SNLR

Volume 1 Issue 1 (2021)

TELEMEDICINE: - A STUDY OF REGULATORY FRAMEWORK IN INDIA

- Raghav Pareek* & Shaunak Deshpande*

Abstract-
Telemedicine is the practice of using various means of telecommunication
technologies to conduct remote diagnosis treatment and consultation by healthcare
professionals. In India Telemedicine can be the answer to providing access to
substantial healthcare solutions in underdeveloped and low-income regions. Although
Telemedicine in India is still in its nascent stages with multiple growing start-ups
providing healthcare solutions through various telemedicine platforms and the
government bringing in multiple policy regulations in the past 3-4 years field still has
the potential to grow exponentially. This article explores all the current legislation and
guidelines in force around the Telemedicine sector.

Keywords-
Telemedicine, Healthcare, Covid-19, IT Regulations, Data Protection

* rd
BB.A.LL.B. (3 Year), Symbiosis Law School Nagpur
* rd
BB.A.LL.B (3 Year), Symbiosis Law School Nagpur

67
 SNLR
Volume 1 Issue 1 (2021)

TELEMEDICINE: - A STUDY OF REGULATORY FRAMEWORK IN INDIA

INTRODUCTION
Internet access and online infrastructure in India have experienced an exponential boost over
the past few years. Internet access today has an increased penetration across the country,
allowing for e commerce platforms to expand their market base from Tier-I cities and move
into smaller towns and even villages, areas which were previously dominated by traditional
brick and mortar stores.
With an active user base of over 624 million daily internet users and growing1, and e
commerce having an active penetration of 76.7% in the country, opportunities in this sector
are endless. E commerce is set to become a 73-billion-dollar industry by 2022 in India.
Telemedicine is one such sector of this E-Commerce industry, which has seen a huge boost in
recent times. India has adopted the WHO definition of Telemedicine, which is as follows;
“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”
Telemedicine holds promise to expand people's access to high-quality healthcare across the
country. Telemedicine holds promise to expand people's access to high-quality healthcare
across the country. WHO prescribes for a 1:1000 Doctor/Patient Ratio as an ideal standard.
This means one doctor for every 1000 patients. India has a population of 1.3 billion people
and according to the data published by the 15th Finance Commission in 2021; our ratio is 0.66
doctors for every 1000 people2. Even within this ratio, the dispersion of practicing Healthcare
Professionals is widely skewed between urban and rural areas, with most of the professionals
preferring to work in urban areas over rural areas. This has led to a situation where multiple
states in India such as Tamil Nadu, Punjab having a ratio well above the WHO prescribed
norms, while states like Chhattisgarh, Uttar Pradesh and Bihar lag behind. Telemedicine can
assist in overcoming these barriers by allowing doctors in urban areas to deliver consultations
and specialised care to patients in rural areas as needed.
The Covid outbreak in the country has also highlighted the poor state of the Indian healthcare
infrastructure. Hospitals were overwhelmed with patients and the system almost collapsed
under the pressure. Along-with much needed investment and reforms healthcare sector,
telemedicine can act as the perfect support system in these times of need. Healthcare
practitioners can provide remote consultations to those patients who are not in non-
emergency situations, allowing for a more efficient management of patients. This would also

1
Total internet users in India | Statista, Statista (2021), https://www.statista.com/statistics/255146/number-of-
internet-users-in-india/ (last visited Dec 11, 2021).
2
A Report of high level group on Health Sector submitted to the Fifteenth Finance Commission of India,
https://fincomindia.nic.in/writereaddata/html_en_files/fincom15/StudyReports/High%20Level%20group%20of
%20Health%20Sector.pdf (last visited Dec 11, 2021)

