NATIONAL MEDICAL COMMISSION
NEW DELHI, DATED
National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022.
The concerns and objections of RMPs:
Although there are uncountable number of contentious clauses in the draft,
we are picking up a few important ones and expressing our disappointment and dissent. The original clauses are mentioned in black and our concerns are mentioned in red.
Chapter 2 Professional Conduct of RMPs
4.Prefix, Suffix and Modern Medicine:
(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. (L1).
Why should we be re-registering ourselves, while we have registered ourselves with the respective state medical councils by paying the due fees to register our UG and PG separately. we already have single permanent registration number. Prefix of state name would suffice- For example- Tamilnadu as TN. Repeating the registration process once again with the NMC, amounts to duplication of work, and unnecessary wastage of money and human hours.
We are now living in a global village where our doctors are invited speakers at international conferences and our authors send publications to international journals. Changing our prefix to ‘med dr’ which is followed nowhere in the world, would result in unnecessary and avoidable confusion. This assumes added significance, since these international academic activities qualify as CPD activity under category- 3, and are essential for renewal of license. ( CPD delivery- Page 39). Moreover, this prefix violates the statement in the same draft that “modern medicine has international uniformity in theory and practice” ( chapter-1, 2-e) , and CPD guidelines, EMRB CPD committee, point 10(3), page 45, which waxes eloquent on ‘international recognition’.
There should be a compelling and ‘felt’ need to indulge in a major change like this. As of now, no country in the world feels/ has felt such a need, including our own country.
To prevent confusion, practitioners of the alternative system of medicines can have different prefixes of their choice, and they should not be allowed to use the prefix ‘Dr’.
5. Continuing Professional Development Program: A RMP should attend continuing professional development programs regularly each year, totaling at least 30 credit hours every five years.
As such, it is an added burden on the already overburdened RMP. It is very difficult to accumulate 30 credit hours in five years, especially since the number of conferences is expected to go down without the participation of pharma in academics. The division of CPD into 3 categories with an arbitrary individual capping on each, the minimum requirement may be reduced to 20 credit hours in 5 years. In the larger interest of RMPs and their patients, renewal of license should be done free of cost.
7 .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. (L2)
It is clear that a RMP cannot solicit directly or directly.
It is deliberately left unmentioned whether the institutions like corporate hospitals can solicit patients directly or indirectly.
8.Prescribing Generic Medicine: Every RMP is expected to prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixeddose combination tablets. (L1, L2) (Generic Drugs and Prescription guidelines)
In a patient centric health care system, there should be always a choice in the form of an informed consent after adequate counseling, to choose between generic and branded alternatives of the same drug.
Without getting the consent of the patient, and without informing about the choice of drugs available to the patient, without giving any freedom of choice to the patient, forcing him/her to consume a drug whose efficacy and reliability are at question, tantamounts to violation of basic human rights, and is against the spirit of modern medicine.
This is especially important in our country, where there is no proper regulation of generic market, like in the United States, for example where the production and distribution of generic drugs is tightly monitored with the process like ANDA (ABBREVIATED NEW DRUG APPLICATION)
Before forcing RMPs to write generic drugs only, the NMC must
1) Put in place a foolproof system at par with the prevailing international standards, that ensures that the generic drugs are of equal efficacy and carry a ‘certificate of analysis’ ( CoA) for each batch.
2) Give statutory assurance of highest possible quality standards, and the responsibility to continuously assure the same quality in all the batches of the generic drugs, should be the responsibility of the NMC. RMPs cannot take the blame for mishaps that may be caused by inferior quality of generic drugs. There is no mention of ‘fixing the responsibility ’ in the draft. This is a serious issue, and needs to be addressed clearly.
3) Be ready to take the blame. Since the NMC is unilaterally forcing the RMPs to write only generic drugs, it must be ready to take the blame if the generic drug fails to work as desired. Unfortunately, this important topic has been overlooked in the draft.
4) Must take the responsibility of putting in place a system that ensures that global & national pharma research don’t get slowed down due to lack of funds.
