On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”. However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to make drugs affordable and accessible as well. So, from April 1, 2020 (i.e. the effective date of the notification), all manufacturers and importers of medical devices and medical equipment sold in India will have to be careful to not increase the maximum retail price of their products by more than 10% within 12 months. They will have to make periodic trade-related filings with the Government in which they will have to submit price information such as price to distributors, price to stockist, price to hospital and price to retailer. And, on top of all this, they will have to operate under constant risk of price fixation at the hands of the Government, like was done in the case of coronary stents and knee implant systems in 2017.
Background
The quality and safety of drugs sold in India is regulated by the Drugs and Cosmetics Act, 1940 (“DCA”). There is no equivalent legislation for medical devices. Therefore, the Indian Government notifies those medical devices whose quality and safety it intends to regulate as ‘drugs’ from time to time.
Prior to February 11, 2020, the Indian Government used to regulate the quality and safety of medical devices in a piecemeal manner. There were only 37 categories of medical devices and medical equipments that had been notified as drugs under DCA (see annexure for this list). However, on February 11, 2020, the Government declared all medical device and medical equipment to be drugs in order to bring them under the fold of quality and safety regulation under DCA, effective April 1, 2020. We have written extensively about it here.
There was a collateral impact of this decision of the Government on price and supply chain of medical devices and medical equipment. India regulates production, control and supply of all essential commodities through a law called the Essential Commodities Act, 1955 (“ECA”). ‘Drugs’ are regulated as an essential commodity under ECA. Therefore, the Government has power to regulate product control and supply of all drugs under ECA. In furtherance of the provision of ECA, the Government has notified a price control order for drugs called the Drugs (Prices Control) Order, 2013 (“DPCO”).
On February 11, 2020, when the Government decided to regulate all medical devices and medical equipment by notifying them as drugs, it automatically subjected them to the provision of DPCO. The authority responsible for the administration of DPCO, the National Pharmaceutical Pricing Authority (NPPA), has already brought out a clarificatory order stating that the provision of DPCO will squarely apply to all medical devices and medical equipment.
Impact on price and supply of medical devices after April 1, 2020
From April 1, 2020, all medical devices and medical equipment manufacturers and importers will have to comply with the provisions of DPCO. The obligations imposed by DPCO on all manufactures and importers of medical devices and medical equipment are as follows:
Retail sale price to be mentioned on all medical devices, including ones for institutional use: The DPCO requires that every SKU of medical device and medical equipment must be labelled with its maximum retail price (“MRP”) that is to be set by the importer/manufacturer/marketer. The said price must be prefixed by the words “Maximum Retail Price” and suffixed by the words “inclusive of all taxes”.
Before April 1, 2020, there was an exemption available for medical devices and medical equipment that weighed more than 25 kg or that were intended for institutional use, from declaration of MRP under the Legal Metrology (Packaged Commodity) Rules, 2011. However, from April 1, 2020, all medical devices and medical equipment, irrespective of their weight and intended use, will have to declare MRP on the label of each SKU in the manner specified above.
% cap on variation of retail sale price: The importers, manufactures and marketers of medical devices will have to be cognizant about variation of the MRP declared on the label of their medical devices. The MRP of the product should not be varied by more than 10% in any 12 month period, else the variation in excess of 10% will be recovered as ‘overcharging’ from the business concerned. For example, if an importer of medical device decides to reduce the MRP by 20%, but after a single quarter decides to return to the original retail price (i.e. increase by around 20%), then it won’t be permitted to do so. It can, at best, increase its MRP by 10% of the reduced price. If it starts selling the product at the original MRP, then the 10% excess will be recovered from the importer on MRP basis i.e. by multiplying the number of units sold with the 10% excess, along with intrest and penalty.
Risk of price fixation: The NPPA has the powers to fix ceiling prices of any drug under extra-ordinary circumstances and in public interest. Now, from April 1, 2020, this power will extend to all medical devices and medical equipment. Once a price is fixed, the importer, manufacturer and marketer of said medical device has to set its MRP either equal to or below the ceiling price. Most of the times, NPPA also fixes the margins that may be offered to the supply chain and makes the concerned importer/manufacturer/marketer liable for any breach of margin by the supply chain.
