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 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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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.
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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].


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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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Gujarat - A Re-emerging Pharma Destination

Gujarat has been the flag bearer of India’s pharmaceutical industry since the establishment of the country’s second oldest drug company, the Alembic Chemical Works Company Limited in Vadodara in 1907. Gujarat’s strategic location on the western coast, coupled with dynamic entrepreneurial talent and favourable policies from the State Government has led it to become one of the premiere industrial hubs for investors looking to invest in India.

Gujarat currently has 33 percent of the aggregate share of the pharmaceutical industry in India[1] and the State also accounts for at least 28 percent of the pharmaceutical exports from India[2]. Moreover, with the advent of the Goods and Service Tax (GST) coupled with the upcoming expiry of tax holidays granted by some northern states of India, the pharmaceutical industry is witnessing a jurisdictional shift, with some of the largest pharmaceutical companies looking to relocate or establish their manufacturing plants in Gujarat.
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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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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.
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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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