Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
India’s Competition Watchdog gets new powers to issue interim orders to stop potentially infringing action, until case is finally decided The Indian Government has made Section 33 of The Competition Act, 2002 effective from 20th February 2024. The Section gives powers to Competition Commission of India (CCI) to prevent commission of any potentially anti-competitive action or combination, including mergers and acquisitions, until it reaches a final decision on the matter. This new power puts the CCI’s powers on par with that of other anti-trust regulators around the world. Source: bit.ly/4bFlPhj
Under narcotics law, the weight of carrier articles used to carry narcotics cannot be included in calculation of weight of narcotics seized: High Court India’s Delhi High Court has held that ‘carrier articles’ do not qualify as ‘neutral substances’ in which narcotics are mixed, and therefore their weight cannot be included in the calculation of the weight of the narcotics seized from the accused. The weight of contraband is a critical criteria in deciding whether the quantity of contraband seized from accused is of small quantity or commercial quantity, which has direct ramification on accused’s ability to get bail and ultimately on the tenure of imprisonment. Source: bit.ly/4bD9OJv
India’s Insurance Regulator will increase scrutiny of health and savings plan aimed at elderly in a bid to keep a check on misselling India’s insurance regulator, the Insurance Regulatory and Development Authority of India (IRDAI), is proposing to introduce several checks in insurance products aimed at the elderly, including mandatory video verification before policy acceptance. There is also a proposal to restrict targets and incentives for insurance products sold to elderly through banks. Source: bit.ly/4bFHWEr
Acute shortage of Doctors licensed to inspect workers in hazardous industries and food establishments reported in Maharashtra Maharashtra’s labour department has reportedly not renewed licenses of many authorized certifying surgeons (ACS) for the past one and half years. The ACS are responsible for carrying out medical examination of workers in hazardous industries once in six months, and very hazardous industries once every month. Source: bit.ly/3I7fm1c
Telemedicine abortions are safe and effective: Study. A study published in Nature Medicine has confirmed that telemedicine abortions conducted after video call or text message consultations are safe and effective as in-person care. In India, medical termination of pregnancy (MTP) is not permitted except under direct supervision of a registered medical practitioner duly qualified to conduct MTP. Source: bit.ly/3OPUNKB
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Indian Government tacitly endorses use of AI in screening patients India has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is that it is leveraging Artificial Intelligence (AI) for screening patients. The patient narrates his illness or complaint in his native language and the AI understands the language and responds to the patient in the same language. Once the patient has been screened, he is referred to a specialist doctor for teleconsultation. Source: bit.ly/3SISGt8
Code for regulation of marketing practices of medical devices industry will continue to remain in a draft form for some time The Department related Standing Committee on Chemicals and Fertilizers has stated that draft Uniform Code for Pharmaceutical/Medical Device Marketing Practices (“UCMPMD”) will be finalized once the Supreme Court adjudicates a related writ petition, in which it has been prayed that code for regulation of pharmaceutical marketing practices (UCPMP) be given the status of law. Source: bit.ly/49J8Mdb
Home based care models should be developed specifically for elderly population: Government Policy Think Tank Taking note of the fact that there are more than 100 million elderly people in India, India’s apex government think-tank, NITI Ayog, has made case for development of Comprehensive and Integrated Senior Care Package. The package will include all aspects of senior care such as home-based care models, R&D in geriatric care, palliative and end-of-life services, Capacity building healthcare professionals and caregivers, development of assistive devices such as Mobility aids, Personal emergency response systems, Medication reminders, Smart home technology and Hearing and visual aids. Source: bit.ly/3T5XYjP
Courts should be slow in granting anticipatory bail in narcotic matters, if the quantity is large: Supreme Court India’s Supreme Court has held that in bail matters pertaining to dealing in illegal Narcotics Drugs and Psychotropic Substances, the Courts should first satisfy itself that accused may not be guilty of the offence alleged and that accused is not likely to commit any offence while on bail. Source: bit.ly/3uGeCx2
Promotion of prescription drugs by Social Media Influencers in US a cause of concern, but US FDA may not have jurisdiction to regulate them The US Food and Drug Administration (US FDA) is under scrutiny for its inability to regulate social media influencers engaged in marketing of prescription drugs without providing warnings about risks associated with their use. US FDA is reportedly unsure whether it can or cannot regulate such actions of social media influencers. Source: bit.ly/3OMCYfj
The COVID-19 pandemic, coupled with legitimisation of telemedicine in March 2020, has propelled the popularity of telemedicine manifold, with telemedicine platforms at the forefront. A question that arises is what the liability of these platforms is for any mishaps or complaints that patients may have about the consultations that they have with doctors through these platforms. The general perception is that, as technology providers, the platforms are intermediaries and are exempt from liability for consultations that take place on the platform. However, it is not quite that straightforward.
