Drug Regulation

General Comment on the IPO’s Draft Pharmaceutical Guidelines (2026)

/ By / Drug Regulation, Others, Patent

A few days ago, we had informed our readers that they could participate in the open call for comments and suggestions on the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (2026). Several such notifications have been released by the office of the Controller General of Patents, Designs and Trademarks (CGPDTM) in the past few weeks (see here and here). The notification of the new draft of the Pharmaceutical Guidelines was released on September 4, 2026

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SpicyIP Tidbit: CGPDTM Calls for Comments and Suggestions on New Draft Pharma and Biotech Patent Application Guidelines (2026)

/ By / Biological Diversity, Drug Regulation, Others, Patent

In the time of this oncoming monsoon, it feels like its raining draft guidelines from the Controller General’s office! The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has released two new sets of draft guidelines today for the examination of patent applications related to pharmaceutical & biotechnology inventions. These draft guidelines are targeted towards streamlining the patenting procedures of healthcare inventions. All stakeholders invited to submit their comments or suggestions within 15 days from the date of

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SpicyIP Weekly Review (August 24-August 30)

/ By / Copyright, Drug Regulation, Others, Patent, Trademark

After an action-packed week, we have posts remembering one of the most remarkable IP administrators– Mr. P. H Kurian, on the appointment of an amicus in the Vivek Oberoi personality rights case, and on the DHC decision in Array Biopharma Inc. v. Deputy Controller of Patents. This and much more in the last Weekly Review of the month. Anything that we are missing out? Drop a comment and let us know. Highlights of the Week Remembering Mr. P. H. Kurian

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Mavyret Patent Abandonment Does Not Open the Field for Hepatitis C Generics

/ By / Drug Regulation, Patent

July 28, 2026 marked eight years of the National Viral Hepatitis Control Program (NVHCP). Launched under the National Health Mission, the program aims to eliminate Hepatitis C from India by 2030 through free testing and access to generic versions of direct acting-antivirals (DAAs). One of the most effective drugs for curing patients of Hepatitis C virus (HCV) currently in the market is AbbVie’s Mavyret. It is recognised as the first and only DAA approved to treat both acute and chronic

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SpicyIP Weekly Review (27 July-2 August)

/ By / Copyright, Drug Regulation, Others, Patent, Trademark

Stepping into August with posts on the DHC’s order in ANI v. OpenAI, Interdigital v Transsion, the Ribociclib saga, and digital archive. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment and let us know. Highlights of the Week ANI v. OpenAI: User Rights, Fair Dealing, and the Future of AI in Indian Copyright Law (Part I) The Delhi High Court’s much-awaited interim order in ANI v. OpenAI addresses several

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Part II: To CL Or Not To CL: That Ought Not Be The Question

/ By / Drug Regulation, Patent

Continuing from Part I, Rishabh Upadhyay explains that making a patented medicine free on paper does not necessarily make it accessible in practice. Through Rajasthan’s procurement and distribution model for Ribociclib, he argues that India’s access-to-medicines challenge is ultimately an infrastructural one, not merely a patent-law problem. Rishabh is an LL.M. candidate at South Asian University, having completed his undergraduate legal studies at the Faculty of Law, Banaras Hindu University. His interest lies in intellectual property jurisprudence, with particular emphasis

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SpicyIP Weekly Review (July 13- July 26)

/ By / Copyright, Drug Regulation, Patent, Trademark

A round-up of all the important developments from the last  2 weeks, here is the SpicyIP Weekly Review featuring discussions on the Delhi High Court decision in the OpenAI case, the comments submitted to CDSCO on brand name extension, and the missing public consultations on the proposed Copyright Act amendments. This and much more in this week’s Weekly Review. Anything we are missing out? Drop a comment and let us know. Highlights of the Weeks Training ChatGPT on Copyrighted Works

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Comments on CDSCO’s Brand Name Extension Policies

/ By / Drug Regulation, Trademark

Earlier this month, we had shared the news of CDSCO inviting comments on the long standing problem of Brand Name Extensions (BNE) practices. While this problem is one with severe consequences, it appears to have very little public discourse around it. Thanks to the quick work of 2 very industrious SpicyIP Summer School alumni, Rishabh Upadhyay and Umeshawari Ranjan, we were able to put together and send some comments just in time for the deadline. Instead of putting out the

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Brand Name Extensions by Pharma May Finally Be Receiving Scrutiny? 

/ By / Drug Regulation, Trademark

On July 6, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), published a notice inviting comments on the use of brand name extensions by Pharma Companies. This stems from a representation made before the Drugs Consultative Committee alleging that a pharma company was selling different formulations under one brand name with different extensions. However, this problem has been a long-standing one, as explained by Prashant and Dinesh Thakur.  In effect, this notice seems to be towards

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SpicyIP Weekly Review (29 June – 5 July)

/ By / Biological Diversity, Copyright, Drug Regulation, Patent, Trademark

What an eventful week it was, with the post announcing the long-awaited results of the SpicyIP-jhana Blogpost Writing Competition, and posts on legal deposits, black-box AI, and house marks. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment and let us know.    Highlights of the Week Announcing the Results of SpicyIP-jhana Blogpost Writing Competition 2025 After carefully reviewing a range of thoughtful and insightful entries from participants across the

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