68
 SNLR
Volume 1 Issue 1 (2021)

reduce the risk of transmission to healthy individuals from hospitals by reducing the need for
visits at every stage.
How Telemedicine is Changing Healthcare
According to a World Health Organization study, 59.2% of all health workers work in cities,
which account for 27.8% of the population, and 40.8 percent work in rural areas, which
account for 72.2 percent of the population.3
This is where telemedicine may help. You may obtain 24/7 diagnosis and treatment from the
comfort of your own home instead of scheduling an in-person visit for non-emergency
injuries or illnesses. Minor ailments can be treated via remote consultations before they
become big problems. This can save both patients and healthcare providers a significant
amount of time.
Telemedicine may also link you with specialists, which is especially useful if you have
restricted access to transportation or healthcare facilities. Because they do not have to travel,
these specialists can give care to patients even in rural regions.
Intel is working with Medical Informatics Corporation (MIC) to develop systems that will
help hospitals centralise and analyse data from devices that monitor patients' vital signs,
reducing the number of rounds care teams must make and "alarm fatigue" by triaging the
patients to whom they must respond.4
Secure cabling, high-resolution cameras, speakers, and monitors may need to be installed in
hospitals, clinics, nursing homes, and physicians' offices. The future of telemedicine will
equip health facilities to serve as distant care centres.
This extraordinary increase in teleconsultations, telepathology, teleradiology, and e-
pharmacies is anticipated to drive the Indian telemedicine industry to $5.5 billion by 2025.5
In India, start-ups such as Phable, Practo, mFine, CallHealth, and Lybrate are launching new
telemedicine platforms. Telemedicine has meant that Doctors and medical personnel can
more efficiently prioritize critical situations. Human error and delays can be eliminated as
well. More financing and investment in the industry are projected as a result of the
government's support, eventually improving the country's place on the global healthcare map.
With increasing digital penetration in India, the rise of telemedicine as an antidote to public
health gaps is likely to be one of the pandemic's significant findings.
Regulatory framework governing telemedicine
The following laws and guidelines regulate the practice of telemedicine in India
3
Sudhir Anand and Victoria Fam, THE HEALTH WORKFORCE IN INDIA,WHO,
https://www.who.int/hrh/resources/16058health_workforce_India.pdf (last visited Dec 11, 2021)
4
Insights Team, Forbes Insights: How Telemedicine Is Transforming Healthcare: How AI And Edge Are
Shaping The Future Forbes (2021), https://www.forbes.com/sites/insights-inteliot/2020/12/03/how-
telemedicine-is-transforming-healthcare-how-ai-and-edge-are-shaping-the-future/?sh=1e525f753e4e (last
visited Dec 11, 2021).
5
Telemedicine market in India to reach USD 5.5 billion by 2025: EY-IPA study, The Economic Times (2021),
https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/telemedicine-market-in-india-
to-reach-usd-5-5-billion-by-2025-ey-ipa-study/articleshow/77996931.cms?from=mdr (last visited Dec 11,
2021).

69
 SNLR
Volume 1 Issue 1 (2021)

1. National Medical Commission Act, 2019: -6

In September 2020, the Ministry of Health and Welfare declared the NMC Act to be
the fundamental law governing medical education and practise in India. It took the
place of the Indian Medical Council Act, 1956, which had previously been in force.
The new law states that the rules and regulations framed asunder the old act will still
apply and remain in force as a transition mechanism until new guidelines are notified
under the present act. The MCI code which establishes the professional and ethical
norms that doctors must adhere to when dealing with patients and pharmaceutical
corporations. still remains in force and will continue to do so until new guidelines are
set under the present law.

2. Telemedicine Practice Guidelines: -7

Issued by The Ministry of Health and Welfare in collaboration with the NITI Aayog;
these guidelines form a part of the existing ethics code. The goal of these
recommendations is to provide doctors with practical guidance so that all services and
models of care utilised by doctors and health professionals may embrace telemedicine
as a part of standard practise. These standard operating procedures are binding on all
doctors practicing allopathy and enable them to use telemedicine platforms in any part
of the country. The guidelines have categorically explained over what kind of
consultation and care may be provided by doctors while engaging over telemedicine
platforms and in what manner such care and consultation may be provided. For
example, the guidelines have classified various medicines in List B, List A, List O
and Prohibited Category; allowing for a clear distinction between different medicines
and outlining which kinds of drugs can be prescribed over the platform and in which
conditions.

3. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945: -8
The act and the rules established through this act aim to regulate the import,
manufacture sale and distribution of drugs and cosmetics in India. The definition of a
"drug" is found in Section 3(b) of the act. To sell any kind of drug in India except
certain drugs intended for non-medical use or certain malaria-curing drugs, a License
is required and no distinction is made between drugs which may be sold exclusively
on the prescription given by a physician and drugs which may be brought over the
counter. However, the Rules made through this act form a clear distinction between
prescription and non-prescription drugs. Schedules H, H1, and X of the D&C Rules
detail the medications that can only be purchased with a prescription.
Even the drugs sold over telemedicine platform on the basis of a prescription must
satisfy all legal requirements. A legitimate prescription is one that has been written,
signed, and dated by the doctor who is writing it. The prescription must also provide
the quantity of the prescription suggested by the doctor and the name and the address
of the patient who is getting the treatment.