Liability exposure
The principles of vicarious liability and intermediary liability, though derived from different laws, are closely linked and are both paramount factors for telemedicine platforms to take into consideration while structuring their business and governance policies. Both concepts define the liability of an entity – in this case the telemedicine platform – for the actions of another person. Vicarious liability arises when the platform had the right, ability or duty to control the activities of the violator i.e., the doctor. Intermediary liability, on the other hand, arises because the platform facilitates the violator’s actions, and would cover violations by both the doctors and patients who use the platform. The former is largely dealt with by the Consumer Protection Act, 2019, while intermediary liability is derived from the Information Technology Act, 2000.
Vicarious liability
A common misconception is that platforms cannot be held vicariously liable since they do not employ the doctors that consult on the platform and there is no master-servant relationship between them; in fact, several platforms are structured as marketplaces, where anyone (subject to their credentials) can list themselves on the platform and offer their services. Further, telemedicine platforms typically make it clear that they are merely facilitating the interactions, not rendering medical advice themselves, so there is no doctor-patient relationship between the platform and patient, and the platform cannot be held liable for any deficiencies in service or negligence by the doctor.
However, these arguments would likely not pass the muster. A parallel may be drawn to hospitals, which typically raise the same defences in cases of medical negligence.
In the case of Smt. Savita Garg vs. The Director, National Heart Institute, the Supreme Court observed that when a patient goes to a private hospital/clinic, he goes by the reputation of the hospital and with the hope that proper care will be taken by the hospital authorities. Since these hospitals charge a fee for the services rendered by them, they are duty bound to bestow the best care, and if the hospital fails to discharge their duties through their doctors being employed on job basis or employed on contract basis, it is the hospital which has to justify.
In Smt. Rekha Gupta v. Bombay Hospital Trust & Anr., the National Consumer Disputes Redressal Commission held that a hospital cannot escape liability by taking the defence that it only provided infrastructural facilities and support staff, and did not perform or recommend any treatment itself. The NCDRC pointed out that the bills for doctor’s consultations are raised by the hospital and they charge a commission before remitting the fee to the consultant.
In Dr. Krishna Mohan Bhattacharjee vs. Bombay Hospital Medical Research Centre, the National Consumer Disputes Redressal Commission further stated that the terms under which a hospital employs the doctors is immaterial insofar as the hospital’s liability towards a patient is concerned, and that the defence that there is no master-servant relationship between the hospital and doctor cannot be taken in cases of established negligence, and held that patients go and get themselves admitted in the hospital relying on the hospital to provide them the medical service for which they pay the necessary fee.
The same rationale that courts apply to hold hospitals vicariously liable would logically apply to telemedicine platforms as well, and it is thus unlikely that they would be eligible for a blanket exemption from liability for negligence or deficiencies in services offered through the platform by claiming that they are merely technology providers that do not play a role in the actual rendering of medical services.
That being said, there are safeguards that can be put in place to minimise the risk of prosecution. Courts have recognised that a hospital – and therefore, by extension, a telemedicine platform – can mitigate their liability by showing that they had undertaken due diligence and adopted appropriate measures to prevent negligence or deficiencies in service. For a telemedicine platform, this would mean verifying the credentials of all doctors or healthcare professionals listed on the platform, ensuring that the doctors are: sufficiently well-versed with the practicalities, legalities and limitations of telemedicine; are aware of the functionalities of the platform; are following proper documentation processes, are compliant with the platform’s policies, etc.
The platform would also have to follow measures to mitigate their direct liability for medical negligence, such as ensuring that only qualified professionals are listed, the data protection systems are secure and compliant with the law, the technology supports smooth consultations.
It is also important to keep in mind the quality of care to be expected (and hence the liability for falling short of the expectations) of a medical establishment is directly proportional to its reputation. Thus, for a platform that makes claims of (facilitating) quality consultations, it is especially important to have stringent quality control measures in place, especially as they grow.
