Woman writhing in labor made to wait 4 hours, loses baby

As per a video that went viral last week, a pregnant woman is seen sitting on the floor of the empty Kolar’s KGF government hospital, writhing in labur pains. She was allegedly made to wait for four hours. When she was not attended to by a doctor, the woman was eventually taken to a private hospital for the delivery. Her baby, however, did not survive.

22-year-old Sameena, a resident of Kolar, was taken to KGF Government Hospital on Tuesday noon last week after she began experiencing contractions. She was accompanied by her husband Riyaz and two other female relatives. Dr Shivakumar, the surgeon who was on call at the time at KGF has since been suspended by officials.

Questions

·         Hospital fault: In an empty hospital, where no staff is visible in the video, how did the patient walk in?

·         Administrative fault: Why did no one attend to the woman?

·         Medical fault: If the doctor was on call, why did he or she not come?

·         Govt fault: As it was government hospital, how can you have no staff?

See the video at: https://timesofindia.indiatimes.com/videos/city/bengaluru/on-cam-woman-shivering-in-pain-at-karnataka-hospital-loses-baby-due-to-medical-negligence/videoshow/69555091.cms

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Wheat belly: Why is wheat the culprit?

More than 37% of Indians have belly obesity, which is defined as abdominal circumference > 80 cm in women and > 90 cm in men.

The reason for this is the every day consumption of wheat in diet. Wheat is a part of staple diet, particularly in North India. Traditionally Indians have been asked to do one wheat fast a week, extra wheat fast on the day of Ekadashi and nine-day wheat fast every three months during Navratras.

Why is wheat the culprit? Wheat contains amylopectin A, gliadin and gluten.

Amylopectin A is a chemical unique to wheat. It is a trigger of small LDL particles. When wheat is removed from the diet, these small LDL levels reduce by 90%.

Gliadin is a protein, which stimulates appetite. Eating wheat increases the average person’s calorie intake by 400 calories a day. Gliadin also has opiate-like properties, which make it “addictive”.

Gluten is inflammatory to the gut.

But wheat was a part of diet earlier also. Wheat eating patterns changed in the 70s and 80s, when newer techniques came to be used to increase yield, including hybridization. It was bred to be shorter and sturdier and also to have more gliadin. The wheat that is available today and what we eat today is not the wheat that was eaten many, many years ago.

Corn starch, rice starch, tapioca starch or potato starch are the four basic ingredients of gluten-free products. These dried, powdered starches increase the blood sugar even higher.

According to Dr Tom O’Bryan, an international expert on wheat and wheat-related disorders, for every one person who has intestinal manifestations of wheat sensitivity, there are 8 who don’t have any GI symptoms. No human has the capability to breakdown wheat. But, whether wheat causes a problem for them depends on whether they have crossed the line of tolerance. The inflammatory mechanisms begin once all tolerance is lost, which trigger the immune system resulting in an autoimmune disease. Females are three times more likely to develop autoimmune celiac disease than males.

Earlier, the term gluten sensitivity was used, but now wheat sensitivity is used as wheat has several components other than gluten, which may be a problem.

All people are wheat sensitive to some degree, so wheat can be called an inflammatory diet.

The defense mechanisms vary between individuals; while some may react to it, some may overcome it, until they cross the line of tolerance.

If after eating wheat, you get discomfort, you should get yourself tested or try a wheat elimination diet.

About 50% of wheat-sensitive people also cross react with corn and dairy. Hence, a wheat elimination diet has no wheat of any type, no sugar, no corns/grains and no dairy products. Eliminate these from your diet for three weeks and observe the change. Then eat a pizza on day 22. If you notice any worsening effect, then you are wheat sensitive.

If you are sensitive, omit wheat in the diet.

So, is rice safe? Rice does not increase the blood sugar levels to the extent that wheat does; rice also does not contain amylopectin A or gliadin.

