Status of Online Medical Consultation in India Has Regulatory Issues

Highlights

• Online medical consults in India have no regulatory authority from the state or central medical bodies like the Medical Council of India
• Many websites and apps in India continue to provide this facility despite the lack of regulations
• The Karnataka Medical Council in May 2019 gave a statement calling it unsafe

In India, online medical consultations are offered by several health sites and apps for quite a few years, but there is no regulatory body or licensing authority that permits doctors to practice this form of medicine. In countries like the USA, each state allows doctors to not only practice but also provide reimbursement for such practice. One common area where this is regularly practiced is for refill prescription for a medication used for chronic illnesses like blood pressure or diabetes.

In August last year, the Indian Medical Association (IMA) had asked for precise guidelines regarding the matter of telephonic medication and online consultations from the Medical Council of India (MCI), as it considered the practice as unlawful and unethical.

There are four primary methods of telehealth consultation - live video consults, store-and-forward type of consult through email, remote-patient monitoring and mobile health consults.

In May this year, the Karnataka Medical Council (KMC) had urged doctors to avoid participating in online consultations declaring that it openly contradicts the regulatory body’s ethical code.

“Such consultations are detrimental to both patients as well as the doctor and may lead to many complications, which is nothing but playing with the life of a patient” said H. Veerabhadrappa, President of the council. He further added that the Karnataka Medical Council could even go to the extent of initiating action (including cancellation of registration) against doctors who take up online consultations.

The KMC’s verdict came out following a complaint filed by the Bangalore Dermatological Society (BDS) on an advertisement printed in a newspaper by a technological health services company that invited doctors to join as their online consultants.

P. Jagadish, Secretary of Bangalore Dermatological Society said, “At the same time, it is detrimental for patients, too, as online consultation may end up with a wrong diagnosis. They can also develop complications as many medicines may have side effects.” However, on April 13, 2019, Bombay High Court has declared that telephonic medical consultation cannot be criminalized.

The Bombay High Court’s judgment on Ratnagiri based doctor couple - Deepa and Sanjeev Pawaskar resulted in them getting booked under Section 304 (culpable homicide not amounting to murder) of the Code of Criminal Procedure after a woman died within a few days of being discharged from their hospital. Apparently, prescription of medication was prescribed over the phone to a woman who had given birth a few days previously and she died. The court even rejected the anticipatory bail of the doctor couple and observed that prescribing medicines to patients without diagnosis amounted to culpable negligence.

The Bombay High Court order resulted in the Indian Medical Association (IMA) sending out warnings to doctors over online consults and prescribing over phone, a fairly common habit in India. Dr Piyush Jain, President of the East Delhi chapter of IMA which happens to be the largest chapter of the IMA with 9643 members, held an internal meeting with its members and issued the the following statement, “In the meeting we decided to come up with warnings for patients and doctors asking them to refrain from offering consultation over phone or WhatsApp. For this purpose, we created two posters – one stating that patients will be arrested for consulting doctors and the other warning doctors. These posters were then sent out to members of the East Delhi chapter asking them for their opinion.”

Dr. Ravi Wankhedkar, the national president of IMA at that time, said that all doctors in Maharashtra had been told to refrain from offering consultation without first having physically diagnosed the patient. He promised to create an official guideline for the medical fraternity across the country on this subject.

“The matter being sub-judice we cannot issue official guidelines. For now we have conveyed the same to doctors via word of mouth but will put it in the rules once the case is closed,” he said.

“The practice of offering consultations on text or call without diagnosing the patient is not right. It is highly risky to prescribe medicines based on how the patients or their family members describe symptoms,” said the secretary of IMA Dr. Sanghavi.

Six months have passed since this episode but IMA has still to release its guidelines. The Medical Council of India has the regulatory authority; however it has been in a state of flux and paralysis for the last few years and now there is a new body in its place.

The Prime Minister has been keen to make India digital and the Government of India has always supported telemedicine through Indian Space Research Organization by lending out its satellites free of cost for over a decade now. Many big groups like Apollo healthcare practice telemedicine consults in thousands every day. Some state governments like Andhra Pradesh have encouraged the use of tele-ophthalmolgy for the prevention of blindness by installing fundus cameras in their primary health centers.

India has advanced in adopting digital health despite the lack of regulation by the government. The Indian healthcare ecosystem, however, is very complex; consider the following shocking facts and stats –

1. A 2016 WHO report on the health workforce in India stated that 57.3percent of those practicing allopathic medicine were not qualified. Which indirectly meant they were likely to be quacks.(1^✔ ✔Trusted Source
   The Health Workforce In India
   
   Go to source)
2. Another report a bit old by WHO in 2001 said that barely 20percent of those who practiced medicine in rural India had any medical qualification and many were only educated up to Class 12.
3. Many quacks also have regularly performed surgery. The most common example is for the treatment of anal canal diseases such as piles and fistulas or for setting fractures. One can find their advertisements in every city and town or watch their hoardings or advertisement on the walls if one travels into a city by train. Quacks have also in fact gone on to perform transplant surgery - who can forget the infamous case of Dr. Amit Kumar of Gurgaon. He had performed kidney transplants for many years until he was nabbed in Kathmandu in 2008 and locked up.(2^✔ ✔Trusted Source
   Gurgaon kidney scandal
   