Dilemma of quality management vs. “control”: A threat to intermediary status
Implementing quality control measures to mitigate risk is essential for telemedicine platforms to mitigate risk of being held vicariously liable for negligence and deficiencies in service on the platform. However, it also poses a challenge to telemedicine platforms – it could potentially weaken their position as an intermediary that can avail of safe harbour protections under the Information Technology Act.
It is important to understand that telemedicine platforms are a kind of e-commerce entity. An e-commerce entity may either be set up as an inventory or a marketplace entity. An inventory e-commerce entity “owns” i.e. exercises control over the service provider doctors, whereas a marketplace entity merely provides the technological infrastructure to facilitate consultations. In case of the latter, the entity could be considered an internet intermediary that can avail of safe harbour protections, which is why most telemedicine platforms are structured as “aggregators”.
Essentially, the law recognises that an intermediary does not control what third-parties do on the platform and they cannot reasonably be expected to monitor every single transaction. Thus, provided that the intermediary complies with certain requirements, they are exempted from liability for wrongdoings done by third-parties on the platform without their knowledge.
In order to be eligible for the protection, the intermediary must follow the due diligence requirements stipulated in the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, which include publishing and complying with a privacy policy and terms of service which specifies the types of content and activities that is prohibited on the website and/or mobile application, taking action against violators upon receiving knowledge of wrongdoings, cooperating with governmental authorities, etc, as well as certain compliances under the Consumer Protection (E-Commerce) Rules, 2020 such as executing an undertaking with service providers to ensure that the descriptions and other contents pertaining to the services offered through the platform is accurate.
Thus, the law envisages a fairly “hands-off” and reactive approach to managing third-parties on the platform, and adopting more prescriptive policies and quality control measures could be viewed as the platform exercising control over the service providers, which would threaten their position as an intermediary.
Add-on services: changing dimension of intermediary status.
Most telemedicine platforms nowadays also offer value added services such as algorithmic matching of doctors/healthcare providers and patients, facilitating payments, electronic health record management, etc.
As per Section 79 of the Information Technology Act, the exemption from liability would also apply only if the intermediary is merely a passive conduit of the information, and is not involved in the initiation of the transmission, selecting the receiver of the transmission, and does not modify the information. Questions have been raised as to whether the value-added services dilute their role as a passive conduit, and result in the platform playing an active role in the transaction, which would mean that they cannot avail of the protection.
In the case of Amazon Sellers Services Private Limited vs. Modicare Limited & Ors. the Delhi High Court recognised that the FDI Press Note 2 of 2018 allows marketplace e-commerce entities to offer value added services to businesses, and held that Section 79 does not appear to differentiate between active and passive intermediaries. When an intermediary provides services in addition to access, it must comply with the requirements of Section 79 i.e. must remain a passive conduit in relation to the information. So long as that is complied with, the intermediary may avail of the protection.
It is important to note that the Intermediary Guidelines recognises not only human editorial control, but also automatic and algorithmic control. This means that a platform would not be able to take the defence that any service which dilutes their position as a passive conduit is entirely algorithmic and hence does not amount to active involvement.
Key Takeaway
If a telemedicine platform was to lose its status as an intermediary and the protections conferred by the law, they would be required to proactively monitor everything that takes place on the platform, since they would be liable for any non-compliances or wrongdoings. For platforms dealing with large volumes of consultations, this would be logistically challenging, if not impossible. The cost of operations and litigations that would arise would make it an untenable business.
Thus, it is essential that telemedicine platforms closely evaluate their structure, policies, features and service offerings to strike a balance between ensuring that high quality services are offered through the platform, while still minimising their liability.
Summary: The
Indian Government has published Telemedicine Practice Guidelines (“Telemedicine
Guidelines”) on March 25, 2020. These guidelines finally clarify India’s
position on the legality of teleconsultation. It is now perfectly legal to provide
teleconsultation by registered medical practitioners (M.B.B.S and above) in
line with the requirements of the Telemedicine Guidelines. It has been
clarified that the first consultation between doctor and patient need not be an
in-person consultation, and doctors in India can provide the first consultation
to patients located in any State remotely through teleconsultation. However,
going forward, all doctors who provide teleconsultation will have to display
their registration number in all communications exchanged with the patient –
for example, in emails or WhatsApp messages, on prescriptions and on fee receipts.
Doctors will also have to be careful while issuing a prescription during teleconsultation.
