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 on Patent Law, Access to Medicines, and International Law. He was also a participant at the SpicyIP Summer School 2026.
Part II: To CL Or Not To CL: That Ought Not Be The Question
By Rishabh Upadhyay
Part I left off with both compulsory licensing under Section 92 and government use under Section 100 converging on the same practical dead end: even a favourable order would have created an entitlement with no one positioned to act on it — no generic manufacturer willing to take on Section 92’s undercutting risk, and no functioning public-sector capacity to answer a Section 100 order. If neither route within the Patents Act was ever going to deliver Ribociclib to patients, the natural question is whether routing around patent law altogether does any better. Rajasthan’s own experience with the drug suggests not, and for a related reason: the gap this time isn’t a willing manufacturer, but scale.
The Way of Rajasthan: State Essential Drug List
Section 92 and government use, then, are insufficient on their own. But one point, at this juncture, is worth underlining: access to medicines is about ensuring access to drugs, and healthcare, not about bypassing patent monopolies. The point being that to ensure access to patented medicines, the first response being a CL is bringing a fire truck to a fire with no water in its tank — the right instrument in principle, rendered useless by the absence of the supportive framework needed to operationalise it in India.
The state of Rajasthan takes a different route to ensure access to Ribociclib by its breast cancer patients. Rajasthan lists Ribociclib 200 mg as NRD-760 on the Nirogi Rajasthan Drug List, under MCH category(See here). Meaning thereby that the drug Ribociclib is available at zero cost to an inpatient or an outpatient of any medical college hospital in Rajasthan, and the entire cost of the drug is borne by the Rajasthan Government out of its health budget. Since the out-of-pocket cost borne by the patient is zero, and one doesn’t have to rely on complex mechanics of CL, diluted working statement, defining public emergency, and depend on red-tapism to catch up, thus, all the states across India should simply replicate this model. Except the model doesn’t hold up. Firstly, the claim of free access to Ribociclib in Rajasthan is much narrower since it is only available to be dispensed by a medical college hospital. The nuance here is that: since medical college hospitals are often present in major city centers, and only in some cities of a state, not all the cities of a state, any drug to be available free of cost through MCH only cannot be said to actually be accessible by the needy patients.
This is compounded by another finding. In order to procure Ribociclib for distribution, Rajasthan Medical Services Corporation floated a 2-year tenure e-bid for the supply of drugs and medicines (see entry 110 on page 68 here). An estimated bid for Ribociclib was placed at an estimated quantity of 285600 tablets, at an estimated cost of over 25 Crores. This raises a question: is it enough? Sadly, no.
The estimated bid quantity would cater to only 174 patients for 2 years at the maximum prescribed daily dosage of 600 mg. As per a 2024 Lok Sabha reply, the “estimated incidence of cancer cases” in Rajasthan had grown consistently from 2019 to 2023, with an estimated number of 11488 incidents of breast cancer in Rajasthan. As per a 2021 study, Luminal HER2 negative (HR positive/HER2 negative) was the most common molecular subtype prevalent in the sample studied, accounting for an approx 50% prevalence in the patient sample. Ribociclib is one of the three leading drugs (the other two being Palbociclib and Abemaciclib) to treat the prevalent type of breast cancer. Thus, based on these data points, approximately 50% of the breast cancer patients in Rajasthan would have prospectively needed ribociclib for treatment back in 2023, and the marked trend indicates that the number would have grown substantially by 2025 when the e-bid was floated for an estimated number of 174 patients only. Epidemiologically, Ribociclib still remains to the majority of the breast cancer patients. This holds true even if we account for two similar—but non-interchangeable—drugs like Palbociclib and Abemaciclib, or the fact that not all patients seek treatment at an MCH.”
Even at full procurement scale, the problem wouldn’t be solved because India’s public trust deficit in public healthcare limits the extent of benefits any government procurement scheme can provide, regardless of how low the price is.
In other words, the state-list route fails for a structural reason that mirrors Section 92 and 100’s failure: a legal entitlement — free access on paper — with no system built at the scale needed to actually deliver on it.
To Look at the Horizon, Look at the Horizon
The discussion till this point might tend to reflect that there is no way to achieve actual access to medicines. However, that is not the point I seek to establish. Access to medicine is not a simple problem, and it cannot be fixed like a tyre puncture. It needs a holistic superstructure which has several elements acting in coherence to achieve access. The exercise of figuring out the fault lines in the current frameworks is to find the optimum way to build the best approach for ensuring access. The solutions discussed in the earlier portions try to solve the access problem with affordability. As Murali Neelakantan put it at the SpicyIP Summer School, affordability doesn’t itself warrant access. Truly so, what is the meaning of pricing a drug at zero, if a patient cannot buy it from the nearest and most convenient point; or there is no accurate epidemiological study around the disease and incident rates of disease. What is the meaning of even granting a CL for a drug like Ribociclib, if the patients’ trust is still in private health infrastructure for specialty treatments which incur costs even beyond the cost of the medicine, and that cannot be fixed by a CL grant.
On the petition-specific point, the conclusion that Ribociclib was structurally unlikely to receive a licence should not be read as “the government evaded a procedure, and fixing the procedure fixes the problem.” The failure is systemic. Compulsory licensing is, definitionally, a last-resort remedy, and its viability depends on background conditions the government is separately responsible for — chief among them a credible Form 27 working-statement regime, the primary evidentiary basis on which Section 84 or Section 92 applications are typically built. The 2024 Patent Amendment Rules relaxed those filing and disclosure obligations; to that extent, the dilution does not merely make this case harder, it structurally weakens the compulsory-licensing route as a mechanism going forward, independent of any government’s willingness to act in a given dispute.
There is also a trade-policy cost too. A more aggressive domestic CL practice affects India’s negotiating position in trade agreements where partners seek stronger data-exclusivity and trade-secret protection in exchange for market access, protections that would constrain the very policy space Sections 92 and 100 preserve. This creates an asymmetric calculation: the domestic benefit of a licence is contingent on a manufacturer who is willing and able to produce the drug, which does not exist as per the records discussed earlier, while the external cost of appearing CL-permissive is immediate and visible. A government weighing that trade-off has limited incentive to invoke Section 92 even in a strong prima facie case.
Ultimately, access to medicine is not solely a patent-law or essential-medicines-list question. It depends on manufacturing capacity that exists independent of any single case, on public-hospital infrastructure credible enough to be a first resort, and on data systems like patent-working data, epidemiological data, etc, robust enough to let regulators and courts decide, efficiently, based on current facts.
Read this way, the Kerala High Court’s 15 July pivot to Palbociclib is a step in the direction where it recognises, correctly, that the compulsory licence is not the only variable worth examining. But if Ribociclib shows anything, it is that swapping one drug, or one legal instrument, for another does not by itself fix an access problem that is infrastructural at its root. The next drug that runs into this same litigation, and there will be one, will hit the same wall, dressed differently, unless that infrastructure is built.
I am grateful to Dr. Prabhat Kumar Saha, Swaraj Barooah, Praharsh Gour and Manasvi Kaushik, for their insightful comments and contribution, without which this post would not have been possible.
