General and Pediatric Surgeon

M;S , DNB ( General Surgery) , DNB (Pediatric surgery)

LLB.