Mint Explainer | Can the government make life-saving drugs cheaper?

A Kerala high court order opens a legal route for the government to make expensive drugs available to patients on a non-commercial basis.

The Kerala high court on 28 September gave the Centre a legal route to intervene when patented life-saving medicines become unaffordable, holding that the government can invoke Section 100 of the Patents Act, 1970, to use a patented drug for public health purposes.

Mint explains how the ruling could help improve access to expensive remedies.

What was the ruling?

The case began in June 2022, when a breast cancer patient approached the Kerala high court seeking government intervention to make ribociclib, a patented Novartis AG drug costing around ₹75,000 a month, more affordable.

The petitioner died in September 2022. However, the court continued the matter as a suo motu proceeding, treating it as a broader public health issue. It expanded the scope of the case to include Eli Lilly’s abemaciclib, also used to treat breast cancer.

While it did not direct the government to immediately invoke the provision or share a timeline to do so, it asked the Centre to collect data on how many patients need the medicine, how many cannot afford it, and whether existing subsidies and price-control measures are effective.

The caveat remains that high costs alone don’t call for government intervention. Rather, a thorough examination of the drug is required.

The court concluded that palbociclib, another breast cancer drug by Pfizer, which lost exclusivity in 2023 and is cheaper, cannot be used interchangeably with ribociclib.

What is section 100?

Section 100 of the Patents Act allows the Centre to use a patented invention for the “purposes of government”.

The court examined whether this was limited to medicines required for direct government use or could also cover medicines supplied to individual patients for public health purposes. It held that the provision is broad enough to allow the government, or a person authorized by it, to use a patented medicine and supply it to needy patients on a non-commercial basis.

The court linked this power to the government's responsibility to protect public health under Article 47 of the Constitution, as well as to the public health principles set out in Section 83 of the Patents Act.

Currently, the government can allow a third party to make, use or sell a patented invention without the patent holder’s consent through “compulsory licensing” in specified circumstances, including when the invention is not available at a reasonably affordable price. India has granted such a licence only once, in 2012, to Natco Pharma for Nexavar (sorafenib tosylate), a kidney and liver cancer drug patented by Bayer.

The ruling gives the government another legal option to make expensive life-saving drugs accessible, said Sudarshan Singh Shekhawat, advocate, patent attorney and founder of Shekhawat Law.

What do experts say?

Lawyers said the judgment seeks to balance patent protection with public health needs, but may lead to uncertainty and deter pharmaceutical firms from investing in India.

“The judgment is calibrated to preserve patent sanctity, not erode it. The court was explicit that recognizing a government-use route does not compromise the patentee's underlying exclusivity,” said Gitika Suri, director-patents, Cyril Amarchand Mangaldas.

However, Amit Panigrahi, a partner at Kochhar & Co. who handles the intellectual property practice, said the ruling could create regulatory uncertainty. “While the court protected pharmaceutical companies from arbitrary judicial mandates, the legal confirmation that the government can override a patent based solely on pricing data creates a regulatory risk that could make companies more cautious about investing in or launching expensive patented medicines in India,” he said.

How does this impact patients?

India registered over 237,000 new breast cancer cases in 2024, according to data from the World Health Organisation. Ribociclib, abemaciclib and palbociclib are targeted therapies belonging to the CDK4/6 inhibitor class, and are used to treat certain types of breast cancers, but are not interchangeable.

Access to specialized treatments for cancers and rare diseases remains a recurring issue for Indian patients. A 2022 study by the Tata Memorial Centre (TMC) found that fewer than 3% of patients in India had access to immunotherapies.

Patients rights experts believe that this judgement could have far-reaching implications, extending to other life saving drugs. However the absence of a direct ruling or timeline increases uncertainty.

How does this impact companies?

The Indian market typically accounts for a very small share of global pharmaceutical companies' overall revenues. However, the ruling highlights a ‘policy tension’ between innovators and access to life-saving medicines, said Tushar Gulati, associate partner, Dentons Link Legal.

“Pharmaceutical companies invest heavily and for many years in research and development, and predictable patent protection is intended to provide an incentive for that investment,” he said. At the same time, Gulati noted that when a life-saving medicine is priced beyond the reach of a substantial section of patients, patent exclusivity can create an access problem.

About the Authors

Krishna Yadav is a Senior Correspondent at Mint, based in New Delhi, and part of the corporate bureau. He joined the newsroom as a trainee in 2023 and quickly grew into his current role. He writes on legal and regulatory developments in corporate India, with a focus on insolvency, taxation, company law, and policy. His reporting includes tracking and breaking key legal stories from the Supreme Court, Delhi High Court, NCLT, and NCLAT.<br><br>With a background in law, Krishna is known for simplifying complex legal developments into clear, accessible stories for readers. His work focuses on trends in corporate law and policy that affect businesses. This ranges from explaining tax disputes—like whether coconut hair oil is edible—to writing on why celebrities are seeking personal rights protection. He closely tracks India’s insolvency system, covering issues such as creditor losses, gaps in the process, and challenges in how the framework works in practice.<br><br>Krishna also tracks developments within law firms—covering hiring trends, how firms help companies navigate global challenges, and how the legal industry is adapting to artificial intelligence. Beyond legal reporting, he has written long-form pieces, including on-ground coverage of the 2024 general elections, capturing the scale and logistics of polling across India.<br><br>Outside work, he enjoys travelling, exploring new places, and reading about geopolitics and history.

Jessica has been tracking the pharmaceutical, life sciences and healthcare sector for Mint since November 2024. Based in the country's financial capital, she reports on everything to do with health and medicines. This includes corporate action, patent wars, deals, startup activity and consumer trends. She also keeps a keen eye on the ever-evolving world wellness and preventive health, which moves faster than regulation can keep up. She has a deep interest in what the future of health looks like and how science, innovation, policy and company decisions inform and impact the health of citizens. She has been a reporter for five years, working with publications like The Core and News18 prior to this, covering various sectors like automobiles, real estate, energy, sustainability and urban mobility. Jessica has a bachelor’s degree in English from St Xavier’s College, Mumbai and a postgraduate diploma in media from Sophia’s College, Mumbai. Her work is driven by a desire to decode how macro decisions and events alter and shape the lives of ordinary people. Drop her a mail or a message to discuss business scoops, exciting new medicines and inventions, or your latest wellness routine.