IUCIPRS Panel Discussion: Implications of Data Exclusivity on Access to Medicines and the Pharmaceutical Industry

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Yogesh Byadwal

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Nov 29, 2025, 4:10:10 AM (yesterday) Nov 29

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Inter-University Centre for IPR Studies (IUCIPRS), CUSAT is organising a hybrid webinar on “Panel Discussion on the Implications of Data Exclusivity on Access to Medicines and the Pharmaceutical Industry” on December 1, 2025, at IUCIPRS and via Google Meet virtual room. The Moderator for the session will be Mr. Gopakumar K. M., and the Panelists will be Prof. (Dr.) Biswajit Dhar and Ms. Chetali Rao.

Background of the Panel Discussion

Data exclusivity grants a pharmaceutical company exclusive rights to regulatory data for a specified period—typically 5 to 10 years—during which regulators cannot approve generic versions of the medicine even if the patent has expired or was never obtained. Unlike test data protection, which merely prevents competitors from unfairly copying or misusing clinical and non-clinical data, data exclusivity actively prohibits government regulators from relying on an originator’s submitted data to review generic applications. This mechanism effectively delays generic market entry and, consequently, keeps medicine prices elevated.

If India were to adopt data exclusivity, the availability of affordable generic medicines would be significantly postponed beyond patent expiry, resulting in higher medicine prices and reduced patient access to essential treatments. Given India’s role as a major supplier of generic medicines to developing countries, such a policy would also have detrimental effects on global access to affordable medicines, particularly in low-income nations. The Risdiplam case illustrates these concerns concretely. Roche’s branded version costs approximately ₹6.2 lakh per bottle, while Natco’s generic version is priced at around ₹15,900 per bottle, representing a 97% price reduction. Following a Delhi High Court ruling in March 2025, Natco obtained approval to commercialise its generic version. According to news reports, there are renewed efforts to introduce data exclusivity in India.

Against this background, we are organising a panel discussion to unpack data exclusivity protection and its implications on the people and the domestic industry.

Mode: Hybrid Mode
Venue: Conference Hall, IUCIPRS and Google Meet Virtual Room
Date & Time: Monday, 1 December 2025, 2:00 PM – 3;00 PM Indian Standard Time (IST)

There is no registration fee. However, Registration is mandatory to attend the programme. The registration link is provided below

https://forms.gle/3oWYPcWhRztE2q9U7

Last Date for registration: November 30, 2025.

Google meet link for joining the meeting is provided below.

Panel Discussion on IMPLICATIONS OF DATA EXCLUSIVITY ON ACCESS TO MEDICINE AND PHARMACEUTICAL INDUSTRY
Monday, December 1 · 2:00 – 3:00pm
Time zone: Asia/Kolkata
Google Meet joining info
Video call link: https://meet.google.com/ndq-btys-emt
Or dial: (US) +1 413-591-4020 PIN: 150 931 461#