As a thumb rule, prescribing medicines for chronic diseases (such as asthma, diabetes
or hypertension) should be avoided during teleconsultation, unless it is an
add-on or refill of an earlier prescription obtained during an in-person
consultation less than six months ago. If a prescription for chronic diseases is
to be issued, then the teleconsultation should be done strictly via video. A
prescription can be sent through any electronic medium such as email, WhatsApp
etc. as a photo/scan / digital copy of a signed prescription or an
e-prescription.
3.8.1. Consultation through Telemedicine by the Registered Medical Practitioner under the Indian Medical Council Act, 1956 shall be permissible in accordance with the Telemedicine Practice Guidelines contained in Appendix 5 (of Code of Conduct).
A registered
medical practitioner under Indian Medical Council Act, 1956 is a person who is
enrolled in the State Medical Register or the Indian Medical Register under the
Indian Medical Council Act, 1956 (or National Medical Commission Act, 2019 as
and when it comes into
full force and replaces the Indian Medical Council Act, 1956). Every practising
doctor in India today is required by law to be enrolled in the State Medical
Register or Indian Medical Register before the start of his or her medical practice.
Therefore, the amendment does not add any new requirement of registration for
doctors who want to practice telemedicine and provide teleconsultation to his
or her patients.
Telemedicine is
defined under the Telemedicine Guidelines as:
“The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”
Now, doctors who
are providing teleconsultation independently or through such companies can rest
assured that such practice is lawful as long as it is done in compliance with
Telemedicine Guidelines. Doctors can also provide teleconsultations to patients
from any part of India.
In fact, the
Telemedicine Guidelines specifically permit Doctors to provide teleconsultation
for prescribing medicines, providing counselling (e.g. food restrictions, do’s
and don’t’s for a patient on anticancer drugs, proper use of a hearing aid etc.)
and imparting health education (e.g. advice on contagious infections,
immunizations, exercises, hygiene practices, mosquito control etc.).
What
does the amendment mean for patients?
India does
not have a great doctor to patient ratio. This, coupled with the fact that
India is a huge country and that the density of doctors is far higher in cities
than in rural areas where the bulk of India’s population resides, is the reason
why teleconsultation has great demand and potential in India.
Unfortunately, there
were hardly any standards for doctors to follow and patients to expect during a
teleconsultation. For example, Indian patients sometimes felt short-changed
when a doctor was not clear or audible, or the doctor refused to issue a
prescription or did not provide a report of the consultation after the
consultation ended. Some patients feared whether the person on the other end
was, in fact, a doctor or not. A few worried about their privacy, as electronic
communications over mobile application or email, can leave a trail.
Indian patients
now will be able to hold doctors accountable to provide teleconsultation as per
the Telemedicine Guidelines, which provide a clear set of do’s and don’ts for
doctors. A violation of the Telemedicine Guidelines will give patients avenue
to complain against the doctor before appropriate State Medical Council for ‘misconduct’.
Telemedicine
Guidelines – Salient features
Doctor can choose the medium of teleconsultation: A doctor may use any medium for patient consultation, e.g. telephone, mobile or landline phones, chat platforms like WhatsApp, Facebook Messenger etc., other mobile apps or internet-based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. However, before proceeding with the teleconsultation, the doctor should exercise professional judgement to decide whether the teleconsultation is, in fact, appropriate and in the interest of the patient. If the answer is yes, then the doctor should evaluate which medium would be preferred for the teleconsultation. For example, a complaint of appendicitis may require a physical examination and teleconsultation may not be preferred. On the other hand, some common complaints may not require physical examination or even consultation in real-time. For example, a complaint of headache or fever may not always require the doctor to examine the patient physically or audio-visually through a mobile or computer application. However, in certain cases, for example, on presentation of allergy or inflammation (e.g. Conjunctivitis), the doctor may choose to examine the patient in-person or through an audio-visual teleconsultation. Thus, the decision to examine the patient physically or remotely i.e. through teleconsultation, and the medium of teleconsultation, is to be taken by the doctor himself or herself on case to case basis.
Doctor has to maintain the same standard of care during teleconsultation as during in-person consultation: The Telemedicine Guidelines require doctors to maintain the same standard of care towards a patient during a teleconsultation as they would during an in-person consultation. In other words, the fact that the teleconsultation took place over a mobile app or email or telephone cannot be taken as a defence by a doctor against an allegation of medical negligence. Every doctor is expected to know the limitation of teleconsultation and advise or prescribe accordingly.