To know more about this, attend the International Symposium on Wheat Related Disorders at India Habitat Centre, New Delhi from January 12-13, 2019.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Law on Euthanasia in India

Life and death as concepts have invited many a thinker, philosopher, writer and physician to define or describe them. Swami Vivekananda expects one to understand that life is the lamp that is constantly burning out and further suggests that if one wants to have life, one has to die every moment for it. One may like to compare life with constant restless moment spent in fear of extinction of a valued vapour; and another may sincerely believe that it is beyond any conceivable metaphor.  Death is complicated and life is a phenomenon which possibly intends to keep away from negatives that try to attack the virtue and vigour of life from any arena. In spite of all the statements, references and utterances, be it mystical, philosophical or psychological, the fact remains, at least on the basis of conceptual majority, that people love to live – whether at eighty or eighteen – and do not, in actuality, intend to treat life like an ―autumn leaf.

The perception is not always the same at every stage. There comes a phase in life when the spring of life is frozen, the rain of circulation becomes dry, the movement of body becomes motionless, the rainbow of life becomes colourless and the word life, which one calls a dance in space and time becomes still and blurred and the inevitable death comes near to hold it as an octopus gripping firmly with its tentacles so that the person shall rise up never.

The ancient Greet philosopher, Epicurus, has said, although in a different context:-

Why should I fear death?

If I am, then death is not.

If death is, then I am not.

Why should I fear that which can only exist when I do not?

But there is a fallacy in the said proposition. It is because mere existence does not amount to presence. And sometimes there is a feebleness of feeling of presence in semi-reality state when the idea of conceptual identity is lost, quality of life is sunk and the sanctity of life is destroyed and such destruction is denial of real living.

The society at large feels that a patient should be treated till he breathes his last breath.

Every doctor is supposed to take a specific oath that he will make every attempt to save the life of the patient whom he/she is treating and who is under his/her treatment. This oath, thus, puts a moral and professional duty upon a doctor to do everything possible, till the last attempt, to save the life of a patient.

The Medical Council of India (MCI) Code of Ethics Regulations rejects Euthanasia (deliberately ending a patient’s life at his or her own request or at the request of close relatives).  “6.7 Euthanasia: Practicing euthanasia shall constitute unethical conduct. However, on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death, shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.”

While MCI Code of Ethics rejects euthanasia, it does not talk about physician-assisted-suicide (where a physician deliberately enables a patient to end his or her life by prescribing or providing medical substances with the sole intent of causing death. But practically it is included in the same as both acts are contrary to the ethics of medicine and the role of the physician.

Medical scientists have been, relentlessly and continuously, experimenting and researching to find out better tools for not only curing the disease with which human beings suffer from time to time, noble attempt is to ensure that human life is prolonged and in the process of enhancing the expectancy of life, ailments and sufferings therefrom are reduced to the minimal. There is, thus, a fervent attempt to impress the quality of life.

It is this very advancement in the medical science which creates dilemma at that juncture when, in common perception, life of a person has virtually become unlivable but the medical doctors, bound by their Hippocratic Oath and medical ethics want to still spare efforts in the hope that there may still be a chance, even if it is very remote, to bring even such a person back to life.

The Hippocratic Oath taken by a doctor and the MCI Code of Ethics may make him feel that there has been a failure on his part and sometimes also make him feel scared of various laws. There can be allegations against him for negligence or criminal culpability.

No physician should be forced to participate in euthanasia or assisted suicide, nor should any physician be obliged to make referrals to this end. However, the right to decline medical treatment is a basic right of the patient.  

The physician does not act unethically in respecting the patient’s wish to decline medical treatment, even if such a wish may result in the patient’s death by allowing the natural dying process to unfold in the course of terminal phases of sickness.

A doctor has a crucial role to play in such situations as there is a very thin line between this ethical and unethical act.

Remember it is the patient who has a right to deny the treatment and not the relatives. However, the patient must be in his or her sound state of mind to take any such decision.

There is a distinction between the administration of lethal injection or certain medicines to cause painless death and non-administration of certain treatment which can prolong the life in cases where the process of dying that has commenced is not reversible or withdrawal of the treatment that has been given to the patient because of the absolute absence of possibility of saving the life. To explicate, the first part relates to an overt act whereas the second one would come within the sphere of informed consent and authorized omission. The omission of such a nature will not invite any criminal liability if such action is guided by certain safeguards. The concept is based on non-prolongation of life where there is no cure for the state the patient is in and he, under no circumstances, would have liked to have such a degrading state.