Risk of being subject to market based pricing: The Ministry of Health and Family welfare brings about a National List of Essential Medicines (“NLEM”) every few years. Medical devices are also included in the said list from time (e.g. coronary stent). The consequence of being included in NLEM from pricing perspective is that the medical device in question automatically becomes subject to a market price based price control i.e. the MRP of the said device must not exceed the average MRP of all importers, manufacturers and marketers who sell the same device and who have more than 1% market share in that particular device market. The said average MRP (referred to as “Ceiling Price”) is decided and set by NPPA. The Ceiling Price may go up or down every year, depending on the wholesale price index of the Government. The MRP of the medical device will have to be adjusted accordingly. A prior permission from NPPA is required to withdraw or to reduce production / import of medical device which are recognized as ‘essential’ by the Government.
Consequences of non-compliance
There are different consequences associated with different violations. Any violation of DPCO is serious because its parent legislation, the Essential Commodities Act, 1955, stipulates that any breach of DPCO may result in imprisonment and fine for the company and person(s) in-charge of the company for conduct of its business. However, undoubtedly, the most draconian provision of DPCO is the liability to deposit any amount ‘overcharged’ by the importer or manufacturer in breach of DPCO in addition to the interest and penalty.
Final comments
It is extremely important for medical devices and medical equipment companies doing business in India to be aware of the compliance requirements and obligation under India’s price control law (i.e. EC Act and DPCO). Since all medical devices and medical equipment are now regulated as drugs, and all drugs are treated as essential commodities, an inadvertent violation of India’s price control laws may have serious consequences for the business of these companies.
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.
From September 16, 2019, all research conducted in
India which focuses on human diseases or conditions in the context of a drug,
medical device or cosmetics will have to be reviewed and overseen by a
non-governmental body known as Ethics Committee.
More specifically, from that date, the Drugs and
Cosmetics Act, 1940 (DCA) will begin to apply to “biomedical and health
research”, which is defined as “research including studies on
basic, applied and operational research or clinical research, designed
primarily to increase scientific knowledge about diseases and conditions (physical
or socio-behavioral); their detection and cause; and evolving strategies for
health promotion, prevention, or amelioration of disease and
rehabilitation”. The New Drugs and Clinical Trials Rules, 2019
(NDCTR), notified under the DCA, will make it mandatory for any person, company
or institution involved in biomedical and health research regulated by NDCTR to
ensure that a registered Ethics Committee reviews and oversees the conduct of
the research.
Background
Prior to notification of
NDCTR on March 19, 2019, there was no
law as such that regulated biomedical and health research carried out on human
participants other than such clinical research which involved a ‘new drug’. The
Indian Council of Medical Research, India’s apex medical research and
scientific body, had published The National
Ethical Guidelines for Biomedical and Health Research on Human Subjects but there was no law that could enforce these
guidelines on sponsors, professionals and institutions involved in the research.
This lacuna in the law has been addressed by NDCTR. The provisions in NDCTR that relate to
biomedical and health research were to take effect after 180 days from March 19,
2019 (i.e. the date of its notification). This time was sought, perhaps, to put
the administrative machinery in place, such as the National Ethics Committee
Registry for Biomedical and Health Research.
Who will be impacted
Any legal person, whether an individual or company, undertaking any biomedical or health research regulated by NDCTR for academic or business purposes, will have to approach a registered Ethics Committee for approval of the research proposal.
A laundry list of those who may be impacted the most
is described below for convenience –
Pharma Companies – Pharma companies usually undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Pharma companies also undertake non-mandatory post-marketing surveillance of pharmaceutical drugs. To the extent that such research concerns the health of the patient, it would have to be approved and overseen by a registered Ethics Committee.
Medical Device Companies – Like pharma companies, medical device companies undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Medical device companies also commission research to analyse secondary health data in patient registries. Such research would have to be approved and overseen by a registered ethics committee.
