For years, Section 92 and 100 levers have occupied a central place in discussions on improving access to patented medicines in India. Yet, despite repeated calls for their use, the mechanism has remained almost entirely dormant. This 2-part post by Rishabh Upadhyay explains that the ongoing Ribociclib litigation before the Kerala High Court offers an opportunity to ask whether inaction over Section 92 and 100 requests is a consequence of governmental reluctance, or whether it reveals a deeper structural reality. In Part I of the post, he explains why Sections 92 and 100 were never going to produce a licence for Ribociclib in the first place. In Part II of the post, he discusses a state-level alternative — Rajasthan’s essential drugs list — and asks whether routing around patent law altogether fares any better. 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 I: To CL Or Not To CL: That Ought Not Be The Question
By Rishabh Upadhyay
The 15 July Order: The Right Question, the Wrong Method
On July 15th 2026, the Kerala High Court in the writ petition XXXX v. Union of India, regarding CL grant for patented breast cancer drug Ribociclib, recorded the submission of respondents arguing that Sections 92 (to fast track compulsory license in a national emergency, extreme urgency, or public non-commercial use) and 100 (allowing to use the inventions for purposes of government) need not be invoked at all. This is because the proposed alternative – Palbociclib, originally Pfizer’s, is now off-patent and produced by multiple Indian companies at a lower price. Based on the arguments, the Court’s provisional view was that if Palbociclib serves the same clinical purpose, any ruling on Sections 92 or 100 would be “purely academic,” and it directed four expert and regulatory bodies to report on interchangeability. (See para 4 of the order and a recent report on the interchangeability of the said drugs here). The Court’s observation points towards an approach to access to medicines which is not a compulsory license. At this point though, I am not going to comment on the correctness of the specific solution being considered by the court, since it has been discussed by Tejaswini (read here).
However, this does make one contemplate: are compulsory licenses not the apt solution when we are dealing with access to medicines, or is the problem that no single legal instrument — whether a licence or a state procurement list — can substitute for infrastructure that doesn’t exist?
I use the Ribociclib litigation as a case study to test this, tracing what actually happens when each available route — Section 92, Section 100, and even a state’s own essential-drugs list — is followed through to its practical end. The pattern that emerges is not that the government is merely unwilling to use these tools, though it is that too, but that each tool, even used in good faith, runs into the same wall: no willing or able manufacturer, no reliable data on who needs the drug and where, and no public health delivery system patients trust enough to use. Read this way, the Court’s instinct to look past the compulsory licence question is the right one — it just stops one step too early.
This post is in two parts. Part I, below, asks why Sections 92 and 100 were never going to produce a licence for Ribociclib in the first place. Part II turns to the state-level alternative — Rajasthan’s essential drugs list — and asks whether routing around patent law altogether fares any better, before drawing the two threads together.
The Case So Far
W.P.(C) No. 18999 of 2022, now titled In Re: Exorbitant Pricing of Life Saving Patented Medicines, has been before the Kerala High Court for close to five years. It began as an individual writ by a breast cancer patient seeking a compulsory licence under Section 92, or government-use authorisation under Section 100, of the Patents Act, 1970, for Ribociclib — the CDK4/6 inhibitor manufactured by Novartis and used to treat HR-positive, HER2-negative metastatic breast cancer. The petitioner died during the pendency of the case in September 2022, and the Court converted the matter into a suo motu proceeding, appointing her counsel as amicus curiae. Novartis and Eli Lilly (manufacturer of Abemaciclib, drug for treating similar subtype of breast cancer) were later impleaded, and four expert bodies — the National Cancer Institute Jhajjar, Chittaranjan National Cancer Institute, the Regional Cancer Centre Thiruvananthapuram, and the Drug Controller General of India — were suo motu added as respondents by the Court’s order of 15 July 2026.