6
National Medical Commission Act, 2019;https://egazette.nic.in/WriteReadData/2019/210357.pdf
7
Telemedicine Practice Guidelines ;https://www.mohfw.gov.in/pdf/Telemedicine.pdf
8
Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945;
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

70
 SNLR
Volume 1 Issue 1 (2021)

Certain drugs and cosmetic are completely prohibited to be sold over telemedicine
platforms. The Drugs and Cosmetics Act, 1940 for example, prohibits Anti-Cancer
drugs from being prescribed over telemedicine platforms.

4. The Information Technology Act, 20009, The Information Technology

(Reasonable security practices and procedures and sensitive personal data or
information) Rules, 201110 (Data Protection Rules) and the Information
Technology Rules, 2011 (Intermediary Guidelines)11: -
As internet access permeates deeper within the Indian Society and traditional brick
and mortar stores too start to go online, a huge chunk of information and data is being
transferred in the digital space; data which normally would’ve remained only on paper
and confidential between the customer and service provider. This raises significant
issues of privacy and fundamental rights.
Same is true for the Telemedicine sector. Under the Data Protection Rules, a Patient's
personal information that he provides on such sites is considered Sensitive Personal
Data. When a corporate entity such as a telemedicine service providing platform
collects, stores, transfers or processes such information; these Data protection Rules
are prompted. The Data Protection Rules are formed on the cornerstone of consent of
the consumer; and require entities such as telemedicine providers to obtain consent
while transferring and or collecting Sensitive Personal Data Information. They are
also required to inform the end user of such collected data. They also require such
corporate entities to have a robust privacy policy and to ensure the security of data of
the end user.

5. Telecom Commercial Communication Customer Preference Regulations,

201812:-
Apart from the interaction over the platform, Healthcare practitioners may have to
interact with the patients through other means such as SMS or the platform itself may
end up interacting with the user through promotional messages/offers/follow up
reminders etc. Actions of the Telemedicine platform in which they engage with the
Healthcare providers and end user in terms of promotional, marketing and
transactional messages being sent are governed by these regulations.

6. OSP Regulations under the New Telecom Policy, 199913: -

The Department of Telecommunication requires service providers who render
“Application Services” and use telecom resources provided by Telecom Service
Providers to be registered as Other Service Providers. Service Providers have to

9
The Information Technology Act,
2000;https://eprocure.gov.in/cppp/rulesandprocs/kbadqkdlcswfjdelrquehwuxcfmijmuixngudufgbuubgubfugbubu
bjxcgfvsbdihbgfGhdfgFHytyhRtMjk4NzY=
10
The Information Technology (Reasonable security practices and procedures and sensitive personal data or
information) Rules, 2011;https://www.meity.gov.in/writereaddata/files/GSR313E_10511%281%29_0.pdf
11
(Data Protection Rules) and the Information Technology Rules, 2011 (Intermediary Guidelines)
https://www.meity.gov.in/writereaddata/files/Draft_Intermediary_Amendment_24122018.pdf
12
Telecom Commercial Communication Customer Preference Regulations,
2018;https://trai.gov.in/sites/default/files/RegulationUcc19072018.pdf
13
OSP Regulations under the New Telecom Policy, 1999;https://dot.gov.in/new-telecom-policy-1999

71
 SNLR
Volume 1 Issue 1 (2021)

obtain a license before providing such services and have to comply with certain
regulatory norms and requirements to be granted such license.