If we as a country, are forced to use generic drugs alone, who will compensate for Indian market’s contribution to the global drug research, which is extremely costly?. We cannot be continuously doing ‘compulsory licensing’ as per the WTO free trade agreement. Voluntary licensing of ‘in patent’ drugs will not be introduced as generics but as branded drugs, because the licenced company will have to pay royalty to the originator company.
These are complex financial-legal issues, and have been dealt with in the NMC draft in an astonishingly lacklustre manner.
The NMC has no right to make the Indian citizen wait for five years till a new drug goes off patent.
Nowadays, a new drug is brought to India in the same month it is launched in the U.S, only because the pharma companies are spending a large part of the extra money generated by branded drugs, to pay royalty to the originator company as royalty, to get ‘voluntary licencing’ even when the original drug is ‘in patent’ protected period.
The hallmark of modern medicine is constant research and progress without stagnation.
The NMC, is attempting to nullify the spirit and essence of modern medicine in a single stroke. This is against the interest of mankind as a whole.
5).If the NMC believes that the generic drugs are at par with the branded drugs in terms of quality, why should there be an exemption for drugs with narrow therapeutic index?. Does this mean that the NMC is aware that generics are undependable when it matters the most?
6) One another concern – are medical tourists who bring in precious foreign exchange too should be compulsorily given generic medicine without informed consent?. Will not our country’s image as ‘provider of high quality treatment at affordable cost’, take a huge hit and result in loss of precious foreign exchange, which can be used to reduce the cost of healthcare for resident Indians?
7) If the DCGI has permitted a fixed dose combination and it is readily available in the market, can the NMC unilaterally label
it as irrational, especially because the DCGI’s decisions are out of the ambit of the NMC?.
12.Responsibility of RMP regarding the sale of drugs:
A). 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. (L2)
This clause infringes upon the RMP’s right as an individual human being/ a citizen of Indian union, to open/ run any business deemed legal as per the law of the land. Being an RMP should not be a hindrance or handicap to a citizen just because he/ she happens to be a RMP.
13.Responsibility of RMP regarding the Medical Records:
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)
Health is the responsibility of the individual not the state or RMP.
In case of outpatients, the RMP can be expected to be responsible for handing over the prescription and other medical reports to the patient at the end of each visit, and properly instruct the patient to store the data safely. The onus of maintaining the op records should not be placed on the RMP so as not to burden him/her from unnecessary expenses and wastage of time.
In case of inpatients, the duration of record keeping may be reduced from the arbitrary 3 years to 2 years to ensure practicality and save costly cloud space, as well as to comply with the consumer protection Act.
Moreover, any medical record starts with the identification of the patient. This essentially means that the patient has to prove his / her identity by submitting one government authorised photo identity document at the time of seeking consultation as outpatient/ inpatient for the first time, and every time thereafter. The RMPs should be empowered to collect the identity of each patient, and the NMC must get legal clearance for this from the union government.
Without this identification system in place, it would be impossible to retrieve the data of any patient after 3 years when in most cases, the RMP would not be sure about the identity of the patient. This important point is wilfully and glaringly omitted in the NMC draft.
B.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. (L2)
This clause which makes it compulsory for a RMP to hand over the medical records to patient/ authorised attendant within 5 days directly contradicts the chapter-3, point- 24 of the same draft which elaborates about confidentiality, stating that “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 of another human being”.This clause also lays down L2, L3 levels of punishment for violating the same. We request the NMC to remove the words – the patient/authorized attendant and mention only ‘the legal authorities’, in the clause. The patient is expected to preserve his/her record, while the word
“authorized attendant” is not adequately defined or explained clearly.
D. 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, 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. (L1, L2
Digitisation of extremely high volume of medical records in a country with a population of 120 crores, with limited resources at disposal entails recurring diversion of monetary resources and wastage of precious productive human hours, which could otherwise be spent on making the health care more affordable. Expenses towards the storage of data and protecting it carefully will entail a huge overhead expense which will ultimately increase cost of healthcare and affect the common citizen of the country. Data storage and protection from data leaks and cyber-attacks which are not under the direct control of the RMP, will affect the primary responsibility of RMP which is patient care at affordable cost.