Patient is responsible for the accuracy of information: During the course of teleconsultation, if the doctor inquires for relevant information from the patient, then the patient is supposed to disclose the right information. The Telemedicine Guidelines have clarified that is the patient who will be responsible for accuracy for the information shared with the doctor, and not the doctor. However, since the standard of care is as high in the case of teleconsultation as in-person consultation, the doctor must make all efforts to gather sufficient medical information about the patient’s condition before deciding on a diagnosis or a treatment. If a patient provides any contradictory information, or if the doctor is not convinced with the information at hand to make a professional decision, he may ask patient to provide such documents or undertake such tests as he/she may feel proper in his/her professional judgement without fear of liability.
Caregiver is deemed to be authorized on behalf of minor or incapacitated patients: If the age of the patient is 16 years or less, or if the patient is incapacitated (due to mental conditions like dementia or physical disability due to an accident), then the caregiver is deemed to be authorized to consult on behalf of the patient. The Telemedicine Guidelines clarify that in such cases, the teleconsultation can take place with the caregiver without the presence of the patient.
No fixed Format for issuing a prescription: There is no fixed format for issuing a prescription in a teleconsultation. The Telemedicine Guidelines has recommended a format, but following it is not mandatory. However, the doctor must provide photo/scan /digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. Please note that a doctor can transfer the prescription to a pharmacy only if he/ she has the explicit consent of the patient.
Invoice for fees: Doctors can charge appropriate fees for teleconsultation. A receipt or invoice should be given to the patient against the fees.
Do’s
and Don’t’s for Doctors
Patient identification is mandatory during first consultation: If the teleconsultation is, in fact, the first consultation of the patient with the doctor, then doctor should confirm the patient’s identity to his/her satisfaction by asking patient’s name or age or address or email I.D. or phone number or any other identification that may be reasonable.
Patient identity confirmation is not mandatory during follow-up consultation, but may be carried out on need basis: It is not mandatory to identify the patient during a follow-up teleconsultation with a known patient, especially if the doctor is communicating through the registered user id, email id or phone number. However, in case of doubt, the doctor should confirm patient identity as during the first consultation.
Caregiver identity and authorization should be checked: If the patient is not a minor or is not incapacitated, then a caregiver cannot consult on behalf of the patient unless he or she has a formal authorization such as a signed authority letter by the patient or his/her legal representatives (family members) or, where the caregiver is a family member himself or herself, if he or she has a document that verifies his or her relationship with the patient such as a government identity proof. The caregiver’s identity and authorization should be checked by the doctor before offering teleconsultation. In the case of minors, the identity of the caregiver should be confirmed.
Doctor should identify himself/herself to the patient before start of every teleconsultation: A doctor should begin any teleconsultation by informing the patient about his/her name and qualification. This may be uncomfortable to be done every time, especially to a known patient. However, this is the requirement of Telemedicine Guidelines at present.
Doctor should display his/her registration number at every touch-point with patient: A doctor who provides teleconsultation is required to display his/her registration number provided by respective State Medical Council on his/her prescription, website, electronic communications (WhatsApp/Message/Email etc.) and fee receipts given to his/her patients.
Doctor should not continue with teleconsultation if it not appropriate: the doctor is not satisfied with the information provided by the patient to provide specific treatment, i.e. prescription or health advice, then he/she should provide limited consultation as appropriate and refer the patient for an in-person consultation.
Doctor should maintain patient records of teleconsultation: For in-person O.P.D. consultations in India, the doctors, in general, do not maintain patient records. Appropriate patient history, observations and findings are recorded on the prescription and it is handed over to the patient. However, for teleconsultation, it is mandatory for doctors to prepare, maintain and preserve the patient’s records (e.g. case history, investigation reports, images, etc.), copy of prescription issued and proof of teleconsultation (e.g. phone call history, email records, chat/ text record, video interaction logs etc.). While no time period is prescribed for how long such records are required to be preserved, it is generally recommended to maintain these records for three years.
Patient’s personal data should not be disclosed or transferred without written consent of the patient: Since teleconsultation happens on an electronic medium, the Indian law that protects personal information, including medical and health-related information of patients, squarely applies to doctors who provide teleconsultation and receive such information from patients. This is in addition to the ethical obligation to protect patient privacy that is recognized in the Code of Conduct. The most important thing to note here is that Doctors who provide teleconsultation should not disclose or transfer any information that may identify the patient without the prior written consent of the patient.
