Photo of Biplab Lenin

Partner in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Biplab is an alumnus of IIT Kharagpur Law School. He is also an Industrial Biotech Engineer and a registered patent agent. Biplab specializes in regulatory, transactions, advisory and disputes pertaining to drugs, medical devices, healthcare, food, biotechnology, intellectual property matters including patents, plant variety and biodiversity. He can be reached at biplab.lenin@cyrilshroff.com

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)

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

Patent Licensing in times of Covid-19 Pandemic

The entire world has been grappling with the COVID-19 pandemic for some time now, and efforts are on to find a treatment protocol and vaccine. Several drugs and treatment therapies are being tried and tested to find a cure for this pandemic. In the middle of this fervent R&D activity, some questions come to mind — what about IP protection? How would companies commercialise a cure — if and when it is finally found? How would the cure be available to the public en-masse at affordable prices? Enter patent law and the aspect of Licencing.
Continue Reading To Protect or Not to Protect that is the Question : Patent Licensing in times of Covid-19 Pandemic

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

Introduction to the Biodiversity Act of India

India is known to the world for its diversified biological resources. Arising out of its obligations as a signatory to the United Nations Convention on Biological Diversity held at Rio de Janerio in 1992, and “to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of benefits arising out of the use of biological resources and knowledge”, the Biological Diversity Act, 2002 (BD Act) was enacted by India to regulate access to, and use of, its biological resources.

In essence, the BD Act mandates approvals from the National Biodiversity Authority (NBA) and to inform State Biodiversity Authorities (SBAs) for people to access and use biological resources, or knowledge associated thereto, for research purposes, commercial utilisation, bio-survey and bio-utilisation, for applying intellectual property or for transferring results of research.
Continue Reading The Biodiversity Act of India: An Introduction

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

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.
Continue Reading New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview

Ban on advertising of Ayurvedic drugs

The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) vide notification G.S.R. 1230(E) on December 21, 2018 has notified the Drugs and Cosmetics (Eleventh Amendment) Rules, 2018 (Amendment) ,which was subsequently published on December 24, 2018[1]. This Amendment seeks to regulate advertisements of Ayurvedic, Unani and Siddha drugs (ASU Drugs) in an attempt to curb misleading advertisements.

This step has been taken in light of the government’s reaction to the recent increase in the number of misleading advertisements relating to ASU Drugs. In 2017, the Ministry of AYUSH stated that it had signed a Memorandum of Understanding (MoU) with the Advertising Standards Council of India (ASCI), a self-regulatory organisation for the advertising industry, to monitor misleading advertisements being published in print and TV media.[2]
Continue Reading You shall not pass! A look at the Recent Ban on Advertising of Ayurvedic drugs

Drug and Medicine Promotion and Marketing Laws in India

Unethical marketing practices have for long been a bone of contention for the Government as well as patient right groups. Time and again, the pharmaceutical industry has been accused of adopting questionable practices in relation to the marketing of their products. The main focus of attention in this respect has been suspect interactions between pharmaceutical companies and healthcare practitioners/ providers (“HCPs”). So much so that the Draft Pharmaceutical Policy,2017[1] also notes that unethical practices deployed by pharma companies is an area of concern.
Continue Reading Now you see it, now you don’t!! The Law on Drug Promotion and Marketing in India