In the landmark judgment Common Cause versus Union of India, 2018 (5) SCC 1, the Hon’ble 4-Judge Constitution Bench of the Supreme Court held that Euthanasia is basically an intentional premature termination of another person‘s life either by direct intervention (active euthanasia) or by withholding life-prolonging measures and resources (passive euthanasia) either at the express or implied request of that person (voluntary euthanasia) or in the absence of such approval/consent (non-voluntary euthanasia).

Active euthanasia also includes physician-assisted suicide, where the injection or drugs are supplied by the physician, but the act of administration is undertaken by the patient himself. Active euthanasia is not permissible in most countries.

Passive euthanasia is when medical practitioners do not provide life-sustaining treatment (i.e. treatment necessary to keep a patient alive) or remove patients from life sustaining treatment. This could include disconnecting life support machines or feeding tubes or not carrying out life-saving operations or providing life extending drugs. In such cases, the omission by the medical practitioner is not treated as the cause of death; instead, the patient is understood to have died because of his underlying condition.

Further, in Gian Kaur versus State of Punjab, (1996) 2 SCC 648, the Hon’ble Constitution Bench  of Apex Court expounded that the word "life" in Article 21 has been construed as life with human dignity and it takes within its ambit the "right to die with dignity" being part of the "right to live with dignity". As part of the right to die with dignity in case of a dying man who is terminally ill or in a persistent vegetative state, only passive euthanasia would come within the ambit of Article 21 and not the one which would fall within the description of activeeuthanasia in which positive steps are taken either by the treating physician or some other person. That is because the right to die with dignity is an intrinsic facet of Article 21.

In Aruna Ramachandra Shanbaug versus Union of India, 2011 (15) SCC480, Hon’ble Supreme Court has observed that autonomy means the right to self-determination where the informed patient has a right to choose the manner of his treatment. To be autonomous the patient should be competent to make decisions and choices. In the event that he is incompetent to make choices, his wishes expressed in advance in the form of a Living Will, or the wishes of surrogates acting on his behalf (substituted judgment) are to be respected.

Thus, all adults with the capacity to consent have the common law right to refuse medical treatment and the right of self - determination. Doctors would be bound by the choice of self-determination made by the patient who is terminally ill and undergoing a prolonged medical treatment or is surviving on life support, subject to being satisfied that the illness of the patient is incurable and there is no hope of his being cured.

In “Common Cause versus Union of India, 2018 (5) SCC 1 the Constitution Bench of Hon’ble Supreme Court held that Advance Medical Directive would serve as a fruitful means to facilitate the fructification of the sacrosanct right to life with dignity. The said directive will dispel many a doubt at the relevant time of need during the course of treatment of the patient. That apart, it will strengthen the mind of the treating doctors as they will be in a position to ensure, after being satisfied, that they are acting in a lawful manner. However, Advance Medical Directive cannot operate in abstraction. The Hon’ble Court in the said judgment has enumerated various safeguards and procedure of advance medical derivatives and also in cases where there is no advance medical derivatives which will remain enforced till Parliament makes a law on Advance Medical Derivatives. 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

More than 4 lakh patients die from medical errors in the US: Medical errors are inevitable in medical practice

According to a new study published in the BMJ, online May 3, 2018, more than 2 lakh deaths in the US are due to medical errors.

Researchers from Johns Hopkins University School of Medicine examined four separate studies that analyzed medical death rate data from 2000 to 2008. Then, using hospital admission rates from 2013, they extrapolated that based on a total of 35,416,020 hospitalizations; they calculated 251,454 deaths were due to a medical error, which translates to 9.5% of all deaths annually in the US. This number is much higher than respiratory disease, which as per the CDC is the third leading cause of death and kills around 150,000 people in a year.

But, according to other organisations, the number of deaths due to medical errors is much higher than 2 lakhs and is around 440,000.

Medical errors are the third-leading cause of death in the US after heart disease and cancer.