CHAPTER 3 DUTIES OF RMPS TOWARDS THEIR PATIENT 22. Keeping appointments:
(A). An RMP shall endeavour 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. (L1)
Every RMP is a human being first. There may be sudden undisclosable reasons for not keeping in time with the appointments.
Since most of the consultations are walk-in nature , this clause may lead to unnecessary complaints of frivolous nature against the RMPs. This clause should be done away with.
23. 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)
While it is perfectly acceptable that the use of alcohol or other intoxicants during duty constitutes misconduct, the NMC has no right to intrude into the private life of a RMP which he/she is entitled to, as per the law of land. Hence the use of alcohol or intoxicants by an RMP off-duty cannot be considered as misconduct as it does not come under the preview of NMC.
Chapter-5 point-35, page 12: // 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 allied health sectors//
This clause is practical in an ideal utopian world, but is totally detached from the ground reality.
Each and every invited speaker from India, to the world congress of various specialities, is sponsored by big pharma. Otherwise most of
them would find it difficult/impossible to spend from their pockets and exchange knowledge at international platforms.
Keeping pharma out of academics will seriously hamper Indian participation in international conferences, where original ideas are exchanged.
Even within India, 3 day conferences will become things of the past, if the delegates have to share the entire expenditure among themselves, in the form of registration fees alone.
Keeping pharma out of academics is detrimental to the real updation of academic development, and in turn, will affect the quality of patient care, in the guise of reducing cost.
The RMPs would be forced to literally “buy” credit hours by organizing physical conferences by pooling in money out of their pockets. The financial burden of travel, accommodation and loss of income will increase the tangible and intangible cost of any conference, CME/CPD.
Consequently, the cost of healthcare will also rise because the cost of “buying” credit hours will ultimately be passed on to the patient, which is highly unfair in a resource starved country like ours.
There are ‘haves’ and ‘have-not’s among RMPs, and the difference in financial capacities are huge. The NMC should realize this. Since most of the ‘have-not’ RMPs cater to the poorest of patients, they will be the worst hit.
A RMP cannot be expected to collect consultation fees, save it and spend it on “buying” credit hours alone.
There are other expenses like food, clothing, operating cost of the clinic and family maintenance.
Remember, even Swami Vivekananda needed sponsorship from Raja. Sethupathi of Ramnad to deliver his speech at Chicago, which
is still being celebrated across the globe. We will miss many such masterpieces in the future if sponsorship and merit are kept away from each other.
This is the reality. NMC should allow pharma participation in academics, with proper regulations in place.
Chapter-5 point-36, page 12:RMPs may be required to file an affidavit regarding their financial earnings and or benefits received in the last 5 years from any pharmaceutical companies or allied health sector (L3 punishment) :
All the RMPs are filing their annual returns to the income tax department every year as per the law of the land. The same thing should not be scrutinized by two different agencies. Seeking such affidavits concerning the past events, and threat of severe punishments in case of non compliance are uncalled for.
28. 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)
Electronic generation of prescription and automation of information will be close to impossible for a RMP who serves around 200 patients each day in a rural area. This clause may be done away with, as it is against the interest of the poorest of patients and the RMPs who serve them.
CHAPTER 6 PROFESSIONAL MISCONDUCT 39. Procedure for a complaint of professional misconduct
B. Where the aggrieved person is unable to make a complaint on account of physical or mental incapacity, a complaint may be filed by
a. a family member or relative or friend; or
b. the guardian or authority under whose care treatment was received
c. the legal heir or guardian in case of death of the patient
In the list of eligible complainants, the term ‘friend’ has been used which is vague and subjective in nature.
Anybody can pose as a friend of the aggrieved person with an ulterior motive against RMP, with the aim of extortion of money, as we see every day. We request the NMC to remove the word ‘friend’ from the list.
Guidelines – 1
GENERIC MEDICINE AND PRESCRIPTION GUIDELINES
Guidance to RMPs:
1.Prescribe drugs with “generic”/“nonproprietary”/“pharmacological” names only
Instead of assuming that every patient is poor and forcibly ordering him/her to consume a generic drug with doubtful efficacy, the patient should be given a choice to choose between a branded drug and it’s generic equivalent. Denying a patient who can afford a branded drug and along with it, the additional benefit and reliability of the same by deliberately not informing him/her of the choices available amounts to violation of human rights and
concealing of facts. This directly contradicts the preamble of NMC code of medical ethics- (Respect for patient autonomy). This also contradicts the Geneva declaration – Physician’s pledge.( Point-13- I will not use my medical knowledge to violate human rights and civil liberties , even under threat. In this case, the threat is in the form of level-2 penalty by NMC (page-26).
