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Biplab Lenin

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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

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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

Online Pharmacy Regulations in India

The Indian Pharmaceutical industry is in its prime phase of growth today at 11-12% per year. While exports occupy a huge chunk, the country meets nearly 95% of its own domestic demands through indigenous production and the domestic retail market is growing by leaps and bounds.

Sale of drugs in India is currently governed by the Drugs and Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). At present, the law permits sale of drugs through brick-and-mortar pharmacies only. The law as it currently stands is somewhat out of tune with the times in that it is still to catch up with the concept of online sales of drugs.
Continue Reading Medicines in Your Mail: The India Regulatory Story

To Regulate or Not To Regulate DPCO 2013 and The Modi-Mundi Pharma Case

Drug price control has been a source of considerable agony to the pharmaceutical industry. Price caps on drugs, though flowing from a larger public interest perspective, has the power to throttle growth of the industry and limit availability of new life saving-drugs to the public at large. It is much to the chagrin of the major players and their business models. The Government has of course adopted the public comes first policy, which has also seen considerable support by the courts. Right or wrong depends on which side of the street one is on.

Price control as a measure has met with its fair share of challenges and is, as a policy issue, here to stay. Interpretation of price control regulations (DPCO) on the other hand is still a topic for many a contentious litigation before courts. The most recent one is a case where the Hon’ble Delhi High Court on July 17, 2018, passed a judgment in the case of Modi-MundiPharma Pvt. Ltd. v Union of India & Ors[1]. Here, the court opined that drugs developed through incremental innovation or a novel drug delivery system could only be included under the National List of Essential Medicines 2015 (NLEM) for the purpose of fixing the ceiling price, procurement etc. if they were explicitly listed. In other words, the court clarified on what kind of drugs are included.Continue Reading To Regulate or Not To Regulate: DPCO 2013 and The Modi-Mundi Pharma Case