Medical error-related deaths occur due to:

·         Preventable adverse effects

·         Error in judgment

·         Lack of care

·         Inadequately trained staff (most important)

·         Out of date computer systems that break down

·         Medication mix-ups

·         Undiagnosed complications after surgeries

·         Communication failures with patients

The number of medical error-related deaths will be much higher in India because of the large population; also, there is no system of reporting of errors of other pathies. This is further compounded by the fact that even non-qualified doctors are treating patients. 

The public, including the patients, needs to understand that medicine is an art, based on science, yet it is not an exact science. No two patients are alike and clinical decisions are tailored to individual patients. Therefore, uncertainty is a part of day-to-day medical practice, where errors are inevitable. 

So, for someone to be able to say it is negligence the following circumstances must be present:

·         Doing what the healthcare provider should not have done under the circumstances.

·         Not doing what the healthcare provider should have done under the circumstances.

·         Medical error must have caused identifiable injury

Because medical errors are bound to occur, there should not be a public media trial for making a mistake, unless the error is gross. If every medical error is flashed on the front page of newspapers and cases are filed against doctors in courts, it will adversely affect the doctor-patient relationship, which is already very fragile.

The possible answers can be:

·         Explain the cost right at the time of admission

·         Be transparent in your cost

·         Have a contract signed by the patient at admission, which explains about existing and non-existing facilities

·         Sign a contract about the liability limit for any possible mishap

·         Make likelihood of medical errors a part of informed consent process

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Is not notifying TB punishable? If yes, should positive XDR patients be isolated?

A few days back a police complaint was filed by the Ahmedabad Municipal Corporation (AMC) against a doctor couple who have a clinic in Vejalpur in Ahmedabad for failing to notify tuberculosis to the AMC, as reported in TOI. This is the first such complaint in the state against any doctor for suppressing information about tuberculosis. According to government statistics for 2018, Gujarat was among the top five states in reporting tuberculosis after Uttar Pradesh, Rajasthan, Madhya Pradesh, and Maharashtra.  According to medical health officer Bhavin Solanki, the AMC had in April 2018 directed all doctors to inform it about tuberculosis cases. Solanki said 100 doctors were issued such notices. However, it was observed that private doctors were not reporting all tuberculosis cases. The AMC found during an investigation that a patient from Srinand Nagar was undergoing treatment at Akshar Hospital in Vejalpur. The AMC had issued a notice to Dr Nilesh Makkani and Dr Pragni Makkani of the hospital on April 21. However, despite getting the notice, the couple did not inform the AMC about the Srinand Nagar case.

TB has been a notifiable disease since 2012 (notification Z-28015/2/2012-TB ) and “all healthcare providers (clinical establishments run or managed by the Government (including local authorities), private or NGO sectors and/or individual practitioners) are required to notify every TB case to local authorities i.e. District Health Officer/Chief Medical Officer of a district and Municipal health Officer of a Municipal Corporation/Municipality every month in a given format.

In a notification issued on March 16 this year, the Health Ministry also made it mandatory for all Pharmacies, Chemists and Druggists dispensing anti-tubercular medicines to notify respective TB patients along with details of medicines. They are also required to maintain a copy of the prescription and submit to the appropriate local authority. As per this notification, failure on the part of the doctor, Pharmacy, Chemist and Druggist to notify a TB patient to the Ministry of Health and Family Welfare would invite punishment in the form of imprisonment and fine or both, under sections 269 and 270 of the Indian Penal Code.

Section 269 IPC: “Negligent act likely to spread infection of disease dangerous to life. - Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both”.

Section 270 IPC: “Malignant act likely to spread infection of disease dangerous to life. - Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.”

Besides the IPC, India also has other regulatory Acts such as the Epidemic Diseases Act 1987, which also provide for the control of communicable diseases such as TB. The Act empowers state and central government to take special measures and prescribe regulations that are to be observed by public to contain the spread of disease. It gives legal protection to persons acting under the act and has also defined penalty - a punishment under Section 188 IPC (disobedience of order duly promulgated by public servant) of either description for a term which may extend upto 6 months imprisonment or 1,000 rupees fine or both, for violating the regulations.