Continuous Professional Development Guidelines 3.CPD:
DELIVERY AND REVIEW
Content approval: Development of the CPD programme
f.30% of the programme should be devoted to cross-disciplinary areas which include, (this list is not exhaustive) bioethics, professionalism, communication, public health, policy, evaluating evidence, biostatistics etc. This will constitute Category 2 CPD. They are helpful for improving quality of care backed by scientific evidence.
The list of cross-disciplinary areas which qualify for CPD should be listed completely, finitely and objectively and clearly defined.
Moreover the 30% minimum rule should not be forced upon. Ideally, the arbitrary capping of categories 1-(70%), 2- (30%), 3- (50%) must be made ‘desirable’ and not mandatory.
Strict enforcement of arbitrary category capping must be done away with, since medicine is not mathematics and the professional demands of each RMP varies.
C). While faculty in recognised medical colleges /recognised DNBE hospitals are engaged in the training of medical students (undergraduate / postgraduate), routine medical education will not be allocated CPD credit points (earlier awarded as 2 points every 6 months). Thus, these faculty will be required to achieve the mandated CPD credit hours as for other RMPs.
CPD credit points (earlier awarded 2 points for every 6 months for RMPs working as teachers in the training of medical students should be continued, especially in a scenario where numerous new medical colleges are opened/medical seats are increased and hence, there is shortage of teaching faculty.
Teaching activity should be incentivised and not punished. This will prevent brain drain out of teaching career.
FRAMEWORK OF ACCREDITATION.
Table 1: Framework for accreditation –EMRB Category-3
Publications in indexed journals require a high degree of dedication, hard work and passion. Moreover they constitute the very essence of modern medicine, i.e.- constant evolution of medical science. Such being the case, research and publications may be given more credit hours than what is proposed in the draft. (for example, publications in PubMed journals with IF>2, may be given 3 credit points instead of 2) . All the authors must get the same credit hours given to the lead author, because, publication is a team work.
(3) Guidelines for Telemedicine in India
3.7 PATIENT MANAGEMENT: HEALTH EDUCATION, COUNSELING & MEDICATION
9.Issue a Prescription and Transmit
• RMPs shall provide a clear photograph, scanned or digital copy of a duly signed prescription (e-Prescription) to the patient via email or over any other messaging platform with their full name, qualifications and registration number with the State medical council or the Indian Medical register clearly visible on the prescription.
• Prescriptions can be conveyed to patients who do not have a smartphone by using an online web application that can be accessed from a mobile browser. Link for the prescription can be sent as SMS to the recipient.
• There is no need to take print out of the e-prescription. Epriscription should comply with the guidelines. The e-prescription is valid for two weeks from the date of issue or once a pharmacist dispenses the prescribed medications, whichever is earlier.In cases where RMPs have to transmit the e-prescription directly to a pharmacy, they must ensure that the patient explicit consent is taken or the patient’s right of choice of the pharmacy where the prescription has to be transmitted is respected so that they procure the drugs dispensed from a pharmacy of their choice and convenience.
A single prescription generated after a telemedicine consultation is mentioned to be valid for 2 weeks time. But there is no mechanism in place to prevent multiple refilling of the same prescription by the same patient, from different pharmacies within the 2 weeks, with the intention of self medication, and saving the doctor’s consultation fees, which is a very common scenario in our country.
Without a nation wide foolproof system to ensure that a prescription is honoured only once, this clause might end in false allegations against the RMP. For example, a prescription given for an NSAID for 3 weeks may be used by the patient to buy the same for any number of times within the 2 weeks period. If that patient ends up with renal damage and sues the doctor, the RMP will be held negligent, since he/she would have no means to prove that a patient has overused any drug.
We insist that the NMC must put proper systems, checks and balances in place before trying to regulate futuristic systems like telemedicine.