On July 17th 2026, the Supreme Court also considered the matter suo motu on a representation made by the Working Group on Access to Medicine, In Re: Access to Life-Saving Medicines and Judicial Expediency in Article 21 Matters. The Apex Court issued notice, allowing two public health organisations to intervene, and directed the Kerala High Court to decide the case expeditiously. Over the intervening period, the matter has been listed 57 times without a final hearing. The genus patent for Ribociclib, held by Novartis and Astex Therapeutics, expires on 24 May 2027. Whatever the High Court decides now will apply, at most, to the residual months of a patent term that is already ending. A case which was originally positioned around obtaining a compulsory licence for Ribociclib has, through the 15 July 2026 hearing, effectively been repositioned around finding an alternative to that licence, specifically, whether Palbociclib, an out-of-patent drug in the same drug class, can substitute for it. The writ petition has been discussed in earlier posts as well at different instances by Matthews, Praharsh, and Tejaswini.
Why Sections 92 and 100 Were Never Going to Produce a Licence
In the specific case of Ribociclib, Sections 92 and 100 were unlikely to produce a CL ever— not for one reason, but for a set of reasons that compound each other: a government that evaded the question on procedure, a licensing design that no manufacturer had reason to use even if it wanted to, and a government-use route that assumed a manufacturing capacity India no longer has.
A. Procedural Evasion
Both sections empower the “Central Government” to take decisions on the grant of CL. Yet, the attitude of the Government towards them has been lopsided. The Ministry of Health (MoHFW) and the CDSCO, in a meeting, acknowledged that the request by the petitioner was made for either a CL under Section 92 or government use under Section 100 (see exhibit R1(a)). However, they exclusively deliberated upon Section 92 only, even though, as discussed later, a full deliberation on both provisions would not have changed the practical outcome. Furthermore, there was no discussion as to why and how it was decided that none of the grounds–national emergency, extreme public urgency or public non-commercial use–under Section 92 of the Patents Act, 1970 are satisfied.
Later, the DPIIT, in its 2022 order deciding upon the representation of the petitioner to consider grant of CL under Section 92 or government use under Section 100, reaches the conclusion that the conditions are not satisfied to warrant a Section 92 CL for Ribociclib, without disclosing the grounds upon which this conclusion was formed.
With regard to the applicability of Section 100, DPIIT looked back at MoHFW’s silence and declared that the issue of Section 100 is “non-est” (legally non-existent) because no formal requisition was made. (Refer to para 16 of the order.) Notably, the petitioner filed the representation before the DPIIT, not the MoHFW, and the DPIIT is the nodal authority of the Central Government for dealing with matters pertaining to Patents. The DPIIT cannot evade the discussion of the possibility of the Section 100 applicability to the matter only because MoHFW didn’t raise it.
The evasion by the executive to even consider the case on the merits of either Section 92 or Section 100, signifies that it is not inclined towards using the flexibilities under the Patents Act to ensure access to medicine, and lacks the political will to do so.
This is consistent with the government’s conduct in recent times. During COVID-19, in a suo moto matter where the Supreme Court examined the scope of Sections 66, 92, and 100, the government’s own preference was for voluntary licensing over compulsory licensing. If a declared global pandemic did not prompt the executive to invoke Section 92 or Section 100, it is unclear what evidentiary threshold a single non-emergency disease could meet to trigger it. This lack of political will is further tracked by the recent Patent Amendment Rules, 2024 (for an analysis read here), and the signing of the recent FTAs of India with the UK, EFTA, and EU. These developments cumulatively have produced an effect where the Indian Patents Law is “harmonized” with the international standards.
B. Why Political Will Alone Wouldn’t have been Enough
Solely reading the lack of political will as a reason why CL has not been used or even showed a possibility that it could be, would be misleading. There is a design flaw in the CL framework, and how it is to be operationalised, making it hard to even consider it as a solution for access to medicine in the first place. The deeper problem, in other words, is not simply that the government won’t use Sections 92 or 100 — it’s that these provisions cannot, on their own, produce access even when they are used.
Let’s assume that the DPIIT under Section 92 issued a notification declaring that CLs will be issued for Ribociclib. What would happen next? Applications were to be made to the Controller by the prospective licensees to be granted those CLs. In the case of Ribociclib, these licensees would have been generic manufacturers.