In most of the municipal corporation acts for example DMC Act (Delhi) TB is defined as a dangerous disease under 2 (9) "dangerous disease" means— (a) Cholera, plague, chicken-pox, small-pox, tuberculosis, leprosy, enteric fever, cerebrospinal meningitis and diphtheria; and (b) any other epidemic, endemic or infectious disease which the Commissioner may, by notification in the Official Gazette, declare to be a dangerous disease for the purposes of this Act; Prevention of dangerous diseases. The DMC act also mandates reporting under section 371. " Obligation to give information of dangerous disease: Any person being in charge of, or in attendance, whether as a medical practitioner or otherwise, upon any person whom he knows or has reason to believe to be suffering from a dangerous disease, or being the owner, lessee, or occupier of any building in which he knows that any such person is so suffering shall forthwith give information respecting the existence of such disease to the Municipal Health Officer. Under Section 482 DMC, the person shall be fined as penalty for breaches for bye-laws.

India launched a TB Free India Campaign on March 13, 2018 and set itself a target of eliminating TB from the country by the year 2025, five years before the global target at the Delhi End TB Summit. The global target for eliminating TB is 2030.

Certainly, notification is important to know the prevalence and incidence of TB cases in the country. A strategy can be then drawn up to eliminate the disease from the country to meet the target.

It is equally important to ensure that patients complete the full course of treatment. Those who discontinue treatment may become infectious, or the period of infectiousness may be extended if currently infectious, and also are at risk of developing drug resistance. 

But, a question then arises “Is it enough to only notify TB?” without ensuring that they are not spreading the infection to close contacts or the community?

TB spreads by airborne droplet infection.

Open cases are considered contagious and just being within close proximity of an infected person who had just coughed, sneezed or spat (even if only while speaking) may expose a person to the risk of acquiring the infection.

The risk of disease transmission is particularly high in overcrowded conditions.

Such open cases could be found anywhere in all walks of life and could be anybody. And they may expose a large number of people to the TB bacteria in day to day life.

So, “Shouldn’t TB patients (especially NDR and XDR), especially open cases, be isolated?”

“Shouldn’t persons who have been exposed to the TB bacteria be quarantined?”

Isolation means separating sick persons with a contagious disease from those who are not sick. Quarantine, on the other hand, means separating and restricting the movement of people who have been exposed to a contagious disease, but are not yet ill, to see if they become sick.

The CDC has defined the “minimum period of isolation of the patient – pulmonary tuberculosis (also includes mediastinal, laryngeal, pleural, or miliary). Until bacteriologically negative based on three appropriately collected and processed sputum smears that are collected in eight – 24 hour intervals (one of which should be an early morning specimen), and/or until 14 days after the initiation of appropriate effective chemotherapy, provided therapy is continued as prescribed, and there is demonstration of clinical improvement (i.e., decreasing cough, reduced fever, resolving lung infiltrates, or AFB smears showing decreasing numbers of organisms.” (Available at: https://www.cdc.gov/tb/programs/laws/menu/isolation.htm)

In its “Guidelines for the prevention of tuberculosis in health care facilities in resource-limited settings” published in 1999, the WHO says, “Ideally, infectious TB patients should be isolated from other patients so that others are not exposed to the infectious droplet nuclei that they generate.”

On discontinuing isolation, it further says that “In settings where MDR-TB is uncommon, those with a diagnosis of sputum-positive pulmonary TB can be considered to be non-infectious and eligible for transfer from isolation or discharge for outpatient management when two criteria are met: they have received appropriate anti-tuberculosis chemotherapy directly observed for a minimum of two weeks and they have shown clinical improvement.”

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Using the Smartphone to monitor heart rate: This is the future

Smartphones have become an integral part of our daily life now, so much so that a world without smartphones now seems inconceivable.

As technology has evolved, the use of phones has undergone a revolution. Each new version of the smartphone is equipped with better and often some mind-boggling features. Physical keypads have made way for touch screen. You can video chat with someone anywhere in the world. All you need is an internet connection on your smartphone. Apps like Google Assistant make it possible to interact with the phone through natural voice. Phones today, therefore, can perform many more functions beyond just making calls.

Apple has now taken a step ahead leaving a trail for the future with two new features in Apple Watch Series 4.

