Photo of Kartik Jain

Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi office of Cyril Amarchand Mangaldas. Kartik graduated from National Law University, Delhi in 2018 and specializes in regulatory compliance, advisory work and litigation pertaining to the pharmaceutical and health-care industry. He also has experience in labour and employment matters, having worked in the Employment laws practice at the firm’s Delhi office. He can be reached at kartik.jain@cyrilshroff.com.

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

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.
Continue Reading NCOVID-19: From detection to a cure. A regulatory overview

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.
Continue Reading The National Medical Commission Act, 2019. Community Health Providers: Legitimate or Not

National Medical Commission Act 2019 - Part 2

This blog post is a part of a multi-part series. In the first part, we had written about the salient features of the National Medical Commission Act, 2019 (NMC Act) and the regime proposed by it. In this part, we will analyse some of the contentious issues in relation to the NMC Act.

Independence of Autonomous Boards:

The NMC Act has made provisions for the constitution of 4 (four) autonomous boards, namely, the Under-Graduate Medical Education Board; the Post-Graduate Medical Education Board; the Medical Assessment and Rating Board; and the Ethics and Medical Registration Board (Boards). However, in terms of Section 16(1) of the NMC Act, these “autonomous” Boards will remain under the overall supervision of the National Medical Commission (NMC). Section 16(2) of the NMC Act further provides that each of the abovementioned Boards shall be an autonomous body, however, in the same breath, it also dictates that these Boards shall carry out their functions subject to regulations made by the NMC. Furthermore, the Central Government has been entrusted with the responsibility of appointing the President and Members of these Boards on the recommendation of a ‘Search Committee’, which itself is comprised majorly of Central Government appointees. In terms of Section 23(1) of the NMC Act, the presidents of the Boards have been allowed only such administrative and financial powers, “as may be delegated” by the NMC.
Continue Reading The National Medical Commission Act, 2019. A Look : Part 2

Over the Counter drugs Regulations in India

Over The Counter (OTC) drugs are drugs that can be sold by pharmacists without a prescription from a Registered Medical Practitioner (RMP). Many drugs are sold over the counter without prescription, but the regulatory regime is grey in this regard, primarily because the term OTC has not been expressly defined under the Drugs & Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). Regulatory ambiguity is set to change, however, as the Central Government is now actively considering regulating the sale and distribution of OTC drugs[1].


Continue Reading Over The Counter Drugs – Regulatory Clarity on the Horizon

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].
Continue Reading The Oxytocin Ban Story

The National Medical Commission Act, 2019

The National Medical Commission Act, 2019 (NMC Act) has been notified vide the Gazette Notification dated August 8, 2019. The NMC Act aims to repeal the Indian Medical Council Act, 1956 (IMC Act) and constitute the National Medical Commission (NMC), which shall supersede the Medical Council of India (MCI).

This blog post is part of a multi-part series. In this first part, we provide an overview of the salient features of the NMC Act and the regime proposed by it. In subsequent parts, we will endeavour to analyse the various contentious issues in the NMC Act in greater detail as the same has been met with significant angst from medical professionals.
Continue Reading The National Medical Commission Act, 2019. A look : Part 1

New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview India 

Issues around payment of compensation in cases of clinical trial related injury, disability and death have long remained open. Despite a directive from the Hon’ble Apex Court, much was left open to question. On March 19 of this year, the Ministry of Health and Family Welfare (MoHFW) eventually took steps in this regard and notified the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the aegis of the Drugs and Cosmetics Act, 1940 (D&C Act), thus bringing an end to a long-drawn-out process to codify the rules applicable to clinical trials.
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Sec 377 LGBT Employment in India

The Supreme Court of India has held Section 377 of the Indian Penal Code, 1860 (IPC) to be unconstitutional, in so far as it penalises any consensual sexual relationship between two adults, be it homosexuals, heterosexuals or lesbians (Navtej Singh Johar v. Union of India and Ors. (2018) (Johar Judgment). By way of this landmark judgment, the Supreme Court has overruled its earlier decision in Suresh Kumar Koushal v. Naz Foundation (2013), whereby, the validity of Section 377 of the IPC had been upheld.
Continue Reading What Does the Section 377 Judgment Mean for a Modern Day Employer?