Biplab Lenin

Practice Areas

Pharmaceuticals, Healthcare, Lifesciences, Health & Med Tech, Technology, and Intellectual Property

With over 12 years of experience spanning both law firms and corporate environments, Biplab brings deep expertise in the intersections of healthcare, biotechnology, and regulatory compliance. His practice focuses on advising clients on complex regulatory frameworks governing pharmaceuticals, clinical trials, medical devices, nutraceuticals, and digital health organizations, enabling them to confidently navigate approvals and ensure compliance. He has played a key role in significant transactions, advisory mandates, and litigations within the drugs, medical devices, and life sciences sectors, with a particular emphasis on product liability matters in India. In the intellectual property domain, Biplab provides strategic counsel on biodiversity issues, patent prosecution, oppositions, and enforcement.

A published author and accomplished speaker, he is frequently invited to share insights on digital health and the transformative role of technology in the healthcare sector.

Professional Memberships

1. Bar Council of Delhi, India

2. Delhi High Court Bar Association

3. Registered Patent Agent, Indian Patent Office

4. Working Group Member on Intellectual Property, ICC India

Publications

1. Article on “Trust as crucial currency: Strengthening regulations in India’s healthcare sector,” published by Financial Express on Nov 30, 2024.

2. Article on “India’s Food Future: Navigating Global Comparisons And Local Realities” published by NDTV Profit on Oct 10, 2024

3. Article on “Embracing cannabis in ayurvedic products: A progressive step forward?" published in Express Pharma on Sep 07, 2024

4. Article on “The TRICS of digital health: Empowering India’s healthcare transformation” published by Express Healthcare on Aug 10, 2024

5. Article on “AI in Indian Healthcare: The Future Is Now, But Are We Ready?” published by NDTV Profit on July 29, 2024

6. Article on “Digital Health: The Future of Indian Healthcare or Another Hurdle?” published by SCC Online on July 17, 2024

7. Article on “India’s Healthcare Landscape” published by IJPIEL on June 5, 2023

8. Article on “Digital Health—The Internet of (Healthcare) Things and Beyond” published by BW Legalworld on Sep 28, 2022

9. COVID-19 vaccine distribution primer for India, published by Baker McKenzie in 2021

10. Article on “Comparative advertising and the consumer-changing dynamics,” published by Journal of Intellectual Property Rights (JIPR), Vol 22, May 2017, pp 113-120.

11. Article on “Exceptions and Limitation of Patent Rights and its Enforcement in India,” Journal of Intellectual Property Rights (JIPR), Vol 20, September 2015, pp 297-304.

12. Article on “India: A hot spot for medical tourism (legal perspective)” Medico-legal update, International journal from AIIMS, ISSN No.0971-720X, Vol 11, (July-December 2011) No.2 at p.50

Cyril Amarchand Mangaldas Blogs:

• Cure or Supplement: Overlap Between Drugs and Nutraceuticals Dec 9, 2024

• Advertisements of Illusions: A Look into Advertising Practices of Clinical Establishments in India, October 16, 2024

• Prescription for Deception—An Analysis of Pharmaceutical Advertising in India, Oct 08, 2024

• Beyond the Basket: Inside India’s Diverse E-Commerce Food Landscape—Part 2 August 6, 2024

• Beyond the Basket: Analyzing Underlying Challenges for India’s E-FBOs—Part 1, July 24, 2024

• From Farm to Fork: Demystifying India’s Food Safety Standards June 12, 2024

• Mind Your Meds and Metrics: Navigating the Indian Health Data Protection Labyrinth June 11, 2024

• Impact of the Jan Vishwas Act, 2023, on the Pharmaceuticals Industry—Decriminalizing Minor Offences One Step at a Time June 5, 2024

• Ayurvedic Medicine in Contemporary Times: Part 2—Spicing Up Food Products April 30, 2024

• Ayurvedic Medicine in Contemporary Times: Part 1—Understanding Clinical Evaluation and Drug Development April 23, 2024

• Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape April 15, 2024

• Pre-Clinical Testing on Claws and Paws: Decoding the Permissibility of Animal Experimentation March 19, 2024

• Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time March 12, 2024

• Linking Patents to Pills: Unraveling the Patent Linkage Framework for Pharmaceutical Products in India February 20, 2024

• Innovative Medical Devices under the Lens of Clinical Investigations—A Dormant Volcano Waiting to Erupt? August 14, 2023

• Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma July 31, 2023

• What Does the Box Say? Exploring the legality of advertisement strategies commonly deployed by FMCG companies, July 25, 2023

• Barking up the Right Tree: A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas July 3, 2023

• The (Pawsome) Pet Care Sector: Legal Insights June 29, 2023

• Beneath the Surface: Scrutinizing India’s Organ Donation Laws and the Dilemmas of ‘Brain-Stem Death’ June 22, 2023

• Concept to Compliance: Unveiling the Untapped Realm of Customized Cosmetics Regulation in India June 13, 2023

• Examining the Regulatory and Operational Issues Affecting M&A in Pharmaceuticals and the Healthcare Industry, March 27, 2023

• Evolving Landscape of Diagnostics’ Regulation in India & Digital Healthcare March 20, 2023

• Genetic Testing: A New Doorway Towards Opportunities and Challenges in Preventive Healthcare September 22, 2022

• Pharmaceutical and Healthcare Industry: A Case for Regulation Through Blockchain June 20, 2022

• Consent in Healthcare: Outline, Gaps, and Conundrum (Part 2) June 16, 2022

• Consent in Healthcare: Outline, Gaps, and Conundrum (Part 1) May 24, 2022

• In Search of a Vaccine for Covid-19: A Race to The Finish July 20, 2020

• To Protect or Not to Protect: That is the Question: Patent Licensing in Times of Covid-19 Pandemic, May 22, 2020

• NCOVID-19: From detection to a cure. A regulatory overview March 23, 2020

• The Biodiversity Act of India: An Introduction October 31, 2019

• Over-the-Counter Drugs: Regulatory Clarity on the Horizon September 20, 2019

• New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview July 31, 2019

• You shall not pass! A look at the recent ban on advertising of Ayurvedic drugs January 23, 2019

• Now you see it, now you don’t!! The Law on Drug Promotion and Marketing in India October 15, 2018

• Medicines in Your Mail: The India Regulatory Story September 25, 2018

• To Regulate or Not to Regulate: DPCO 2013 and The Modi-Mundi Pharma Case August 21, 2018

Work Highlights

1. Advised Advent International in its proposed investment of INR 2,475 crore in Apollo Healthco Limited—a material subsidiary of Apollo Hospitals Enterprises Limited.

2. Advised Qure.ai, an entity engaged in the business of providing AI solutions to the healthcare sector in its Series D fundraise.

3. Advised Biocon Biologics Limited in the sale of its dermatology and nephrology branded formulations business units in India to Eris Lifesciences Limited.

4. Advised Laurus Labs Limited in its Series B investment in Immunoadoptive Cell Therapy Private Limited.

5. Advised Novozymes in acquiring a majority stake in Synergia Life Sciences Private Limited.

6. Advised Vitol Asia Pte. Limited's investment in Sun Mobility.

7. Advised promoters of Suven Pharmaceuticals Limited in relation to acquisition by Advent for a majority stake followed by an open offer.

8. Advised Mastercard (a technology company in the global payment industry) in relation to its investment in Pine Labs, Asia’s leading merchant commerce platform.

9. Advised Colorcon Inc., a world leader in the design and development of specialty excipients for the pharmaceutical and nutritional industries, in the acquisition of a majority stake in Ideal Cures.

10. Advised TAKE Solutions on the sale of a majority stake in its clinical research organization to HIG Capital Partners.

Personal

Thought Leadership/Public Speaking Engagements:

1. Speaker at the 3rd edition of the Patient First Summit, by IHW Council at Mumbai on December 13, 2024

2. Speaker at India Blockchain Summit, New Delhi, October 19, 2024.

3. Speaker at the General Counsel Conclave by BW Legal World on May 11, 2024.

4. Speaker for workshop on legal and regulatory challenges related to the pharmaceutical industry, organized by RGSOIPL, IIT Kharagpur, December 2022.

5. Speaker for webinar on “Patent infringement and legal recourse available” hosted by BW Legal World on July 30, 2022.

6. Speaker at Startup Law and Policy Summit, CIILE-CNLU, on August 24, 2024

7. Regular speaking engagements at IIT Kharagpur, KIIT Law School, NMIMS-Indore, IIM Bodhgaya, CNLO, and CNLU.

Clients

Korindea Healthcare, Becton Dickinson, BBraun, and Urban Company

Education

Awards