An ECG app on Apple Watch Series 4 is now available. As the first direct-to-consumer product, it helps people to take an ECG right from their wrist, whenever they experience symptoms such as rapid or missed heart beat and also share the data with their doctors.

The irregular rhythm notification feature on Apple Watch can now also monitor heart rhythms in the background and send a notification if an irregular heart rhythm is detected on five rhythm checks over a minimum of 65 minutes

According to a news release from Apple, “New electrodes built into the back crystal and Digital Crown on Apple Watch Series 4 work together with the ECG app to enable customers to take an ECG similar to a single-lead reading. To take an ECG recording at any time or following an irregular rhythm notification, users launch the new ECG app on Apple Watch Series 4 and hold their finger on the Digital Crown. As the user touches the Digital Crown, the circuit is completed and electrical signals across their heart are measured. After 30 seconds, the heart rhythm is classified as either AFib, sinus rhythm or inconclusive. All recordings, their associated classifications and any noted symptoms are stored securely in the Health app on iPhone. Users can share a PDF of the results with physicians”.

Rhythm classification from a 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG app in around 600 participants. The ECG app on Apple Watch showed 98.3% sensitivity in classifying AFib and 99.6% specificity in classifying sinus rhythm in classifiable recordings; 87.8% of recordings could be classified by the ECG app.

In a sub-study of the Apple Heart Study, which included participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80% showed AF on the ECG patch and 98% showed AF or other clinically relevant arrhythmias. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date.

The ECG App and the irregular heart rhythm notification have been provided De Novo classification by the US FDA. They are available as part of a free update to watch OS 5.1.2.

Health care today has shifted from being ‘paternalistic’ to ‘patient-centric’. The patient now wants to be a part of decision making. He has literally all information related to his illness at his fingertips because he has a smartphone.  

Technology has again empowered patients, who can use the App to monitor themselves for signs of AF and be alerted about the event right at the time it is occurring.

It’s a promising tool indeed, yet it needs to be used cautiously.

(Source: Medscape, Apple News)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Hon’ble Delhi High Court bans online sale of medicines across the country

On Wednesday i.e. 12.12.2018, the Hon’ble Division Bench of Chief Justice of Delhi High Court has directed the Central government and the Delhi government to restrain the online sale of medicines by e-pharmacies, as the same it is not permitted under the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948 in a petition filed by one Dermatologist Dr Zaheer Ahmed. 

The petition claimed that lakhs of medicines are being sold online through e-pharmacies, in spite of a direction of the Drug Controller General of India to the State Drug Controllers, “to put a strict vigil on online sale of medicines in violation of the Drugs and Cosmetics Act and Rules thereunder, to protect the interest of public health”, thus violating the citizens’ Right to Life guaranteed under Article 21 of the Constitution.

The petition also highlights the serious consequence that misuse or abuse of drugs can have on human health:

“A large number of children/minor or people from uneducated rural background use internet and can be victims of wrong medication while ordering medicines online which are operating without a drug license…The unregulated sale of medicines online will increase the risk of spurious, misbranded and substandard drugs being sold. Some drugs have psychotropic substances and can be easily ordered on internet and misused for criminal activities or drug abuse.”

Earlier in the month of October, 2018 the Hon’ble Madras High Court had granted an injunction restraining the sale of medicines and drugs online, on a plea moved by the Tamil Nadu Chemists and Druggists Association (TNCDA).

One more petition is pending before the Hon’ble Delhi High Court which is also seeking closure of online pharmacies that are offering drugs and prescription medicines through websites.

The above decisions of both the Hon’ble High Courts are welcome particularly as an online pharmacy sounds convenient; there is no waiting in queues, no rushing to the chemist shop before it shuts shop for the day, placing the order is easy, moreover, the order can be placed any time of the day and the medicines are conveniently delivered via courier at your doorstep. Yet, this convenience comes at a price. Not only there may be financial implications for the patients, their safety may even be endangered at times.

Indian Medical Association (IMA) has never been in favor of online sale of medicines and had raised this issue during my tenure first as Honorary Secretary and later as National President IMA.