   Go to source)
4. An estimated 1,500 quack doctors were booked in the state of Tamil Nadu, however, most escaped or got a bail. Dr K. Kolandaisamy, Director of public health in Chennai said “They get bail or pay fine and restart practice.” IMA believes quackery is endemic in India and in Tamil Nadu alone 50,000 quacks are functioning. Thomas Prabhakaran, deputy superintendent of police said, “These quacks know most families, charge less and give high dose drugs that give them quick relief,” “So people prefer them.” In his words, “It is the trust we are not able to break.”
5. According to another WHO report, 35percent of the world’s spurious drugs are produced in India. The spurious drugs market in India is worth nearly Rs 4000 crores. This accounts for 20percent of the domestic pharmaceutical business in India. USA has put India in 301-watch threat list (The Special 301 Report is prepared annually by the Office of the United States Trade Representative. It identifies trade barriers to United States companies and products due to the intellectual property laws in other countries).(3^✔ ✔Trusted Source
   The Spurious Drug Menance & Remedy
   
   Go to source)
6. Seeking advice on sexual health in India using online platforms is not uncommon. Dr Shyam Mithia, neuropsychiatrist and sexologist in Mumbai said, “Today, as many as 70% of all sexual dysfunction patients go to quacks who don’t have a medical degree.”
7. No health insurance policy factors in digital health or online consultations or telemedicine in India.

This background makes digital health highly prone to Medico-legal and ethical challenges including issues related to lack of professional credentials, possible spurt in spurious medication sales, not maintaining the standard of care, breach in confidentiality of patients, and the possibility of professional misdemeanor.

The medical profession in India is currently regulated by the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945 and the Clinical Establishments (Registration and Regulation) Act, 2010 (‘Clinical Establishments Act’).

The job of creating a regulatory framework with this backdrop of healthcare in India makes the job doubly difficult and maybe one reason why there has been undue delay in formulating any regulation or guidelines. The question that crops up is how does one neutralize these factors and move forward to offer a digital health policy that is safe for the citizens of India.

The laws related to Information Communication Technology include the Information Technology Act, 2000 (IT Act), the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011, the Information Technology (Intermediaries Guidelines) Rules, 2011, Unsolicited Commercial Communications Regulations, 2007 and Telecom Commercial Communication Customer Preference Regulations, 2010 ('TCCP Regulations’).

In none of these laws is telemedicine or digital health included or mentioned. Indirect references to data security will be applied. Consent too is missing.

Dr. Ravi Wankhedkar, Immediate Past President of the IMA said in a statement, “Online consultations, online prescriptions and telemedicine are all topics which have posed ethical dilemmas. But at the same time, advancing technology can be harnessed for augmenting healthcare in remote areas. The MCI must come out with clear-cut guidelines on these important issues.”

Most often there is knee jerk reaction when something goes wrong in medical practice by both the patients and the police and there is a rise in the criminal prosecution of doctors.

Criminal prosecution is possible before the criminal courts on the grounds such as the commission of offenses under any criminal statute and the most common charges faced by doctors are causing death by negligence (Section 304-A of the Indian Penal Code [IPC]), endangering life or personal safety of others (Section 336 of the IPC), causing hurt by an act endangering life or personal safety of others (Section 337 of the IPC) and causing grievous hurt by an act endangering the life or personal safety of others (Section 338 of the IPC). Punishment generally includes imprisonment as well as fine under the relevant sections as has sadly happened to the doctor couple from Ratnagiri.

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Digital Health in European Union (EU) Countries

The eHealth Action Plan was adopted by EU in 2004, to support the application of ICTs in the health sector, which was followed by the eHealth Action Plan for 2012-20.(4^✔ ✔Trusted Source
Telemedicine: The legal Framework (or the Lack of it) in Europe

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The EU has issued different data protection directives and data protection regulations to popularize the use of telemedicine.

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Digital Health and Telemedicine in United States of America

In the United States, different states have allowed the practice of telemedicine and digital health. In the progressive state of California, the Telemedicine Development Act of 1996 actually prohibits face-to-face visits if the service can be provided through telemedicine.

Reimbursement is an important part of the regulation. The Telehealth Advancement Act, 2012, includes a number of telemedicine services including the reimbursement processes.

In Washington DC, too there is a provision for reimbursement of services rendered through telemedicine under the Telemedicine Reimbursement Act of 2013.

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Telemedicine in South Africa

South Africa clearly limits the practice of telemedicine consultation by stating - “It should be given only in those situations where face-to-face consultation is not possible because of a geographical barrier.”

As for the present, as medical consults in India have no legal standing, there is a high possibility of accusations and finding negligence by a legal forum and the doctors need to take cognizance of this fact before offering their services to this form of practice.

In all this doom and gloom, the Managing Editor of Medindia also spoke to Dr. Ganpathy, a senior neuro-surgeon who has been an evangelist for telemedicine in India for 20 years on his views and he seemed very positive about the future of telehealth in India (watch the video interview).

References:

1. The Health Workforce In India - (https://www.who.int/hrh/resources/16058health_workforce_India.pdf)
2. Gurgaon kidney scandal - (https://en.wikipedia.org/wiki/Gurgaon_kidney_scandal)
3. The Spurious Drug Menance & Remedy - (http://medind.nic.in/haa/t06/i1/haat07i1p29.pdf)
4. Telemedicine: The legal framework (or the lack of it) in Europe - (https://www.ncbi.nlm.nih.gov/pubmed/27579146)

Source-Medindia