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).
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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.
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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”).
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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].
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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.
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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.
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NCOVID-19: From detection to a cure, A regulatory overview

COVID-19 is the latest pandemic after cholera, the bubonic plague, smallpox, NIPAH, ZIKA and influenza-SARS, etc., to have accosted the world. A more aggressive variant of human coronaviruses that cause upper-respiratory tract illnesses, COVID-19 is a new disease, caused by a novel (or new) coronavirus that had hitherto not been seen in humans. The virus, having originated in China, has crossed borders and resulted in global lockdown. The race to find speedy detection and cure has begun at a feverish pace. Meanwhile, more than 300 Indians have already been diagnosed as COVID-19 positive. Six have succumbed to the disease.
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The Green Wave - Legal Challenges, Considerations for Investors in Cannabis Industry

Marijuana or cannabis can be used to treat a multitude of diseases; more importantly, it is known to be effective in reducing pain. In countries or states where medical marijuana is legal, doctors can prescribe it to alleviate nerve pain or glaucoma, or at times to help with nausea caused due to chemotherapy for cancer patients as well as treatment of HIV patients.

Investment in cannabis/ marijuana is not new. Venture capitalist Peter Thiel’s Founders Fund invested in the cannabis industry in 2015. Pharmaceutical companies and governments have long been investing in medical cannabis and conducting scientific research into its medicinal properties. Wellness and health brand, Goop, owned by Oscar winning actor Gwyneth Paltrow, is actively investing in the cannabis industry and selling CBD Oil (a cannabis derivative with potential therapeutic/ medicinal uses).
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KARNATAKA-GOVERNMENT’S-LEGISLATIVE-ATTEMPT-TO-TACKLE-COVID-19-OUTBREAK

The Karnataka Government is reported to have notified the Karnataka Epidemic Diseases, COVID-19 Regulations, 2020 (“COVID Regulations”), on March 11, 2020, late evening, as an attempt to contain the outbreak and spread of coronavirus, COVID-19, which was incidentally declared as a ‘pandemic’ by the World Health Organisation the same day. Issued with immediate effect and for a period of 1 (one) year from its notification, the COVID Regulations empower the district administration to put in place containment measures and also ensure the public takes special measures to prevent the outbreak and spread of the potentially fatal disease, as fears around its ramifications have reached a feverish high worldwide.


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The National Medical Commission Act, 2019. Community Health Providers

This blog post is part of a multi-part series. Our previous posts 1, 2 covered the salient features of the National Medical Commission Act, 2019 (NMC Act) where we highlighted some issues arising out of the same.

The NMC Act has some interesting aspects that relate to Community Health Providers (CHPs). We attempt to shed some light on this proposal.

Community Health Providers

The NMC Act, under Section 32(1) provides for granting of a limited license, “to practice medicine at mid-level as Community Health Provider to such person connected with modern scientific medical profession who qualify such criteria as may be specified by the regulations”. However, it also clarifies that the limited license granted under Section 32(1) shall not exceed one-third of the total number of licensed medical practitioners. Secondly, the scope of practice of CHPs has been limited and they can prescribe specified medicine independently, only in primary and preventive healthcare[1]. It has been clarified that in any situation other than primary and preventive healthcare, they may provide medicines only under the supervision of medical practitioners.
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