The need of the hour is to come out with a defined policy for both online consultations and online pharmacy. In an earlier judgement, the Supreme Court has said no to telephonic consultation, unless it is an emergency. 

So, if telephonic consults are not allowed, then how can online consults or online pharmacy be permitted for patients with no established doctor-patient relationship? 

After much persuasion and objections, the Central Government has introduced some draft rules to amend the Drugs and Cosmetics laws to regulate and allow only licensed e-Pharmacies.

Online sale of medicines has several ill-effects, such as:

·         There are no well-defined dedicated laws for online pharmacies. Pharmacies in India are governed by the Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956.Laws related to ecommerce are defined under the Information Technology Act, 2000.

·         The major issue of concern is that prescription drugs cannot be sold online as there is no provision in any law for sale of prescription drugs online.

·         Online pharmacies may not abide by regulations and rules relating to scheduled drugs as mentioned in Schedule E1, G, H, H1 and X and bypass them. The objective of Schedule H1 was primarily to check the indiscriminate use of antibiotics in India, in view of the rising incidence of multi-drug resistant bacteria, a serious public health issue worldwide. Easy access to antibiotics via online pharmacies will defeat this very purpose.

·         The Drugs and Cosmetics Act has no provisions for online sale of medicines, or home delivery of medicines. Hence, online sale of medicines cannot be legally permitted.

·         The prescriptions submitted via fax/email may be fake, and it could be difficult to verify their authenticity. Online correspondence and/or scanned copies are legally not permitted.

·         Online pharmacies will promote drug abuse, drug misuse, self-medication etc. Any mediation taken without the supervision of doctors may be dangerous and even potentially life-threatening.

·         Pharmacists are not allowed to accept and dispense prescriptions that are brought in by children. Online pharmacies will provide easy access to controlled drugs or even street drugs to this vulnerable group.

·         Regulation 5.3 of MCI Code of Ethics stipulates that pharmacists and doctors should work together. If online pharmacies are allowed, then this relationship will be lost.

·         Many online pharmacies may be operating without the appropriate license. This increases the chances that drugs sold by such unlicensed pharmacies maybe counterfeit, substandard, or adulterated and therefore risky to the patient. There are no checks in place to make sure that the drugs sold by online pharmacies are not spurious.

·         If online pharmacies are allowed, the National Pharmacovigilance Program, initiated by Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, will become a futile exercise. This program is not only meant for doctors but also for pharmacists.

·         Medicines have to be stored properly as recommended by the manufacture. Exposure of medicines to high temperatures in storage or in transit could diminish their efficacy and are a potential health risk. There is no way to check the storage conditions of the drugs sold by the online pharmacies.

·         Regulatory authorities continue to monitor a drug for any adverse effect even after it has been on the market. If the safety/quality of the medicine comes under question or, if it is potentially contaminated, mislabeled or is improperly packaged, then they may recall or withdraw a prescription or OTC drug from the market even after it has been approved. Sometimes, the manufacturer may voluntarily recall a drug. If online pharmacies are permitted, the drug recalls become very, very difficult, almost next to impossible.

·         Breach of confidentiality is another major concern. Online pharmacies may misuse personal and financial information of the patient as well as of doctors leading to cases of identity thefts and fraud.

·         Online pharmacies offer drugs at low cost or at discounted prices to lure customers. If the online pharmacy gives cheaper alternatives of drug/s prescribed, this violates the doctor-patient-pharmacist relationship, which is based on trust.

·         Pharmacy laws in India do not allow a pharmacist to substitute a brand written by a doctor.

·         Pharmacists are also not authorized to change potency of the prescribed drug, even if the patient asks for it.

·         Refilling of a prescription is not allowed by pharmacists unless authorized by the doctor. If the doctor has prescribed a drug, e.g., 3 days, the pharmacist cannot dispense drugs for more than this duration.

·         Online pharmacies may provide rebates and commissions to doctors to provide prescriptions on the basis of online information that has been filled by the patient. This way doctors will be vulnerable to malpractice suits. Regulation 6.4 of MCI Code of Ethics prohibits doctors from giving or receiving any rebates or commissions.

·         Similar to the online search service Justdial.com, online pharmacies may also promote doctor substitution, which is unethica

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA