Pharmaceutical and Healthcare

Since the inception of the ‘world wide web’, no other technology in the digital space has caught the attention of the world quite like ‘blockchain’. It has the potential to be a gamechanger with its promise of unmatched data security. Even though the implementation/ application of blockchain’s much-coveted underlying technology into various other industries has been a very recent phenomenon, the learned are already prophesising about  its ability  to shepherd us into a completely new way of network interactions and data storage. This future reality has been nick-named  ‘Web3’.

Continue Reading Pharmaceutical and Healthcare Industry: A Case for Regulation Through Blockchain

Consent in Healthcare

In Part 1 of this series (Consent in Healthcare: Outline, Gaps and Conundrum), we presented a brief regulatory background on informed consent in healthcare in India, as well as judicial pronouncements on the topic. We also focussed on specific methods of obtaining consent as prescribed by such regulations.

In this section, we’ll look at the practical implications of such legislations and rulings, particularly in the context of telemedicine and digital health, as well as instances in which the patient is unable to provide consent.

Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 2)

Consent in Healthcare

Informed consent is the bedrock of ethical medical practice. It is when a medical practitioner explains a medical treatment, irrespective of whether it is simple, sophisticated, fundamental, or specific, to a patient, before the patient agrees to it. It is crucial from a liability perspective as well. The Delhi High Court, in a recent order[1], noted with concern the absence of informed consent taken from a patient who underwent a hair transplant, which resulted in complications, leading to death of the said patient. The Court pointed out that hair transplantation, being an aesthetic surgery, needs to be performed by qualified dermatologists or trained surgeons with informed consent of the patient. While this matter relates to the limited aspect of informed consent in a cosmetic surgery setting, the issues raised in the case may have broader implications.

Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 1)

Coercive Vaccination! Explaining the Jacob Puliyel v. Union of India case

On May 02, 2022, the Hon’ble Supreme Court of India passed its judgement in a matter titled Jacob Puliyel v. Union of India & Ors[1], wherein it closely examined the details of the vaccination policy, the dissemination of clinical trials data, veracity of emergency approvals of vaccines and the reporting of adverse impacts of vaccination.

Continue Reading Coercive Vaccination! Explaining the Jacob Puliyel v. Union of India case

In Search of a Vaccine for Covid-19 - A Race to The Finish

The Covid-19 pandemic has wreaked havoc on mankind, infecting well over 13 million, and claiming over half a million lives. It has also severely impacted economies across the world. Our healthcare infrastructure has been pushed to its limits and our frontline healthcare professionals are working to the brink of exhaustion, risking their own lives to save others. We bow to them.

In the midst of all this, scientists across the world are working feverishly to find a vaccine for this disease. The hopes of billions rest on this. The World Health Organization (“WHO”) has (as of July 15, 2020) declared that there are about 23 potential vaccine candidates that are currently in various stages of clinical trials[1]. Out of these 23 vaccines, vaccines being developed by: (a) Sinovac (inactivated +alum); and (b) University of Oxford / AstraZeneca has entered into the Phase-III of its clinical trials[2]. In addition, as of July 15, 2020, there are around 140 vaccine candidates in preclinical evaluation (trials not commenced).
Continue Reading In Search of a Vaccine for Covid-19: A Race to The Finish

BIO-MEDICAL WASTE AND LIABILITY OF HOSPITALS IN WAKE OF THE COVID-19 PANDEMIC

Introduction:                 

The handling, disposal and management of bio-medical waste (“BM Waste”)in India is government by inter-alia, the Biomedical Waste Management & Handling Rules, 1998 (“1998 Rules”) were notified by the Central Government in exercise of the powers conferred by Section 6,8 & 25 of the Environmental Protection Act, 1986. These rules provide for the framework of the management and Handling of disposal and scientific management of BM Waste

In wake of the COVID-19 pandemic, the Centre Pollution Control Board (“CPCB”) recently issued guidelines dated March 27, 2020 for handling, treatment and safe disposal of BM Waste generated during treatment, diagnosis and quarantine of patients confirmed or suspected to have COVID-19 (“Guidelines”). The Guidelines have been necessitated due to the super infectious nature of the Novel corona virus and provide for a mechanism for the segregation, packaging, transportation, storage and disposal of BM Waste in order to avoid further spread of the virus through BM Waste.
Continue Reading BIO-MEDICAL WASTE AND LIABILITY OF HOSPITALS IN WAKE OF THE COVID-19 PANDEMIC