Doctor should not deny emergency teleconsultation, but limit it for immediate assistance or first aid: Emergency teleconsultation should not be provided remotely except when it is the only way to provide timely care.Even then, such emergency teleconsultation should be limited to first aid, life-saving measures, counselling and advice on referral. Every emergency teleconsultation must end with an advise to the patient or his/her carer for in-person interaction with a Doctor at the earliest.
Limitation on prescribing medicines to patients: This is, perhaps, the most significant limitation imposed by Telemedicine Guidelines on the practice of telemedicine in India. Going forward, doctors will not be able to prescribe medicines over teleconsultation freely.
In order to
prevent abuse, the Telemedicine Guidelines require every doctor to “prescribe
medicines via telemedicine ONLY when (the doctor) is satisfied that he/ she has
gathered adequate and relevant information about the patient’s medical
condition and prescribed medicines are in the best interest of the patient.” Prescribing
Medicines without an appropriate diagnosis/provisional diagnosis will amount to
professional misconduct.
Before issuing a prescription
through teleconsultation, every doctor is supposed to inquire about the age of
the patient. If there is any doubt about the age of the patient, then the
doctor should seek age proof. If the patient turns out to be a minor, then further
teleconsultation should be done and prescription should be issued only in the presence
of an adult, whose identity should also be ascertained by the doctor.
If the teleconsultation
with the patient does not take place over video, then the concerned doctor
cannot prescribe drugs to the patient other than common over-the-counter (“O.T.C.”)
medications such as paracetamol, O.R.S. solutions, cough lozenges etc. Such patient
also cannot be prescribed medication for which diagnosis is possible only by
video consultation such as antifungal medications for Tinea Cruris,
Ciprofloxacillin eye drops for Conjunctivitis etc. The doctor may, however,
prescribe ‘add-on’ medication to such patient to optimize the existing
treatment through drugs if such existing treatment was prescribed in an
in-person consultation less than six months ago. Please note that there is no
bar in prescribing emergency medications, even if they are not O.T.C. medicines,
as and when notified by the government, through any form of teleconsultation,
whether video or not.
A list of common O.T.C.
medications that can be prescribed without video teleconsultation is described
in List O, Appendix 5 of the Code of Conduct. A list of ‘add-on’ medications to
optimize existing treatment is described in List B, Appendix 5 of the Code of
Conduct. For the purpose of this list, emergency medications would be included
in the list of O.T.C. medications, i.e. List O.
If the patient is
examined through video, then the doctor may prescribe medications other than O.T.C.
medicines described in List A of Appendix 5 of Code of Conduct. Some examples
of such medicines are:
Ointments/Lotion for skin
ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate
Lotion etc.
Local Ophthalmological
drops such as: Ciprofloxacillin for Conjunctivitis, etc
Local Ear Drops such as:
Clotrimazole ear drops, drops for ear wax etc.
The doctor may
also prescribe a ‘refill’ of medication already prescribed during an in-person consultation
for chronic illnesses (hypertension, diabetes, asthma etc.) or an ‘add-on’ medication
to optimize the existing treatment (like in the case of non-video consultation).
Please note,
however, that no doctor is permitted to prescribe habit forming drugs (i.e.
drugs in Schedule X of Drugs and Cosmetics Rules, 1945) or narcotic or
psychotropic drug (i.e. drugs regulated by Narcotic Drugs and Psychotropic
Substances Act, 1985) through any medium of teleconsultation.
For details on restrictions
on the ability of doctors to issue prescriptions during teleconsultation,
please refer to the table below:
Type
I (Non-video consultation)
Prior in-person consultation
Scope and limitation of prescription
List of drugs that may be prescribed
No prior in-person consultation
+ Can prescribe only O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc.
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O, Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.
– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O & List B of Appendix V of Code of Conduct
Type
II (Video consultation)
Prior in-person consultation
Scope and limitation of prescription
List of drugs that may be prescribed
No prior in-person consultation
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc – Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O & List A of Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.
+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
+ Can prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O, List A & List B of Appendix V of Code of Conduct
Mandatory
training in telemedicine
At some point of time in future, the Board of Governors in supersession of Medical Council or National Medical Commission would introduce training programs in telemedicine. It will be mandatory to participate in those training programs for all doctors who intend to offer teleconsultations to patients. However, until those training programs are developed, there is no restriction in terms of prior training or qualification for registered doctors to engage in teleconsultation.
Do
Telemedicine Practice Guidelines apply to doctors who are practising Indian
medicine?
The Telemedicine
Guidelines do not apply to practitioners of Ayurveda, Yoga, Homeopathy, Unani
or Siddha.
What
happens to the Telemedicine Guidelines when the National Medical Commission is
set-up?
The Board of Governors in supersession of Medical Council of India will soon make way for the National Medical Commission. However, this transition will not impact the Telemedicine Guidelines and the practice of telemedicine in India. The National Medical Commission Act, 2019 has a savings clause, which will allow the Code of Conduct and Telemedicine Guidelines to survive and remain enforceable until new regulations are made.
Impact of 2018 judgement of Deepa Sanjeev Pawaskar and Anr. v. State of Maharashtra on Telemedicine Practice Guidelines
In 2018, a judgement
of High Court of Bombay caused panic amongst doctors who offered
teleconsultation. In that case, two gynaecologists were denied anticipatory
bail on the grounds that, prima facie, they were criminally negligent towards their
patient who unfortunately died while under their care. The material facts of
the case are that the deceased patient had presented herself with a complaint
of fever and severe vomiting. She was admitted to the nursing home of the
accused doctors by the hospital staff without examination, as the doctors were
out of town. One of the doctors started treatment for the patient
telephonically, by instructing the on duty nurse. Unfortunately, the patient
died. The Court held that the patient died because, amongst other things, she
was prescribed treatment over telephone without appropriate diagnosis, and
found such practice to be an act of criminal negligence. The application of the
doctors for bail in anticipation of arrest was rejected. However, the doctors
were successful in receiving the bail in appeal and were not arrested.
This judgement was
interpreted
by some doctors as deeming the practice of telemedicine and teleconsultation itself
illegal. However, such an interpretation is without basis and incorrect.
The Court was only concerned failure of the doctor to diagnose the patient. The
fact that the drugs for treatment of patient were communicated by the doctor through
telephone is only incidental to the outcome of the judgement. It is not the
basis of the judgement. In other words, had the doctor communicated the same
drugs to the nurse orally while being physically present but without examining
the patient, and then patient would have died, the Court would have come to the
same conclusion. Thus, the judgement should not be extrapolated to state that
the practice of telemedicine and teleconsultation itself is illegal.
Therefore, the above
judgement of Bombay High Court does not interfere with the Telemedicine
Guidelines at all. In fact, it supports it. The Telemedicine Guidelines require
doctors who provide teleconsultation to start patient treatment only if the
doctor is satisfied that he/ she has gathered adequate and relevant information
about the patient’s medical condition and prescription of medicines which are
in the best interest of the patient. Else, the doctor should not prescribe
medication to the patient. If the doctor prescribes patient in violation of the
Telemedicine Guidelines, he/she risks losing his/her registration with
respective State Medical Council i.e. the license to practice medicine on
grounds of professional misconduct.
Enforcement
of the Telemedicine Guidelines
The Telemedicine
Guidelines have been published in form of an amendment to the Code of Conduct. Therefore,
any violation of the Telemedicine Guidelines will be looked at as a
‘misconduct’ at hands of the concerned doctor under the Code of Conduct. A
patient, who suffers due to misconduct, has the right to complain to the
respective State Medical Council with whom the doctor is registered about the
misconduct. If the doctor is found guilty of the misconduct, he or she may be
reprimanded, or his/her registration may be suspended or cancelled. A
suspension or cancellation of registration would effectively stop the doctor from
carrying on his/her medical practice.
Conclusion
The notification
of the Telemedicine Guidelines marks the dawn of a new era in the practice of
modern medicine. The law has finally caught up with the reality and necessity of
modern times.
The Telemedicine
Guidelines enable doctors to confidently provide teleconsultation via any
medium (such as email, phone call, message, fax, WhatsApp, other mobile and
computer applications such as Skype, Google Hangouts etc.) to the
patients.
At the same time, they
protect patient interest by mandating doctors to identify themselves before
consultations, disclose their registration number, offer the same standard of
care to patients as during in-person consultation and limit medicines that can be
prescribed through a teleconsultation.
Indians will now
be able to enjoy access to quality healthcare remotely, and doctors will be
able to extend their services to many more needy patients.
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