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Utkarsh Bhatnagar

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Senior Associate in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi office of Cyril Amarchand Mangaldas. Utkarsh specializes in corporate transactions, regulatory, and advisory pertaining to pharmaceutical and fintech sectors. He can be reached at utkarsh.bhatnagar@cyrilshroff.com

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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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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Oxytocin Ban in India

Oxytocin is life-saving drug that is used for the induction and assistance of labour in women during childbirth. It is also used to stop postpartum haemorrhage (excessive bleeding). The drug also aids milk secretion during the lactation process. Because of its inherent lifesaving properties in humans and cattle, Oxytocin is identified as an essential medicine in the 20th World Health Organization (WHO) Model List of Essential Medicines, March, 2017[i]. It also continues to be included as an essential medicine in the National List of Essential Medicines (NLEM), 2015[ii].…
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The Healthcare Service Personnel and Clinical Establishments Bill, 2019

In the backdrop of recent attacks and acts of violence against medical practitioners and a growing demand for protection in this regard, the Central Government is considering steps to ensure protection is granted to healthcare professionals and clinical establishments, by making such acts punishable offences under law. After numerous meetings with doctors and other stakeholders, the Department of Health and Family Welfare (Medical Services Division), of the Ministry of Health and Family Welfare, Government of India, vide notification dated September 2, 2019,  proposed a draft legislation titled ‘The Healthcare Service Personnel and Clinical Establishments (Prohibition of Violence and Damage To Property) Bill, 2019’ (the “Bill”).…
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