The Epidemic Ordinance, 2020 - An ‘opportune’ armour for the protectors

The world is grappling with an unknown virus that has escalated to a global pandemic in no time. At the very forefront of this battle against the unknown, are the medical healthcare professionals who have been working relentlessly to treat the rising number of patients across the globe, sometimes even without adequate protective gear[1]. Therefore, it is disheartening when one comes across news regarding them being subject to unprovoked violence from the public[2] in this time of crisis. The need to protect these frontline healthcare professionals was felt strongly by the Indian government in order to ensure seamless treatment of patients during the current pandemic. With these objectives in mind, the President of India on April 22, 2020, promulgated the Epidemic Diseases Amendment Ordinance 2020 (“Amendment Ordinance”), to amend the Epidemic Diseases Act, 1897 (“Epidemic Act”).
Continue Reading The Epidemic Ordinance, 2020: An ‘opportune’ armour for the protectors?

COVID-19 TEST KITS. A CHEAT SHEET

The COVID-19 pandemic has literally brought the world to a standstill. Large scale infections have resulted in lockdowns across the globe. At this critical juncture, testing continues to remain the most important step to get a grip over the situation. The situation in India is no different. With an upsurge in the number of COVID-19 cases in India, the need for largesse testing has become paramount. Low availability of test kits remains a cause of great concern to the government and healthcare practitioners. This is compounded by our massive populace, given the quantity that is required in the current scenario. This lack of availability of test kits is primarily because India does not have adequate indigenous manufacturing units of COVID-19 test kits and relies heavily on imported kits.

From a regulatory standpoint, such kits fall under the category of ‘in-vitro diagnostic’ kits under the Drugs and Cosmetics Act, 1940 (D&C Act) read with the Medical Devices Rules, 2017 (MD Rules) and are regulated as ‘medical devices’[1].
Continue Reading COVID-19 Test Kits. A Cheat Sheet

DIAL-A-DOCTOR-A-look-at-the-Telemedicine-Practice-Guidelines-2020

The Ministry of Health and Family Welfare (“MoHFW”), on March 25, 2020, issued the Telemedicine Practice Guidelines (“Guidelines”) providing Registered Medical Practitioners (“RMPs”) with guidelines to treat patients remotely by using the telemedicine tools at their disposal.

Concepts such as telemedicine have gained prominence pursuant to the rapid development of information technology and the need to service the requirements of patients who may not be able to visit healthcare facilities, or have little to no access to the same. Such services involve the transfer of medical information and expertise through telecommunication and computer technologies and aim to facilitate diagnosis, treatment and management of patients. Currently, in India, platforms such as ‘practo’ and ‘DocOnline’ exist which facilitate online medical consultations albeit in a restricted manner given stringent regulatory controls on the practice of medicine. Though such platforms would help to deliver widespread healthcare services, there exist several concerns that exist about the medicolegal implications of telemedicine relating to registration, licensing, insurance, quality, privacy and confidentiality issues, as well as other risks associated with electronic health care communication.
Continue Reading DIAL A DOCTOR- A look at the Telemedicine Practice Guidelines, 2020

COVID-19 - A lot done, more needs to be done

With the World Health Organization (WHO) declaring Coronavirus or COVID-19 a pandemic, it is now essential that countries and organisations that have the ability to find solutions come together, share information as much as possible and work together across borders. Already, experts are worried that the impact of Covid-19 may surpass that of the 2008 global downturn. Till date, globally, nearly 4,71,417 people have tested positive and approximately 21,295 have lost their lives to the deadly virus. On the date of drafting this article, the number of COVID-19 positive cases in India had crossed 700 (seven hundred), with 14 (fourteen) people succumbing to the disease. India is now under a full government ordered 21-day lockdown. A cure remains elusive till date. But in the words of famous author Louisa May Alcott, ‘Be comforted, dear soul! There is always light behind the clouds’. And it is this light that India needs to focus on in order to secure a future that survives the present.
Continue Reading COVID-19: A lot done, more needs to be done