Cosmetics Companies – Cosmetics companies commission health-related studies from time to time. For example, cosmetic companies pay market research companies to assess the impact of the product from a psychological perspective (e.g. increase in confidence, reduction in stigma related to pimples or scars etc.). Such studies would henceforth be required to be approved and overseen by a registered Ethics Committee.
Diagnostic Companies – Diagnostic companies, especially those operating in the field of precision diagnostics, commission studies on existence and determination of various biological markers that aid in the diagnosis of diseases and conditions prevalent in the Indian market. Such studies would henceforth be required to be overseen by a registered Ethics Committee.
Technology Companies – Some technology companies, such as IBM, offer products and services that help clinicians in making better decisions with respect to the choice of medicines by analyzing a database of patient records (e.g. IBM Watson). Such technology companies, before deploying their products and services that analyze patient data with reference to pharmaceutical drugs, notified medical devices or cosmetics, would require the approval of a registered Ethics Committee.
Contract Research Organizations – There are numerous contract research organizations that undertake comparative Bio-availability and Bio-equivalence studies in India for pharmaceutical drugs that have been in the market for some time (i.e. drugs other than new drugs). Such comparative studies would henceforth be required to be approved and overseen by a registered Ethics Committee.
Market Research Organizations – Many market research organizations collect health data or undertake health-related primary research (e.g. patient interviews) and secondary research (e.g. prescription analysis) to reach certain conclusions for its clients (e.g. distinctive health-related product claims). Such marketing research organization would also have to submit their research to a registered Ethics Committee for review and approval.
Who will not be impacted
Companies undertaking health research on traditional medicinal products (Ayurvedic, homoeopathic medicines etc.) – The NDCTR have been framed under powers that the Central Government has with respect to pharmaceutical drugs, notified medical devices and cosmetics. Therefore, logically, it does not apply to all other categories of drugs such as ayurvedic medicines and homoeopathic medicines. Since the obligations with respect to biomedical and health research are provided under the NDCTR, these logically cannot apply such other category of drugs due to the inherent limitations of NDCTR.
Companies undertaking health research on non-notified medical devices – The DCA applies to a very small number of notified medical devices at present. Any bio-medical and health research that concerns non-notified medical devices should not be covered by NDCTR.
Food & Beverage companies – The DCA does not apply to food or beverages. A separate legislation, called Food Safety and Standards Act, 2006 (FSSA), regulates the quality of food and beverages sold in India. There is no requirement to obtain an Ethics Committee permission to undertake biomedical and health research related to food products under FSSA.
Educational institutions – Students, academicians and professionals in numerous educational institutions undertake epidemiological research i.e. biomedical and health research that is related to diseases and conditions in general and not related to any particular medicine, notified medical device or cosmetics. Such research should not fall in the scope of NDCTR.
Challenges
Shortage of registered ethics committees – Almost all major research institutions in India have a registered ethics committee that they have formed themselves. Some research institutions who don’t have a registered ‘institutional’ ethics committee of their own seek services of a registered ‘independent’ ethics committee. These ethics committees are registered to review clinical trials on new drugs and investigational notified medical devices. The challenge, however, is that a separate registration is required for ethics committees which will review biomedical and health research proposals. In fact, the authority which will grant such registration to ethics committees was designated only a few days ago by the government (i.e. on September 12, 2019). Therefore, at the time of commissioning biomedical and health research, the sponsor of such must carefully evaluate the ‘registered’ status of the ethics committee who has offered its services.
Lack of clarity in definition – The definition of “biomedical and health research” is very broad, so much that it could arguably extend to research on how a medicine “tastes” or a medical device “feels”. Further, the definition by itself does not restrict the application of NDCTR to research that involves medicines, notified medical device and cosmetics only. It is broad enough to cover “basic research” as well, which is not connected any medicine, medical device or cosmetic but instead concerns research on human body and its constituents. Such expansive interpretation of the scope of the definition is not correct, because the parent law to NDCTR, that is the DCA, is applicable only to drugs, notified medical devices and cosmetics. Therefore, rules made under it, cannot go beyond the scope of DCA.
Conclusion
In light of the application of NDCTR to biomedical and
health research, sponsors of any research that concerns human participants and
involves a pharmaceutical drug, notified medical device or cosmetic must be
careful to not inadvertently violate NDCTR. A good practice would be to refer
all such studies for approval of a duly registered Ethics Committee who may,
after review of the study design, itself come to a conclusion that it is within
the scope of NDCTR or not. Needless to say, all eligible biomedical and health
research should under undertaken after review, and under supervision, of a duly
registered Ethics Committee only.
Two separate
incidents, one relating to India’s central drug law enforcement body- the
Central Drugs Standards Control Authority (CDSCO), and another relating to a
State drugs law enforcement body- the Himachal Pradesh Drugs Control
Administration (HPDCA), have received widespread attention. On August 16 2019,
a very senior officer of the CDSCO was arrested while accepting a bribe. On August 23 2019,
the residential and office premises of a very senior officer of HPDCA was
raided by the vigilance department on bribery allegations. These high profile
investigations closely follow the arrest of a Drug Inspector of CDSCO and the
Managing Director of a Pharmaceutical Company on grounds of hatching an alleged
conspiracy to ‘manage’
adverse results of a government lab test. All these individuals have
been charged for commission of offences under India’s anti-bribery law i.e. The
Prevention of Corruption Act, 1988.
The official communication from the Central Government with respect to the arrest of its officer reads: “All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption and is committed to act stringently against any act of corruption.”
The official
communication is very interesting, especially in the background of the reported
facts that prompted the arrests.
The
complaint against the senior officer of the HPDCA was that he was allegedly receiving “undue favours” such as free air tickets and hotel accommodation from
pharmaceutical companies.
The
complaint against the Drug Inspector of CDSCO was that he had allegedly
demanded a bribe to ignore the deficiency in samples of dobutamine injection. The drug is used to
treat acute heart failure
It is not
unusual in India for individuals from different verticals of pharmaceutical /
medical device business – quality, regulatory, government affairs and senior
management, to actually be in direct and repeated contact with officers of the
drugs law enforcement bodies for genuine business reasons.
It may not be right to say that such constant interaction is a bad thing. However, it does increase the possibility of corruption. Therefore, it is important to sensitize those in direct contact with government officers that-
It is a criminal offence not just to demand or take a bribe, but also to offer or give a bribe in India.
A bribe does not necessarily have to be in cash. It may be in kind as well such as by way of flight tickets, hotel stays or expensive liquor bottles.
MNCs doing business in India are at higher risk of corruption because, as subsidiaries of US or UK holding companies, they expose the holding companies to the risk of violation of stringent foreign anti-bribery laws such as US Foreign Corrupt Practice Act and UK Bribery Act.
Some
important take-aways from the recent crack-down on corruption in the drug
enforcement bodies –
The degree of vigilance by CDSCO and other state-level enforcement bodies i.e. State FDAs against corruption has increased. According to reports, a “zero tolerance” policy against corruption has been put in place.
The Managing Director of a pharmaceutical company was arrested along with the Inspector of CDSCO for paying the bribe even though he was not physically present when the bribe was accepted. Therefore, the senior management of a company is especially exposed to an anti-bribery prosecution since they are in charge of day to day operations of the company.
Doing a favour to a government officer, like booking flight ticket or hotel accommodation or providing free medicines/medical devices, may be looked at as an instance of bribe both under Indian and foreign laws.
It is reported that the complaint against HPDCA officer was done by a pharmaceutical company. While it is up to the Courts to establish the veracity of the complaint, it does show that there is scope for refusing a demand of a bribe and for lodging an effective complaint.
Last but not
the least, these developments underscore the importance to put in place
appropriate systems and processes that act as a risk mitigation tool against
the possibility of corruption. At the very minimum, every pharmaceutical and
medical device company should have a written policy on corrupt practices that
is both comprehensive and practical to suit the reality of India. This must be
complemented by regular training sessions to communicate the policy to everyone
in the company in a language that they will understand. Some companies have
already put in place a whistle-blower policy. The policy must be fine-tuned to
escalate potential acts of corruption as well.