Telemedicine Practice Guidelines: -

The Covid-19 pandemic, forced a lot of business entities to start work from home and to go
online. Telemedicine also saw a significant rise as lockdown restrictions became more
forceful and going out became much more dangerous. In light of these events, the
government issued these guidelines to healthcare practitioners in March 2020 to guide them
on the usage of telemedicine amidst the growing pandemic. These guidelines act in
supplement to the existing laws mentioned above and have helped to plug in the gaps which
were present earlier. The purpose of these guidelines is to assist medical practitioners in
developing a sound plan of action for providing effective and safe medical treatment based on
available information, resources at hand, and needs of the patient, in order to protect both
patients and providers.
Only Healthcare Practitioners who practise allopathy and are registered with a state medical
council come under the ambit of Telemedicine Practice Guidelines. Dentists and practitioner
of other forms of medicine e.g., Ayurveda, Homeopathy and Siddhi medicine are not covered
by these Guidelines. The Central Council for Indian Medicine has released a separate set of
standard operating procedures for doctors who practice other traditional forms of Indian
Medicine such as Ayurveda, Siddha and Unani forms of medicine and the Central Council for
Homeopathy has released a separate set of guidelines for homeopathy practitioners as well.
However, these principles do not apply to other telemedicine stakeholders such as patients,
telemedicine platforms, messaging apps, insurance providers, and other entities in the
ecosystem. However, if Telemedicine platforms were to get proactive and comply with these
guidelines, it would help in encouraging Registered Medical practitioners to consult over a
platform which complies with all legal norms rather than the one which does not.
The Bombay High Court's judgement in the case of Deepa Sanjeev Pawaskar and Anr vs The
State of Maharashtra14 in 2018 sparked questions among RMPs about whether they may
provide medical advice over the phone. The Bombay High Court refused the applicant's (Dr.
Deepa's) anticipatory bail application, noting her arrest under Section 304 of the Indian Penal
Code, 1860 (culpable homicide). While the Supreme Court overruled the Bombay High
Court's ruling, many RMPs in India remained leery about giving medical advice over the
phone.
According to the TPG, the RMP shall use their professional judgement to determine if
telemedicine is an appropriate sort of consultation. The factors listed in the guidelines should
be considered when deciding whether or not to consult via telemedicine. The TPG also
specifies which medications may be prescribed and under what circumstances.
Depending on whether the teleconsultation was started by the patient, caregiver, or RMP, the
technique utilised to get patient consent as outlined in the recommendations varies. If the
patient initiates the teleconsultation, the patient's agreement is implied. The patient's explicit
agreement should be documented if the teleconsultation is initiated by the caregiver, health

14
2018 SCC OnLine Bom 1841; https://indiankanoon.org/doc/160266477/

72
 SNLR
Volume 1 Issue 1 (2021)

worker, or RMP. An email, text message, or audio/video message could be used to keep track
of the information.
Platform Guidelines
The Telemedicine Practice Guidelines also provide guidelines that are to be followed by
Telemedicine platforms. Technology platforms that provide telemedicine services must
ensure that patients consult with a registered medical practitioner and must undertake due
diligence before putting any practitioner on their web portal. Every qualified medical
practitioner featured on the platform must have a name, qualification, and registration
number, as well as contact information. Any misbehaviour or noncompliance by the
practitioner must be reported to the appropriate authorities.
Artificial intelligence/machine learning technology-based platforms are not authorized for
telemedicine consultations or medication prescribing, although they may help the certified
medical practitioner in arriving at a sound conclusion while determining the treatment for the
patient concerned.
If a digital platform is proven to be in breach of the Guidelines, it might be banned, and no
licenced medical practitioner could use it to provide telemedicine. RMPs who continue to use
a banned telemedicine platforms and provide services through the same however face no
special penalties. The final prescription or recommendation must always come from a
Registered Medical Practitioner. Telemedicine platforms must also have enough processes in
place to answer any queries that patient may have
Limitations
1) The Telemedicine Practice Guidelines only apply to healthcare practitioners who are
licenced under the MCI Act; i.e they only apply to Allopathy practicing doctors
registered with a particular State council. They do not apply to dentists or other
telemedicine providers.
2) The Telemedicine Practice Guidelines don't give enough advice on how to get
patients' informed consent or how to use their personal data.
3) When patients consult with individual RMPs using informal messaging applications,
it is the RMP's obligation to secure patient data in accordance with India's data
protection regulations. However, due to the fact that India's data protection laws
cannot be enforced on individuals, patient data supplied to individual RMPs is
practically unprotected.
4) List B drugs can only be prescribed via telemedicine if they were previously
prescribed in person by the same RMP. There is no provision, however, for a situation
in which the prescription was previously administered during an in-person session
with an RMP other than the one contacted through a telemedicine platform.
5) Consultation for minors by RMP requires the presence of an adult at all times.While
this allows for well required adult supervision, on the other side, this could provide
problems for children who want to discuss sensitive topics without consulting their
parents or guardians, such as mental health or reproductive health consultations.

Policy Suggestions

73
 SNLR
Volume 1 Issue 1 (2021)

All aspects of telemedicine practise need to be regulated by the government. To provide

further security, special safeguards in the TPG should ensure a basic degree of data protection
for health data submitted during a teleconsultation. This would also ensure that any
unsolicited health information provided by the patient is suitably safeguarded. It's also
important to simplify the definitions of follow-up consultations. In addition to this, the six-
month gap between in-person sessions should be eliminated. These initiatives will assist India
in streamlining its Telemedicine practise, which has the potential to improve healthcare
access in the country.

Conclusion
Telemedicine may not be the answer to all problems, but it can be a significant step in
transforming India's healthcare system. The government must take significant steps to make it
simpler for the people to adapt to this system and for telemedicine to realize its full potential.

74