India: Life Sciences, Biotechnology & Nanotechnology

India's Patent Office has released draft biotechnology examination guidelines that fundamentally reshape how U.S. patent practitioners should approach Indian filings. With strict limits on claim amendments and new standards for diagnostics, efficacy data, and enablement, the window to optimize claims closes at PCT national-phase entry—making pre-filing strategy more critical than ever.

India has redrawn how it examines biotech patents for the first time since 2013. If you own a portfolio in pharma, biologics, biosimilars or diagnostics, the draft changes what will get granted in India — and what won’t.

The Delhi High Court (Justice Jyoti Singh) allowed a cancellation petition under Section 57 and struck DAPLOGIN (Class 5) from the Register, finding it deceptively similar to Dr. Reddy’s earlier coined mark DAPLO for a diabetes drug with the same active ingredient, dapagliflozin.

For years, the medical device industry has operated in a regulatory tug-of-war caught between the labelling requirements of the Legal Metrology (Packaged Commodities) Rules, 2011 & amendments thereof (“LM Rules”) and Medical Devices Rules, 2017 (“MD Rules”).

India's life sciences and healthcare sector saw significant regulatory shifts in April 2026, including proposed decriminalization of minor violations, new medical device testing fees, and streamlined foreign training requirements for healthcare professionals. Courts also delivered key rulings on pharmaceutical trademark disputes, reinforcing stricter standards for drug name similarity.

India's healthcare and pharmaceutical sectors are undergoing significant regulatory transformation through new frameworks for AI adoption, enhanced surveillance of drug supply chains, and streamlined approval processes.

Welcome to the October 2025 edition of our Life Sciences and Healthcare Newsletter, where we highlight the latest developments shaping the industry.

Welcome to the September 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry.

Agriculture has always been the backbone of human civilization and safeguarding plant genetic resources has become a crucial endeavor in the 21st century.