Time and again, the pharmaceutical
industry has been accused of indulging in unethical practices concerning the
marketing of medicines around the world. These unethical marketing practices are, in fact,
a major area of concern for the Government as well as patient groups. Amongst
all unethical practices, the one that attracts the highest amount of scrutiny
is the (questionable) interaction between pharmaceutical companies and
healthcare practitioners (HCPs).
India is no exception. The Draft
Pharmaceutical Policy, 2017 published by the Government itself makes a note
that unethical practices employed by pharma companies are an area of major concern
and that Doctors are lured to recommend a particular brand through all expenses
paid trips often disguised as ‘educational conventions’. Unfortunately, the cost
of such trips and other incentives gets added to the overhead cost of marketing
of the medicine and is ultimately passed on to the patients.
There is no law at present that
regulates the promotion and marketing of drugs (including medical devices) by
companies before HCPs. Interactions between pharma companies and HCPs are
regulated, at best, by way of restrictions cast on HCPs through their respective
professional and ethical guidelines. For example, the Indian
Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
regulate the professional and ethical conduct of doctors practising modern
medicine and prohibits doctors from accepting any kind of freebies (including
travel and accommodation) from pharma and allied healthcare industry. Unfortunately, the principal
legislation that regulates the pharma industry i.e. The Drugs and Cosmetics
Act, 1940 does not say what pharma companies can and cannot say, or give or
cannot give, to HCPs.
It is true that there are consumer
protection legislations in India such as the Consumer Protection Act, 1986 (now
the Consumer Protection Act, 2019) and the Drugs and Magic Remedies
(Objectionable Advertisement) Act, 1954 and Rules, 1955 but these legislations
regulate misleading advertisements, not unethical industry-HCP interaction.
It is, perhaps, not right to say that
the government has turned a blind eye to this problem. In fact, in light of the
increasing number of complaints of unethical practices adopted by pharma
companies, the Department of Pharmaceuticals had introduced the Uniform Code of
Pharmaceutical Marketing Practices (UCPMP) back in 2011 (later revised
in 2014). The intent behind UCPMP code was to guide the pharma industry in its
interaction with HCPs. However, the voluntary nature of UCPMP has relegated its
own status to that of a “non-binding guideline”.
However, not all is lost. There is no
dearth of pharma companies who are proudly ethical in their dealings with HCPs.
In fact, most pharma MNCs have put in place exhaustive internal guidelines and
robust internal systems which guide interactions of their medical
representatives/marketing personnel with HCPs.
Interestingly, HCPs also seem to value such ethical behaviour. It is
obvious that, at the end of the day, a HCP will prescribe medicines from only
those pharma companies whose quality he or she trusts.
It is quite likely that the Indian
government may decide to give legal teeth to UCPMP and make it binding. After
all, the UCPMP is the nearest Indian equivalent to the US Physicians Payment Sunshine
Act that we have. Interestingly, the enforcement of the Sunshine Act by US
Authorities have resulted in hundreds of millions of dollars in fines for some
pharma companies.
There is no doubt that making UCPMP into
a law would certainly help to curb the rampant quid-pro-quo arrangements
that exist today between pharma companies and HCPs. More so, those companies which
currently engage in unethical practices will be forced to re-evaluate their
sales and marketing strategies and become compliant, or else they will have to face
legal consequences.
In the meanwhile, at least those
companies who have achieved leadership positions in India’s pharma industry may
lead by example and assume voluntary responsibility to follow UCPMP in text and
spirit. The pharma industry associations would also do much good if they could
adopt the UCPMP and direct their members to ensure compliance with the
provisions of UCPMP at all costs. Such proactiveness will go a long way in
instilling a sense of confidence amongst the Government and patients groups. And
if that happens, needless to say, the
heavily regulated industry that is pharma industry will have one less
regulation to worry about.