And this is the point where it gets tricky. Even in such a scenario, no generic manufacturer would have made an application for the grant of a CL for Ribociclib. The first reason being that the Central Government filed a response which noted that CDSCO was “requested to examine the possibility of examining the drugs in India by companies already granted permission,” which was met with no results. Moreover, across the period of nearly five years, no domestic generic manufacturer sought impleadment to express interest in producing Ribociclib under a CL. This points to a direction that CL under Section 92 is not self-executing, since it not only requires a politically willing government but also depends on willing manufacturers who can be licensees. Additionally, this is not a Section 92-specific problem, CL framework under Section 84 also requires a willing manufacturer to apply for a CL.
Section 92 has another structural feature which compounds the problem. Section 92 contemplates “compulsory licences” to potentially multiple manufacturers rather than one exclusive licensee. Therefore, any first mover risks being undercut on price by later entrants, as well as risks bad relationships with the innovator pharmaceutical companies who might grant them voluntary licenses in other jurisdictions, therefore, reducing any incentive a prospective CL-holder might have under Section 92.
C. “Government Use” provisions runs into the same wall
Let’s turn to Section 100. Section 100 is arguably the more direct fit regarding the petition, since it does not require proof of “emergency.” DPIIT had entirely ignored the question posed in the representation made by the deceased petitioner. However, even a favourable finding or an order under Section 100 would not have resolved the problem. Government Use requires the government to manufacture the drug itself or authorise a specific person to do so. Borrowing from the Ayyangar Report, government use contemplates manufacture by governmental organisations and can extend to private bodies manufacturing on behalf of the government under a tender or a contract. However, the problem of manufacturing still seems to be persistent on two fronts. Assuming that a Section 100-positive order was passed, then someone had to manufacture the drug. Even though a private manufacturer still can produce for the government under the government use, as earlier noted, no private manufacturer has shown interest. Coming to the capacity of the government institutions to manufacture the drug, the scenario becomes further bleak.
As per a reply by the Union Minister of State in the Ministry of Chemicals and Fertilizers, Smt. Anupriya Patel, in Lok Sabha, there are five Central Public Sector Enterprises (CPSEs) under the Department of Pharmaceuticals, namely, Indian Drugs and Pharmaceuticals Limited (IDPL), Rajasthan Drugs and Pharmaceuticals Limited (RDPL), Hindustan Antibiotics Limited (HAL), Bengal Chemicals and Pharmaceuticals Limited (BCPL) and Karnataka Antibiotics and Pharmaceutical Limited (KAPL). As per the reply, the government had initiated the closure, strategic sale, or disinvestment of sick CPSEs including IDPL, BCPL, HAL, RDPL, and KAPL, following the prolonged losses and failed revival attempts.
Even though the Indian PSUs lacked the capability to competitively manufacture essential drugs, the focus of government intervention had been entirely on liquidation and balance-sheet cleanup. The reply notes that no schemes have been implemented by the government to modernize, revitalize, or boost the manufacturing competitiveness of these enterprises. Moreover, in the last four financial years, 100% of the government’s ₹397.55 crore expenditure in this sector was directed solely toward the closure of IDPL, leaving the remaining PSUs with zero budgetary support (See here). While operational units like HAL, BCPL, and KAPL initiated basic facility upgrades to meet minimum compliance standards, their primary remedial focus has been clearing debts, for instance, HAL used amnesty schemes to settle over ₹101 crore in statutory and tax liabilities (See here). Thus, the focus has been to prepare for disinvestment rather than scaling drug manufacturing.
So in any case even a successful Section 100 order, like Section 92, would have created a legal entitlement with no identified party able to exercise it — different routes converging on the same practical outcome.
Both routes into a compulsory licence for Ribociclib, then, run into the same wall from different directions: one blocked by an executive unwilling to even engage with the question, the other blocked by an absence of anyone able to act on a favourable answer even if it came. If neither the licence nor the government-use route was ever going to deliver the drug, the natural next question is whether stepping outside the Patents Act altogether does any better. Part II turns to that — Rajasthan’s own attempt to guarantee access to Ribociclib outside the compulsory-licensing framework, and what its limits reveal about the larger picture.
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.
